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VIDEO: Use oil-based contrast for HSG fertility boost
VANCOUVER – Ongoing pregnancies and live births were substantially higher when oil-based contrast, instead of water-based contrast, was used for hysterosalpingography (HSG) in a randomized trial at 27 hospitals in the Netherlands.
It’s long been known that HSG, commonly used to assess reproductive tract patency, also improves fertility, perhaps by immunologic effects or simply by flushing debris and mucus out of the fallopian tubes. Until now, however, it’s been unclear if oil or water contrast boosts fertility the most.
To find out, investigators randomized 554 infertile women scheduled for HSG to poppy seed oil contrast (Lipiodol Ultra-Fluid, Guerbet) and 554 others to water contrast (Telebrix Hystero, Guerbet).
A total of 220 women in the oil group (39.7%), but 161 in the water group (29.1%), achieved ongoing pregnancies (rate ratio in favor of oil, 1.37; 95% CI, 1.16-1.61; P less than 0.001). Of 552 women in each of the groups, 214 in the oil group (38.8%) and 155 in the water group (28.1%) had live births (RR, 1.38; 95% CI, 1.17-1.64; P less than 0.001). Rates of adverse events were low and similar in the two groups. About three-quarters of the pregnancies were naturally conceived, and most of the rest resulted from intrauterine insemination. Only a few women in each group used in vitro fertilization (N Engl J Med. 2017 May 18. doi: 10.1056/NEJMoa1612337).
Three women in the oil group, but none in the water group, delivered a child with a congenital anomaly. “This finding is probably due to chance. The frequency of congenital anomalies with oil contrast was not greater than rates reported in the general population, and we are unaware of other data suggesting an increased risk of congenital anomalies with oil contrast,” the researchers said.
In an interview at the World Congress on Endometriosis, senior investigator Ben Mol, MD, PhD, a professor of obstetrics and gynecology at the University of Adelaide (Australia), shared his thoughts on how the new findings should be used in routine practice when women with endometriosis and other conditions experience difficulty conceiving.
There was no industry funding for the work. Dr. Mol reported personal fees from Guerbet unrelated to the study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – Ongoing pregnancies and live births were substantially higher when oil-based contrast, instead of water-based contrast, was used for hysterosalpingography (HSG) in a randomized trial at 27 hospitals in the Netherlands.
It’s long been known that HSG, commonly used to assess reproductive tract patency, also improves fertility, perhaps by immunologic effects or simply by flushing debris and mucus out of the fallopian tubes. Until now, however, it’s been unclear if oil or water contrast boosts fertility the most.
To find out, investigators randomized 554 infertile women scheduled for HSG to poppy seed oil contrast (Lipiodol Ultra-Fluid, Guerbet) and 554 others to water contrast (Telebrix Hystero, Guerbet).
A total of 220 women in the oil group (39.7%), but 161 in the water group (29.1%), achieved ongoing pregnancies (rate ratio in favor of oil, 1.37; 95% CI, 1.16-1.61; P less than 0.001). Of 552 women in each of the groups, 214 in the oil group (38.8%) and 155 in the water group (28.1%) had live births (RR, 1.38; 95% CI, 1.17-1.64; P less than 0.001). Rates of adverse events were low and similar in the two groups. About three-quarters of the pregnancies were naturally conceived, and most of the rest resulted from intrauterine insemination. Only a few women in each group used in vitro fertilization (N Engl J Med. 2017 May 18. doi: 10.1056/NEJMoa1612337).
Three women in the oil group, but none in the water group, delivered a child with a congenital anomaly. “This finding is probably due to chance. The frequency of congenital anomalies with oil contrast was not greater than rates reported in the general population, and we are unaware of other data suggesting an increased risk of congenital anomalies with oil contrast,” the researchers said.
In an interview at the World Congress on Endometriosis, senior investigator Ben Mol, MD, PhD, a professor of obstetrics and gynecology at the University of Adelaide (Australia), shared his thoughts on how the new findings should be used in routine practice when women with endometriosis and other conditions experience difficulty conceiving.
There was no industry funding for the work. Dr. Mol reported personal fees from Guerbet unrelated to the study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
VANCOUVER – Ongoing pregnancies and live births were substantially higher when oil-based contrast, instead of water-based contrast, was used for hysterosalpingography (HSG) in a randomized trial at 27 hospitals in the Netherlands.
It’s long been known that HSG, commonly used to assess reproductive tract patency, also improves fertility, perhaps by immunologic effects or simply by flushing debris and mucus out of the fallopian tubes. Until now, however, it’s been unclear if oil or water contrast boosts fertility the most.
To find out, investigators randomized 554 infertile women scheduled for HSG to poppy seed oil contrast (Lipiodol Ultra-Fluid, Guerbet) and 554 others to water contrast (Telebrix Hystero, Guerbet).
A total of 220 women in the oil group (39.7%), but 161 in the water group (29.1%), achieved ongoing pregnancies (rate ratio in favor of oil, 1.37; 95% CI, 1.16-1.61; P less than 0.001). Of 552 women in each of the groups, 214 in the oil group (38.8%) and 155 in the water group (28.1%) had live births (RR, 1.38; 95% CI, 1.17-1.64; P less than 0.001). Rates of adverse events were low and similar in the two groups. About three-quarters of the pregnancies were naturally conceived, and most of the rest resulted from intrauterine insemination. Only a few women in each group used in vitro fertilization (N Engl J Med. 2017 May 18. doi: 10.1056/NEJMoa1612337).
Three women in the oil group, but none in the water group, delivered a child with a congenital anomaly. “This finding is probably due to chance. The frequency of congenital anomalies with oil contrast was not greater than rates reported in the general population, and we are unaware of other data suggesting an increased risk of congenital anomalies with oil contrast,” the researchers said.
In an interview at the World Congress on Endometriosis, senior investigator Ben Mol, MD, PhD, a professor of obstetrics and gynecology at the University of Adelaide (Australia), shared his thoughts on how the new findings should be used in routine practice when women with endometriosis and other conditions experience difficulty conceiving.
There was no industry funding for the work. Dr. Mol reported personal fees from Guerbet unrelated to the study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT WEC 2017
VIDEO: Chronic cough drug shows phase II efficacy, tolerability
WASHINGTON – A new oral drug that blocks a nerve ion channel was generally tolerable and effective at reducing chronic, refractory cough in a placebo-controlled, dose-ranging, phase II study with 252 patients.
A 50 mg b.i.d dosage of MK-7264 cut cough frequency by at least 30% in 80% of patients, compared with 44% of patients on placebo, Jaclyn A. Smith, MD, said at an international conference of the American Thoracic Society.
At that dosage, 48% of patients reported some change in their taste sensations, an expected drug effect, with about 40% characterizing it as very bothersome or extremely bothersome. An additional 9% reported a complete loss of taste. However, only 6 patients out of 63 randomized to this dosage stopped taking their medication, suggesting that the drug was tolerable for most patients. The results also suggested that lower dosages with less potent taste adverse effects produced significant cough reductions in some patients.
“Patients with chronic, refractory cough are often “willing to accept some taste change to reduce their cough count. Patients are willing to put up with the taste side effects,” Dr. Smith said in a video interview.
The study enrolled patients with chronic, refractory cough at U.S. and UK centers and randomized 63 to each of three active treatment arms receiving 7.5 mg, 20 mg, or 50 mg b.i.d. of MK-7264 or to placebo for 12 weeks. The patients averaged 60 years of age and about three-quarters were women. On average, they had their cough for more than 10 years, and these patients coughed roughly 30 times an hour when awake.
The study’s primary endpoint was reduction in awake cough frequency, and, after 12 weeks on treatment with 50 mg b.i.d., this had fallen an average of 37%, compared with placebo, said Dr. Smith, a professor of respiratory medicine at the University of Manchester, England.
The 7.5-mg and 20-mg b.i.d. dosages each led to cough frequency reductions of about 22% over placebo that were not statistically significant. This was likely a result of the unexpectedly strong placebo effect in the study, Dr. Smith said. Most of the cough effect was evident after the first 4 weeks on treatment.
Dr. Smith noted that she and her associates “most definitely” plan to progress to a phase III trial. “We really lack effective treatments for cough,” she said.
The study was sponsored by Merck, the company developing MK-7264. Dr. Smith is a consultant to Merck and has a licensing agreement with Vitalograph.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A new oral drug that blocks a nerve ion channel was generally tolerable and effective at reducing chronic, refractory cough in a placebo-controlled, dose-ranging, phase II study with 252 patients.
A 50 mg b.i.d dosage of MK-7264 cut cough frequency by at least 30% in 80% of patients, compared with 44% of patients on placebo, Jaclyn A. Smith, MD, said at an international conference of the American Thoracic Society.
At that dosage, 48% of patients reported some change in their taste sensations, an expected drug effect, with about 40% characterizing it as very bothersome or extremely bothersome. An additional 9% reported a complete loss of taste. However, only 6 patients out of 63 randomized to this dosage stopped taking their medication, suggesting that the drug was tolerable for most patients. The results also suggested that lower dosages with less potent taste adverse effects produced significant cough reductions in some patients.
“Patients with chronic, refractory cough are often “willing to accept some taste change to reduce their cough count. Patients are willing to put up with the taste side effects,” Dr. Smith said in a video interview.
The study enrolled patients with chronic, refractory cough at U.S. and UK centers and randomized 63 to each of three active treatment arms receiving 7.5 mg, 20 mg, or 50 mg b.i.d. of MK-7264 or to placebo for 12 weeks. The patients averaged 60 years of age and about three-quarters were women. On average, they had their cough for more than 10 years, and these patients coughed roughly 30 times an hour when awake.
The study’s primary endpoint was reduction in awake cough frequency, and, after 12 weeks on treatment with 50 mg b.i.d., this had fallen an average of 37%, compared with placebo, said Dr. Smith, a professor of respiratory medicine at the University of Manchester, England.
The 7.5-mg and 20-mg b.i.d. dosages each led to cough frequency reductions of about 22% over placebo that were not statistically significant. This was likely a result of the unexpectedly strong placebo effect in the study, Dr. Smith said. Most of the cough effect was evident after the first 4 weeks on treatment.
Dr. Smith noted that she and her associates “most definitely” plan to progress to a phase III trial. “We really lack effective treatments for cough,” she said.
The study was sponsored by Merck, the company developing MK-7264. Dr. Smith is a consultant to Merck and has a licensing agreement with Vitalograph.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – A new oral drug that blocks a nerve ion channel was generally tolerable and effective at reducing chronic, refractory cough in a placebo-controlled, dose-ranging, phase II study with 252 patients.
A 50 mg b.i.d dosage of MK-7264 cut cough frequency by at least 30% in 80% of patients, compared with 44% of patients on placebo, Jaclyn A. Smith, MD, said at an international conference of the American Thoracic Society.
At that dosage, 48% of patients reported some change in their taste sensations, an expected drug effect, with about 40% characterizing it as very bothersome or extremely bothersome. An additional 9% reported a complete loss of taste. However, only 6 patients out of 63 randomized to this dosage stopped taking their medication, suggesting that the drug was tolerable for most patients. The results also suggested that lower dosages with less potent taste adverse effects produced significant cough reductions in some patients.
“Patients with chronic, refractory cough are often “willing to accept some taste change to reduce their cough count. Patients are willing to put up with the taste side effects,” Dr. Smith said in a video interview.
The study enrolled patients with chronic, refractory cough at U.S. and UK centers and randomized 63 to each of three active treatment arms receiving 7.5 mg, 20 mg, or 50 mg b.i.d. of MK-7264 or to placebo for 12 weeks. The patients averaged 60 years of age and about three-quarters were women. On average, they had their cough for more than 10 years, and these patients coughed roughly 30 times an hour when awake.
The study’s primary endpoint was reduction in awake cough frequency, and, after 12 weeks on treatment with 50 mg b.i.d., this had fallen an average of 37%, compared with placebo, said Dr. Smith, a professor of respiratory medicine at the University of Manchester, England.
The 7.5-mg and 20-mg b.i.d. dosages each led to cough frequency reductions of about 22% over placebo that were not statistically significant. This was likely a result of the unexpectedly strong placebo effect in the study, Dr. Smith said. Most of the cough effect was evident after the first 4 weeks on treatment.
Dr. Smith noted that she and her associates “most definitely” plan to progress to a phase III trial. “We really lack effective treatments for cough,” she said.
The study was sponsored by Merck, the company developing MK-7264. Dr. Smith is a consultant to Merck and has a licensing agreement with Vitalograph.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT ATS 2017
Key clinical point:
Major finding: A 50 mg b.i.d. dosage of MK-7264 reduced awake cough frequency by an average of 37%, compared with placebo.
Data source: A multicenter, randomized, placebo-controlled, dose-ranging study with 252 patients.
Disclosures: The study was sponsored by Merck, the company developing MK-7264. Dr. Smith is a consultant to Merck and has a licensing agreement with Vitalograph.
Biologic may reduce glucocorticoid use
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
WASHINGTON – The biologic benralizumab cut glucocorticoid dosage by nearly 75% among patients with severe, uncontrolled asthma, compared with a 25% reduction in dosage among patients using a placebo, according to a study.
In this three-armed, double-blind study of 220 patients, those administered benralizumab every 4 and 8 weeks were 4.09 (95% confidence interval, 2.22-7.57) and 4.12 (95% CI, 2.22-7.57) times as likely to see a reduction in glucocorticoid dose, compared with those in the placebo group, according to investigators (NEJM. 2017 May 21. doi: 10.1056/NEJMoa1703501).The study was presented at an international conference of the American Thoracic Society and published simultaneously in the New England Journal of Medicine.
“Frequent or long-term use of systemic corticosteroids can lead to potentially life-threatening complications, including osteoporosis, diabetes, cardiovascular disease, and adrenal suppression,” Parameswaran Nair, MD, PhD, professor at McMaster University, Hamilton, Ont., said in a press release. “We need new, safe therapies that would replace the need for systemic corticosteroids for patients with severe asthma.”
To test benralizumab’s effectiveness, investigators measured a baseline level of glucocorticoid dosage of 220 patients with severe, uncontrolled asthma. Patients were then given one of three treatment options: one dose of benralizumab every 4 weeks, one dose of benralizumab every 8 weeks, or a placebo. All three treatments were decreased each time until minimal dosage was found while still maintaining asthma control. The average age of patients was around 50 years, with the majority of patients in both treatment groups and the placebo group having been female.
The researchers also analyzed patients’ accounts of any worsening asthma symptoms, which were recorded in an electronic asthma daily diary.
Along with the median 75% decrease in glucocorticoid dosage seen in both groups of patients receiving benralizumab, 24 patients (33%) in the 4-week group and 27 patients in the 8-week group (37%) showed a 90% reduction from their baseline glucocorticoid dosage. In contrast, only nine patients (12%) in the placebo group experienced a 90% drop in glucocorticoid use.
The researchers observed an additional finding suggesting benralizumab’s usefulness in a subgroup of patients with a baseline prednisone dose of less than 12.5 mg. These patients were more likely to stop taking their glucocorticoid dose if they were taking benralizumab instead of the placebo. Specifically, patients who took benralizumab every 4 weeks were 5.23 times more likely and those who took the biologic every 8 weeks were 4.19 times more likely to cease using glucocorticoids.
Similar to the current biologics used to treat severe eosinophilic asthma, mepolizumab and reslizumab, benralizumab is a form of a monoclonal antibody. Instead of targeting interleukin-5, benralizumab works against a subunit of the iterleukin-5 receptor. They investigators said this aspect of benralizumab may explain why it was successful in this study.
“Targeting of the alpha-subunit of the iterleukin-5 receptor with benralizumab has potential advantages over existing anti–interleukin-5 therapies,” according to Dr. Nier and fellow investigators. “By targeting the interleukin receptor rather than the cytokine, luminal depletion of eosinophils can occur, which may be related to greater clinical efficiency.”
The investigators noted that FEV1 levels seemed relatively unaffected by benralizumab.
This study was limited by the length of the trials, which lasted 28 weeks. Investigators also note that 20% of the original patients were not used in the final population.
This study was sponsored by, and organized in partnership with, AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
[email protected]
On Twitter @eaztweets
FROM ATS 2017
Key clinical point:
Major finding: Patients administered benralizumab averaged a 75% reduction rate in final glucocorticoid dosage, compared with 25% in the control group (P less than .001).
Data source: Randomized, double blind, placebo-controlled study of 220 patients with severe asthma given benralizumab every 4 weeks or every 8 weeks or a placebo between April 2014 and November 2015.
Disclosures: The study was sponsored by and designed in collaboration with AstraZeneca. All of the investigators reported having a financial or other type of relationship with AstraZeneca.
Treatment challenges for lichen planopilaris
SYDNEY – Responses to treatments for lichen planopilaris varied widely, and decreased with second- and third-line therapies, in a retrospective study, Karolina Kerkemeyer, MD, said at the annual meeting of the Australasian College of Dermatologists.
An analysis of computerized medical records for 32 patients who had been treated for lichen planopilaris at a tertiary referral hair center in Australia was conducted from 2012 to 2016 by Dr. Kerkemeyer of the University of Notre Dame Australia, Werribee, and Jack Green, MD, of the Skin and Cancer Foundation and St. Vincent’s Hospital in Melbourne. The study excluded patients with a dual diagnosis, or those followed for less than 12 months.
The most common treatment was topical steroids, used to treat 31 patients, followed by tetracyclines – minocycline or doxycycline – used to treat 21 patients, and hydroxychloroquine, used to treat 18 patients. Some patients were also treated with steroid-sparing immunosuppressants, including methotrexate, mycophenolate, and cyclosporine. Fourteen patients were also treated with intralesional steroids, and seven were treated with topical tacrolimus.
The researchers used a graded four-point scale to assess patients’ response to treatment, which corresponded to remission, partial improvement, no change, and worsening of disease, based on patients’ clinical signs, symptoms, and extent of alopecia.
Only a small proportion – about 15% – of patients achieved remission, which was seen with topical steroids, hydroxychloroquine, and doxycycline. About one-third of patients treated with doxycycline actually showed a worsening of symptoms.
The greatest proportion (75%) of patients with partial remission was among those treated with systemic acitretin, although the numbers were low (three of four patients who received this therapy).
In addition, one of the seven patients treated with minocycline achieved partial remission during this therapy, one showed a worsening of the condition, and the remaining five were unchanged. Among those treated with an immunosuppressant, the 3 patients treated with mycophenolate had no change in the condition; 4 of the 10 patients treated with methotrexate achieved partial remission, 4 were unchanged, and 2 experienced a worsening of the condition. One of the three patients treated with cyclosporine achieved partial remission while the other two remained unchanged. With topical tacrolimus, two patients achieved partial remission, two showed a worsening of the condition, and the remaining three were unchanged.
The response rates to treatment significantly decreased with subsequent therapies: 18 of the 32 patients responded to first-line treatments, compared with 7 of 19 who received second-line treatment and only 1 of 9 patients who received third-line treatment. “Many patients were not responsive to therapy, highlighting the difficulty of treating this scarring alopecia,” Dr. Kerkemeyer said.
In an interview, she said that topical or intralesional steroids seemed to be the best first-line option because they are associated with fewer side effects than other options. “They were easier to start off in patients first,” and for those who do not respond, switching to another treatment, such as topical tacrolimus, if they wanted a topical option, or an oral treatment, such as an immunosuppressant like methotrexate, she noted.
No conflicts of interest were declared.
SYDNEY – Responses to treatments for lichen planopilaris varied widely, and decreased with second- and third-line therapies, in a retrospective study, Karolina Kerkemeyer, MD, said at the annual meeting of the Australasian College of Dermatologists.
An analysis of computerized medical records for 32 patients who had been treated for lichen planopilaris at a tertiary referral hair center in Australia was conducted from 2012 to 2016 by Dr. Kerkemeyer of the University of Notre Dame Australia, Werribee, and Jack Green, MD, of the Skin and Cancer Foundation and St. Vincent’s Hospital in Melbourne. The study excluded patients with a dual diagnosis, or those followed for less than 12 months.
The most common treatment was topical steroids, used to treat 31 patients, followed by tetracyclines – minocycline or doxycycline – used to treat 21 patients, and hydroxychloroquine, used to treat 18 patients. Some patients were also treated with steroid-sparing immunosuppressants, including methotrexate, mycophenolate, and cyclosporine. Fourteen patients were also treated with intralesional steroids, and seven were treated with topical tacrolimus.
The researchers used a graded four-point scale to assess patients’ response to treatment, which corresponded to remission, partial improvement, no change, and worsening of disease, based on patients’ clinical signs, symptoms, and extent of alopecia.
Only a small proportion – about 15% – of patients achieved remission, which was seen with topical steroids, hydroxychloroquine, and doxycycline. About one-third of patients treated with doxycycline actually showed a worsening of symptoms.
The greatest proportion (75%) of patients with partial remission was among those treated with systemic acitretin, although the numbers were low (three of four patients who received this therapy).
In addition, one of the seven patients treated with minocycline achieved partial remission during this therapy, one showed a worsening of the condition, and the remaining five were unchanged. Among those treated with an immunosuppressant, the 3 patients treated with mycophenolate had no change in the condition; 4 of the 10 patients treated with methotrexate achieved partial remission, 4 were unchanged, and 2 experienced a worsening of the condition. One of the three patients treated with cyclosporine achieved partial remission while the other two remained unchanged. With topical tacrolimus, two patients achieved partial remission, two showed a worsening of the condition, and the remaining three were unchanged.
The response rates to treatment significantly decreased with subsequent therapies: 18 of the 32 patients responded to first-line treatments, compared with 7 of 19 who received second-line treatment and only 1 of 9 patients who received third-line treatment. “Many patients were not responsive to therapy, highlighting the difficulty of treating this scarring alopecia,” Dr. Kerkemeyer said.
In an interview, she said that topical or intralesional steroids seemed to be the best first-line option because they are associated with fewer side effects than other options. “They were easier to start off in patients first,” and for those who do not respond, switching to another treatment, such as topical tacrolimus, if they wanted a topical option, or an oral treatment, such as an immunosuppressant like methotrexate, she noted.
No conflicts of interest were declared.
SYDNEY – Responses to treatments for lichen planopilaris varied widely, and decreased with second- and third-line therapies, in a retrospective study, Karolina Kerkemeyer, MD, said at the annual meeting of the Australasian College of Dermatologists.
An analysis of computerized medical records for 32 patients who had been treated for lichen planopilaris at a tertiary referral hair center in Australia was conducted from 2012 to 2016 by Dr. Kerkemeyer of the University of Notre Dame Australia, Werribee, and Jack Green, MD, of the Skin and Cancer Foundation and St. Vincent’s Hospital in Melbourne. The study excluded patients with a dual diagnosis, or those followed for less than 12 months.
The most common treatment was topical steroids, used to treat 31 patients, followed by tetracyclines – minocycline or doxycycline – used to treat 21 patients, and hydroxychloroquine, used to treat 18 patients. Some patients were also treated with steroid-sparing immunosuppressants, including methotrexate, mycophenolate, and cyclosporine. Fourteen patients were also treated with intralesional steroids, and seven were treated with topical tacrolimus.
The researchers used a graded four-point scale to assess patients’ response to treatment, which corresponded to remission, partial improvement, no change, and worsening of disease, based on patients’ clinical signs, symptoms, and extent of alopecia.
Only a small proportion – about 15% – of patients achieved remission, which was seen with topical steroids, hydroxychloroquine, and doxycycline. About one-third of patients treated with doxycycline actually showed a worsening of symptoms.
The greatest proportion (75%) of patients with partial remission was among those treated with systemic acitretin, although the numbers were low (three of four patients who received this therapy).
In addition, one of the seven patients treated with minocycline achieved partial remission during this therapy, one showed a worsening of the condition, and the remaining five were unchanged. Among those treated with an immunosuppressant, the 3 patients treated with mycophenolate had no change in the condition; 4 of the 10 patients treated with methotrexate achieved partial remission, 4 were unchanged, and 2 experienced a worsening of the condition. One of the three patients treated with cyclosporine achieved partial remission while the other two remained unchanged. With topical tacrolimus, two patients achieved partial remission, two showed a worsening of the condition, and the remaining three were unchanged.
The response rates to treatment significantly decreased with subsequent therapies: 18 of the 32 patients responded to first-line treatments, compared with 7 of 19 who received second-line treatment and only 1 of 9 patients who received third-line treatment. “Many patients were not responsive to therapy, highlighting the difficulty of treating this scarring alopecia,” Dr. Kerkemeyer said.
In an interview, she said that topical or intralesional steroids seemed to be the best first-line option because they are associated with fewer side effects than other options. “They were easier to start off in patients first,” and for those who do not respond, switching to another treatment, such as topical tacrolimus, if they wanted a topical option, or an oral treatment, such as an immunosuppressant like methotrexate, she noted.
No conflicts of interest were declared.
Key clinical point: Lichen planopilaris is a scarring alopecia that is particularly difficult to treat, and a significant number of patients may have refractory disease.
Major finding:
Data source: A retrospective analysis of 32 patients with lichen planopilaris.
Disclosures: No conflicts of interest were declared.
Trump presidency prompts Goldwater Rule debate at APA
SAN DIEGO – Over the past year, the American Psychiatric Association has reasserted its commitment to the Goldwater Rule, yet many psychiatrists have questioned – some publicly – whether the rule needs to be revisited based on their concerns about Donald Trump’s mental fitness to be president.
[polldaddy:9767626]Both sides of the issue got a hearing during a pro and con discussion of the Goldwater Rule at the annual meeting of the American Psychiatric Association. A trio of leading psychiatrists called for the Goldwater Rule to be revised and APA past leadership defended the ethical standards of the existing rule. One past-president of the APA remarked that psychiatrists who object to the rule can choose to quit the APA, a comment that one audience member said harkened back to the Vietnam War–era rebuttal to protesters: “Love it or leave it.”
Several news stories in recent months have highlighted the Trump-spawned debate over the Goldwater Rule, which states that “it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.”
The APA created the rule in 1973 after a backlash over the hundreds of U.S. psychiatrists who responded to a magazine survey by diagnosing 1964 GOP presidential candidate Barry Goldwater. He later won a libel suit against the magazine.
Prior to last year’s presidential election, the APA stood by its rule. Then, in March 2017, the APA’s Ethics Committee affirmed that “the rule applies to all professional opinions offered by psychiatrists, not just diagnoses. For example, saying an individual does not have a mental disorder would also constitute a professional opinion.”
During the pro and con discussion at the annual meeting, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University in New York, called the Goldwater incident “a major embarrassment for psychiatry.”
But, he added, “there are more important justifications than whether we’re embarrassed or not. Part of [the rule] is to protect persons who may be harmed by our blithe speculation to the media. We’re also interested in avoiding an impact on people who may be in need of psychiatric care but are discouraged by what they see and hear about psychiatry in the media,” he said.
“A diagnosis based on casual encounters with a person through the media is necessarily inadequate as a basis for a psychiatric diagnosis or formulation of any reliable sort,” he pointed out.
Claire Pouncey, MD, PhD, a psychiatrist who practices in Philadelphia, questioned why speaking publicly about a public figure is inherently harmful.
“How does it threaten my integrity or integrity of the profession for me to choose to speak publicly about a public figure? The APA seems to not trust its members or recognize us as moral agents who are the arbiters of our own integrity. I wish the APA would trust me,” Dr. Pouncey said.
Last year, she outlined her concerns in an article written with Jerome Kroll, MD, and published in the Journal of the American Academy of Psychiatry and the Law (June 2016;44[2]:226-35).
As for concerns about the adequacy of information, she added, “we never have complete information. And I know we don’t always have a full consent of the person being evaluated. Anyone who’s been in an emergency room knows that in their heart and soul.”
Nassir Ghaemi, MD, MPH, who chaired the session and is professor and director of the mood disorders program at Tufts University in Boston, said that strictly abiding by the Goldwater Rule is “sending out the message that the world’s psychiatrists think it’s bad to get diagnosed with a psychiatric illness. … You are not going to harm patients by talking about psychiatric illness. You help them. We know that.”
Further, Dr. Ghaemi, author of the book “A First-Rate Madness: Uncovering the Links Between Leadership and Mental Illness” (Penguin Books, 2012), argued that the “very qualities that mark those with mood disorders also make for the best leaders in times of crisis.”
President Trump’s reported traits, such as lack of sleep and talkativeness, could be portrayed as mania, he said. However, those qualities also could boost his creativity and resilience.
Jerrold M. Post, MD, a pioneer in profiling for the Central Intelligence Agency and professor of psychiatry, political psychology, and international affairs at George Washington University in Washington, D.C., said that psychiatrists have a role to play as experts, especially now. “I’m increasingly uncomfortable in not having commented on a welter of psychiatric diagnoses by people without psychiatric training,” he said. “It seems unethical to not comment at this time.”
Paul Summergrad, MD, a former APA president and chair of the department of psychiatry at Tufts, dismissed the idea that psychiatrists could mold public debate. “The assumption that we’ll somehow change opinion if we all speak out about these matters is giving us much more credit than we deserve.”
“The reality,” he said, “is that we need to wear a certain yoke of limitation and responsibility rather than thinking this is simply an issue of freedom.”
Dr. Post, Dr. Summergrad, and Dr. Pouncey reported no relevant disclosures. Dr. Ghaemi reported support (consultant/advisory board, speakers bureau, honoraria) from Sunovion. Dr. Appelbaum disclosed stock/other financial relationship with COVR.
[polldaddy:9767626]
SAN DIEGO – Over the past year, the American Psychiatric Association has reasserted its commitment to the Goldwater Rule, yet many psychiatrists have questioned – some publicly – whether the rule needs to be revisited based on their concerns about Donald Trump’s mental fitness to be president.
[polldaddy:9767626]Both sides of the issue got a hearing during a pro and con discussion of the Goldwater Rule at the annual meeting of the American Psychiatric Association. A trio of leading psychiatrists called for the Goldwater Rule to be revised and APA past leadership defended the ethical standards of the existing rule. One past-president of the APA remarked that psychiatrists who object to the rule can choose to quit the APA, a comment that one audience member said harkened back to the Vietnam War–era rebuttal to protesters: “Love it or leave it.”
Several news stories in recent months have highlighted the Trump-spawned debate over the Goldwater Rule, which states that “it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.”
The APA created the rule in 1973 after a backlash over the hundreds of U.S. psychiatrists who responded to a magazine survey by diagnosing 1964 GOP presidential candidate Barry Goldwater. He later won a libel suit against the magazine.
Prior to last year’s presidential election, the APA stood by its rule. Then, in March 2017, the APA’s Ethics Committee affirmed that “the rule applies to all professional opinions offered by psychiatrists, not just diagnoses. For example, saying an individual does not have a mental disorder would also constitute a professional opinion.”
During the pro and con discussion at the annual meeting, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University in New York, called the Goldwater incident “a major embarrassment for psychiatry.”
But, he added, “there are more important justifications than whether we’re embarrassed or not. Part of [the rule] is to protect persons who may be harmed by our blithe speculation to the media. We’re also interested in avoiding an impact on people who may be in need of psychiatric care but are discouraged by what they see and hear about psychiatry in the media,” he said.
“A diagnosis based on casual encounters with a person through the media is necessarily inadequate as a basis for a psychiatric diagnosis or formulation of any reliable sort,” he pointed out.
Claire Pouncey, MD, PhD, a psychiatrist who practices in Philadelphia, questioned why speaking publicly about a public figure is inherently harmful.
“How does it threaten my integrity or integrity of the profession for me to choose to speak publicly about a public figure? The APA seems to not trust its members or recognize us as moral agents who are the arbiters of our own integrity. I wish the APA would trust me,” Dr. Pouncey said.
Last year, she outlined her concerns in an article written with Jerome Kroll, MD, and published in the Journal of the American Academy of Psychiatry and the Law (June 2016;44[2]:226-35).
As for concerns about the adequacy of information, she added, “we never have complete information. And I know we don’t always have a full consent of the person being evaluated. Anyone who’s been in an emergency room knows that in their heart and soul.”
Nassir Ghaemi, MD, MPH, who chaired the session and is professor and director of the mood disorders program at Tufts University in Boston, said that strictly abiding by the Goldwater Rule is “sending out the message that the world’s psychiatrists think it’s bad to get diagnosed with a psychiatric illness. … You are not going to harm patients by talking about psychiatric illness. You help them. We know that.”
Further, Dr. Ghaemi, author of the book “A First-Rate Madness: Uncovering the Links Between Leadership and Mental Illness” (Penguin Books, 2012), argued that the “very qualities that mark those with mood disorders also make for the best leaders in times of crisis.”
President Trump’s reported traits, such as lack of sleep and talkativeness, could be portrayed as mania, he said. However, those qualities also could boost his creativity and resilience.
Jerrold M. Post, MD, a pioneer in profiling for the Central Intelligence Agency and professor of psychiatry, political psychology, and international affairs at George Washington University in Washington, D.C., said that psychiatrists have a role to play as experts, especially now. “I’m increasingly uncomfortable in not having commented on a welter of psychiatric diagnoses by people without psychiatric training,” he said. “It seems unethical to not comment at this time.”
Paul Summergrad, MD, a former APA president and chair of the department of psychiatry at Tufts, dismissed the idea that psychiatrists could mold public debate. “The assumption that we’ll somehow change opinion if we all speak out about these matters is giving us much more credit than we deserve.”
“The reality,” he said, “is that we need to wear a certain yoke of limitation and responsibility rather than thinking this is simply an issue of freedom.”
Dr. Post, Dr. Summergrad, and Dr. Pouncey reported no relevant disclosures. Dr. Ghaemi reported support (consultant/advisory board, speakers bureau, honoraria) from Sunovion. Dr. Appelbaum disclosed stock/other financial relationship with COVR.
[polldaddy:9767626]
SAN DIEGO – Over the past year, the American Psychiatric Association has reasserted its commitment to the Goldwater Rule, yet many psychiatrists have questioned – some publicly – whether the rule needs to be revisited based on their concerns about Donald Trump’s mental fitness to be president.
[polldaddy:9767626]Both sides of the issue got a hearing during a pro and con discussion of the Goldwater Rule at the annual meeting of the American Psychiatric Association. A trio of leading psychiatrists called for the Goldwater Rule to be revised and APA past leadership defended the ethical standards of the existing rule. One past-president of the APA remarked that psychiatrists who object to the rule can choose to quit the APA, a comment that one audience member said harkened back to the Vietnam War–era rebuttal to protesters: “Love it or leave it.”
Several news stories in recent months have highlighted the Trump-spawned debate over the Goldwater Rule, which states that “it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.”
The APA created the rule in 1973 after a backlash over the hundreds of U.S. psychiatrists who responded to a magazine survey by diagnosing 1964 GOP presidential candidate Barry Goldwater. He later won a libel suit against the magazine.
Prior to last year’s presidential election, the APA stood by its rule. Then, in March 2017, the APA’s Ethics Committee affirmed that “the rule applies to all professional opinions offered by psychiatrists, not just diagnoses. For example, saying an individual does not have a mental disorder would also constitute a professional opinion.”
During the pro and con discussion at the annual meeting, Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University in New York, called the Goldwater incident “a major embarrassment for psychiatry.”
But, he added, “there are more important justifications than whether we’re embarrassed or not. Part of [the rule] is to protect persons who may be harmed by our blithe speculation to the media. We’re also interested in avoiding an impact on people who may be in need of psychiatric care but are discouraged by what they see and hear about psychiatry in the media,” he said.
“A diagnosis based on casual encounters with a person through the media is necessarily inadequate as a basis for a psychiatric diagnosis or formulation of any reliable sort,” he pointed out.
Claire Pouncey, MD, PhD, a psychiatrist who practices in Philadelphia, questioned why speaking publicly about a public figure is inherently harmful.
“How does it threaten my integrity or integrity of the profession for me to choose to speak publicly about a public figure? The APA seems to not trust its members or recognize us as moral agents who are the arbiters of our own integrity. I wish the APA would trust me,” Dr. Pouncey said.
Last year, she outlined her concerns in an article written with Jerome Kroll, MD, and published in the Journal of the American Academy of Psychiatry and the Law (June 2016;44[2]:226-35).
As for concerns about the adequacy of information, she added, “we never have complete information. And I know we don’t always have a full consent of the person being evaluated. Anyone who’s been in an emergency room knows that in their heart and soul.”
Nassir Ghaemi, MD, MPH, who chaired the session and is professor and director of the mood disorders program at Tufts University in Boston, said that strictly abiding by the Goldwater Rule is “sending out the message that the world’s psychiatrists think it’s bad to get diagnosed with a psychiatric illness. … You are not going to harm patients by talking about psychiatric illness. You help them. We know that.”
Further, Dr. Ghaemi, author of the book “A First-Rate Madness: Uncovering the Links Between Leadership and Mental Illness” (Penguin Books, 2012), argued that the “very qualities that mark those with mood disorders also make for the best leaders in times of crisis.”
President Trump’s reported traits, such as lack of sleep and talkativeness, could be portrayed as mania, he said. However, those qualities also could boost his creativity and resilience.
Jerrold M. Post, MD, a pioneer in profiling for the Central Intelligence Agency and professor of psychiatry, political psychology, and international affairs at George Washington University in Washington, D.C., said that psychiatrists have a role to play as experts, especially now. “I’m increasingly uncomfortable in not having commented on a welter of psychiatric diagnoses by people without psychiatric training,” he said. “It seems unethical to not comment at this time.”
Paul Summergrad, MD, a former APA president and chair of the department of psychiatry at Tufts, dismissed the idea that psychiatrists could mold public debate. “The assumption that we’ll somehow change opinion if we all speak out about these matters is giving us much more credit than we deserve.”
“The reality,” he said, “is that we need to wear a certain yoke of limitation and responsibility rather than thinking this is simply an issue of freedom.”
Dr. Post, Dr. Summergrad, and Dr. Pouncey reported no relevant disclosures. Dr. Ghaemi reported support (consultant/advisory board, speakers bureau, honoraria) from Sunovion. Dr. Appelbaum disclosed stock/other financial relationship with COVR.
[polldaddy:9767626]
EXPERT ANALYSIS FROM APA
HM17 session summary: The art of story in delivering memorable lectures
Presenter
Ethan Cumbler, MD, FACP, FHM
Session summary
This session was designed to give learners a different paradigm in thinking about the structure and organization of presentations, for a more dynamic and engaging lecture.
Memorable teaching points are tied to a narrative with emotional impact. One study of surgery residents immediately after finishing grand rounds found that learners only remember approximately 10% of the material embedded in a lecture. Therefore, the focus of the lecture should not necessarily be to include a comprehensive amount of information, but to make the major points as “sticky” as possible.
This will help anchor your presentation and will hopefully assist in creating an organizational framework. Most people are familiar with lectures that have a “standard” format: “I’m going to talk about disease/problem X. This is the scope of the problem, epidemiology, pathology, etiology, diagnosis, treatment, complications, and prognosis.” While this is an organizational structure, it doesn’t draw the audience in. Instead, what was suggested was to think about a real patient case to keep the audience engaged. Since everything may not be known in real time, you can add drama and suspense as the audience and the speaker work through the case together.
One should have a “hook” as an analogy to engage with the audience while reinforcing the central “take-home” message. One can think of it as a kind of leitmotif. Another example would be the “call-back” in stand-up comedy where a concept or joke is introduced early in the routine, is not addressed for a period of time, and then reintroduced and becomes more funny the second time around.
Many people are used to seeing PowerPoint presentations with 5-7 lines per slide, 5-7 words per line, with greater than 24 point font. Dr. Cumbler recommends thinking of one’s slide from a design perspective. For example, in TED talks, one will often see large images that act as a reference but there is often very little text on the slide. In order to provide more content while not burdening slides with more text, one should reconsider handouts. Instead of sheets of paper with 6 slides which are repeats of the PowerPoint, use the handout to provide information that one cannot show during the presentation.
It is incredibly difficult to stay engaged in a lecture delivered at the same pace and in a monotone. Timing is important in music, comedy, and presentations. One should vary the volume and tempo during the talk and allow for pauses when appropriate. An example to illustrate the point was dubstep music; it is set at a tempo of 140 beats per minute, but the song is not 140 beats per minute the entire time. It will sometimes slow down, and there is always a point where the “beat drops.”
Again, a good talk is not only the information itself, but a presenter’s presence, so one should think of body language and positioning. One should use hand gestures to emphasize points in the lecture and draw the learners in. Dr. Cumbler recommended making eye contact with individuals periodically instead of a distant, vacant stare into the great expanse. One should feel free to move across the stage or walk through the audience, so ask for a wireless microphone to liberate oneself from the podium.
Key takeaways for HM
- Consider the stand-up comedy concept of the “call-back.” Start with a concept, and then return to this concept in different forms through the presentation. One can return to another variation of this for a surprise at the end. One can make a key point memorable by using a theme with multiple variations.
- Think about structure in order to draw listeners into a talk and keep them invested (organizational framework centered around a patient); create a “hook”; think about slides visually, not from a content perspective (that’s what handouts are for); keep the tempo, timing, and volume dynamic; use body language and presence to engage the room.
- If one would like to learn more, consider reading the book Presentation Zen; watch TED talks; practice multiple times to hone various aspects of the talk; give the talk multiple times for iterative improvement; always ask for feedback and try to change at least one thing from one talk to another to continuously improve.
Dr. Kim is a hospitalist who works at Emory University Hospital in Atlanta, and is an editorial board member of The Hospitalist.
Presenter
Ethan Cumbler, MD, FACP, FHM
Session summary
This session was designed to give learners a different paradigm in thinking about the structure and organization of presentations, for a more dynamic and engaging lecture.
Memorable teaching points are tied to a narrative with emotional impact. One study of surgery residents immediately after finishing grand rounds found that learners only remember approximately 10% of the material embedded in a lecture. Therefore, the focus of the lecture should not necessarily be to include a comprehensive amount of information, but to make the major points as “sticky” as possible.
This will help anchor your presentation and will hopefully assist in creating an organizational framework. Most people are familiar with lectures that have a “standard” format: “I’m going to talk about disease/problem X. This is the scope of the problem, epidemiology, pathology, etiology, diagnosis, treatment, complications, and prognosis.” While this is an organizational structure, it doesn’t draw the audience in. Instead, what was suggested was to think about a real patient case to keep the audience engaged. Since everything may not be known in real time, you can add drama and suspense as the audience and the speaker work through the case together.
One should have a “hook” as an analogy to engage with the audience while reinforcing the central “take-home” message. One can think of it as a kind of leitmotif. Another example would be the “call-back” in stand-up comedy where a concept or joke is introduced early in the routine, is not addressed for a period of time, and then reintroduced and becomes more funny the second time around.
Many people are used to seeing PowerPoint presentations with 5-7 lines per slide, 5-7 words per line, with greater than 24 point font. Dr. Cumbler recommends thinking of one’s slide from a design perspective. For example, in TED talks, one will often see large images that act as a reference but there is often very little text on the slide. In order to provide more content while not burdening slides with more text, one should reconsider handouts. Instead of sheets of paper with 6 slides which are repeats of the PowerPoint, use the handout to provide information that one cannot show during the presentation.
It is incredibly difficult to stay engaged in a lecture delivered at the same pace and in a monotone. Timing is important in music, comedy, and presentations. One should vary the volume and tempo during the talk and allow for pauses when appropriate. An example to illustrate the point was dubstep music; it is set at a tempo of 140 beats per minute, but the song is not 140 beats per minute the entire time. It will sometimes slow down, and there is always a point where the “beat drops.”
Again, a good talk is not only the information itself, but a presenter’s presence, so one should think of body language and positioning. One should use hand gestures to emphasize points in the lecture and draw the learners in. Dr. Cumbler recommended making eye contact with individuals periodically instead of a distant, vacant stare into the great expanse. One should feel free to move across the stage or walk through the audience, so ask for a wireless microphone to liberate oneself from the podium.
Key takeaways for HM
- Consider the stand-up comedy concept of the “call-back.” Start with a concept, and then return to this concept in different forms through the presentation. One can return to another variation of this for a surprise at the end. One can make a key point memorable by using a theme with multiple variations.
- Think about structure in order to draw listeners into a talk and keep them invested (organizational framework centered around a patient); create a “hook”; think about slides visually, not from a content perspective (that’s what handouts are for); keep the tempo, timing, and volume dynamic; use body language and presence to engage the room.
- If one would like to learn more, consider reading the book Presentation Zen; watch TED talks; practice multiple times to hone various aspects of the talk; give the talk multiple times for iterative improvement; always ask for feedback and try to change at least one thing from one talk to another to continuously improve.
Dr. Kim is a hospitalist who works at Emory University Hospital in Atlanta, and is an editorial board member of The Hospitalist.
Presenter
Ethan Cumbler, MD, FACP, FHM
Session summary
This session was designed to give learners a different paradigm in thinking about the structure and organization of presentations, for a more dynamic and engaging lecture.
Memorable teaching points are tied to a narrative with emotional impact. One study of surgery residents immediately after finishing grand rounds found that learners only remember approximately 10% of the material embedded in a lecture. Therefore, the focus of the lecture should not necessarily be to include a comprehensive amount of information, but to make the major points as “sticky” as possible.
This will help anchor your presentation and will hopefully assist in creating an organizational framework. Most people are familiar with lectures that have a “standard” format: “I’m going to talk about disease/problem X. This is the scope of the problem, epidemiology, pathology, etiology, diagnosis, treatment, complications, and prognosis.” While this is an organizational structure, it doesn’t draw the audience in. Instead, what was suggested was to think about a real patient case to keep the audience engaged. Since everything may not be known in real time, you can add drama and suspense as the audience and the speaker work through the case together.
One should have a “hook” as an analogy to engage with the audience while reinforcing the central “take-home” message. One can think of it as a kind of leitmotif. Another example would be the “call-back” in stand-up comedy where a concept or joke is introduced early in the routine, is not addressed for a period of time, and then reintroduced and becomes more funny the second time around.
Many people are used to seeing PowerPoint presentations with 5-7 lines per slide, 5-7 words per line, with greater than 24 point font. Dr. Cumbler recommends thinking of one’s slide from a design perspective. For example, in TED talks, one will often see large images that act as a reference but there is often very little text on the slide. In order to provide more content while not burdening slides with more text, one should reconsider handouts. Instead of sheets of paper with 6 slides which are repeats of the PowerPoint, use the handout to provide information that one cannot show during the presentation.
It is incredibly difficult to stay engaged in a lecture delivered at the same pace and in a monotone. Timing is important in music, comedy, and presentations. One should vary the volume and tempo during the talk and allow for pauses when appropriate. An example to illustrate the point was dubstep music; it is set at a tempo of 140 beats per minute, but the song is not 140 beats per minute the entire time. It will sometimes slow down, and there is always a point where the “beat drops.”
Again, a good talk is not only the information itself, but a presenter’s presence, so one should think of body language and positioning. One should use hand gestures to emphasize points in the lecture and draw the learners in. Dr. Cumbler recommended making eye contact with individuals periodically instead of a distant, vacant stare into the great expanse. One should feel free to move across the stage or walk through the audience, so ask for a wireless microphone to liberate oneself from the podium.
Key takeaways for HM
- Consider the stand-up comedy concept of the “call-back.” Start with a concept, and then return to this concept in different forms through the presentation. One can return to another variation of this for a surprise at the end. One can make a key point memorable by using a theme with multiple variations.
- Think about structure in order to draw listeners into a talk and keep them invested (organizational framework centered around a patient); create a “hook”; think about slides visually, not from a content perspective (that’s what handouts are for); keep the tempo, timing, and volume dynamic; use body language and presence to engage the room.
- If one would like to learn more, consider reading the book Presentation Zen; watch TED talks; practice multiple times to hone various aspects of the talk; give the talk multiple times for iterative improvement; always ask for feedback and try to change at least one thing from one talk to another to continuously improve.
Dr. Kim is a hospitalist who works at Emory University Hospital in Atlanta, and is an editorial board member of The Hospitalist.
California Opens Treatment Center for Native Youth
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
The IHS announced the opening of another youth regional treatment center (YRTC) to provide culturally centered, evidence-based substance use disorder services to Native youth.
Desert Sage Youth Wellness Center in Hemet is the first federally owned and operated health care facility in California to serve American Indians and Alaska Natives (AI/AN). Although California has the largest population of AI/AN in the country, IHS says, teens were usually sent out of state to non-IHS or nontribal facilities that do not always meet their “unique cultural needs.”
Desert Sage is 1 of 11 YRTCs funded by IHS across the country. The YRTCs provide comprehensive, holistic care, including mental health assessments, individualized treatment plans, academic education, vocational and life-skills training, and activities to meet the spiritual and cultural needs of Native American youth.
The Desert Sage center, which includes 3 buildings with 32 beds and 5 family suites, will employ 70 full-time employees and treat about 100 tribal youth annually.
Sacred Oaks Healing Center in Davis, the next YRTC planned for California, is expected to be completed in 2019.
Why fewer blood cancer patients receive hospice care
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.” 
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.”
New research provides an explanation for the fact that US patients with hematologic malignancies are less likely to enroll in hospice care than patients with solid tumor malignancies.
Results of a national survey suggest that concerns about the adequacy of hospice may prevent hematologic oncologists from referring their patients.
Researchers say this finding, published in Cancer, points to potential means of improving end-of-life care for patients with hematologic malignancies.
Oreofe Odejide, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues carried out this study.
The team conducted a survey of a national sample of hematologic oncologists listed in the publicly available clinical directory of the American Society of Hematology.
More than 57% of physicians who were contacted provided responses, for a total of 349 respondents.
The survey included questions about views regarding the helpfulness and adequacy of home hospice services for patients with hematologic malignancies, as well as factors that would impact oncologists’ likelihood of referring patients to hospice.
More than 68% of hematologic oncologists strongly agreed that hospice care is “helpful” for patients with hematologic malignancies.
However, 46% of the oncologists felt that home hospice is “inadequate” for the needs of patients with hematologic malignancies, when compared to inpatient hospice.
Still, most of the respondents who believed home hospice is inadequate said they would be more likely to refer patients if platelet and red blood cell transfusions were readily available.
“Our findings are important as they shed light on factors that are potential barriers to hospice referrals,” Dr Odejide said. “These findings can be employed to develop targeted interventions to address hospice underuse for patients with blood cancers.”
Global study reveals healthcare inequity, preventable deaths
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
A global study has revealed inequity of access to and quality of healthcare among and within countries and suggests people are dying from causes with well-known treatments.
“What we have found about healthcare access and quality is disturbing,” said Christopher Murray, MD, DPhil, of the University of Washington in Seattle.
“Having a strong economy does not guarantee good healthcare. Having great medical technology doesn’t either. We know this because people are not getting the care that should be expected for diseases with established treatments.”
Dr Murray and his colleagues reported these findings in The Lancet.
For this study, the researchers assessed access to and quality of healthcare services in 195 countries from 1990 to 2015.
The group used the Healthcare Access and Quality Index, a summary measure based on 32 causes* that, in the presence of high-quality healthcare, should not result in death. Leukemia and Hodgkin lymphoma are among these causes.
Countries were assigned scores for each of the causes, based on estimates from the annual Global Burden of Diseases, Injuries, and Risk Factors study (GBD), a systematic, scientific effort to quantify the magnitude of health loss from all major diseases, injuries, and risk factors by age, sex, and population.
In addition, data were extracted from the most recent GBD update and evaluated using a Socio-demographic Index based on rates of education, fertility, and income.
Results
The 195 countries were assigned scores on a scale of 1 to 100 for healthcare access and quality. They received scores for the 32 causes as well as overall scores.
In 2015, the top-ranked nation was Andorra, with an overall score of 95. Its lowest treatment score was 70, for Hodgkin lymphoma.
The lowest-ranked nation was Central African Republic, with a score of 29. Its highest treatment score was 65, for diphtheria.
Nations in much of sub-Saharan Africa, as well as in south Asia and several countries in Latin America and the Caribbean, also had low rankings.
However, many countries in these regions, including China (score: 74) and Ethiopia (score: 44), have seen sizeable gains since 1990.
‘Developed’ nations falling short
The US had an overall score of 81 (in 2015), tied with Estonia and Montenegro. As with many other nations, the US scored 100 in treating common vaccine-preventable diseases, such as diphtheria, tetanus, and measles.
However, the US had 9 treatment categories in which it scored in the 60s: lower respiratory infections (60), neonatal disorders (69), non-melanoma skin cancer (68), Hodgkin lymphoma (67), ischemic heart disease (62), hypertensive heart disease (64), diabetes (67), chronic kidney disease (62), and the adverse effects of medical treatment itself (68).
“America’s ranking is an embarrassment, especially considering the US spends more than $9000 per person on healthcare annually, more than any other country,” Dr Murray said.
“Anyone with a stake in the current healthcare debate, including elected officials at the federal, state, and local levels, should take a look at where the US is falling short.”
Other nations with strong economies and advanced medical technology are falling short in some areas as well.
For example, Norway and Australia each scored 90 overall, among the highest in the world. However, Norway scored 65 in its treatment for testicular cancer, and Australia scored 52 for treating non-melanoma skin cancer.
“In the majority of cases, both of these cancers can be treated effectively,” Dr Murray said. “Shouldn’t it cause serious concern that people are dying of these causes in countries that have the resources to address them?”
*The 32 causes are:
- Adverse effects of medical treatment
- Appendicitis
- Breast cancer
- Cerebrovascular disease (stroke)
- Cervical cancer
- Chronic kidney disease
- Chronic respiratory diseases
- Colon and rectum cancer
- Congenital anomalies
- Diabetes mellitus
- Diarrhea-related diseases
- Diphtheria
- Epilepsy
- Gallbladder and biliary diseases
- Hodgkin lymphoma
- Hypertensive heart disease
- Inguinal, femoral, and abdominal hernia
- Ischemic heart disease
- Leukemia
- Lower respiratory infections
- Maternal disorders
- Measles
- Neonatal disorders
- Non-melanoma skin cancer
- Peptic ulcer disease
- Rheumatic heart disease
- Testicular cancer
- Tetanus
- Tuberculosis
- Upper respiratory infections
- Uterine cancer
- Whooping cough.
FDA supports continued, cautious use of GBCAs
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.
The US Food and Drug Administration (FDA) said it has not found any evidence of adverse health effects from gadolinium retention in the brain following the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI).
The agency noted that all GBCAs may be associated with some gadolinium retention in the brain and other body tissues.
However, an FDA review showed no evidence that gadolinium retention in the brain is harmful.
Therefore, the FDA said it will not restrict GBCA use, although the agency will continue to assess the safety of GBCAs and plans to have a public meeting on the issue in the future.
The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention. The FDA said it is reviewing the labels of other GBCAs to determine if changes are needed.
Recommendations
The FDA said its recommendations regarding GBCAs have not changed.
The agency advises healthcare professionals to limit GBCA use to circumstances in which the contrast agent can provide necessary information. Professionals should also consider the necessity of repetitive MRIs with GBCAs.
Patients, parents, and caregivers with any questions or concerns about GBCAs should discuss the agents with their healthcare professionals.
The FDA is also urging patients and healthcare professionals to report side effects involving GBCAs to the agency’s MedWatch program.
About the FDA review
For its review, the FDA looked at scientific publications and adverse event reports submitted to agency.
These data showed that gadolinium is retained in organs and suggested that linear GBCAs cause retention of more gadolinium in the brain than macrocyclic GBCAs. However, the data did not show adverse health effects related to this brain retention.
The only known adverse health effect related to gadolinium retention is nephrogenic systemic fibrosis (NSF), a disease characterized by thickening of the skin, which can involve the joints and limit motion.
NSF is known to occur in patients with pre-existing kidney failure. However, recent publications have shown reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF. Some of these patients also had evidence of gadolinium retention.
The FDA said it is evaluating such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.
The agency is also continuing its assessment of GBCAs, investigating how gadolinium is retained in the body. And the FDA’s National Center for Toxicological Research is conducting a study on brain retention of GBCAs in rats.
PRAC review
A recent review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) suggested there are no adverse health effects associated with gadolinium retention in the brain.
However, the PRAC recommended suspending the marketing authorization of certain linear GBCAs because they cause greater retention of gadolinium in the brain than macrocyclic GBCAs.
The PRAC’s recommendation is undergoing an appeal, which will be further reviewed by the PRAC and the Committee for Medicinal Products for Human Use.