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AFib on the rise in end-stage COPD patients hospitalized for exacerbations
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Atrial fibrillation is being seen with increasing frequency in patients admitted to U.S. hospitals for exacerbations of end-stage chronic obstructive pulmonary disease, based on a retrospective analysis of data from the Nationwide Inpatient Sample.
The prevalence of atrial fibrillation (AFib) among patients with end-stage chronic obstructive pulmonary disease (COPD) on home oxygen who were admitted with COPD exacerbations increased from 12.9% in 2003 to 21.3% in 2014, according to Xiaochun Xiao of the department of health statistics at Second Military Medical University in Shanghai and colleagues.
Additionally, “we found that comorbid [AFib] was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation. Moreover, comorbid [AFib] was associated with adverse clinical outcomes, including increased in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke,” the researchers wrote in the study published in the journal CHEST.
Patients included in the study were aged at least 18 years, were diagnosed with end-stage COPD and on home oxygen, and were hospitalized because of a COPD-related exacerbation. Based on 1,345,270 weighted hospital admissions of adults with end-stage COPD on home oxygen who met the inclusion criteria for the study, 18.2% (244,488 admissions) of patients had AFib, and the prevalence of AFib in COPD patients increased over time from 2003 (12.9%) to 2014 (21.3%; P less than .0001).
Patients with AFib, compared with patients without AFib, were older (75.5 years vs. 69.6 years; P less than .0001) and more likely to be male (50.7% vs. 59.1%; P less than .0001) and white (80.9% vs. 74.4%; P less than .0001). Patients with AFib also had higher stroke risk reflected in higher CHA2DS2-VASc scores (3.26 vs. 2.45; P less than .0001), and higher likelihood of in-hospital mortality and readmission reflected in Elixhauser scores greater than or equal to 4 (51.2% vs. 35.6%).
In addition, the prevalence of AFib increased with increasing income. Larger hospitals in terms of bed size, urban environment, and Medicare insurance status also were associated with a higher AFib prevalence.
AFib was associated with an increased cost of $1,415 and an increased length of stay of 0.6 days after adjustment for potential confounders. AFib also predicted risk for several adverse events, including stroke (odds ratio, 1.80; in-hospital death, [OR, 1.54]), invasive mechanical ventilation (OR, 1.37), sepsis (OR, 1.23), noninvasive mechanical ventilation (OR, 1.14), acute kidney injury (OR, 1.09), and acute respiratory failure (OR, 1.09).
The researchers noted the database could have potentially overinflated AFib prevalence, as they could not differentiate index admissions and readmissions. The database also does not contain information about secondary diagnoses codes present on admission, which could make it difficult to identify adverse events that occurred during hospitalization.
“Our findings should prompt further efforts to identify the reasons for increased [AFib] prevalence and provide better management strategies for end-stage COPD patients comorbid with [AFib],” the researchers concluded.
This study was funded by a grant from the Fourth Round of the Shanghai 3-year Action Plan on Public Health Discipline and Talent Program. The authors reported no relevant conflict of interest.
SOURCE: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
FROM CHEST
Key clinical point: Comorbid atrial fibrillation was associated with an increased risk of the need for mechanical ventilation, especially invasive mechanical ventilation, and of adverse outcomes including in-hospital death, acute respiratory failure, acute kidney injury, sepsis, and stroke.
Major finding: The prevalence of atrial fibrillation with end-stage chronic obstructive pulmonary disease increased over time from 2003 (12.9%) to 2014 (21.3%). Study details: A retrospective analysis based on 1,345,270 weighted hospital admissions of adults with end-stage chronic obstructive pulmonary disease on home oxygen from the Nationwide Impatient Sample during 2003-2014.
Disclosures: The study was funded by a grant from the Fourth Round of the Shanghai 3-Year Action Plan on Public Health Discipline and Talent Program. The authors reported no conflicts of interest.
Source: Xiao X et al. CHEST. 2019 Jan 23. doi: 10.1016/j.chest.2018.12.021.
Hormone use linked to hair loss in transgender adults
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Use of hormone therapy had a significant impact on scalp and hair loss in trans men who used masculinizing hormones.
Major finding: Scalp hair loss or hair thinning was reported by 65% of trans women, 43% of trans men, and 35% of nonbinary individuals.
Study details: The data come from a cross-sectional study including 991 adults self-identifying as gender minorities.
Disclosures: The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
Source: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Antiangiogenics linked to fatal bleeds after RT in patients with “ultracentral” lung tumors
In patients with tumors bordering the central airway, use of antiangiogenic agents has been linked to fatal hemorrhage after radiation treatment, according to investigators reporting a large, retrospective case series.
Most hemorrhagic events in these patients with so-called “ultracentral” lung tumors occurred in those who received bevacizumab or pazopanib within 30 days of stereotactic body radiation therapy (SBRT), according to radiation oncologist Abraham J. Wu, MD, and coinvestigators at Memorial Sloan Kettering Cancer Center in New York.
Based on these new data, the combination of antiangiogenic agents (AAAs) and SBRT should be avoided in patients with ultracentral lung tumors, the researchers wrote.
“Although this report is limited by its retrospective nature, these findings strongly suggest that AAAs potentiate severe SBRT-related toxic effects,” Dr. Wu and coinvestigators wrote in a report on the study in JAMA Oncology. While AAAs are not indicated for treatment of patients with early-stage lung cancer, they may be used to treat oligometastatic disease, which may also be treated with SBRT.
The study included 88 patients with a median age of 74 years who had a lung tumor abutting the proximal bronchial tree, a planned target volume overlapping the esophagus, or both. There were lung metastases in 35 patients.
Nine patients had received bevacizumab, pazopanib, or ramucirumab, stopping a median of 30 days prior to SBRT and resuming a median of 29 days after the end of the radiation treatment.
There were six fatal pulmonary hemorrhages in 19.6 months of follow-up, Dr. Wu and coinvestigators reported. Of those six patients, four had received an antiangiogenic agent (three bevacizumab, one pazopanib) within 30 days of SBRT.
The probability of fatal pulmonary hemorrhage was significantly higher in the patients receiving AAAs versus those who did not (hazard ratio, 16.9; 95% confidence interval, 3.2-88.8; P less than .001).
Another six patients received AAAs more than 90 days before or after SBRT, and none of them had fatal hemorrhages.
A high rate of fatal hemorrhage was reported in another recent study of patients with ultracentral lung tumors, but that study did not identify any risk factors related to this toxic effect, Dr. Wu and coauthors wrote.
The research was partly supported by the National Institutes of Health, the China Scholarship Council, and the Joanne & John Dallepezze Foundation. The investigators reported disclosures related to AstraZeneca, CivaTech Oncology, Alpha Tau Medical, Varian Medical Systems, Boehringer Ingelheim, Pfizer, Merck, and Elekta.
SOURCE: Wu AJ et al. JAMA Oncol. 2019 Apr 4. doi: 10.1001/jamaoncol.2019.0205.
In patients with tumors bordering the central airway, use of antiangiogenic agents has been linked to fatal hemorrhage after radiation treatment, according to investigators reporting a large, retrospective case series.
Most hemorrhagic events in these patients with so-called “ultracentral” lung tumors occurred in those who received bevacizumab or pazopanib within 30 days of stereotactic body radiation therapy (SBRT), according to radiation oncologist Abraham J. Wu, MD, and coinvestigators at Memorial Sloan Kettering Cancer Center in New York.
Based on these new data, the combination of antiangiogenic agents (AAAs) and SBRT should be avoided in patients with ultracentral lung tumors, the researchers wrote.
“Although this report is limited by its retrospective nature, these findings strongly suggest that AAAs potentiate severe SBRT-related toxic effects,” Dr. Wu and coinvestigators wrote in a report on the study in JAMA Oncology. While AAAs are not indicated for treatment of patients with early-stage lung cancer, they may be used to treat oligometastatic disease, which may also be treated with SBRT.
The study included 88 patients with a median age of 74 years who had a lung tumor abutting the proximal bronchial tree, a planned target volume overlapping the esophagus, or both. There were lung metastases in 35 patients.
Nine patients had received bevacizumab, pazopanib, or ramucirumab, stopping a median of 30 days prior to SBRT and resuming a median of 29 days after the end of the radiation treatment.
There were six fatal pulmonary hemorrhages in 19.6 months of follow-up, Dr. Wu and coinvestigators reported. Of those six patients, four had received an antiangiogenic agent (three bevacizumab, one pazopanib) within 30 days of SBRT.
The probability of fatal pulmonary hemorrhage was significantly higher in the patients receiving AAAs versus those who did not (hazard ratio, 16.9; 95% confidence interval, 3.2-88.8; P less than .001).
Another six patients received AAAs more than 90 days before or after SBRT, and none of them had fatal hemorrhages.
A high rate of fatal hemorrhage was reported in another recent study of patients with ultracentral lung tumors, but that study did not identify any risk factors related to this toxic effect, Dr. Wu and coauthors wrote.
The research was partly supported by the National Institutes of Health, the China Scholarship Council, and the Joanne & John Dallepezze Foundation. The investigators reported disclosures related to AstraZeneca, CivaTech Oncology, Alpha Tau Medical, Varian Medical Systems, Boehringer Ingelheim, Pfizer, Merck, and Elekta.
SOURCE: Wu AJ et al. JAMA Oncol. 2019 Apr 4. doi: 10.1001/jamaoncol.2019.0205.
In patients with tumors bordering the central airway, use of antiangiogenic agents has been linked to fatal hemorrhage after radiation treatment, according to investigators reporting a large, retrospective case series.
Most hemorrhagic events in these patients with so-called “ultracentral” lung tumors occurred in those who received bevacizumab or pazopanib within 30 days of stereotactic body radiation therapy (SBRT), according to radiation oncologist Abraham J. Wu, MD, and coinvestigators at Memorial Sloan Kettering Cancer Center in New York.
Based on these new data, the combination of antiangiogenic agents (AAAs) and SBRT should be avoided in patients with ultracentral lung tumors, the researchers wrote.
“Although this report is limited by its retrospective nature, these findings strongly suggest that AAAs potentiate severe SBRT-related toxic effects,” Dr. Wu and coinvestigators wrote in a report on the study in JAMA Oncology. While AAAs are not indicated for treatment of patients with early-stage lung cancer, they may be used to treat oligometastatic disease, which may also be treated with SBRT.
The study included 88 patients with a median age of 74 years who had a lung tumor abutting the proximal bronchial tree, a planned target volume overlapping the esophagus, or both. There were lung metastases in 35 patients.
Nine patients had received bevacizumab, pazopanib, or ramucirumab, stopping a median of 30 days prior to SBRT and resuming a median of 29 days after the end of the radiation treatment.
There were six fatal pulmonary hemorrhages in 19.6 months of follow-up, Dr. Wu and coinvestigators reported. Of those six patients, four had received an antiangiogenic agent (three bevacizumab, one pazopanib) within 30 days of SBRT.
The probability of fatal pulmonary hemorrhage was significantly higher in the patients receiving AAAs versus those who did not (hazard ratio, 16.9; 95% confidence interval, 3.2-88.8; P less than .001).
Another six patients received AAAs more than 90 days before or after SBRT, and none of them had fatal hemorrhages.
A high rate of fatal hemorrhage was reported in another recent study of patients with ultracentral lung tumors, but that study did not identify any risk factors related to this toxic effect, Dr. Wu and coauthors wrote.
The research was partly supported by the National Institutes of Health, the China Scholarship Council, and the Joanne & John Dallepezze Foundation. The investigators reported disclosures related to AstraZeneca, CivaTech Oncology, Alpha Tau Medical, Varian Medical Systems, Boehringer Ingelheim, Pfizer, Merck, and Elekta.
SOURCE: Wu AJ et al. JAMA Oncol. 2019 Apr 4. doi: 10.1001/jamaoncol.2019.0205.
FROM JAMA ONCOLOGY
Key clinical point: In patients with tumors bordering the central airway, use of antiangiogenic agents has been linked to fatal hemorrhage after stereotactic body radiation therapy.
Major finding: There were six fatal pulmonary hemorrhages, of which four occurred in patients receiving bevacizumab or pazopanib within 30 days of stereotactic body radiation therapy.
Study details: A retrospective case series including 88 patients with lung tumors abutting the proximal bronchial tree or a planned target volume overlapping the esophagus.
Disclosures: Partial support came from the National Institutes of Health, the China Scholarship Council, and the Joanne & John Dallepezze Foundation. The investigators reported disclosures related to AstraZeneca, CivaTech Oncology, Alpha Tau Medical, Varian Medical Systems, Boehringer Ingelheim, Pfizer, Merck, and Elekta.
Source: Wu AJ et al. JAMA Oncol. 2019 Apr 4. doi: 10.1001/jamaoncol.2019.0205.
Skip metastasis rate low in node-negative oral cancers
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
Although this meta-analysis shows that the risk of level IV involvement is less than 5% in patients with clinically node-negative (cN0) oral cavity cancers, going beyond standard supraomohyoid neck dissection (SOHND) may still be warranted for specific patients.
While the authors conclude that elective treatment of level IV is not required in patients with cN0 oral cavity cancer, there are two situations in which clinicians should consider adding level IV to standard SOHND.
The first is when a patient has gross macroscopic disease in upper levels, particularly level III. Most studies in the meta-analysis had insufficient data to determine whether involvement of upper levels increased risk of level IV involvement. When encountering gross disease during an elective neck dissection, some researchers have recommended including level IV and V.
The second scenario is when a posterolateral oral tongue cancer is near or at the tongue base, since oropharyngeal cancers are known to drain to levels II-IV.
The decision to make exceptions in these two situations should be based on the combination of clinical judgment and evidence-based medicine in certain situations. That said, for most patients with cNO oral cavity cancer, SOHND is enough.
Arun Sharma, MD, MS , is with the division of otolaryngology–head and neck surgery at Southern Illinois University, Springfield. He had no conflict of interest related to his editorial, which appears in JAMA Otolaryngology–Head & Neck Surgery .
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
In patients with clinically node-negative oral cavity cancers, the rate of skip metastasis to neck level IV is extremely low, according to authors of a recent meta-analysis.
The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5% in the analysis, which comprised 11 retrospective studies and 2 randomized clinical trials including a total of 1,359 patients with clinically node-negative oral cavity squamous cell carcinomas.
Encountering a suspected positive lymph node during neck dissection does not appear to be an indicator of high rates of level IV involvement, according to Anton Warshavsky, MD, and colleagues in the department of otolaryngology–head and neck surgery and maxillofacial surgery at Tel Aviv Sourasky Medical Center, Israel.
“Supraomohyoid neck dissection [SOHND] is adequate for this subset of patients,” Dr. Warshavsky and coauthors wrote in a report on the study that appears in JAMA Otolaryngology–Head & Neck Surgery.
SOHND, a type of selective neck dissection, refers to removal of lymph nodes in levels I-III. This approach is now frequently used in managing clinically node-negative oral cavity squamous cell carcinoma and provides control rates similar to those associated with more extensive neck dissections, Dr. Warshavsky and colleagues wrote.
However, concern regarding the risk of skip metastases, or involvement of neck level IV without involvement of lower levels, has stirred controversy. SOHND might not be adequate in these patients because of the possibility of occult metastasis to neck level IV.
Accordingly, Dr. Warshavsky and colleagues combed the available medical literature to find relevant articles for a meta-analysis to better characterize the rate of skip metastasis to level IV in patients who had undergone neck dissection.
Level IV involvement rates in clinically node-negative patients ranged from 0% to 11.4% in the 13 included studies. Based on fixed-effects modeling, the rate of involvement was 2.53% (95% CI, 1.64-3.55%), according to the published report.
The rate of skip metastasis was “extremely low,” wrote Dr. Warshavsky and coauthors. Rates ranged from 0% to 5.50%, with a fixed-effects model of 0.50% (95% CI, 0.09%-1.11%).
Cases involving higher levels of the neck did not impact the rate of level IV metastasis, results of a subgroup analysis found. Likewise, an analysis based on T stage showed that rates of level 4 involvement were comparable and low for T stages I-II and III-IV.
These findings are limited, however, not only by the retrospective nature of this study, but also by the fact that many studies reported limited data, hampering the investigators’ ability to run statistics and perform subgroup analyses.
“Unfortunately, data in almost all of the analyzed articles failed to report the relations between the primary tumor site and the neck levels involved by metastatic tumor,” they wrote. “Only primary lesions of the tongue could be accurately assessed.”
Dr. Warshavsky and coauthors reported no conflicts of interest related to the research.
SOURCE: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
FROM JAMA OTOLARYNGOLOGY–HEAD & NECK SURGERY
Key clinical point: In patients with clinically node-negative oral cavity cancers, rates of skip metastasis to neck level IV are extremely low, meaning that supraomohyoid neck dissection is likely sufficient for most cases.
Major finding: The rate of level IV involvement was about 2.5%, and the rate of skip metastasis was 0.5%.
Study details: A meta-analysis of 11 retrospective studies and 2 randomized clinical trials, including a total of 1,359 patients who had undergone neck dissection.
Disclosures: The study authors reported no conflicts of interest.
Source: Warshavsky A et al. JAMA Otolaryngol Head Neck Surg. 2019 May 9. doi: 10.1001/jamaoto.2019.0784.
Smoking rates remain steady among the poor
While an increasing number of U.S. citizens are saying no to cigarettes, a recent study shows.
The odds of current smoking, versus never smoking, declined significantly during 2008-2017 for individuals with none of six disadvantages tied to cigarette use, including disability, unemployment, poverty, low education, psychological distress, and heavy alcohol intake, according to researchers.
Individuals with one or two of those disadvantages have also been cutting back, the data suggest. But, by contrast, odds of current versus never smoking did not significantly change for those with three or more disadvantages, according to Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and coinvestigators.
“How this pattern can inform a cohesive policy agenda is unknown, but it is clear from these findings that the crux of the recently expanding tobacco-related health disparity problem in the United States is not tied to groups facing merely a single form of disadvantage,” Dr. Leventhal and coauthors wrote in a report on the study in JAMA Internal Medicine.
The cross-sectional analysis by Dr. Leventhal and colleagues was based on National Health Interview Survey (NHIS) data from 2008-2017 including more than 278,000 respondents aged 25 years or older.
A snapshot of that 10-year period showed that current smoking prevalence was successively higher depending on the number of socioeconomic or health-related disadvantages.
The mean prevalence of current smoking over that entire time period was just 13.8% for people with zero of the six disadvantages, 21.4% for those with one disadvantage, and so on, up to 58.2% for those with all six disadvantages, according to data in the published report.
Encouragingly, overall smoking prevalence fell from 20.8% in 2008-2009 to 15.8% in 2016-2017, the researchers found. However, the decreasing trend was not apparent for individuals with many disadvantages.
The odds ratio for change in odds of smoking per year was 0.951 (95% confidence interval, 0.944-0.958) for those with zero disadvantages, 0.96 (95% CI, 0.95-0.97) for one disadvantage, and 0.98 (95% CI, 0.97-0.99) for two, all representing significant annual reductions in current versus never smoking, investigators said. By contrast, no such significant changes were apparent for those with three, four, five, or six such disadvantages.
Tobacco control or regulatory policies that consider these disadvantages separately may be overlooking a “broader pattern” showing that the cumulative number of disadvantages correlates with the magnitude of disparity, wrote Dr. Leventhal and colleagues in their report.
“Successful prevention of smoking initiation and promotion of smoking cessation in multi-disadvantaged populations would substantially reduce the smoking-related public health burden in the United States,” they concluded.
Dr. Leventhal and colleagues reported no conflicts related to their research, which was supported in part by a Tobacco Centers of Regulatory Science award from the National Cancer Institute and the Food and Drug Administration, among other sources.
SOURCE: Leventhal AM et al. JAMA Intern Med. 2019 Apr 22. doi: 10.1001/jamainternmed.2019.0192.
While an increasing number of U.S. citizens are saying no to cigarettes, a recent study shows.
The odds of current smoking, versus never smoking, declined significantly during 2008-2017 for individuals with none of six disadvantages tied to cigarette use, including disability, unemployment, poverty, low education, psychological distress, and heavy alcohol intake, according to researchers.
Individuals with one or two of those disadvantages have also been cutting back, the data suggest. But, by contrast, odds of current versus never smoking did not significantly change for those with three or more disadvantages, according to Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and coinvestigators.
“How this pattern can inform a cohesive policy agenda is unknown, but it is clear from these findings that the crux of the recently expanding tobacco-related health disparity problem in the United States is not tied to groups facing merely a single form of disadvantage,” Dr. Leventhal and coauthors wrote in a report on the study in JAMA Internal Medicine.
The cross-sectional analysis by Dr. Leventhal and colleagues was based on National Health Interview Survey (NHIS) data from 2008-2017 including more than 278,000 respondents aged 25 years or older.
A snapshot of that 10-year period showed that current smoking prevalence was successively higher depending on the number of socioeconomic or health-related disadvantages.
The mean prevalence of current smoking over that entire time period was just 13.8% for people with zero of the six disadvantages, 21.4% for those with one disadvantage, and so on, up to 58.2% for those with all six disadvantages, according to data in the published report.
Encouragingly, overall smoking prevalence fell from 20.8% in 2008-2009 to 15.8% in 2016-2017, the researchers found. However, the decreasing trend was not apparent for individuals with many disadvantages.
The odds ratio for change in odds of smoking per year was 0.951 (95% confidence interval, 0.944-0.958) for those with zero disadvantages, 0.96 (95% CI, 0.95-0.97) for one disadvantage, and 0.98 (95% CI, 0.97-0.99) for two, all representing significant annual reductions in current versus never smoking, investigators said. By contrast, no such significant changes were apparent for those with three, four, five, or six such disadvantages.
Tobacco control or regulatory policies that consider these disadvantages separately may be overlooking a “broader pattern” showing that the cumulative number of disadvantages correlates with the magnitude of disparity, wrote Dr. Leventhal and colleagues in their report.
“Successful prevention of smoking initiation and promotion of smoking cessation in multi-disadvantaged populations would substantially reduce the smoking-related public health burden in the United States,” they concluded.
Dr. Leventhal and colleagues reported no conflicts related to their research, which was supported in part by a Tobacco Centers of Regulatory Science award from the National Cancer Institute and the Food and Drug Administration, among other sources.
SOURCE: Leventhal AM et al. JAMA Intern Med. 2019 Apr 22. doi: 10.1001/jamainternmed.2019.0192.
While an increasing number of U.S. citizens are saying no to cigarettes, a recent study shows.
The odds of current smoking, versus never smoking, declined significantly during 2008-2017 for individuals with none of six disadvantages tied to cigarette use, including disability, unemployment, poverty, low education, psychological distress, and heavy alcohol intake, according to researchers.
Individuals with one or two of those disadvantages have also been cutting back, the data suggest. But, by contrast, odds of current versus never smoking did not significantly change for those with three or more disadvantages, according to Adam M. Leventhal, PhD, of the University of Southern California, Los Angeles, and coinvestigators.
“How this pattern can inform a cohesive policy agenda is unknown, but it is clear from these findings that the crux of the recently expanding tobacco-related health disparity problem in the United States is not tied to groups facing merely a single form of disadvantage,” Dr. Leventhal and coauthors wrote in a report on the study in JAMA Internal Medicine.
The cross-sectional analysis by Dr. Leventhal and colleagues was based on National Health Interview Survey (NHIS) data from 2008-2017 including more than 278,000 respondents aged 25 years or older.
A snapshot of that 10-year period showed that current smoking prevalence was successively higher depending on the number of socioeconomic or health-related disadvantages.
The mean prevalence of current smoking over that entire time period was just 13.8% for people with zero of the six disadvantages, 21.4% for those with one disadvantage, and so on, up to 58.2% for those with all six disadvantages, according to data in the published report.
Encouragingly, overall smoking prevalence fell from 20.8% in 2008-2009 to 15.8% in 2016-2017, the researchers found. However, the decreasing trend was not apparent for individuals with many disadvantages.
The odds ratio for change in odds of smoking per year was 0.951 (95% confidence interval, 0.944-0.958) for those with zero disadvantages, 0.96 (95% CI, 0.95-0.97) for one disadvantage, and 0.98 (95% CI, 0.97-0.99) for two, all representing significant annual reductions in current versus never smoking, investigators said. By contrast, no such significant changes were apparent for those with three, four, five, or six such disadvantages.
Tobacco control or regulatory policies that consider these disadvantages separately may be overlooking a “broader pattern” showing that the cumulative number of disadvantages correlates with the magnitude of disparity, wrote Dr. Leventhal and colleagues in their report.
“Successful prevention of smoking initiation and promotion of smoking cessation in multi-disadvantaged populations would substantially reduce the smoking-related public health burden in the United States,” they concluded.
Dr. Leventhal and colleagues reported no conflicts related to their research, which was supported in part by a Tobacco Centers of Regulatory Science award from the National Cancer Institute and the Food and Drug Administration, among other sources.
SOURCE: Leventhal AM et al. JAMA Intern Med. 2019 Apr 22. doi: 10.1001/jamainternmed.2019.0192.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Current U.S. smoking rates have not declined among individuals with multiple socioeconomic or health-related disadvantages.
Major finding: The odds ratio for change in odds of smoking per year was 0.951 for individuals with zero disadvantages, 0.96 for one disadvantage, and 0.97-0.99 for two, with no significant annual reductions in those with three or more disadvantages.
Study details: Cross-sectional analysis of 278,048 respondents aged 25 years or older in the National Health Interview Survey during 2008-2017.
Disclosures: Authors reported no conflicts of interest related to the study, which was supported in part by a Tobacco Centers of Regulatory Science award from the National Cancer Institute and the Food and Drug Administration, among other sources.
Source: Leventhal AM et al. JAMA Intern Med. 2019 Apr 22. doi: 10.1001/jamainternmed.2019.0192.
Medicare withdraws plans to exclude drugs from Part D protected classes
Proposals that would have allowed Medicare Part D prescription drug plan sponsors to exclude certain drugs in the six protected classes have been withdrawn by the Centers for Medicare & Medicaid Services.
In a final rule that targets drug pricing in Medicare Advantage and Part D – released online May 16 and scheduled for publication in the Federal Register on May 23 – CMS did not finalize a proposal that would have allowed a plan sponsor to exclude a drug in a protected class from a formulary, if the price of that drug increased faster than the rate of inflation.
“In considering whether to propose these exceptions, CMS took our other enrollee access protections into account, which have successfully protected beneficiary access to needed medications in the more than 12 years the Part D program has been operational,” the agency stated in the final rule.
Agency officials cited rules on formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the expedited coverage determination and appeals process as policies that have protected beneficiary access.
Agency officials said that they believe the current enrollee access protections are “sufficient,” and they are not finalizing the pricing threshold exception.
The agency also chose not to finalize a plan’s ability to exclude a drug in a protected class if the drug represents a new formulation of an existing single-source product, regardless of whether the older formulation remains on the market.
Part D plan sponsors are required by law to cover “all or substantially all” drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for the treatment of transplant rejection, antiretrovirals, and antineoplastics.
CMS chose not to finalize this proposal because it was persuaded by comments noting that under the proposed policy, “in a scenario where our other formulary requirements did not require Part D sponsors to have the new formulation on their formulary, a Part D enrollee who is stable on the old formulation could be left without access to the new formulation,” the agency stated in the final rule. “Consequently, we decline to finalize this exception.”
The final rule codifies in regulation a plan’s ability to impose prior authorization and step therapy for beneficiaries initiating therapy in five of the six classes, as has been the policy since 2006 (antiretrovirals are excluded from prior authorization and step therapy).
CMS also finalized a policy implemented in 2019 that allows Medicare Advantage plans to implement step therapy for drugs administered in the physician office under Medicare Part B. Similar to step therapy in Medicare Part D, this applies only to beneficiaries newly starting on treatment and includes an appeals process similar to Part D.
Another proposal finalized is one that prohibits so-called “gag clauses” in Part D contracts, which prevent or penalize pharmacists from discussing lower-cost pharmaceutical options with customers.
CMS also will be requiring Part D plans to adopt tools no later than Jan. 1, 2021, that integrate with a prescriber’s electronic health record or e-prescribing software to inform providers when lower-cost pharmaceutical options are available under a patient’s drug benefit. Similarly, the Part D explanation of benefits statement, effective the same date, will be required to inform beneficiaries of drug price increases and lower-cost alternatives.
Proposals that would have allowed Medicare Part D prescription drug plan sponsors to exclude certain drugs in the six protected classes have been withdrawn by the Centers for Medicare & Medicaid Services.
In a final rule that targets drug pricing in Medicare Advantage and Part D – released online May 16 and scheduled for publication in the Federal Register on May 23 – CMS did not finalize a proposal that would have allowed a plan sponsor to exclude a drug in a protected class from a formulary, if the price of that drug increased faster than the rate of inflation.
“In considering whether to propose these exceptions, CMS took our other enrollee access protections into account, which have successfully protected beneficiary access to needed medications in the more than 12 years the Part D program has been operational,” the agency stated in the final rule.
Agency officials cited rules on formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the expedited coverage determination and appeals process as policies that have protected beneficiary access.
Agency officials said that they believe the current enrollee access protections are “sufficient,” and they are not finalizing the pricing threshold exception.
The agency also chose not to finalize a plan’s ability to exclude a drug in a protected class if the drug represents a new formulation of an existing single-source product, regardless of whether the older formulation remains on the market.
Part D plan sponsors are required by law to cover “all or substantially all” drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for the treatment of transplant rejection, antiretrovirals, and antineoplastics.
CMS chose not to finalize this proposal because it was persuaded by comments noting that under the proposed policy, “in a scenario where our other formulary requirements did not require Part D sponsors to have the new formulation on their formulary, a Part D enrollee who is stable on the old formulation could be left without access to the new formulation,” the agency stated in the final rule. “Consequently, we decline to finalize this exception.”
The final rule codifies in regulation a plan’s ability to impose prior authorization and step therapy for beneficiaries initiating therapy in five of the six classes, as has been the policy since 2006 (antiretrovirals are excluded from prior authorization and step therapy).
CMS also finalized a policy implemented in 2019 that allows Medicare Advantage plans to implement step therapy for drugs administered in the physician office under Medicare Part B. Similar to step therapy in Medicare Part D, this applies only to beneficiaries newly starting on treatment and includes an appeals process similar to Part D.
Another proposal finalized is one that prohibits so-called “gag clauses” in Part D contracts, which prevent or penalize pharmacists from discussing lower-cost pharmaceutical options with customers.
CMS also will be requiring Part D plans to adopt tools no later than Jan. 1, 2021, that integrate with a prescriber’s electronic health record or e-prescribing software to inform providers when lower-cost pharmaceutical options are available under a patient’s drug benefit. Similarly, the Part D explanation of benefits statement, effective the same date, will be required to inform beneficiaries of drug price increases and lower-cost alternatives.
Proposals that would have allowed Medicare Part D prescription drug plan sponsors to exclude certain drugs in the six protected classes have been withdrawn by the Centers for Medicare & Medicaid Services.
In a final rule that targets drug pricing in Medicare Advantage and Part D – released online May 16 and scheduled for publication in the Federal Register on May 23 – CMS did not finalize a proposal that would have allowed a plan sponsor to exclude a drug in a protected class from a formulary, if the price of that drug increased faster than the rate of inflation.
“In considering whether to propose these exceptions, CMS took our other enrollee access protections into account, which have successfully protected beneficiary access to needed medications in the more than 12 years the Part D program has been operational,” the agency stated in the final rule.
Agency officials cited rules on formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the expedited coverage determination and appeals process as policies that have protected beneficiary access.
Agency officials said that they believe the current enrollee access protections are “sufficient,” and they are not finalizing the pricing threshold exception.
The agency also chose not to finalize a plan’s ability to exclude a drug in a protected class if the drug represents a new formulation of an existing single-source product, regardless of whether the older formulation remains on the market.
Part D plan sponsors are required by law to cover “all or substantially all” drugs in six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for the treatment of transplant rejection, antiretrovirals, and antineoplastics.
CMS chose not to finalize this proposal because it was persuaded by comments noting that under the proposed policy, “in a scenario where our other formulary requirements did not require Part D sponsors to have the new formulation on their formulary, a Part D enrollee who is stable on the old formulation could be left without access to the new formulation,” the agency stated in the final rule. “Consequently, we decline to finalize this exception.”
The final rule codifies in regulation a plan’s ability to impose prior authorization and step therapy for beneficiaries initiating therapy in five of the six classes, as has been the policy since 2006 (antiretrovirals are excluded from prior authorization and step therapy).
CMS also finalized a policy implemented in 2019 that allows Medicare Advantage plans to implement step therapy for drugs administered in the physician office under Medicare Part B. Similar to step therapy in Medicare Part D, this applies only to beneficiaries newly starting on treatment and includes an appeals process similar to Part D.
Another proposal finalized is one that prohibits so-called “gag clauses” in Part D contracts, which prevent or penalize pharmacists from discussing lower-cost pharmaceutical options with customers.
CMS also will be requiring Part D plans to adopt tools no later than Jan. 1, 2021, that integrate with a prescriber’s electronic health record or e-prescribing software to inform providers when lower-cost pharmaceutical options are available under a patient’s drug benefit. Similarly, the Part D explanation of benefits statement, effective the same date, will be required to inform beneficiaries of drug price increases and lower-cost alternatives.
Key clinical point: A proposal that would have allowed for drugs to be excluded from Medicare Part D protected classes was not finalized by the Centers for Medicare & Medicaid Services.
Major finding: Agency officials wrote that there are “sufficient” enrollee access protections in place, and they were not finalizing the proposal.
Study details: The proposal would have allowed a plan sponsor to exclude a drug in a protected class from a formulary, if the price of that drug increased faster than the rate of inflation.
Disclosures: CMS makes no disclosures in issuing the final rule.
Source: CMS final rule.
Vitamin D levels linked to depression in teens
BALTIMORE – Anna-Lisa Munson, MD, MPH, of Denver Health Medical Center in Colorado, told attendees at the Pediatric Academic Societies annual meeting.
Although several studies in adults have suggested a link between vitamin D deficiency and depression, no large-scale studies have investigated whether such a relationship exists in adolescents, up to half of whom have a vitamin D deficiency, Dr Munson said.
The researchers relied on National Health and Nutrition Examination Survey (NHANES) data from 2005 to 2010 to assess prevalence of major depressive disorder and vitamin D 25-hydroxy levels in teens aged 12-17 years. Serum vitamin D levels of less than 30 nmol/L were considered deficient while 30-50 nmol/L was considered insufficient, and at least 50 nmol/L was sufficient. A score between 10 and 27 on the Patient Health Questionnaire-9 (PHQ-9) qualified as depression.
The researchers adjusted their findings for age and sex, as well as other covariates linked to vitamin D levels or depression in previous research: latitude, season, race/ethnicity, and poverty to income ratio.
Among the 2,815 participants who completed the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC), 8% had major depression. Among the 2,420 of participants with serum vitamin D values, 8% had vitamin D deficiency, 33% had insufficiency, and 59% had sufficiency.
Risk of depression dropped 10% for every additional 10 nmol/L of vitamin D, the analysis showed (odds ratio, 0.90).
Although non-Hispanic white students had about twice the odds of depression as other ethnic groups, risk of depression did not vary according to gender, age, season, latitude, poverty to income ratio, or use of vitamin D supplements.
The findings are limited by the cross-sectional data and lack of data regarding other factors that could affect vitamin D absorption, such as sunscreen use or clothing worn in the sun. The researchers also had only broad – not precise – data on latitude, and the PHQ-9 was used as a proxy for major depression instead of a clinical diagnosis.
The research was funded by the Denver Health Division of General Pediatrics. The authors had no relevant financial disclosures.
BALTIMORE – Anna-Lisa Munson, MD, MPH, of Denver Health Medical Center in Colorado, told attendees at the Pediatric Academic Societies annual meeting.
Although several studies in adults have suggested a link between vitamin D deficiency and depression, no large-scale studies have investigated whether such a relationship exists in adolescents, up to half of whom have a vitamin D deficiency, Dr Munson said.
The researchers relied on National Health and Nutrition Examination Survey (NHANES) data from 2005 to 2010 to assess prevalence of major depressive disorder and vitamin D 25-hydroxy levels in teens aged 12-17 years. Serum vitamin D levels of less than 30 nmol/L were considered deficient while 30-50 nmol/L was considered insufficient, and at least 50 nmol/L was sufficient. A score between 10 and 27 on the Patient Health Questionnaire-9 (PHQ-9) qualified as depression.
The researchers adjusted their findings for age and sex, as well as other covariates linked to vitamin D levels or depression in previous research: latitude, season, race/ethnicity, and poverty to income ratio.
Among the 2,815 participants who completed the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC), 8% had major depression. Among the 2,420 of participants with serum vitamin D values, 8% had vitamin D deficiency, 33% had insufficiency, and 59% had sufficiency.
Risk of depression dropped 10% for every additional 10 nmol/L of vitamin D, the analysis showed (odds ratio, 0.90).
Although non-Hispanic white students had about twice the odds of depression as other ethnic groups, risk of depression did not vary according to gender, age, season, latitude, poverty to income ratio, or use of vitamin D supplements.
The findings are limited by the cross-sectional data and lack of data regarding other factors that could affect vitamin D absorption, such as sunscreen use or clothing worn in the sun. The researchers also had only broad – not precise – data on latitude, and the PHQ-9 was used as a proxy for major depression instead of a clinical diagnosis.
The research was funded by the Denver Health Division of General Pediatrics. The authors had no relevant financial disclosures.
BALTIMORE – Anna-Lisa Munson, MD, MPH, of Denver Health Medical Center in Colorado, told attendees at the Pediatric Academic Societies annual meeting.
Although several studies in adults have suggested a link between vitamin D deficiency and depression, no large-scale studies have investigated whether such a relationship exists in adolescents, up to half of whom have a vitamin D deficiency, Dr Munson said.
The researchers relied on National Health and Nutrition Examination Survey (NHANES) data from 2005 to 2010 to assess prevalence of major depressive disorder and vitamin D 25-hydroxy levels in teens aged 12-17 years. Serum vitamin D levels of less than 30 nmol/L were considered deficient while 30-50 nmol/L was considered insufficient, and at least 50 nmol/L was sufficient. A score between 10 and 27 on the Patient Health Questionnaire-9 (PHQ-9) qualified as depression.
The researchers adjusted their findings for age and sex, as well as other covariates linked to vitamin D levels or depression in previous research: latitude, season, race/ethnicity, and poverty to income ratio.
Among the 2,815 participants who completed the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC), 8% had major depression. Among the 2,420 of participants with serum vitamin D values, 8% had vitamin D deficiency, 33% had insufficiency, and 59% had sufficiency.
Risk of depression dropped 10% for every additional 10 nmol/L of vitamin D, the analysis showed (odds ratio, 0.90).
Although non-Hispanic white students had about twice the odds of depression as other ethnic groups, risk of depression did not vary according to gender, age, season, latitude, poverty to income ratio, or use of vitamin D supplements.
The findings are limited by the cross-sectional data and lack of data regarding other factors that could affect vitamin D absorption, such as sunscreen use or clothing worn in the sun. The researchers also had only broad – not precise – data on latitude, and the PHQ-9 was used as a proxy for major depression instead of a clinical diagnosis.
The research was funded by the Denver Health Division of General Pediatrics. The authors had no relevant financial disclosures.
REPORTING FROM PAS 2019
A primer on cannabis for cosmeceuticals: Research and treatments for particular skin conditions
The relatively recent discovery of the endogenous cannabinoid system and the quickly evolving, yet still convoluted, legal status of cannabis in the United States has spurred excitement over expanded research opportunities. Despite its checkered legal history, marijuana – derived from Cannabis sativa and Cannabis indica – has long been used for medical purposes and is one of the most widely used drugs throughout the world.1 Modern medicine has deployed this dynamic plant to treat chronic pain, glaucoma, and nausea, and continues to investigate its application in a broad array of conditions: anorexia, spasticity, atherosclerosis, autoimmune disorders, inflammatory bowel disease, multiple sclerosis, spasticity, tumorigenesis, and multiple cutaneous disorders, including acne, eczematous disorders, lichen simplex, melanoma and nonmelanoma skin cancer, melasma, prurigo, pruritus, psoriasis, scleroderma and systemic sclerosis, and seborrheic dermatitis.1-4 This .
Acne
Oláh et al. have demonstrated that the nonpsychotropic phytocannabinoid ((-)-cannabidiol [CBD]) imparts anti-acne benefits by diminishing sebaceous lipid synthesis, decreasing proliferation, and easing inflammation in human SZ95 sebocytes.5 In additional investigations of nonpsychotropic phytocannabinoids and their effects on human sebocyte function, they reported in 2016 that the phytocannabinoids (-)-cannabigerol [CBG] and (-)-cannabigerovarin (CBGV) appear to exhibit promise in treating xerotic and seborrheic skin, and ((-)-cannabichromene [CBC], (-)-cannabidivarin [CBDV], and (-)-delta9-tetrahydrocannabivarin [THCV], in particular, display notable potential as anti-acne ingredients. The investigators added that these compounds, due to their substantial anti-inflammatory effects, warrant consideration for use in treating skin inflammation.5 Previously, Ali and Akhtar conducted a single-blinded, 12-week comparative study in healthy male volunteers to evaluate the effects of twice-daily application of 3% cannabis seed extract cream on human cheek skin. The researchers found the base with 3% cannabis seed extract to be safe and effective, with skin sebum and erythema content on the treated side reduced significantly compared with the side treated only with the control base. They concluded that this well-tolerated formulation could be indicated for the treatment of acne and seborrhea to enhance facial appearance.6
Psoriasis
The endocannabinoid system itself is thought to play a potentially important role in the treatment of psoriasis, as interactions between the immune and nervous systems via cholinergic anti-inflammatory pathways are considered to be key in psoriasis etiology and the endocannabinoid system interacts with both systems through the cannabinoid (CB) receptors CB1 and CB2.7 Compared with normal human skin, psoriatic skin is characterized by fewer CB receptors.8
In 2007, Wilkinson and Williamson used a keratinocyte proliferation assay to study the phytocannabinoids delta9-tetrahydrocannabinol (THC), CBD, CBG, and cannabinol (CNB) to assess their capacity to halt the growth of a hyper-proliferating human keratinocyte cell line with an eye toward potential use in treating psoriasis. CB1 and CB2 receptors were confirmed present by Western blot and RT-PCR analyses. All cannabinoids investigated concentration-dependently hindered keratinocyte proliferation, as the authors concluded that these compounds show potential for use in psoriasis treatment.9
In 2013, Ramot et al. found that treating human skin culture with the CB1-specific agonist arachidonoyl-chloro-ethanolamide reduced the expression of keratins K6 and K16 in vitro and in situ, which may have implications for psoriasis treatment as K6 and K16 are upregulated in that disorder.10 The same team has also recently shown that the CB1 agonist arachidonyl-2’-chloroethylamide upregulated K10 protein expression in human epidermis and reduced K1 in human skin culture thus suggesting its potential as a treatment for epidermolytic ichthyosis.11
Notably, the synthetic cannabinoid JWH-133, known for its potent antiangiogenic and anti-inflammatory properties, has been shown in vivo and in vitro to suppress various inflammatory cytokines and angiogenic growth factors involved in psoriasis pathogenesis, including hypoxia inducible factor-1 alpha (HIF-1 alpha), vascular endothelial growth factor (VEGF), matrix metalloproteinases, basic fibroblast growth factor (bFGF), angiopoietin-2, interleukin-8 (IL-8), IL-17, and IL-2. While more research is necessary to determine the safety and efficacy of this product, it appears promising as an anti-psoriatic agent.12
Pruritus
Stimulation of the CB1 receptor has been demonstrated to inhibit histamine-induced pruritus.8
In 2005, Szepietowski et al. conducted a preliminary study to ascertain the efficacy and tolerance of a cream with structured physiological lipids and endogenous cannabinoids in managing pruritus in 21 patients on maintenance dialysis. For 3 weeks, the patients with uremic pruritus applied the test cream twice daily, with eight patients experiencing full eradication of pruritus at the end of this period. Further, xerosis was completely eliminated in 17 patients after the study, and significantly decreased during the 3-week period. The investigators suggested that while more research was needed, the well-tolerated product is thought to have been enhanced by the addition of endocannabinoids.13
A year later, Ständer et al. assessed the effects of the use of the topical cannabinoid agonist N-palmitoyl ethanolamine (PEA), which stimulates the endocannabinoid arachidonoyl ethanolamide (AEA) to activate CB1, in an open application study with 22 patients with prurigo, lichen simplex, and pruritus. Antipruritic benefits were seen in 14 patients, with an average decrease in itch of 86.4%. The treatment was reported to be well tolerated, as no patients complained of adverse effects such as contact dermatitis or a burning sensation.14
Eczematic dermatoses
Atopic dermatitis
In a small pilot study on pediatric atopic dermatitis in 2007, Pulvirenti et al. evaluated the safety and efficacy of the twice-daily application of a topical emulsion containing a synthetic aliamide (adelmidrol 2%), comparable to its parent substance PEA, in the treatment of 11 males and 9 females with atopic dermatitis (AD), whose mean age was 8 years. Among the 20 pediatric patients, 16 experienced complete resolution of symptoms after 4 weeks of treatment and had no relapses at the 8-week follow-up assessment. No improvement was noted in the six patches of AD in six patients with several untreated lesions that served as controls.15 Also in 2007, Del Rosso reported on a trial in which a PEA-containing nonsteroidal cream significantly lowered the mean time between flares in pediatric and adult AD patients.16
One year later, Eberlein et al. evaluated an emollient containing PEA in AD patients, finding that itch severity and sleep loss were improved by an average of 60%, with 38% of participants stopping oral antihistamines, 33.6% discontinuing topical steroid regimens, and 20% ending their use of topical immunomodulators as the study concluded.4,17
In 2018, Río et al. suggested that targeted manipulation of the endocannabinoid system at various AD stages might rein in the inflammatory and immune responses and ensuing alterations in keratinocytes, thus helping to preserve epidermal barrier function.18 As Trusler et al. noted, though, no control groups were used in the latter two studies, so it is unknown what effect the application of the vehicle alone would have had on the pruritus in these patients.19
Allergic contact dermatitis
In 2007, Karsak et al. demonstrated that mice lacking CB1/2 receptors exhibited aggravated contact hypersensitivity, whereas mice with higher levels of AEA evinced lower cutaneous allergic responses.20
Recently, Petrosino et al. provided the first evidence that the nonpsychotropic cannabinoid cannabidiol conferred anti-inflammatory activity in an experimental in vitro model of allergic contact dermatitis.21
Dermatomyositis
Robinson et al. have found that treating blood samples of patients with dermatomyositis with the nonpsychoactive cannabinoid ajulemic acid appears to limit the production of pathogenic cytokines. They suggest that oral administration of this cannabinoid merits consideration for dermatomyositis.22
Skin cancer
In 2015, Glodde et al. used a mouse model to investigate the role of cannabinoids in skin cancer pathogenesis. They considered THC, which binds to CB1 and CB2, and the endogenous cannabinoid system. The researchers found that in a CB receptor-dependent fashion THC significantly hindered the tumor growth of HCmel12 melanomas in vivo, verifying the merit of exogenous cannabinoids in melanoma treatment. They did not identify a role of the endogenous cannabinoid system in skin cancer pathogenesis.23
Additional studies suggest that endocannabinoids, phytocannabinoids, and synthetic cannabinoids diminish skin cancer growth (melanoma and nonmelanoma) in vitro and in vivo through CB receptor-dependent and -independent pathways, though in vivo human studies have not yet been conducted.8,24
Epidermolysis bullosa
In a promising observational study in 2018, Chelliah et al. reported on three cases of self-initiated topical cannabidiol use in patients with epidermolysis bullosa. Each patient experienced more rapid wound healing, less blistering, and reduced pain as a result of cannabidiol treatment, and one was able to discontinue oral opioids. The authors were encouraged by such findings, but cautioned that randomized, double-blind clinical trials are needed to establish cannabidiol as an effective therapy.25
This seems particularly important given the climate of expanding legalization of medical and recreational cannabis use, as well as the increasing use of topical cannabinoids among dermatology patients.26 Nevertheless, it is important to be cognizant of one’s own state laws as topical cannabinoids may be restricted; these products are marketed for pain and pruritus on the Internet but are unavailable by prescription unless the physician has a special license.4
Attitudes about cannabinoid use in dermatology
In an intriguing study last year about the knowledge, cognizance, and perceptions of cannabinoids among dermatologists, Robinson et al. created a 20-question online survey that netted a response rate of 21% (n = 531). In terms of awareness, 29% of respondents did not know that THC is psychoactive and a significant majority (64%) did not know that CBD is not psychoactive. Nevertheless, the majority thought that cannabinoids should be legal for medical treatment (86%), and even more (94%) support researching dermatologic applications of cannabinoids. More responders (86%) would prescribe a Food and Drug Administration–approved cannabinoid-containing topical formulation than an oral product (71%). In also noting that 55% revealed at least one conversation about cannabinoids initiated by a patient in the previous year, while 48% expressed concern about a possible stigma associated with suggesting cannabinoid treatments to patients, Robinson et al. call for further education about the benefits and risks of cutaneous cannabinoids for dermatologists.27
Conclusion
It is important that we educate ourselves as to the effects of orally administered and topical products containing cannabis so that we are prepared for questions from patients. Data on psoriasis, pruritus, eczema, and acne warrant optimism and much additional research. Now that the FDA is allowing research sites to enroll for a special license to investigate schedule I drugs, we stand to learn much more about the various effects on the health benefits of cannabis. Despite the longstanding traditional use of C. sativa and C. indica, we are in the early stages of research on the impact of phytocannabinoids and synthetic cannabinoids on human health and the role that the endocannabinoid system plays. The extant findings provide reasons to consider the endocannabinoid system as a target for therapeutic intervention for various cutaneous disorders as research continues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She has no relevant disclosures related to this column. Write to her at [email protected].
References
1. Russo EB. Chem Biodivers. 2007 Aug;4(8):1614-48.
2. Goldenberg M et al. Drug Alcohol Depend. 2017 May 1;174:80-90.
3. Mounessa JS et al. J Am Acad Dermatol. 2017 Jul;77(1):188-90.
4. Shalaby M et al. Pract Dermatol. 2018;68-70.
5. Oláh A et al. Exp Dermatol. 2016 Sep;25(9):701-7.
6. Ali A et al. Pak J Pharm Sci. 2015 Jul;28(4):1389-95.
7. Derakhshan N et al. Curr Clin Pharmacol. 2016;11(2):146-7.
8. Singh D et al. Clin Dermatol. 2018 May-Jun;36(3):399-419.
9. Wilkinson JD et al. J Dermatol Sci. 2007 Feb;45(2):87-92.
10. Ramot Y et al. PeerJ. 2013 Feb 19;1:e40.
11. Ramot Y et al. Br J Dermatol. 2018 Jun;178(6):1469.
12. Norooznezhad AH et al. Med Hypotheses. 2017 Feb;99:15-18.
13. Szepietowski JC et al. Acta Dermatovenerol Croat. 2005;13(2):97-103.
14. Ständer S et al. Hautarzt. 2006 Sep;57(9):801-7.
15. Pulvirenti N et al. Acta Dermatovenerol Croat. 2007;15(2):80-3.
16. Del Rosso JQ. Cosmetic Dermatol. 2007 Apr; 20(4):208-211.
17. Eberlein B et al. J Eur Acad Dermatol Venereol. 2008 Jan;22(1):73-82.
18. Del Río CD et al. Biochem Pharmacol. 2018 Nov;157:122-133.
19. Trusler AR et al. Dermatitis. 2017 Jan/Feb;28(1):22-32.
20. Karsak M et al. Science. 2007 Jun 8;316(5830):1494-7.
21. Petrosino S et al. J Pharmacol Exp Ther. 2018 Jun;365(3):652-63.
22. Robinson ES et al. J Invest Dermatol. 2017 Nov;137(11):2445-7.
23. Glodde N et al. Life Sci. 2015 Oct 1;138:35-40.
24. Soliman E. et al. J Dermatol Clin Res. 2016;4(2):1069-76.
25. Chelliah MP et al. Pediatr Dermatol. 2018 Jul;35(4):e224-e227.
26. Hashim PW et al. Cutis. 2017 Jul;100(1):50-52.
27. Robinson E et al. J Drugs Dermatol. 2018 Dec 1;17(12):1273-8.
The relatively recent discovery of the endogenous cannabinoid system and the quickly evolving, yet still convoluted, legal status of cannabis in the United States has spurred excitement over expanded research opportunities. Despite its checkered legal history, marijuana – derived from Cannabis sativa and Cannabis indica – has long been used for medical purposes and is one of the most widely used drugs throughout the world.1 Modern medicine has deployed this dynamic plant to treat chronic pain, glaucoma, and nausea, and continues to investigate its application in a broad array of conditions: anorexia, spasticity, atherosclerosis, autoimmune disorders, inflammatory bowel disease, multiple sclerosis, spasticity, tumorigenesis, and multiple cutaneous disorders, including acne, eczematous disorders, lichen simplex, melanoma and nonmelanoma skin cancer, melasma, prurigo, pruritus, psoriasis, scleroderma and systemic sclerosis, and seborrheic dermatitis.1-4 This .
Acne
Oláh et al. have demonstrated that the nonpsychotropic phytocannabinoid ((-)-cannabidiol [CBD]) imparts anti-acne benefits by diminishing sebaceous lipid synthesis, decreasing proliferation, and easing inflammation in human SZ95 sebocytes.5 In additional investigations of nonpsychotropic phytocannabinoids and their effects on human sebocyte function, they reported in 2016 that the phytocannabinoids (-)-cannabigerol [CBG] and (-)-cannabigerovarin (CBGV) appear to exhibit promise in treating xerotic and seborrheic skin, and ((-)-cannabichromene [CBC], (-)-cannabidivarin [CBDV], and (-)-delta9-tetrahydrocannabivarin [THCV], in particular, display notable potential as anti-acne ingredients. The investigators added that these compounds, due to their substantial anti-inflammatory effects, warrant consideration for use in treating skin inflammation.5 Previously, Ali and Akhtar conducted a single-blinded, 12-week comparative study in healthy male volunteers to evaluate the effects of twice-daily application of 3% cannabis seed extract cream on human cheek skin. The researchers found the base with 3% cannabis seed extract to be safe and effective, with skin sebum and erythema content on the treated side reduced significantly compared with the side treated only with the control base. They concluded that this well-tolerated formulation could be indicated for the treatment of acne and seborrhea to enhance facial appearance.6
Psoriasis
The endocannabinoid system itself is thought to play a potentially important role in the treatment of psoriasis, as interactions between the immune and nervous systems via cholinergic anti-inflammatory pathways are considered to be key in psoriasis etiology and the endocannabinoid system interacts with both systems through the cannabinoid (CB) receptors CB1 and CB2.7 Compared with normal human skin, psoriatic skin is characterized by fewer CB receptors.8
In 2007, Wilkinson and Williamson used a keratinocyte proliferation assay to study the phytocannabinoids delta9-tetrahydrocannabinol (THC), CBD, CBG, and cannabinol (CNB) to assess their capacity to halt the growth of a hyper-proliferating human keratinocyte cell line with an eye toward potential use in treating psoriasis. CB1 and CB2 receptors were confirmed present by Western blot and RT-PCR analyses. All cannabinoids investigated concentration-dependently hindered keratinocyte proliferation, as the authors concluded that these compounds show potential for use in psoriasis treatment.9
In 2013, Ramot et al. found that treating human skin culture with the CB1-specific agonist arachidonoyl-chloro-ethanolamide reduced the expression of keratins K6 and K16 in vitro and in situ, which may have implications for psoriasis treatment as K6 and K16 are upregulated in that disorder.10 The same team has also recently shown that the CB1 agonist arachidonyl-2’-chloroethylamide upregulated K10 protein expression in human epidermis and reduced K1 in human skin culture thus suggesting its potential as a treatment for epidermolytic ichthyosis.11
Notably, the synthetic cannabinoid JWH-133, known for its potent antiangiogenic and anti-inflammatory properties, has been shown in vivo and in vitro to suppress various inflammatory cytokines and angiogenic growth factors involved in psoriasis pathogenesis, including hypoxia inducible factor-1 alpha (HIF-1 alpha), vascular endothelial growth factor (VEGF), matrix metalloproteinases, basic fibroblast growth factor (bFGF), angiopoietin-2, interleukin-8 (IL-8), IL-17, and IL-2. While more research is necessary to determine the safety and efficacy of this product, it appears promising as an anti-psoriatic agent.12
Pruritus
Stimulation of the CB1 receptor has been demonstrated to inhibit histamine-induced pruritus.8
In 2005, Szepietowski et al. conducted a preliminary study to ascertain the efficacy and tolerance of a cream with structured physiological lipids and endogenous cannabinoids in managing pruritus in 21 patients on maintenance dialysis. For 3 weeks, the patients with uremic pruritus applied the test cream twice daily, with eight patients experiencing full eradication of pruritus at the end of this period. Further, xerosis was completely eliminated in 17 patients after the study, and significantly decreased during the 3-week period. The investigators suggested that while more research was needed, the well-tolerated product is thought to have been enhanced by the addition of endocannabinoids.13
A year later, Ständer et al. assessed the effects of the use of the topical cannabinoid agonist N-palmitoyl ethanolamine (PEA), which stimulates the endocannabinoid arachidonoyl ethanolamide (AEA) to activate CB1, in an open application study with 22 patients with prurigo, lichen simplex, and pruritus. Antipruritic benefits were seen in 14 patients, with an average decrease in itch of 86.4%. The treatment was reported to be well tolerated, as no patients complained of adverse effects such as contact dermatitis or a burning sensation.14
Eczematic dermatoses
Atopic dermatitis
In a small pilot study on pediatric atopic dermatitis in 2007, Pulvirenti et al. evaluated the safety and efficacy of the twice-daily application of a topical emulsion containing a synthetic aliamide (adelmidrol 2%), comparable to its parent substance PEA, in the treatment of 11 males and 9 females with atopic dermatitis (AD), whose mean age was 8 years. Among the 20 pediatric patients, 16 experienced complete resolution of symptoms after 4 weeks of treatment and had no relapses at the 8-week follow-up assessment. No improvement was noted in the six patches of AD in six patients with several untreated lesions that served as controls.15 Also in 2007, Del Rosso reported on a trial in which a PEA-containing nonsteroidal cream significantly lowered the mean time between flares in pediatric and adult AD patients.16
One year later, Eberlein et al. evaluated an emollient containing PEA in AD patients, finding that itch severity and sleep loss were improved by an average of 60%, with 38% of participants stopping oral antihistamines, 33.6% discontinuing topical steroid regimens, and 20% ending their use of topical immunomodulators as the study concluded.4,17
In 2018, Río et al. suggested that targeted manipulation of the endocannabinoid system at various AD stages might rein in the inflammatory and immune responses and ensuing alterations in keratinocytes, thus helping to preserve epidermal barrier function.18 As Trusler et al. noted, though, no control groups were used in the latter two studies, so it is unknown what effect the application of the vehicle alone would have had on the pruritus in these patients.19
Allergic contact dermatitis
In 2007, Karsak et al. demonstrated that mice lacking CB1/2 receptors exhibited aggravated contact hypersensitivity, whereas mice with higher levels of AEA evinced lower cutaneous allergic responses.20
Recently, Petrosino et al. provided the first evidence that the nonpsychotropic cannabinoid cannabidiol conferred anti-inflammatory activity in an experimental in vitro model of allergic contact dermatitis.21
Dermatomyositis
Robinson et al. have found that treating blood samples of patients with dermatomyositis with the nonpsychoactive cannabinoid ajulemic acid appears to limit the production of pathogenic cytokines. They suggest that oral administration of this cannabinoid merits consideration for dermatomyositis.22
Skin cancer
In 2015, Glodde et al. used a mouse model to investigate the role of cannabinoids in skin cancer pathogenesis. They considered THC, which binds to CB1 and CB2, and the endogenous cannabinoid system. The researchers found that in a CB receptor-dependent fashion THC significantly hindered the tumor growth of HCmel12 melanomas in vivo, verifying the merit of exogenous cannabinoids in melanoma treatment. They did not identify a role of the endogenous cannabinoid system in skin cancer pathogenesis.23
Additional studies suggest that endocannabinoids, phytocannabinoids, and synthetic cannabinoids diminish skin cancer growth (melanoma and nonmelanoma) in vitro and in vivo through CB receptor-dependent and -independent pathways, though in vivo human studies have not yet been conducted.8,24
Epidermolysis bullosa
In a promising observational study in 2018, Chelliah et al. reported on three cases of self-initiated topical cannabidiol use in patients with epidermolysis bullosa. Each patient experienced more rapid wound healing, less blistering, and reduced pain as a result of cannabidiol treatment, and one was able to discontinue oral opioids. The authors were encouraged by such findings, but cautioned that randomized, double-blind clinical trials are needed to establish cannabidiol as an effective therapy.25
This seems particularly important given the climate of expanding legalization of medical and recreational cannabis use, as well as the increasing use of topical cannabinoids among dermatology patients.26 Nevertheless, it is important to be cognizant of one’s own state laws as topical cannabinoids may be restricted; these products are marketed for pain and pruritus on the Internet but are unavailable by prescription unless the physician has a special license.4
Attitudes about cannabinoid use in dermatology
In an intriguing study last year about the knowledge, cognizance, and perceptions of cannabinoids among dermatologists, Robinson et al. created a 20-question online survey that netted a response rate of 21% (n = 531). In terms of awareness, 29% of respondents did not know that THC is psychoactive and a significant majority (64%) did not know that CBD is not psychoactive. Nevertheless, the majority thought that cannabinoids should be legal for medical treatment (86%), and even more (94%) support researching dermatologic applications of cannabinoids. More responders (86%) would prescribe a Food and Drug Administration–approved cannabinoid-containing topical formulation than an oral product (71%). In also noting that 55% revealed at least one conversation about cannabinoids initiated by a patient in the previous year, while 48% expressed concern about a possible stigma associated with suggesting cannabinoid treatments to patients, Robinson et al. call for further education about the benefits and risks of cutaneous cannabinoids for dermatologists.27
Conclusion
It is important that we educate ourselves as to the effects of orally administered and topical products containing cannabis so that we are prepared for questions from patients. Data on psoriasis, pruritus, eczema, and acne warrant optimism and much additional research. Now that the FDA is allowing research sites to enroll for a special license to investigate schedule I drugs, we stand to learn much more about the various effects on the health benefits of cannabis. Despite the longstanding traditional use of C. sativa and C. indica, we are in the early stages of research on the impact of phytocannabinoids and synthetic cannabinoids on human health and the role that the endocannabinoid system plays. The extant findings provide reasons to consider the endocannabinoid system as a target for therapeutic intervention for various cutaneous disorders as research continues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She has no relevant disclosures related to this column. Write to her at [email protected].
References
1. Russo EB. Chem Biodivers. 2007 Aug;4(8):1614-48.
2. Goldenberg M et al. Drug Alcohol Depend. 2017 May 1;174:80-90.
3. Mounessa JS et al. J Am Acad Dermatol. 2017 Jul;77(1):188-90.
4. Shalaby M et al. Pract Dermatol. 2018;68-70.
5. Oláh A et al. Exp Dermatol. 2016 Sep;25(9):701-7.
6. Ali A et al. Pak J Pharm Sci. 2015 Jul;28(4):1389-95.
7. Derakhshan N et al. Curr Clin Pharmacol. 2016;11(2):146-7.
8. Singh D et al. Clin Dermatol. 2018 May-Jun;36(3):399-419.
9. Wilkinson JD et al. J Dermatol Sci. 2007 Feb;45(2):87-92.
10. Ramot Y et al. PeerJ. 2013 Feb 19;1:e40.
11. Ramot Y et al. Br J Dermatol. 2018 Jun;178(6):1469.
12. Norooznezhad AH et al. Med Hypotheses. 2017 Feb;99:15-18.
13. Szepietowski JC et al. Acta Dermatovenerol Croat. 2005;13(2):97-103.
14. Ständer S et al. Hautarzt. 2006 Sep;57(9):801-7.
15. Pulvirenti N et al. Acta Dermatovenerol Croat. 2007;15(2):80-3.
16. Del Rosso JQ. Cosmetic Dermatol. 2007 Apr; 20(4):208-211.
17. Eberlein B et al. J Eur Acad Dermatol Venereol. 2008 Jan;22(1):73-82.
18. Del Río CD et al. Biochem Pharmacol. 2018 Nov;157:122-133.
19. Trusler AR et al. Dermatitis. 2017 Jan/Feb;28(1):22-32.
20. Karsak M et al. Science. 2007 Jun 8;316(5830):1494-7.
21. Petrosino S et al. J Pharmacol Exp Ther. 2018 Jun;365(3):652-63.
22. Robinson ES et al. J Invest Dermatol. 2017 Nov;137(11):2445-7.
23. Glodde N et al. Life Sci. 2015 Oct 1;138:35-40.
24. Soliman E. et al. J Dermatol Clin Res. 2016;4(2):1069-76.
25. Chelliah MP et al. Pediatr Dermatol. 2018 Jul;35(4):e224-e227.
26. Hashim PW et al. Cutis. 2017 Jul;100(1):50-52.
27. Robinson E et al. J Drugs Dermatol. 2018 Dec 1;17(12):1273-8.
The relatively recent discovery of the endogenous cannabinoid system and the quickly evolving, yet still convoluted, legal status of cannabis in the United States has spurred excitement over expanded research opportunities. Despite its checkered legal history, marijuana – derived from Cannabis sativa and Cannabis indica – has long been used for medical purposes and is one of the most widely used drugs throughout the world.1 Modern medicine has deployed this dynamic plant to treat chronic pain, glaucoma, and nausea, and continues to investigate its application in a broad array of conditions: anorexia, spasticity, atherosclerosis, autoimmune disorders, inflammatory bowel disease, multiple sclerosis, spasticity, tumorigenesis, and multiple cutaneous disorders, including acne, eczematous disorders, lichen simplex, melanoma and nonmelanoma skin cancer, melasma, prurigo, pruritus, psoriasis, scleroderma and systemic sclerosis, and seborrheic dermatitis.1-4 This .
Acne
Oláh et al. have demonstrated that the nonpsychotropic phytocannabinoid ((-)-cannabidiol [CBD]) imparts anti-acne benefits by diminishing sebaceous lipid synthesis, decreasing proliferation, and easing inflammation in human SZ95 sebocytes.5 In additional investigations of nonpsychotropic phytocannabinoids and their effects on human sebocyte function, they reported in 2016 that the phytocannabinoids (-)-cannabigerol [CBG] and (-)-cannabigerovarin (CBGV) appear to exhibit promise in treating xerotic and seborrheic skin, and ((-)-cannabichromene [CBC], (-)-cannabidivarin [CBDV], and (-)-delta9-tetrahydrocannabivarin [THCV], in particular, display notable potential as anti-acne ingredients. The investigators added that these compounds, due to their substantial anti-inflammatory effects, warrant consideration for use in treating skin inflammation.5 Previously, Ali and Akhtar conducted a single-blinded, 12-week comparative study in healthy male volunteers to evaluate the effects of twice-daily application of 3% cannabis seed extract cream on human cheek skin. The researchers found the base with 3% cannabis seed extract to be safe and effective, with skin sebum and erythema content on the treated side reduced significantly compared with the side treated only with the control base. They concluded that this well-tolerated formulation could be indicated for the treatment of acne and seborrhea to enhance facial appearance.6
Psoriasis
The endocannabinoid system itself is thought to play a potentially important role in the treatment of psoriasis, as interactions between the immune and nervous systems via cholinergic anti-inflammatory pathways are considered to be key in psoriasis etiology and the endocannabinoid system interacts with both systems through the cannabinoid (CB) receptors CB1 and CB2.7 Compared with normal human skin, psoriatic skin is characterized by fewer CB receptors.8
In 2007, Wilkinson and Williamson used a keratinocyte proliferation assay to study the phytocannabinoids delta9-tetrahydrocannabinol (THC), CBD, CBG, and cannabinol (CNB) to assess their capacity to halt the growth of a hyper-proliferating human keratinocyte cell line with an eye toward potential use in treating psoriasis. CB1 and CB2 receptors were confirmed present by Western blot and RT-PCR analyses. All cannabinoids investigated concentration-dependently hindered keratinocyte proliferation, as the authors concluded that these compounds show potential for use in psoriasis treatment.9
In 2013, Ramot et al. found that treating human skin culture with the CB1-specific agonist arachidonoyl-chloro-ethanolamide reduced the expression of keratins K6 and K16 in vitro and in situ, which may have implications for psoriasis treatment as K6 and K16 are upregulated in that disorder.10 The same team has also recently shown that the CB1 agonist arachidonyl-2’-chloroethylamide upregulated K10 protein expression in human epidermis and reduced K1 in human skin culture thus suggesting its potential as a treatment for epidermolytic ichthyosis.11
Notably, the synthetic cannabinoid JWH-133, known for its potent antiangiogenic and anti-inflammatory properties, has been shown in vivo and in vitro to suppress various inflammatory cytokines and angiogenic growth factors involved in psoriasis pathogenesis, including hypoxia inducible factor-1 alpha (HIF-1 alpha), vascular endothelial growth factor (VEGF), matrix metalloproteinases, basic fibroblast growth factor (bFGF), angiopoietin-2, interleukin-8 (IL-8), IL-17, and IL-2. While more research is necessary to determine the safety and efficacy of this product, it appears promising as an anti-psoriatic agent.12
Pruritus
Stimulation of the CB1 receptor has been demonstrated to inhibit histamine-induced pruritus.8
In 2005, Szepietowski et al. conducted a preliminary study to ascertain the efficacy and tolerance of a cream with structured physiological lipids and endogenous cannabinoids in managing pruritus in 21 patients on maintenance dialysis. For 3 weeks, the patients with uremic pruritus applied the test cream twice daily, with eight patients experiencing full eradication of pruritus at the end of this period. Further, xerosis was completely eliminated in 17 patients after the study, and significantly decreased during the 3-week period. The investigators suggested that while more research was needed, the well-tolerated product is thought to have been enhanced by the addition of endocannabinoids.13
A year later, Ständer et al. assessed the effects of the use of the topical cannabinoid agonist N-palmitoyl ethanolamine (PEA), which stimulates the endocannabinoid arachidonoyl ethanolamide (AEA) to activate CB1, in an open application study with 22 patients with prurigo, lichen simplex, and pruritus. Antipruritic benefits were seen in 14 patients, with an average decrease in itch of 86.4%. The treatment was reported to be well tolerated, as no patients complained of adverse effects such as contact dermatitis or a burning sensation.14
Eczematic dermatoses
Atopic dermatitis
In a small pilot study on pediatric atopic dermatitis in 2007, Pulvirenti et al. evaluated the safety and efficacy of the twice-daily application of a topical emulsion containing a synthetic aliamide (adelmidrol 2%), comparable to its parent substance PEA, in the treatment of 11 males and 9 females with atopic dermatitis (AD), whose mean age was 8 years. Among the 20 pediatric patients, 16 experienced complete resolution of symptoms after 4 weeks of treatment and had no relapses at the 8-week follow-up assessment. No improvement was noted in the six patches of AD in six patients with several untreated lesions that served as controls.15 Also in 2007, Del Rosso reported on a trial in which a PEA-containing nonsteroidal cream significantly lowered the mean time between flares in pediatric and adult AD patients.16
One year later, Eberlein et al. evaluated an emollient containing PEA in AD patients, finding that itch severity and sleep loss were improved by an average of 60%, with 38% of participants stopping oral antihistamines, 33.6% discontinuing topical steroid regimens, and 20% ending their use of topical immunomodulators as the study concluded.4,17
In 2018, Río et al. suggested that targeted manipulation of the endocannabinoid system at various AD stages might rein in the inflammatory and immune responses and ensuing alterations in keratinocytes, thus helping to preserve epidermal barrier function.18 As Trusler et al. noted, though, no control groups were used in the latter two studies, so it is unknown what effect the application of the vehicle alone would have had on the pruritus in these patients.19
Allergic contact dermatitis
In 2007, Karsak et al. demonstrated that mice lacking CB1/2 receptors exhibited aggravated contact hypersensitivity, whereas mice with higher levels of AEA evinced lower cutaneous allergic responses.20
Recently, Petrosino et al. provided the first evidence that the nonpsychotropic cannabinoid cannabidiol conferred anti-inflammatory activity in an experimental in vitro model of allergic contact dermatitis.21
Dermatomyositis
Robinson et al. have found that treating blood samples of patients with dermatomyositis with the nonpsychoactive cannabinoid ajulemic acid appears to limit the production of pathogenic cytokines. They suggest that oral administration of this cannabinoid merits consideration for dermatomyositis.22
Skin cancer
In 2015, Glodde et al. used a mouse model to investigate the role of cannabinoids in skin cancer pathogenesis. They considered THC, which binds to CB1 and CB2, and the endogenous cannabinoid system. The researchers found that in a CB receptor-dependent fashion THC significantly hindered the tumor growth of HCmel12 melanomas in vivo, verifying the merit of exogenous cannabinoids in melanoma treatment. They did not identify a role of the endogenous cannabinoid system in skin cancer pathogenesis.23
Additional studies suggest that endocannabinoids, phytocannabinoids, and synthetic cannabinoids diminish skin cancer growth (melanoma and nonmelanoma) in vitro and in vivo through CB receptor-dependent and -independent pathways, though in vivo human studies have not yet been conducted.8,24
Epidermolysis bullosa
In a promising observational study in 2018, Chelliah et al. reported on three cases of self-initiated topical cannabidiol use in patients with epidermolysis bullosa. Each patient experienced more rapid wound healing, less blistering, and reduced pain as a result of cannabidiol treatment, and one was able to discontinue oral opioids. The authors were encouraged by such findings, but cautioned that randomized, double-blind clinical trials are needed to establish cannabidiol as an effective therapy.25
This seems particularly important given the climate of expanding legalization of medical and recreational cannabis use, as well as the increasing use of topical cannabinoids among dermatology patients.26 Nevertheless, it is important to be cognizant of one’s own state laws as topical cannabinoids may be restricted; these products are marketed for pain and pruritus on the Internet but are unavailable by prescription unless the physician has a special license.4
Attitudes about cannabinoid use in dermatology
In an intriguing study last year about the knowledge, cognizance, and perceptions of cannabinoids among dermatologists, Robinson et al. created a 20-question online survey that netted a response rate of 21% (n = 531). In terms of awareness, 29% of respondents did not know that THC is psychoactive and a significant majority (64%) did not know that CBD is not psychoactive. Nevertheless, the majority thought that cannabinoids should be legal for medical treatment (86%), and even more (94%) support researching dermatologic applications of cannabinoids. More responders (86%) would prescribe a Food and Drug Administration–approved cannabinoid-containing topical formulation than an oral product (71%). In also noting that 55% revealed at least one conversation about cannabinoids initiated by a patient in the previous year, while 48% expressed concern about a possible stigma associated with suggesting cannabinoid treatments to patients, Robinson et al. call for further education about the benefits and risks of cutaneous cannabinoids for dermatologists.27
Conclusion
It is important that we educate ourselves as to the effects of orally administered and topical products containing cannabis so that we are prepared for questions from patients. Data on psoriasis, pruritus, eczema, and acne warrant optimism and much additional research. Now that the FDA is allowing research sites to enroll for a special license to investigate schedule I drugs, we stand to learn much more about the various effects on the health benefits of cannabis. Despite the longstanding traditional use of C. sativa and C. indica, we are in the early stages of research on the impact of phytocannabinoids and synthetic cannabinoids on human health and the role that the endocannabinoid system plays. The extant findings provide reasons to consider the endocannabinoid system as a target for therapeutic intervention for various cutaneous disorders as research continues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She has no relevant disclosures related to this column. Write to her at [email protected].
References
1. Russo EB. Chem Biodivers. 2007 Aug;4(8):1614-48.
2. Goldenberg M et al. Drug Alcohol Depend. 2017 May 1;174:80-90.
3. Mounessa JS et al. J Am Acad Dermatol. 2017 Jul;77(1):188-90.
4. Shalaby M et al. Pract Dermatol. 2018;68-70.
5. Oláh A et al. Exp Dermatol. 2016 Sep;25(9):701-7.
6. Ali A et al. Pak J Pharm Sci. 2015 Jul;28(4):1389-95.
7. Derakhshan N et al. Curr Clin Pharmacol. 2016;11(2):146-7.
8. Singh D et al. Clin Dermatol. 2018 May-Jun;36(3):399-419.
9. Wilkinson JD et al. J Dermatol Sci. 2007 Feb;45(2):87-92.
10. Ramot Y et al. PeerJ. 2013 Feb 19;1:e40.
11. Ramot Y et al. Br J Dermatol. 2018 Jun;178(6):1469.
12. Norooznezhad AH et al. Med Hypotheses. 2017 Feb;99:15-18.
13. Szepietowski JC et al. Acta Dermatovenerol Croat. 2005;13(2):97-103.
14. Ständer S et al. Hautarzt. 2006 Sep;57(9):801-7.
15. Pulvirenti N et al. Acta Dermatovenerol Croat. 2007;15(2):80-3.
16. Del Rosso JQ. Cosmetic Dermatol. 2007 Apr; 20(4):208-211.
17. Eberlein B et al. J Eur Acad Dermatol Venereol. 2008 Jan;22(1):73-82.
18. Del Río CD et al. Biochem Pharmacol. 2018 Nov;157:122-133.
19. Trusler AR et al. Dermatitis. 2017 Jan/Feb;28(1):22-32.
20. Karsak M et al. Science. 2007 Jun 8;316(5830):1494-7.
21. Petrosino S et al. J Pharmacol Exp Ther. 2018 Jun;365(3):652-63.
22. Robinson ES et al. J Invest Dermatol. 2017 Nov;137(11):2445-7.
23. Glodde N et al. Life Sci. 2015 Oct 1;138:35-40.
24. Soliman E. et al. J Dermatol Clin Res. 2016;4(2):1069-76.
25. Chelliah MP et al. Pediatr Dermatol. 2018 Jul;35(4):e224-e227.
26. Hashim PW et al. Cutis. 2017 Jul;100(1):50-52.
27. Robinson E et al. J Drugs Dermatol. 2018 Dec 1;17(12):1273-8.
Methotrexate does not cause rheumatoid interstitial lung disease
BIRMINGHAM, ENGLAND – Data from two early RA inception cohorts provide reassurance that methotrexate does not cause interstitial lung disease and suggest that treatment with methotrexate might even be protective.
In the Early RA Study (ERAS) and Early RA Network (ERAN), which together include 2,701 patients with RA, 101 (3.7%) had interstitial lung disease (ILD). There were 92 patients with RA-ILD who had information available on exposure to any conventional synthetic disease-modifying antirheumatic drug (csDMARD); of these, 39 (2.5%) had been exposed to methotrexate (n = 1,578) and 53 (4.8%) to other csDMARDs (n = 1,114).
Multivariate analysis showed that methotrexate exposure was associated with a reduced risk of developing ILD, with an odds ratio of 0.48 (P = .004). In a separate analysis that excluded 25 patients who had ILD before they received any csDMARD therapy (n = 67), there was no association between methotrexate use and ILD (OR, 0.85; P = .578). In fact, there was a nonsignificant trend for a delayed onset of ILD in patients who had been treated with methotrexate (OR, 0.54; P = .072).
Methotrexate use is associated with an acute hypersensitivity pneumonitis in patients with RA, explained Patrick Kiely, MBBS, PhD, of St. George’s University Hospitals NHS Foundation Trust in London at the British Society for Rheumatology annual conference. “This is well recognized, it’s very rare [0.43%-1.00%], it’s easy to spot, and usually goes away if you stop methotrexate,” said Dr. Kiely, adding that “it’s not benign, and severe cases can be life threatening.”
Because of the association between methotrexate and pneumonitis, there has been concern that methotrexate may exacerbate or even cause ILD in RA but there are sparse data available to confirm this. The bottom line is that you should not start someone on methotrexate if you think their existing lung capacity is not up to treatment with methotrexate, Dr. Kiely said.
ILD is not always symptomatic in RA, but when it is, it is associated with very poor survival. The lung disease can be present before joint symptoms, Dr. Kiely said. Although less than 10% of cases may be symptomatic, this “is a big deal, because it has a high mortality, with death within 5 years. It’s the second-commonest cause of excess mortality in RA after cardiovascular disease.”
To look at the association between incident RA-ILD and the use of methotrexate, Dr. Kiely and associates analyzed data from ERAS (1986-2001) and ERAN (2002-2013), that together have more than 25 years of follow-up data on patients who were recruited at the first sign of RA symptoms. Patients within these cohorts have been treated according to best practice, and a range of outcomes – including RA-ILD – have been assessed at annual intervals.
In the patients who developed ILD after any csDMARD exposure, older age at RA onset (OR, 1.04; P less than .001) and having ever smoked (OR, 1.91; P = .016) were associated with the development of the lung disease. Incident ILD was also associated with being positive for rheumatoid factor (OR, 2.02; P = .029) at baseline. Being male was also associated with a higher risk for developing ILD, Dr. Kiely reported, as was a longer duration of time between the onset of first RA symptoms and the first secondary care visit. Conversely, the presence of nonrespiratory, major comorbidities at baseline appeared to be protective (OR, 0.62; P = .027).
“We found no association between methotrexate treatment and incident RA-ILD and a possibility that it may be protective,” Dr. Kiely concluded, noting that these data were now published in BMJ Open (2019;9:e028466. doi: 10.1136/bmjopen-2018-028466).
Following Dr. Kiely’s presentation, an audience member asked if the protective effect seen with methotrexate could have been caused by better disease control overall.
Dr. Kiely answered that, up until 2001, the time when ERAS was ongoing, standard practice in the United Kingdom was to use sulfasalazine, but then methotrexate started to be used in higher and higher doses, as seen in ERAN.
The interesting thing is that in ERAN more methotrexate was used in higher doses, but less RA-ILD was seen, Dr. Kiely observed. The overall prevalence of RA-ILD in the later early RA cohort was 3.2% and the median dose of methotrexate used was 20 mg. In ERAS, the prevalence was 4.2% and the median dose of methotrexate used was 10 mg.
There was a suggestion that disease control was slightly better in ERAN than ERAS, but that wasn’t statistically significant, Dr. Kiely said.
So, should a patient with RA and ILD be given methotrexate? There’s no reason not to, Dr. Kiely suggested, based on the evidence shown. Part of the challenge will now be convincing chest physician colleagues that methotrexate is not problematic in terms of causing ILD.
These findings are completely on board with the ILD group’s findings that methotrexate doesn’t cause pulmonary fibrosis in patients with RA, commented Julie Dawson, MD, of St. Helens and Knowsley Teaching Hospitals NHS Trust, St. Helens, England. Her own research, which includes a 10-year follow-up of patients with inflammatory arthritis, has shown that methotrexate does not appear to increase the risk of pulmonary fibrosis.
The study had no specific outside funding. Dr. Kiely reported having no conflicts of interest.
SOURCE: Kiely P et al. Rheumatology. 2019;58(suppl 3), Abstract 009.
BIRMINGHAM, ENGLAND – Data from two early RA inception cohorts provide reassurance that methotrexate does not cause interstitial lung disease and suggest that treatment with methotrexate might even be protective.
In the Early RA Study (ERAS) and Early RA Network (ERAN), which together include 2,701 patients with RA, 101 (3.7%) had interstitial lung disease (ILD). There were 92 patients with RA-ILD who had information available on exposure to any conventional synthetic disease-modifying antirheumatic drug (csDMARD); of these, 39 (2.5%) had been exposed to methotrexate (n = 1,578) and 53 (4.8%) to other csDMARDs (n = 1,114).
Multivariate analysis showed that methotrexate exposure was associated with a reduced risk of developing ILD, with an odds ratio of 0.48 (P = .004). In a separate analysis that excluded 25 patients who had ILD before they received any csDMARD therapy (n = 67), there was no association between methotrexate use and ILD (OR, 0.85; P = .578). In fact, there was a nonsignificant trend for a delayed onset of ILD in patients who had been treated with methotrexate (OR, 0.54; P = .072).
Methotrexate use is associated with an acute hypersensitivity pneumonitis in patients with RA, explained Patrick Kiely, MBBS, PhD, of St. George’s University Hospitals NHS Foundation Trust in London at the British Society for Rheumatology annual conference. “This is well recognized, it’s very rare [0.43%-1.00%], it’s easy to spot, and usually goes away if you stop methotrexate,” said Dr. Kiely, adding that “it’s not benign, and severe cases can be life threatening.”
Because of the association between methotrexate and pneumonitis, there has been concern that methotrexate may exacerbate or even cause ILD in RA but there are sparse data available to confirm this. The bottom line is that you should not start someone on methotrexate if you think their existing lung capacity is not up to treatment with methotrexate, Dr. Kiely said.
ILD is not always symptomatic in RA, but when it is, it is associated with very poor survival. The lung disease can be present before joint symptoms, Dr. Kiely said. Although less than 10% of cases may be symptomatic, this “is a big deal, because it has a high mortality, with death within 5 years. It’s the second-commonest cause of excess mortality in RA after cardiovascular disease.”
To look at the association between incident RA-ILD and the use of methotrexate, Dr. Kiely and associates analyzed data from ERAS (1986-2001) and ERAN (2002-2013), that together have more than 25 years of follow-up data on patients who were recruited at the first sign of RA symptoms. Patients within these cohorts have been treated according to best practice, and a range of outcomes – including RA-ILD – have been assessed at annual intervals.
In the patients who developed ILD after any csDMARD exposure, older age at RA onset (OR, 1.04; P less than .001) and having ever smoked (OR, 1.91; P = .016) were associated with the development of the lung disease. Incident ILD was also associated with being positive for rheumatoid factor (OR, 2.02; P = .029) at baseline. Being male was also associated with a higher risk for developing ILD, Dr. Kiely reported, as was a longer duration of time between the onset of first RA symptoms and the first secondary care visit. Conversely, the presence of nonrespiratory, major comorbidities at baseline appeared to be protective (OR, 0.62; P = .027).
“We found no association between methotrexate treatment and incident RA-ILD and a possibility that it may be protective,” Dr. Kiely concluded, noting that these data were now published in BMJ Open (2019;9:e028466. doi: 10.1136/bmjopen-2018-028466).
Following Dr. Kiely’s presentation, an audience member asked if the protective effect seen with methotrexate could have been caused by better disease control overall.
Dr. Kiely answered that, up until 2001, the time when ERAS was ongoing, standard practice in the United Kingdom was to use sulfasalazine, but then methotrexate started to be used in higher and higher doses, as seen in ERAN.
The interesting thing is that in ERAN more methotrexate was used in higher doses, but less RA-ILD was seen, Dr. Kiely observed. The overall prevalence of RA-ILD in the later early RA cohort was 3.2% and the median dose of methotrexate used was 20 mg. In ERAS, the prevalence was 4.2% and the median dose of methotrexate used was 10 mg.
There was a suggestion that disease control was slightly better in ERAN than ERAS, but that wasn’t statistically significant, Dr. Kiely said.
So, should a patient with RA and ILD be given methotrexate? There’s no reason not to, Dr. Kiely suggested, based on the evidence shown. Part of the challenge will now be convincing chest physician colleagues that methotrexate is not problematic in terms of causing ILD.
These findings are completely on board with the ILD group’s findings that methotrexate doesn’t cause pulmonary fibrosis in patients with RA, commented Julie Dawson, MD, of St. Helens and Knowsley Teaching Hospitals NHS Trust, St. Helens, England. Her own research, which includes a 10-year follow-up of patients with inflammatory arthritis, has shown that methotrexate does not appear to increase the risk of pulmonary fibrosis.
The study had no specific outside funding. Dr. Kiely reported having no conflicts of interest.
SOURCE: Kiely P et al. Rheumatology. 2019;58(suppl 3), Abstract 009.
BIRMINGHAM, ENGLAND – Data from two early RA inception cohorts provide reassurance that methotrexate does not cause interstitial lung disease and suggest that treatment with methotrexate might even be protective.
In the Early RA Study (ERAS) and Early RA Network (ERAN), which together include 2,701 patients with RA, 101 (3.7%) had interstitial lung disease (ILD). There were 92 patients with RA-ILD who had information available on exposure to any conventional synthetic disease-modifying antirheumatic drug (csDMARD); of these, 39 (2.5%) had been exposed to methotrexate (n = 1,578) and 53 (4.8%) to other csDMARDs (n = 1,114).
Multivariate analysis showed that methotrexate exposure was associated with a reduced risk of developing ILD, with an odds ratio of 0.48 (P = .004). In a separate analysis that excluded 25 patients who had ILD before they received any csDMARD therapy (n = 67), there was no association between methotrexate use and ILD (OR, 0.85; P = .578). In fact, there was a nonsignificant trend for a delayed onset of ILD in patients who had been treated with methotrexate (OR, 0.54; P = .072).
Methotrexate use is associated with an acute hypersensitivity pneumonitis in patients with RA, explained Patrick Kiely, MBBS, PhD, of St. George’s University Hospitals NHS Foundation Trust in London at the British Society for Rheumatology annual conference. “This is well recognized, it’s very rare [0.43%-1.00%], it’s easy to spot, and usually goes away if you stop methotrexate,” said Dr. Kiely, adding that “it’s not benign, and severe cases can be life threatening.”
Because of the association between methotrexate and pneumonitis, there has been concern that methotrexate may exacerbate or even cause ILD in RA but there are sparse data available to confirm this. The bottom line is that you should not start someone on methotrexate if you think their existing lung capacity is not up to treatment with methotrexate, Dr. Kiely said.
ILD is not always symptomatic in RA, but when it is, it is associated with very poor survival. The lung disease can be present before joint symptoms, Dr. Kiely said. Although less than 10% of cases may be symptomatic, this “is a big deal, because it has a high mortality, with death within 5 years. It’s the second-commonest cause of excess mortality in RA after cardiovascular disease.”
To look at the association between incident RA-ILD and the use of methotrexate, Dr. Kiely and associates analyzed data from ERAS (1986-2001) and ERAN (2002-2013), that together have more than 25 years of follow-up data on patients who were recruited at the first sign of RA symptoms. Patients within these cohorts have been treated according to best practice, and a range of outcomes – including RA-ILD – have been assessed at annual intervals.
In the patients who developed ILD after any csDMARD exposure, older age at RA onset (OR, 1.04; P less than .001) and having ever smoked (OR, 1.91; P = .016) were associated with the development of the lung disease. Incident ILD was also associated with being positive for rheumatoid factor (OR, 2.02; P = .029) at baseline. Being male was also associated with a higher risk for developing ILD, Dr. Kiely reported, as was a longer duration of time between the onset of first RA symptoms and the first secondary care visit. Conversely, the presence of nonrespiratory, major comorbidities at baseline appeared to be protective (OR, 0.62; P = .027).
“We found no association between methotrexate treatment and incident RA-ILD and a possibility that it may be protective,” Dr. Kiely concluded, noting that these data were now published in BMJ Open (2019;9:e028466. doi: 10.1136/bmjopen-2018-028466).
Following Dr. Kiely’s presentation, an audience member asked if the protective effect seen with methotrexate could have been caused by better disease control overall.
Dr. Kiely answered that, up until 2001, the time when ERAS was ongoing, standard practice in the United Kingdom was to use sulfasalazine, but then methotrexate started to be used in higher and higher doses, as seen in ERAN.
The interesting thing is that in ERAN more methotrexate was used in higher doses, but less RA-ILD was seen, Dr. Kiely observed. The overall prevalence of RA-ILD in the later early RA cohort was 3.2% and the median dose of methotrexate used was 20 mg. In ERAS, the prevalence was 4.2% and the median dose of methotrexate used was 10 mg.
There was a suggestion that disease control was slightly better in ERAN than ERAS, but that wasn’t statistically significant, Dr. Kiely said.
So, should a patient with RA and ILD be given methotrexate? There’s no reason not to, Dr. Kiely suggested, based on the evidence shown. Part of the challenge will now be convincing chest physician colleagues that methotrexate is not problematic in terms of causing ILD.
These findings are completely on board with the ILD group’s findings that methotrexate doesn’t cause pulmonary fibrosis in patients with RA, commented Julie Dawson, MD, of St. Helens and Knowsley Teaching Hospitals NHS Trust, St. Helens, England. Her own research, which includes a 10-year follow-up of patients with inflammatory arthritis, has shown that methotrexate does not appear to increase the risk of pulmonary fibrosis.
The study had no specific outside funding. Dr. Kiely reported having no conflicts of interest.
SOURCE: Kiely P et al. Rheumatology. 2019;58(suppl 3), Abstract 009.
REPORTING FROM BSR 2019
Culture: An unseen force in the hospital workplace
Parallels from the airline industry
“Workplace culture” has a profound influence on the success or failure of a team in the modern-day work environment, where teamwork and interpersonal interactions have paramount importance. Crew resource management (CRM), a technique developed originally by the airline industry, has been used as a tool to improve safety and quality in ICUs, trauma rooms, and operating rooms.1,2 This article discusses the use of CRM in hospital medicine as a tool for training and maintaining a favorable workplace culture.
Origin and evolution of CRM
United Airlines instituted the airline industry’s first crew resource management for pilots in 1981, following the 1978 crash of United Flight 173 in Portland, Ore. CRM was created based on recommendations from the National Transportation Safety Board and from a NASA workshop held subsequently.3 CRM has since evolved through five generations, and is a required annual training for most major commercial airline companies around the world. It also has been adapted for personnel training by several modern international industries.4
From the airline industry to the hospital
The health care industry is similar to the airline industry in that there is absolutely no margin of error, and that workplace culture plays a very important role. The culture being referred to here is the sum total of values, beliefs, work ethics, work strategies, strengths, and weaknesses of a group of people, and how they interact as a group. In other words, it is the dynamics of a group.
According to Donelson R. Forsyth, a social and personality psychologist at the University of Richmond (Virginia), the two key determinants of successful teamwork are a “shared mental representation of the task,” which refers to an in-depth understanding of the team and the tasks they are attempting; and “group unity/cohesion,” which means that, generally, members of cohesive groups like each other and the group, and they also are united in their pursuit of collective, group-level goals.5
Understanding the culture of a hospitalist team
Analyzing group dynamics and actively managing them toward both the institutional and global goals of health care is critical for the success of an organization. This is the core of successfully managing any team in any industry.
Additionally, the rapidly changing health care climate and insurance payment systems requires hospital medicine groups to rapidly adapt to the constantly changing health care business environment. As a result, there are a couple of ways to evaluate the effectiveness of the team:
- Measure tangible outcomes. The outcomes have to be well defined, important and measurable. These could be cost of care, quality of care, engagement of the team etc. These tangible measures’ outcome over a period of time can be used as a measure of how effective the team is.
- Simply ask your team! It is very important to know what core values the team holds dear. The best way to get that information from the team is to find out the de facto leaders of the team. They should be involved in the decision-making process, thus making them valuable to the management as well as the team.
Culture shapes outcomes
We have used the analogy of a convex and concave lens to help understand this better. A well-developed and well-coordinated team is like convex lens. A lens’ ability to converge or diverge light rays depends on certain characteristics like the curvature of surfaces and refractory index. Likewise, the culture of a group determines its ability to transform all the demands of the collective workload toward a unified goal/outcome. If it is favorable, the group will work as one and success will happen automatically.
Unfortunately, the opposite of this, (the concave lens effect), is more commonplace, where the dynamics of a team prevent the goals being achieved, as there is discordance, poor coordination of ideas and values, and team members not liking each other.
Most teams would fall somewhere within this spectrum, spanning the most favorable convex lens–like group to the least favorable concave lens–like group.
Change team dynamics using CRM principles
The concept of using CRM principles in health care is not entirely new. Such agencies as the Joint Commission and the Agency for Healthcare Research and Quality recommend using principles of CRM to improve communications, and as an error-prevention tool in health care.6
This approach can be broken down into four important steps:
1. Recruit right. It is important to make sure that the new recruit is the right fit for the team and that the de facto leaders and a few other team members are involved in interviewing the candidates. Their assessment should be given due consideration in making the decision to give the new recruit the job.
Every program looks for aspects like clinical competence, interpersonal communication, teamwork, etc., in a candidate, but it is even more important to make sure the candidate has the tenets that would make him/her a part of that particular team.
2. Train well. The newly recruited providers should be given focused training and the seasoned providers should be given refresher training at regular intervals. Care should be taken in designing the training programs in such a way that the providers are trained in skills that they don’t always think about, things that aren’t readily obvious, and in skills that they never get trained in during medical school and residency.
Specifically, they should be trained in:
- Values. These should include the values of both the organization and the team.
- Safety. This should include all the safety protocols that are in place in the organization - where to get help, how to report unsafe events etc.
- Communication.
Within the group: Have a mentor for the new provider, and also develop a culture where he/she feels comfortable to reach out to anyone in the team for help.
With patients and families: This training should ideally be done in a simulated environment if possible.
With other groups in the hospital: Consultants, nurses, other ancillary staff. Give them an idea about the prevailing culture in the organization with regard to these groups, so that they know what to expect when dealing with them.
- Managing perceptions. How the providers are viewed in the hospital, and how to improve it or maintain it.
- Nurturing the good. Use positive reinforcements to solidify the positive aspects of group dynamics these individuals might possess.
- Weeding out the bad. Use training and feedback to alter the negative group dynamic aspects.
3. Intervene. This is necessary either to maintain the positive aspects of a team that is already high-functioning, or to transform a poorly functioning team into a well-coordinated team. This is where the principles of CRM are going to be most useful.
There are five generations of CRM, each with a different focus.6 Only the aspects relevant to hospital medicine training are mentioned here.
- Communication. Address the gaps in communication. It is important to include people who are trusted by the team in designing and executing these sessions.
- Leadership. The goal should be to encourage the team to take ownership of the program. This will make a tremendous change in the ability of a team to deliver and rise up to challenges. The organizational leadership has to be willing to elevate the leaders of the group to positions where they can meaningfully take part in managing the team and making decisions that are critical to the team.
- Burnout management. Providers getting disillusioned: having no work-life balance; not getting enough respect from management, as well as other groups of doctors/nurses/etc. in the hospital; they are subject to bad scheduling and poor pay – all of which can all lead to career-ending burnout. It is important to recognize this and mitigate the factors that cause burnout.
- Organizational culture. If the team feels valued and supported, they will, in turn, work hard toward success. Creative leadership and a willingness to accommodate what matters the most to the team is essential for achieving this.
- Simulated training. These can be done in simulation labs, or in-group sessions with the team, re-creating difficult scenarios or problems in which the whole team can come together and solve them.
- Error containment and management. The team needs to identify possible sources of error and contain them before errors happen. The group should get together if a serious event happens and brainstorm why it happened and take measures to prevent it.
4. Reevaluate. Team dynamics tend to change over time. It is important to constantly re-evaluate the team and make sure that the team’s culture remains favorable. There should be recurrent cycles of retraining and interventions to maintain the positive growth that has been attained, as depicted in the schematic below:
Conclusion
CRM is widely accepted as an effective tool in training individuals in many high performing industries. This article describes a framework in which the principles of CRM can be applied to hospital medicine to maintain positive work culture.
Dr. Prabhakaran is director of hospital medicine transitions of care, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts, Worcester. Dr. Medarametla is medical director, hospital medicine, Baystate Medical Center, and assistant professor of medicine, University of Massachusetts.
References
1. Haerkens MH et al. Crew Resource Management in the ICU: The need for culture change. Ann Intensive Care. 2012 Aug 22;2:39.
2. Haerkens MH et al. Crew Resource Management in the trauma room: A prospective 3-year cohort study. Eur J Emerg Med. 2018 Aug;25(4):281-7.
3. Malcolm Gladwell. The ethnic theory of plane crashes. Outliers: The Story of Success. (Boston: Little, Brown and Company; 2008:177-223).
4. Helmreich RL et al. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32.
5. Forsyth DR. The psychology of groups. In R. Biswas-Diener & E. Diener (eds), Noba textbook series: Psychology. Champaign, Ill: DEF publishers; 2017.
6. Crew Resource Management. Available at Aviation Knowledge. Accessed Dec. 20, 2017.
Parallels from the airline industry
Parallels from the airline industry
“Workplace culture” has a profound influence on the success or failure of a team in the modern-day work environment, where teamwork and interpersonal interactions have paramount importance. Crew resource management (CRM), a technique developed originally by the airline industry, has been used as a tool to improve safety and quality in ICUs, trauma rooms, and operating rooms.1,2 This article discusses the use of CRM in hospital medicine as a tool for training and maintaining a favorable workplace culture.
Origin and evolution of CRM
United Airlines instituted the airline industry’s first crew resource management for pilots in 1981, following the 1978 crash of United Flight 173 in Portland, Ore. CRM was created based on recommendations from the National Transportation Safety Board and from a NASA workshop held subsequently.3 CRM has since evolved through five generations, and is a required annual training for most major commercial airline companies around the world. It also has been adapted for personnel training by several modern international industries.4
From the airline industry to the hospital
The health care industry is similar to the airline industry in that there is absolutely no margin of error, and that workplace culture plays a very important role. The culture being referred to here is the sum total of values, beliefs, work ethics, work strategies, strengths, and weaknesses of a group of people, and how they interact as a group. In other words, it is the dynamics of a group.
According to Donelson R. Forsyth, a social and personality psychologist at the University of Richmond (Virginia), the two key determinants of successful teamwork are a “shared mental representation of the task,” which refers to an in-depth understanding of the team and the tasks they are attempting; and “group unity/cohesion,” which means that, generally, members of cohesive groups like each other and the group, and they also are united in their pursuit of collective, group-level goals.5
Understanding the culture of a hospitalist team
Analyzing group dynamics and actively managing them toward both the institutional and global goals of health care is critical for the success of an organization. This is the core of successfully managing any team in any industry.
Additionally, the rapidly changing health care climate and insurance payment systems requires hospital medicine groups to rapidly adapt to the constantly changing health care business environment. As a result, there are a couple of ways to evaluate the effectiveness of the team:
- Measure tangible outcomes. The outcomes have to be well defined, important and measurable. These could be cost of care, quality of care, engagement of the team etc. These tangible measures’ outcome over a period of time can be used as a measure of how effective the team is.
- Simply ask your team! It is very important to know what core values the team holds dear. The best way to get that information from the team is to find out the de facto leaders of the team. They should be involved in the decision-making process, thus making them valuable to the management as well as the team.
Culture shapes outcomes
We have used the analogy of a convex and concave lens to help understand this better. A well-developed and well-coordinated team is like convex lens. A lens’ ability to converge or diverge light rays depends on certain characteristics like the curvature of surfaces and refractory index. Likewise, the culture of a group determines its ability to transform all the demands of the collective workload toward a unified goal/outcome. If it is favorable, the group will work as one and success will happen automatically.
Unfortunately, the opposite of this, (the concave lens effect), is more commonplace, where the dynamics of a team prevent the goals being achieved, as there is discordance, poor coordination of ideas and values, and team members not liking each other.
Most teams would fall somewhere within this spectrum, spanning the most favorable convex lens–like group to the least favorable concave lens–like group.
Change team dynamics using CRM principles
The concept of using CRM principles in health care is not entirely new. Such agencies as the Joint Commission and the Agency for Healthcare Research and Quality recommend using principles of CRM to improve communications, and as an error-prevention tool in health care.6
This approach can be broken down into four important steps:
1. Recruit right. It is important to make sure that the new recruit is the right fit for the team and that the de facto leaders and a few other team members are involved in interviewing the candidates. Their assessment should be given due consideration in making the decision to give the new recruit the job.
Every program looks for aspects like clinical competence, interpersonal communication, teamwork, etc., in a candidate, but it is even more important to make sure the candidate has the tenets that would make him/her a part of that particular team.
2. Train well. The newly recruited providers should be given focused training and the seasoned providers should be given refresher training at regular intervals. Care should be taken in designing the training programs in such a way that the providers are trained in skills that they don’t always think about, things that aren’t readily obvious, and in skills that they never get trained in during medical school and residency.
Specifically, they should be trained in:
- Values. These should include the values of both the organization and the team.
- Safety. This should include all the safety protocols that are in place in the organization - where to get help, how to report unsafe events etc.
- Communication.
Within the group: Have a mentor for the new provider, and also develop a culture where he/she feels comfortable to reach out to anyone in the team for help.
With patients and families: This training should ideally be done in a simulated environment if possible.
With other groups in the hospital: Consultants, nurses, other ancillary staff. Give them an idea about the prevailing culture in the organization with regard to these groups, so that they know what to expect when dealing with them.
- Managing perceptions. How the providers are viewed in the hospital, and how to improve it or maintain it.
- Nurturing the good. Use positive reinforcements to solidify the positive aspects of group dynamics these individuals might possess.
- Weeding out the bad. Use training and feedback to alter the negative group dynamic aspects.
3. Intervene. This is necessary either to maintain the positive aspects of a team that is already high-functioning, or to transform a poorly functioning team into a well-coordinated team. This is where the principles of CRM are going to be most useful.
There are five generations of CRM, each with a different focus.6 Only the aspects relevant to hospital medicine training are mentioned here.
- Communication. Address the gaps in communication. It is important to include people who are trusted by the team in designing and executing these sessions.
- Leadership. The goal should be to encourage the team to take ownership of the program. This will make a tremendous change in the ability of a team to deliver and rise up to challenges. The organizational leadership has to be willing to elevate the leaders of the group to positions where they can meaningfully take part in managing the team and making decisions that are critical to the team.
- Burnout management. Providers getting disillusioned: having no work-life balance; not getting enough respect from management, as well as other groups of doctors/nurses/etc. in the hospital; they are subject to bad scheduling and poor pay – all of which can all lead to career-ending burnout. It is important to recognize this and mitigate the factors that cause burnout.
- Organizational culture. If the team feels valued and supported, they will, in turn, work hard toward success. Creative leadership and a willingness to accommodate what matters the most to the team is essential for achieving this.
- Simulated training. These can be done in simulation labs, or in-group sessions with the team, re-creating difficult scenarios or problems in which the whole team can come together and solve them.
- Error containment and management. The team needs to identify possible sources of error and contain them before errors happen. The group should get together if a serious event happens and brainstorm why it happened and take measures to prevent it.
4. Reevaluate. Team dynamics tend to change over time. It is important to constantly re-evaluate the team and make sure that the team’s culture remains favorable. There should be recurrent cycles of retraining and interventions to maintain the positive growth that has been attained, as depicted in the schematic below:
Conclusion
CRM is widely accepted as an effective tool in training individuals in many high performing industries. This article describes a framework in which the principles of CRM can be applied to hospital medicine to maintain positive work culture.
Dr. Prabhakaran is director of hospital medicine transitions of care, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts, Worcester. Dr. Medarametla is medical director, hospital medicine, Baystate Medical Center, and assistant professor of medicine, University of Massachusetts.
References
1. Haerkens MH et al. Crew Resource Management in the ICU: The need for culture change. Ann Intensive Care. 2012 Aug 22;2:39.
2. Haerkens MH et al. Crew Resource Management in the trauma room: A prospective 3-year cohort study. Eur J Emerg Med. 2018 Aug;25(4):281-7.
3. Malcolm Gladwell. The ethnic theory of plane crashes. Outliers: The Story of Success. (Boston: Little, Brown and Company; 2008:177-223).
4. Helmreich RL et al. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32.
5. Forsyth DR. The psychology of groups. In R. Biswas-Diener & E. Diener (eds), Noba textbook series: Psychology. Champaign, Ill: DEF publishers; 2017.
6. Crew Resource Management. Available at Aviation Knowledge. Accessed Dec. 20, 2017.
“Workplace culture” has a profound influence on the success or failure of a team in the modern-day work environment, where teamwork and interpersonal interactions have paramount importance. Crew resource management (CRM), a technique developed originally by the airline industry, has been used as a tool to improve safety and quality in ICUs, trauma rooms, and operating rooms.1,2 This article discusses the use of CRM in hospital medicine as a tool for training and maintaining a favorable workplace culture.
Origin and evolution of CRM
United Airlines instituted the airline industry’s first crew resource management for pilots in 1981, following the 1978 crash of United Flight 173 in Portland, Ore. CRM was created based on recommendations from the National Transportation Safety Board and from a NASA workshop held subsequently.3 CRM has since evolved through five generations, and is a required annual training for most major commercial airline companies around the world. It also has been adapted for personnel training by several modern international industries.4
From the airline industry to the hospital
The health care industry is similar to the airline industry in that there is absolutely no margin of error, and that workplace culture plays a very important role. The culture being referred to here is the sum total of values, beliefs, work ethics, work strategies, strengths, and weaknesses of a group of people, and how they interact as a group. In other words, it is the dynamics of a group.
According to Donelson R. Forsyth, a social and personality psychologist at the University of Richmond (Virginia), the two key determinants of successful teamwork are a “shared mental representation of the task,” which refers to an in-depth understanding of the team and the tasks they are attempting; and “group unity/cohesion,” which means that, generally, members of cohesive groups like each other and the group, and they also are united in their pursuit of collective, group-level goals.5
Understanding the culture of a hospitalist team
Analyzing group dynamics and actively managing them toward both the institutional and global goals of health care is critical for the success of an organization. This is the core of successfully managing any team in any industry.
Additionally, the rapidly changing health care climate and insurance payment systems requires hospital medicine groups to rapidly adapt to the constantly changing health care business environment. As a result, there are a couple of ways to evaluate the effectiveness of the team:
- Measure tangible outcomes. The outcomes have to be well defined, important and measurable. These could be cost of care, quality of care, engagement of the team etc. These tangible measures’ outcome over a period of time can be used as a measure of how effective the team is.
- Simply ask your team! It is very important to know what core values the team holds dear. The best way to get that information from the team is to find out the de facto leaders of the team. They should be involved in the decision-making process, thus making them valuable to the management as well as the team.
Culture shapes outcomes
We have used the analogy of a convex and concave lens to help understand this better. A well-developed and well-coordinated team is like convex lens. A lens’ ability to converge or diverge light rays depends on certain characteristics like the curvature of surfaces and refractory index. Likewise, the culture of a group determines its ability to transform all the demands of the collective workload toward a unified goal/outcome. If it is favorable, the group will work as one and success will happen automatically.
Unfortunately, the opposite of this, (the concave lens effect), is more commonplace, where the dynamics of a team prevent the goals being achieved, as there is discordance, poor coordination of ideas and values, and team members not liking each other.
Most teams would fall somewhere within this spectrum, spanning the most favorable convex lens–like group to the least favorable concave lens–like group.
Change team dynamics using CRM principles
The concept of using CRM principles in health care is not entirely new. Such agencies as the Joint Commission and the Agency for Healthcare Research and Quality recommend using principles of CRM to improve communications, and as an error-prevention tool in health care.6
This approach can be broken down into four important steps:
1. Recruit right. It is important to make sure that the new recruit is the right fit for the team and that the de facto leaders and a few other team members are involved in interviewing the candidates. Their assessment should be given due consideration in making the decision to give the new recruit the job.
Every program looks for aspects like clinical competence, interpersonal communication, teamwork, etc., in a candidate, but it is even more important to make sure the candidate has the tenets that would make him/her a part of that particular team.
2. Train well. The newly recruited providers should be given focused training and the seasoned providers should be given refresher training at regular intervals. Care should be taken in designing the training programs in such a way that the providers are trained in skills that they don’t always think about, things that aren’t readily obvious, and in skills that they never get trained in during medical school and residency.
Specifically, they should be trained in:
- Values. These should include the values of both the organization and the team.
- Safety. This should include all the safety protocols that are in place in the organization - where to get help, how to report unsafe events etc.
- Communication.
Within the group: Have a mentor for the new provider, and also develop a culture where he/she feels comfortable to reach out to anyone in the team for help.
With patients and families: This training should ideally be done in a simulated environment if possible.
With other groups in the hospital: Consultants, nurses, other ancillary staff. Give them an idea about the prevailing culture in the organization with regard to these groups, so that they know what to expect when dealing with them.
- Managing perceptions. How the providers are viewed in the hospital, and how to improve it or maintain it.
- Nurturing the good. Use positive reinforcements to solidify the positive aspects of group dynamics these individuals might possess.
- Weeding out the bad. Use training and feedback to alter the negative group dynamic aspects.
3. Intervene. This is necessary either to maintain the positive aspects of a team that is already high-functioning, or to transform a poorly functioning team into a well-coordinated team. This is where the principles of CRM are going to be most useful.
There are five generations of CRM, each with a different focus.6 Only the aspects relevant to hospital medicine training are mentioned here.
- Communication. Address the gaps in communication. It is important to include people who are trusted by the team in designing and executing these sessions.
- Leadership. The goal should be to encourage the team to take ownership of the program. This will make a tremendous change in the ability of a team to deliver and rise up to challenges. The organizational leadership has to be willing to elevate the leaders of the group to positions where they can meaningfully take part in managing the team and making decisions that are critical to the team.
- Burnout management. Providers getting disillusioned: having no work-life balance; not getting enough respect from management, as well as other groups of doctors/nurses/etc. in the hospital; they are subject to bad scheduling and poor pay – all of which can all lead to career-ending burnout. It is important to recognize this and mitigate the factors that cause burnout.
- Organizational culture. If the team feels valued and supported, they will, in turn, work hard toward success. Creative leadership and a willingness to accommodate what matters the most to the team is essential for achieving this.
- Simulated training. These can be done in simulation labs, or in-group sessions with the team, re-creating difficult scenarios or problems in which the whole team can come together and solve them.
- Error containment and management. The team needs to identify possible sources of error and contain them before errors happen. The group should get together if a serious event happens and brainstorm why it happened and take measures to prevent it.
4. Reevaluate. Team dynamics tend to change over time. It is important to constantly re-evaluate the team and make sure that the team’s culture remains favorable. There should be recurrent cycles of retraining and interventions to maintain the positive growth that has been attained, as depicted in the schematic below:
Conclusion
CRM is widely accepted as an effective tool in training individuals in many high performing industries. This article describes a framework in which the principles of CRM can be applied to hospital medicine to maintain positive work culture.
Dr. Prabhakaran is director of hospital medicine transitions of care, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts, Worcester. Dr. Medarametla is medical director, hospital medicine, Baystate Medical Center, and assistant professor of medicine, University of Massachusetts.
References
1. Haerkens MH et al. Crew Resource Management in the ICU: The need for culture change. Ann Intensive Care. 2012 Aug 22;2:39.
2. Haerkens MH et al. Crew Resource Management in the trauma room: A prospective 3-year cohort study. Eur J Emerg Med. 2018 Aug;25(4):281-7.
3. Malcolm Gladwell. The ethnic theory of plane crashes. Outliers: The Story of Success. (Boston: Little, Brown and Company; 2008:177-223).
4. Helmreich RL et al. The evolution of Crew Resource Management training in commercial aviation. Int J Aviat Psychol. 1999;9(1):19-32.
5. Forsyth DR. The psychology of groups. In R. Biswas-Diener & E. Diener (eds), Noba textbook series: Psychology. Champaign, Ill: DEF publishers; 2017.
6. Crew Resource Management. Available at Aviation Knowledge. Accessed Dec. 20, 2017.