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CHEST Clinical Trials Registry announcement
A new clinical trial is now available in the CHEST Clinical Trials Registry (SENSCISTM, or Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). The CHEST Clinical Trials Registry is a free service that connects physicians to information about clinical trials in respiratory disease, conducted by participating pharmaceutical companies. To learn more about the registry and how to participate in this clinical trial, please visit www.chestnet.org/Guidelines-and-Resources/Clinical-Trials/Clinical-Trials-Registry.
A new clinical trial is now available in the CHEST Clinical Trials Registry (SENSCISTM, or Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). The CHEST Clinical Trials Registry is a free service that connects physicians to information about clinical trials in respiratory disease, conducted by participating pharmaceutical companies. To learn more about the registry and how to participate in this clinical trial, please visit www.chestnet.org/Guidelines-and-Resources/Clinical-Trials/Clinical-Trials-Registry.
A new clinical trial is now available in the CHEST Clinical Trials Registry (SENSCISTM, or Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). The CHEST Clinical Trials Registry is a free service that connects physicians to information about clinical trials in respiratory disease, conducted by participating pharmaceutical companies. To learn more about the registry and how to participate in this clinical trial, please visit www.chestnet.org/Guidelines-and-Resources/Clinical-Trials/Clinical-Trials-Registry.
This Month in CHEST: Editor’s Picks
COMMENTARY
Establishing Pulmonary and Critical Care Medicine in China: 2016 Report on Implementation and Government Recognition: Joint Statement of the Chinese Association of Chest Physicians and the American College of Chest Physicians.
By Dr. Renli Qiao et al, on behalf of the China-CHEST PCCM Program Steering Committee.
CONTEMPORARY REVIEWS IN SLEEP MEDICINE
Cancer and OSA: Current Evidence From Human Studies. By Dr. M. A. Martinez-Garcia et al.
ORIGINAL RESEARCH
Association Between Occupational Exposures and Sarcoidosis: An Analysis From Death Certificates in the United States, 1988-1999. By Dr. H. Liu et al.
Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Patients With Acute Respiratory Distress Syndrome. By Dr. S. M. Brown et al.
Blood Eosinophils and Outcomes in Severe Hospitalized Exacerbations of COPD. By Dr. M. Bafadhel et al.
A Randomized Controlled Trial of a Novel Sheath Cryoprobe for Bronchoscopic Lung Biopsy in a Porcine Model. By Dr. L. B. Yarmus et al.
COMMENTARY
Establishing Pulmonary and Critical Care Medicine in China: 2016 Report on Implementation and Government Recognition: Joint Statement of the Chinese Association of Chest Physicians and the American College of Chest Physicians.
By Dr. Renli Qiao et al, on behalf of the China-CHEST PCCM Program Steering Committee.
CONTEMPORARY REVIEWS IN SLEEP MEDICINE
Cancer and OSA: Current Evidence From Human Studies. By Dr. M. A. Martinez-Garcia et al.
ORIGINAL RESEARCH
Association Between Occupational Exposures and Sarcoidosis: An Analysis From Death Certificates in the United States, 1988-1999. By Dr. H. Liu et al.
Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Patients With Acute Respiratory Distress Syndrome. By Dr. S. M. Brown et al.
Blood Eosinophils and Outcomes in Severe Hospitalized Exacerbations of COPD. By Dr. M. Bafadhel et al.
A Randomized Controlled Trial of a Novel Sheath Cryoprobe for Bronchoscopic Lung Biopsy in a Porcine Model. By Dr. L. B. Yarmus et al.
COMMENTARY
Establishing Pulmonary and Critical Care Medicine in China: 2016 Report on Implementation and Government Recognition: Joint Statement of the Chinese Association of Chest Physicians and the American College of Chest Physicians.
By Dr. Renli Qiao et al, on behalf of the China-CHEST PCCM Program Steering Committee.
CONTEMPORARY REVIEWS IN SLEEP MEDICINE
Cancer and OSA: Current Evidence From Human Studies. By Dr. M. A. Martinez-Garcia et al.
ORIGINAL RESEARCH
Association Between Occupational Exposures and Sarcoidosis: An Analysis From Death Certificates in the United States, 1988-1999. By Dr. H. Liu et al.
Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Patients With Acute Respiratory Distress Syndrome. By Dr. S. M. Brown et al.
Blood Eosinophils and Outcomes in Severe Hospitalized Exacerbations of COPD. By Dr. M. Bafadhel et al.
A Randomized Controlled Trial of a Novel Sheath Cryoprobe for Bronchoscopic Lung Biopsy in a Porcine Model. By Dr. L. B. Yarmus et al.
Updated Patient Education guides available
The CHEST Foundation continues to look for new ways to expand our patient education offerings. With the collaboration of the CHEST Foundation’s Patient Education Work Group, the Allergy & Asthma NetWork, and CHEST’s NetWorks, we have completely revamped Living Well With COPD and Living Well With Asthma (previously titled Controlling Your Asthma). At less than 30 pages each, the guides are more user-friendly, featuring multiple diagrams to supplement instructions, take-away glossaries, easy-to-read infographics, and new FAQs.
The guides are available to order in packs of 25 in the CHEST store. Packs are $50 for members and $62.50 for nonmembers. The new guides are available for viewing online at chestnet.org/asthmainfo and chestnet.org/copdinfo.
The CHEST Foundation continues to look for new ways to expand our patient education offerings. With the collaboration of the CHEST Foundation’s Patient Education Work Group, the Allergy & Asthma NetWork, and CHEST’s NetWorks, we have completely revamped Living Well With COPD and Living Well With Asthma (previously titled Controlling Your Asthma). At less than 30 pages each, the guides are more user-friendly, featuring multiple diagrams to supplement instructions, take-away glossaries, easy-to-read infographics, and new FAQs.
The guides are available to order in packs of 25 in the CHEST store. Packs are $50 for members and $62.50 for nonmembers. The new guides are available for viewing online at chestnet.org/asthmainfo and chestnet.org/copdinfo.
The CHEST Foundation continues to look for new ways to expand our patient education offerings. With the collaboration of the CHEST Foundation’s Patient Education Work Group, the Allergy & Asthma NetWork, and CHEST’s NetWorks, we have completely revamped Living Well With COPD and Living Well With Asthma (previously titled Controlling Your Asthma). At less than 30 pages each, the guides are more user-friendly, featuring multiple diagrams to supplement instructions, take-away glossaries, easy-to-read infographics, and new FAQs.
The guides are available to order in packs of 25 in the CHEST store. Packs are $50 for members and $62.50 for nonmembers. The new guides are available for viewing online at chestnet.org/asthmainfo and chestnet.org/copdinfo.
Lidocaine gel doesn’t relieve IUD insertion pain but cuts need for dilation
While vaginal lidocaine gel does not significantly reduce pain from intrauterine device (IUD) insertion, it does appear to reduce the pain from tenaculum placement in nulliparous women and the likelihood that women will need cervical dilation for insertion, according to the results of a randomized controlled trial.
Despite the effectiveness of IUDs in preventing pregnancy, some women don’t choose this contraception method because they fear the pain of insertion, past research has found. Pain is also more likely in women who have not given birth. In fact, just 5.9% of nulliparous women use IUDs, compared with 16.8% of women with one or two prior births, wrote Rachel B. Rapkin, MD, MPH, of the University of South Florida in Tampa, and her colleagues (Obstet Gynecol. 2016;128:621-8. doi: 10.1097/AOG.0000000000001596).
The researchers tested the effectiveness of self-administered lidocaine gel as pain relief with 59 nulliparous women aged 14-50 years from University of Pittsburgh Medical Center clinics between July 2012 and May 2013. All of the women requested an IUD. A total of 30 women were randomized to apply the 2% lidocaine vaginal gel 5 minutes before the IUD insertion. Another 29 women were randomized to apply a placebo gel. Nearly all the women reported that inserting the gel was somewhat or very easy and that they had no pain after insertion.
There was one unsuccessful IUD insertion in the placebo group. That woman had intolerable pain while attempting uterine sound so the procedure was aborted. She was included in the intention-to-treat analysis with all missing data set to 100 mm on a 100-mm visual analog scale.
In the intention-to-treat analysis, the median change in pain from baseline to IUD insertion was 61 mm for women who used the lidocaine gel. Women using placebo reported a median score of 69 mm, which was not significantly different from those using the lidocaine gel (P = .06). However, women using lidocaine did report significantly less pain when the tenaculum was placed: a median 32 mm on the pain scale, compared with 56 mm reported by those who used the placebo gel (P = .02).
Although 87% of the physicians reported that insertion was easy in the women with lidocaine, compared with 64% who said it was easy in women using the placebo gel, the difference was not significant (P = .07). However, significantly more women needed cervical dilation before IUD placement if they used the placebo (34.5%), compared with those using the lidocaine (3.3%, P = .002). The women also reported pain scores after speculum placement, uterine sounding, and 5 minutes after speculum removal, but none of these showed significant differences.
Overall, more than one-third of the women needed to take pain medication for at least 3 days after the IUD was inserted, but the majority of women (86%) would probably or definitely recommend an IUD to a friend, and 76% reported satisfaction with the insertion experience. Cramping and pain medication use after insertion did not vary between the two groups.
The generalizability of the trial may be limited because it enrolled participants who were largely white and college educated and it used clinicians with at least 4 years of IUD insertion experience.
The research was funded by the Society of Family Planning Research Fund. Dr. Rapkin reported having no financial disclosures. Her coauthors reported consulting work for Merck and research funding from Bayer Healthcare and Medicines 360 Inc. One of the coauthors is founder and president of the nonprofit Basic Health International.
While vaginal lidocaine gel does not significantly reduce pain from intrauterine device (IUD) insertion, it does appear to reduce the pain from tenaculum placement in nulliparous women and the likelihood that women will need cervical dilation for insertion, according to the results of a randomized controlled trial.
Despite the effectiveness of IUDs in preventing pregnancy, some women don’t choose this contraception method because they fear the pain of insertion, past research has found. Pain is also more likely in women who have not given birth. In fact, just 5.9% of nulliparous women use IUDs, compared with 16.8% of women with one or two prior births, wrote Rachel B. Rapkin, MD, MPH, of the University of South Florida in Tampa, and her colleagues (Obstet Gynecol. 2016;128:621-8. doi: 10.1097/AOG.0000000000001596).
The researchers tested the effectiveness of self-administered lidocaine gel as pain relief with 59 nulliparous women aged 14-50 years from University of Pittsburgh Medical Center clinics between July 2012 and May 2013. All of the women requested an IUD. A total of 30 women were randomized to apply the 2% lidocaine vaginal gel 5 minutes before the IUD insertion. Another 29 women were randomized to apply a placebo gel. Nearly all the women reported that inserting the gel was somewhat or very easy and that they had no pain after insertion.
There was one unsuccessful IUD insertion in the placebo group. That woman had intolerable pain while attempting uterine sound so the procedure was aborted. She was included in the intention-to-treat analysis with all missing data set to 100 mm on a 100-mm visual analog scale.
In the intention-to-treat analysis, the median change in pain from baseline to IUD insertion was 61 mm for women who used the lidocaine gel. Women using placebo reported a median score of 69 mm, which was not significantly different from those using the lidocaine gel (P = .06). However, women using lidocaine did report significantly less pain when the tenaculum was placed: a median 32 mm on the pain scale, compared with 56 mm reported by those who used the placebo gel (P = .02).
Although 87% of the physicians reported that insertion was easy in the women with lidocaine, compared with 64% who said it was easy in women using the placebo gel, the difference was not significant (P = .07). However, significantly more women needed cervical dilation before IUD placement if they used the placebo (34.5%), compared with those using the lidocaine (3.3%, P = .002). The women also reported pain scores after speculum placement, uterine sounding, and 5 minutes after speculum removal, but none of these showed significant differences.
Overall, more than one-third of the women needed to take pain medication for at least 3 days after the IUD was inserted, but the majority of women (86%) would probably or definitely recommend an IUD to a friend, and 76% reported satisfaction with the insertion experience. Cramping and pain medication use after insertion did not vary between the two groups.
The generalizability of the trial may be limited because it enrolled participants who were largely white and college educated and it used clinicians with at least 4 years of IUD insertion experience.
The research was funded by the Society of Family Planning Research Fund. Dr. Rapkin reported having no financial disclosures. Her coauthors reported consulting work for Merck and research funding from Bayer Healthcare and Medicines 360 Inc. One of the coauthors is founder and president of the nonprofit Basic Health International.
While vaginal lidocaine gel does not significantly reduce pain from intrauterine device (IUD) insertion, it does appear to reduce the pain from tenaculum placement in nulliparous women and the likelihood that women will need cervical dilation for insertion, according to the results of a randomized controlled trial.
Despite the effectiveness of IUDs in preventing pregnancy, some women don’t choose this contraception method because they fear the pain of insertion, past research has found. Pain is also more likely in women who have not given birth. In fact, just 5.9% of nulliparous women use IUDs, compared with 16.8% of women with one or two prior births, wrote Rachel B. Rapkin, MD, MPH, of the University of South Florida in Tampa, and her colleagues (Obstet Gynecol. 2016;128:621-8. doi: 10.1097/AOG.0000000000001596).
The researchers tested the effectiveness of self-administered lidocaine gel as pain relief with 59 nulliparous women aged 14-50 years from University of Pittsburgh Medical Center clinics between July 2012 and May 2013. All of the women requested an IUD. A total of 30 women were randomized to apply the 2% lidocaine vaginal gel 5 minutes before the IUD insertion. Another 29 women were randomized to apply a placebo gel. Nearly all the women reported that inserting the gel was somewhat or very easy and that they had no pain after insertion.
There was one unsuccessful IUD insertion in the placebo group. That woman had intolerable pain while attempting uterine sound so the procedure was aborted. She was included in the intention-to-treat analysis with all missing data set to 100 mm on a 100-mm visual analog scale.
In the intention-to-treat analysis, the median change in pain from baseline to IUD insertion was 61 mm for women who used the lidocaine gel. Women using placebo reported a median score of 69 mm, which was not significantly different from those using the lidocaine gel (P = .06). However, women using lidocaine did report significantly less pain when the tenaculum was placed: a median 32 mm on the pain scale, compared with 56 mm reported by those who used the placebo gel (P = .02).
Although 87% of the physicians reported that insertion was easy in the women with lidocaine, compared with 64% who said it was easy in women using the placebo gel, the difference was not significant (P = .07). However, significantly more women needed cervical dilation before IUD placement if they used the placebo (34.5%), compared with those using the lidocaine (3.3%, P = .002). The women also reported pain scores after speculum placement, uterine sounding, and 5 minutes after speculum removal, but none of these showed significant differences.
Overall, more than one-third of the women needed to take pain medication for at least 3 days after the IUD was inserted, but the majority of women (86%) would probably or definitely recommend an IUD to a friend, and 76% reported satisfaction with the insertion experience. Cramping and pain medication use after insertion did not vary between the two groups.
The generalizability of the trial may be limited because it enrolled participants who were largely white and college educated and it used clinicians with at least 4 years of IUD insertion experience.
The research was funded by the Society of Family Planning Research Fund. Dr. Rapkin reported having no financial disclosures. Her coauthors reported consulting work for Merck and research funding from Bayer Healthcare and Medicines 360 Inc. One of the coauthors is founder and president of the nonprofit Basic Health International.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Vaginal lidocaine gel does not decrease IUD insertion pain but decreases likelihood of needing cervical dilation.
Major finding: More than a third of women using placebo gel required cervical dilation before IUD placement, compared with 3.3% of women using lidocaine gel (P = .002).
Data source: The findings are based on a randomized, double-blind, placebo-controlled trial involving 59 nulliparous women between July 2012 and May 2013.
Disclosures: The research was funded by the Society of Family Planning Research Fund. Dr. Rapkin reported having no financial disclosures. Her coauthors reported consulting work for Merck and research funding from Bayer Healthcare and Medicines 360 Inc. One of the coauthors is founder and president of the nonprofit Basic Health International.
Lipid Screening in Young Adults Still Unsettled
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
FROM ANNALS OF INTERNAL MEDICINE
Lipid screening in young adults still unsettled
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
The value of screening young adults for dyslipidemia remains unknown because there is still no direct evidence regarding the benefits and harms in this patient population, according to an update of the 2008 U.S. Preventive Services Task Force recommendations on lipid screening, which was published online August 8 in Annals of Internal Medicine.
In 2008, the USPSTF also could find no direct evidence regarding asymptomatic men and women aged 21-39 years, and thus could make no recommendation for or against lipid screening “because of the low likelihood of identifying lipid levels high enough to justify treatment.” Now the organization has undertaken an extensive review of all English-language articles released since then, searching the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Medline, reference lists, and ClinicalTrials.gov, said Roger Chou, MD, lead author of the update and director of the Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Portland, and his associates.
They were unable to find any randomized trials, cohort studies, or case-control studies comparing lipid screening against no lipid screening, dyslipidemia treatment against no treatment, or immediate against delayed treatment that assessed mortality, cardiovascular outcomes, or harms in this age group.
Some health organizations recommend starting dyslipidemia screening in asymptomatic adults at age 20, while others don’t recommend the practice until age 35-40 for men and age 50 for women. The 2014 American College of Cardiology/American Heart Association guideline on assessing CV risk deems it “reasonable” to assess traditional risk factors including lipids beginning at age 20, Dr. Chou and his associates said (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0946).
However, the potential adverse effects of statin therapy that is initiated in young adulthood and continued for decades haven’t been well studied, they noted.
In addition, some experts advocate lipid screening to identify young adults who have familial hypercholesterolemia. But this condition has such a low prevalence (estimated at only 1 in 500 people), and affected patients have such a low rate of coronary heat disease events before age 40 (approximately 10%) that the potential benefits of screening for this reason are very limited, the investigators added.
This study was supported by the Agency for Healthcare Research and Quality.
FROM ANNALS OF INTERNAL MEDICINE
Elbasvir-grazoprevir works effectively against HCV despite current drug use
A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.
This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.
They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).
All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.
The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).
Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.
Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.
The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.
“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.
This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.
A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.
This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.
They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).
All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.
The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).
Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.
Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.
The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.
“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.
This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.
A 12-week course of elbasvir plus grazoprevir proved effective against hepatitis C virus in 301 patients who were receiving opioid agonist therapy for injectable drug addiction, according to a report published online August 8 in Annals of Internal Medicine.
This patient population showed excellent treatment adherence and achieved sustained virologic response (SVR) rates of approximately 90%, even though most participants continued to use injectable drugs during the study. These findings demonstrate that current drug users can achieve HCV treatment outcomes that are comparable to those in the general HCV population, and “suggest that access to interferon-free direct-acting antiviral therapy should be expanded to patients receiving opioid agonist therapy, including the removal of drug use-based restrictions,” said Gregory J. Dore, MD, of the Kirby Institute, University of New South Wales, Sydney, and his associates.
They assessed elbasvir-grazoprevir (Zepatier) treatment in patients with untreated chronic HCV who were aged 18 and older and had been receiving opioid agonist therapy with methadone, buprenorphine, or buprenorphine-naloxone for at least 3 months at facilities in 13 countries. The study participants were randomly assigned in double-blind fashion to receive either immediate active treatment for 12 weeks (201 patients) or matching placebo for 12 weeks followed by 4 weeks of follow-up followed by deferred open-label active treatment for 12 weeks (100 control subjects).
All patients were followed for 6 months after they completed active treatment. All underwent frequent urine testing for illegal drugs, and more than half of both study groups tested positive for at least one drug during active treatment and follow-up. Illegal drug use was stable throughout the study period and did not affect either treatment adherence or efficacy. Nearly every participant showed excellent adherence (over 95%) to elbasvir-grazoprevir.
The primary efficacy endpoint, the SVR rate immediately after active treatment, was 91.5% in the immediate-treatment group and 89.5% in the deferred-treatment group. Both rates are substantially higher than the historical reference SVR rate of 67%, Dr. Dore and his associates noted (Ann Intern Med. 2016 Aug 8. doi: 10.7326/M16-0816).
Elbasvir-grazoprevir was equally effective against the GT1a, GT1b, and GT4 strains of HCV, but was less effective against the GT6 strain, which occurs primarily in China and Southeast Asia. It also was effective across important subgroups of patients, including those who had cirrhosis and those who carried HCV variants associated with drug resistance.
Regarding treatment safety, the rate of serious adverse events was low in both study groups (3.5% and 4.0%, respectively), and only one event in each group was deemed to be related to elbasvir-grazoprevir.
The incidence of reinfection for the 24-week period after successful treatment was 4.6 per 100 person-years, and it often was attributed to continuing use of contaminated needles or sexual contact with an infected partner. The effect of reinfection is “of considerable clinical and public health interest,” and will be further examined during a 3-year extension of the follow-up of this study, the investigators said.
“Of interest, 3 of the 6 patients categorized as having HCV reinfection subsequently had undetectable HCV-RNA levels without additional HCV treatment, indicating that not all reinfection cases develop viral persistence,” they added.
This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: A 12-week course of elbasvir plus grazoprevir was effective against HCV in patients receiving opioid agonist therapy for injectable drug addiction.
Major finding: The primary efficacy endpoint, the SVR rate after active treatment, was 91.5% with immediate treatment and 89.5% with deferred treatment.
Data source: An international, randomized, placebo-controlled, double-blind trial involving 301 patients followed for 6 months.
Disclosures: This study was funded primarily by Merck, which markets Zepatier. Dr. Dore reported ties to AbbVie, Merck, Bristol-Myers Squibb, Janssen, Roche, Gilead, GlaxoSmithKline, and Abbott, and his associates reported ties to numerous industry sources.
Skip SNL biopsy for desmoplastic melanoma
SEATTLE – Sentinel lymph node biopsy in patients with head or neck desmoplastic melanoma is positive only 6% of the time, and it doesn’t change the risk of recurrence.
Although sentinel lymph node biopsy (SLNB) is routine in more common forms of cutaneous melanoma, findings from a retrospective case-control study suggest that it’s “not really necessary” for desmoplastic melanoma (DM) of the head or neck, said lead investigator Dylan Roden, MD, of the department of otolaryngology, New York University. General surgeons have pretty much come to that conclusion for DM elsewhere on the body, but it hasn’t been shown before for neck and head lesions, he said.
DM, an invasive form of melanoma in which malignant cells are surrounded by fibrous tissue, accounts for maybe 2% of cutaneous melanomas, with half or so presenting on the head or neck. The reason SLNB is of less use than with other melanomas is that DM “doesn’t often spread through the lymphatics. It’s not that patients won’t ever have metastases, but maybe it will be through the blood. Removing a lymph node won’t necessarily” detect it, Dr. Roden said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.
Forgoing SLNB has the added benefit of shaving an hour and a half or more off surgery, which is important since DM patients tend to be older, he added.
The NYU team matched 32 of their cases with 60 controls with more common superficial spreading or nodular melanoma of the head and neck, based on age, gender, ulceration status, and tumor stage. Mean tumor thickness in both groups was more than 4 mm.
SLNB was performed in 16 DM patients (50%) and 36 control patients (60%); it was positive in one DM patient (6.3%) versus 8 of 28 controls with reported results (28.6%).
Eleven DM patients (34%) had a recurrence, which was less frequent then in controls, where 33 patients (55%) had a recurrence (P = .05). “SNLB did not change the risk of overall or regional recurrence” in DM, Dr. Roden said.
Recurrence was more than twice as likely in control patients (odds ratio, 2.33; P = .06). Meanwhile, recurrence in DM was linked to perineural invasion (P = .02), but not ulceration status (P = .12) or mitoses (P = .40).
DM patients also had better 5-year overall survival (79% versus 62%) and disease-free survival (70% versus 42%; P for both = .06). In general, DM “has a more favorable prognosis,” Dr. Roden said.
Cases and controls were in their mid-60s, on average, and most were men. Ulceration was present in about a quarter of patients. Mitosis was more common in superficial spreading and nodular patients (92% versus 53%; P less than .001), while perineural invasion was more common in DM (40% versus 7%; P less than.001).
Although outcomes were more favorable for DM, previous studies have found a higher rate of sentinel lymph node metastases – above 20% – for DM lesions with mixed, rather than pure, pathology. The 6.3% positive SLNB rate at NYU is more in line with what’s been reported before for pure lesions. The team plans to look into the matter.
There was no outside funding for the work, and Dr. Roden had no disclosures.
SEATTLE – Sentinel lymph node biopsy in patients with head or neck desmoplastic melanoma is positive only 6% of the time, and it doesn’t change the risk of recurrence.
Although sentinel lymph node biopsy (SLNB) is routine in more common forms of cutaneous melanoma, findings from a retrospective case-control study suggest that it’s “not really necessary” for desmoplastic melanoma (DM) of the head or neck, said lead investigator Dylan Roden, MD, of the department of otolaryngology, New York University. General surgeons have pretty much come to that conclusion for DM elsewhere on the body, but it hasn’t been shown before for neck and head lesions, he said.
DM, an invasive form of melanoma in which malignant cells are surrounded by fibrous tissue, accounts for maybe 2% of cutaneous melanomas, with half or so presenting on the head or neck. The reason SLNB is of less use than with other melanomas is that DM “doesn’t often spread through the lymphatics. It’s not that patients won’t ever have metastases, but maybe it will be through the blood. Removing a lymph node won’t necessarily” detect it, Dr. Roden said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.
Forgoing SLNB has the added benefit of shaving an hour and a half or more off surgery, which is important since DM patients tend to be older, he added.
The NYU team matched 32 of their cases with 60 controls with more common superficial spreading or nodular melanoma of the head and neck, based on age, gender, ulceration status, and tumor stage. Mean tumor thickness in both groups was more than 4 mm.
SLNB was performed in 16 DM patients (50%) and 36 control patients (60%); it was positive in one DM patient (6.3%) versus 8 of 28 controls with reported results (28.6%).
Eleven DM patients (34%) had a recurrence, which was less frequent then in controls, where 33 patients (55%) had a recurrence (P = .05). “SNLB did not change the risk of overall or regional recurrence” in DM, Dr. Roden said.
Recurrence was more than twice as likely in control patients (odds ratio, 2.33; P = .06). Meanwhile, recurrence in DM was linked to perineural invasion (P = .02), but not ulceration status (P = .12) or mitoses (P = .40).
DM patients also had better 5-year overall survival (79% versus 62%) and disease-free survival (70% versus 42%; P for both = .06). In general, DM “has a more favorable prognosis,” Dr. Roden said.
Cases and controls were in their mid-60s, on average, and most were men. Ulceration was present in about a quarter of patients. Mitosis was more common in superficial spreading and nodular patients (92% versus 53%; P less than .001), while perineural invasion was more common in DM (40% versus 7%; P less than.001).
Although outcomes were more favorable for DM, previous studies have found a higher rate of sentinel lymph node metastases – above 20% – for DM lesions with mixed, rather than pure, pathology. The 6.3% positive SLNB rate at NYU is more in line with what’s been reported before for pure lesions. The team plans to look into the matter.
There was no outside funding for the work, and Dr. Roden had no disclosures.
SEATTLE – Sentinel lymph node biopsy in patients with head or neck desmoplastic melanoma is positive only 6% of the time, and it doesn’t change the risk of recurrence.
Although sentinel lymph node biopsy (SLNB) is routine in more common forms of cutaneous melanoma, findings from a retrospective case-control study suggest that it’s “not really necessary” for desmoplastic melanoma (DM) of the head or neck, said lead investigator Dylan Roden, MD, of the department of otolaryngology, New York University. General surgeons have pretty much come to that conclusion for DM elsewhere on the body, but it hasn’t been shown before for neck and head lesions, he said.
DM, an invasive form of melanoma in which malignant cells are surrounded by fibrous tissue, accounts for maybe 2% of cutaneous melanomas, with half or so presenting on the head or neck. The reason SLNB is of less use than with other melanomas is that DM “doesn’t often spread through the lymphatics. It’s not that patients won’t ever have metastases, but maybe it will be through the blood. Removing a lymph node won’t necessarily” detect it, Dr. Roden said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.
Forgoing SLNB has the added benefit of shaving an hour and a half or more off surgery, which is important since DM patients tend to be older, he added.
The NYU team matched 32 of their cases with 60 controls with more common superficial spreading or nodular melanoma of the head and neck, based on age, gender, ulceration status, and tumor stage. Mean tumor thickness in both groups was more than 4 mm.
SLNB was performed in 16 DM patients (50%) and 36 control patients (60%); it was positive in one DM patient (6.3%) versus 8 of 28 controls with reported results (28.6%).
Eleven DM patients (34%) had a recurrence, which was less frequent then in controls, where 33 patients (55%) had a recurrence (P = .05). “SNLB did not change the risk of overall or regional recurrence” in DM, Dr. Roden said.
Recurrence was more than twice as likely in control patients (odds ratio, 2.33; P = .06). Meanwhile, recurrence in DM was linked to perineural invasion (P = .02), but not ulceration status (P = .12) or mitoses (P = .40).
DM patients also had better 5-year overall survival (79% versus 62%) and disease-free survival (70% versus 42%; P for both = .06). In general, DM “has a more favorable prognosis,” Dr. Roden said.
Cases and controls were in their mid-60s, on average, and most were men. Ulceration was present in about a quarter of patients. Mitosis was more common in superficial spreading and nodular patients (92% versus 53%; P less than .001), while perineural invasion was more common in DM (40% versus 7%; P less than.001).
Although outcomes were more favorable for DM, previous studies have found a higher rate of sentinel lymph node metastases – above 20% – for DM lesions with mixed, rather than pure, pathology. The 6.3% positive SLNB rate at NYU is more in line with what’s been reported before for pure lesions. The team plans to look into the matter.
There was no outside funding for the work, and Dr. Roden had no disclosures.
AT AHNS 2016
Key clinical point: Sentinel lymph node biopsy in patients with head or neck desmoplastic melanoma is positive only 6% of the time, and it doesn’t change the risk of recurrence.
Major finding: SLNB was performed in 16 DM patients (50%) and 36 control patients (60%); it was positive in one DM patient (6.3%) versus 8 of 28 controls with reported results (28.6%).
Data source: Retrospective case-control study with 92 patients
Disclosures: There was no outside funding for the work, and the presenter had no disclosures.
The Birthmark That Wasn't
A 3-year-old girl is brought to dermatology by her mother, who requests evaluation of a lesion that manifested shortly after the child’s birth. The family’s primary care provider has always dismissed her lesion as a birthmark, but her parents are concerned by its tendency to abruptly change for no apparent reason. It swells up, becomes itchy and red, and then returns to normal within minutes.
According to her parents, the patient is otherwise quite healthy. She has never experienced any breathing problems and is not atopic.
EXAMINATION
The lesion—an orange, 2-cm, round nodule with a smooth surface—is located on the volar aspect of her forearm. When forcefully stroked, it immediately begins to swell and redden, resembling a wheal. The patient verifies that the lesion itches when touched but is not tender. Before the examination ends, the lesion returns to normal.
Her type I skin is otherwise unremarkable.
What is the diagnosis?
DISCUSSION
Mastocytoma is the term for this localized accumulation of mast cells. When traumatized, histamine (among other active components) is released, causing sudden swelling and itching.
Mast cells are normal white cells involved in the natural function of the immune system, but they can be involved in rare but serious pathologic processes. For example, some children develop dozens of lesions (a condition called urticarial pigmentosa); under extreme circumstances, they can release enough histamine to induce shock and even respiratory distress.
Rarely, mast cells can undergo malignant transformation in the bone marrow, leading to mast cell leukemia. Another rare complication is mastocytosis, in which organs and tissue are invaded by mast cells, destroying the function of the organs and causing problems related to histamine release.
While simple, benign mastocytomas are common and easy to identify visually, skin biopsy is the key to diagnosing this family of diseases. With a small, stable lesion such as this patient’s, spontaneous resolution alleviates the need for treatment. Surgical removal does serve as a permanent cure, however, and as an accurate way to distinguish mastocytoma from mast cell tumors and juvenile xanthogranuloma—the other items in the differential.
TAKE-HOME LEARNING POINTS
• Mastocytomas are benign lesions composed of mast cells.
• Present at or soon after birth, mastocytomas are usually orangish brown and round to oval, and measure, on average, 1 to 3 cm.
• When traumatized by friction, they swell due to the release of histamine from the mast cells. They return to normal within minutes to hours.
• Mastocytomas only rarely require removal, since they are benign and resolve on their own.
A 3-year-old girl is brought to dermatology by her mother, who requests evaluation of a lesion that manifested shortly after the child’s birth. The family’s primary care provider has always dismissed her lesion as a birthmark, but her parents are concerned by its tendency to abruptly change for no apparent reason. It swells up, becomes itchy and red, and then returns to normal within minutes.
According to her parents, the patient is otherwise quite healthy. She has never experienced any breathing problems and is not atopic.
EXAMINATION
The lesion—an orange, 2-cm, round nodule with a smooth surface—is located on the volar aspect of her forearm. When forcefully stroked, it immediately begins to swell and redden, resembling a wheal. The patient verifies that the lesion itches when touched but is not tender. Before the examination ends, the lesion returns to normal.
Her type I skin is otherwise unremarkable.
What is the diagnosis?
DISCUSSION
Mastocytoma is the term for this localized accumulation of mast cells. When traumatized, histamine (among other active components) is released, causing sudden swelling and itching.
Mast cells are normal white cells involved in the natural function of the immune system, but they can be involved in rare but serious pathologic processes. For example, some children develop dozens of lesions (a condition called urticarial pigmentosa); under extreme circumstances, they can release enough histamine to induce shock and even respiratory distress.
Rarely, mast cells can undergo malignant transformation in the bone marrow, leading to mast cell leukemia. Another rare complication is mastocytosis, in which organs and tissue are invaded by mast cells, destroying the function of the organs and causing problems related to histamine release.
While simple, benign mastocytomas are common and easy to identify visually, skin biopsy is the key to diagnosing this family of diseases. With a small, stable lesion such as this patient’s, spontaneous resolution alleviates the need for treatment. Surgical removal does serve as a permanent cure, however, and as an accurate way to distinguish mastocytoma from mast cell tumors and juvenile xanthogranuloma—the other items in the differential.
TAKE-HOME LEARNING POINTS
• Mastocytomas are benign lesions composed of mast cells.
• Present at or soon after birth, mastocytomas are usually orangish brown and round to oval, and measure, on average, 1 to 3 cm.
• When traumatized by friction, they swell due to the release of histamine from the mast cells. They return to normal within minutes to hours.
• Mastocytomas only rarely require removal, since they are benign and resolve on their own.
A 3-year-old girl is brought to dermatology by her mother, who requests evaluation of a lesion that manifested shortly after the child’s birth. The family’s primary care provider has always dismissed her lesion as a birthmark, but her parents are concerned by its tendency to abruptly change for no apparent reason. It swells up, becomes itchy and red, and then returns to normal within minutes.
According to her parents, the patient is otherwise quite healthy. She has never experienced any breathing problems and is not atopic.
EXAMINATION
The lesion—an orange, 2-cm, round nodule with a smooth surface—is located on the volar aspect of her forearm. When forcefully stroked, it immediately begins to swell and redden, resembling a wheal. The patient verifies that the lesion itches when touched but is not tender. Before the examination ends, the lesion returns to normal.
Her type I skin is otherwise unremarkable.
What is the diagnosis?
DISCUSSION
Mastocytoma is the term for this localized accumulation of mast cells. When traumatized, histamine (among other active components) is released, causing sudden swelling and itching.
Mast cells are normal white cells involved in the natural function of the immune system, but they can be involved in rare but serious pathologic processes. For example, some children develop dozens of lesions (a condition called urticarial pigmentosa); under extreme circumstances, they can release enough histamine to induce shock and even respiratory distress.
Rarely, mast cells can undergo malignant transformation in the bone marrow, leading to mast cell leukemia. Another rare complication is mastocytosis, in which organs and tissue are invaded by mast cells, destroying the function of the organs and causing problems related to histamine release.
While simple, benign mastocytomas are common and easy to identify visually, skin biopsy is the key to diagnosing this family of diseases. With a small, stable lesion such as this patient’s, spontaneous resolution alleviates the need for treatment. Surgical removal does serve as a permanent cure, however, and as an accurate way to distinguish mastocytoma from mast cell tumors and juvenile xanthogranuloma—the other items in the differential.
TAKE-HOME LEARNING POINTS
• Mastocytomas are benign lesions composed of mast cells.
• Present at or soon after birth, mastocytomas are usually orangish brown and round to oval, and measure, on average, 1 to 3 cm.
• When traumatized by friction, they swell due to the release of histamine from the mast cells. They return to normal within minutes to hours.
• Mastocytomas only rarely require removal, since they are benign and resolve on their own.
Primary care’s rising role in behavioral health requires specialty partnerships
Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.
“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.
Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.
Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.
When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.
But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.
Components of collaborative care
In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.
“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.
“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.
The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.
Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.
An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.
Legislative support
The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.
Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.
Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.
In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.
Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.
Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.
Partnerships inevitable
In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.
“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”
Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.
Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.
“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”
On Twitter @whitneymcknight
Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.
“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.
Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.
Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.
When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.
But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.
Components of collaborative care
In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.
“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.
“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.
The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.
Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.
An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.
Legislative support
The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.
Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.
Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.
In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.
Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.
Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.
Partnerships inevitable
In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.
“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”
Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.
Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.
“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”
On Twitter @whitneymcknight
Amid rising suicide rates and a raging opioid crisis, the key to improving behavioral health care services nationally is to structure primary care practices for collaborative care, according to experts.
“A number of studies have shown that trying to train primary care doctors in mental health and substance abuse treatment does not change outcomes, so I would hope we don’t waste money on doing that,” said Henry Harbin, MD, a psychiatrist and senior health care policy analyst for the Kennedy Forum, while speaking as a panelist in a National Institute of Health Care Management Foundation webinar about mental health care service gaps.
Instead, the most evidence-based approach to caring for those with mental health needs is the collaborative care model, in which a person’s physical and mental needs are treated in one setting, said Dr. Harbin and his copanelists.
Between 2009 and 2013, the United States spent more on mental disorders than on any other health condition – about $200 billion, according to data published earlier this year. Heart conditions were second, at just under $150 billion.
When there is a comorbid mental illness, treatment costs more than double or triple for patients with a medical condition, according to Substance Abuse and Mental Health Services Administration data. For example, the cost of treating a patient with diabetes alone is about $9,500. Adding a mental illness to the mix pushes treatment costs to just under $37,000 annually.
But data from research such as the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) study show that treating the whole person saves money. In that study, it was shown that $522 invested in collaborative care resulted in a net savings of $3,363 4 years later – about a $6.50 return on every $1 spent.
Components of collaborative care
In general, the components of collaborative care emphasize the use of measurement-based care tools. Those tools range from screening for various mental health conditions to systematic use of symptom rating scales, patient registries, and clinical decision-making algorithms. Applying these kinds of metrics-driven protocols can help curb the “clinical inertia, even in specialty care,” that can happen by relying on clinical judgment alone, said Glenda Wrenn, MD, an assistant professor of psychiatry and behavioral sciences at the Morehouse School of Medicine, Atlanta, and a webinar panelist.
“We’re actually really poor at detecting when our patients are going off track,” Dr. Wrenn said, citing a statistic that only about a fifth of patients whose symptom severity is increasing are detected by physicians who do not use measurement-based tools.
“That’s true for specialty providers who have the additional training, and so it’s especially true for those who do not have that kind of diagnostic training,” cautioned Dr. Wrenn, who is also the behavioral health director at the Satcher Health Leadership Institute at Morehouse.
The American Psychiatry Association also now offers training courses for psychiatrists interested in working with primary care practices. However, colocation of mental health specialists with primary care practices is not always necessary, according to John Fortney, PhD, director of population health at the Advancing Integrated Mental Health Solutions Center at the University of Washington, Seattle, and a webinar panelist. Once measurement-based tools are in place, “most first-line treatment of mental illnesses can be handled by the primary care physician without any help,” he said.
Dr. Fortney has conducted numerous studies of integrating behavioral health into primary care, including the use of telemedicine services. He advocates a stepwise approach to treatment once a patient’s needs are determined to be beyond the basic level of care.
An ad hoc consultation usually from an offsite mental health specialist would be the second step, Dr. Fortney noted, progressing as needed through an onsite intervention by a specialist, collaborative care with targeted treatment, and finally an outside referral to specialty care.
Legislative support
The pressure on the health care system to respond to the nation’s rampant rates of opioid abuse and overdose deaths coincides with a dramatic overhaul of regulations for how physicians who participate in Medicaid are measured and paid, along with recently proposed changes to the Physician Fee Schedule.
Together, these reforms call not only for more metric-based care, but, if finalized in their entirety, would create payment codes specifically for a collaborative, team-based approach to mental health care – including addiction treatment – through the use of coordinated services by primary care practitioners, behavioral health care managers, and psychiatric consultants.
Meanwhile, President Barack Obama recently signed into law a comprehensive package of opioid abuse–related reforms. Once finalized, the reforms will expand and support primary care’s use of medication-assisted therapies to combat opioid addiction and overdose, and extend prescribing privileges for buprenorphine and related therapies to practitioners and physician assistants. The new law also strengthens prescription drug monitoring and disposal programs.
In March, the American Board of Medical Specialties helped elevate addiction medicine’s clinical status with the announcement that it will recognize addiction medicine as a subspecialty, sponsored by the American Board of Preventive Medicine. Although no date has been announced for the first certification exam, the ABMS move was reinforced by a recent Obama administration regulatory change that nearly triples the number of patients addiction specialists can see annually.
Pressure is also mounting on primary care providers to play a more active role in reversing the highest suicide rates in 3 decades. Although the U.S. Preventive Services Task Force concluded in 2014 the evidence is insufficient enough to endorse screening for suicide risk, study data show that in the month prior to their death by suicide, nearly half of people had seen their primary care provider at least once.
Partly in response to these data, the federal Center for Integrated Health Solutions has created a resource center for suicide prevention in primary care.
Partnerships inevitable
In an environment where high care costs directly impact reimbursement, physicians and insurers alike are motivated to “aggressively” seek an integrated approach to care, according to webinar panelist Charles Gross, PhD, vice president for behavioral health in Anthem Blue Cross Blue Shield’s government affairs division.
“Doctors should be compensated for the hard work necessary to integrate care,” Dr. Gross said. “It’s not inexpensive. And also, they should be compensated for patient outcomes.”
Increasingly, provider membership contracts are tailored to a practice’s patient panel, the practice’s current level of integration, and its overall objectives, reinforced by metrics and the implementation of measurement-based care. Bundled care codes and other coding strategies are also being developed to support integrated care, according to Dr. Gross.
Whether it is through telemedicine, colocation, or developing referral networks, primary care physicians are in a position now where they must partner with mental health specialists.
“I don’t think more [training] on how to diagnose and treat mental health and substance abuse is going to be effective in primary care,” Dr. Gross cautioned. “That’s why we’ve really come down firmly on the side of the collaborative care model, based on the IMPACT study. That’s where we’re going.”
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM AN NIHCM FOUNDATION WEBINAR