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Facial exercises improved appearance in small study of middle-aged women
The role of skin laxity and substructural fat and muscle loss in the appearance of facial aging has been recognized already, and there has been interest within the nonmedical community regarding use of facial exercise to improve appearance, Murad Alam, MD, of Northwestern University, Chicago, and his colleagues wrote in a research letter published in JAMA Dermatology.
The researchers recruited healthy women aged 40-65 years with some photodamage to the face and an interest in facial exercises. After two 90-minute, in-person training sessions with a certified instructor, the participants were asked to perform a 30-minute facial exercise session daily for 8 weeks at home, followed by sessions every other day during weeks 9-20. Sixteen patients completed the full 20-week study.
Two blinded physicians used validated assessment scales to compare photographs of the participants taken at the beginning and end of the 20-week period. Facial exercise was associated with an improved mean upper-cheek fullness score, compared with baseline (1.1 vs. 1.8, respectively; P = .003), and an improved mean lower-cheek fullness score, compared with baseline (0.9 vs. 1.6; P = .003).
In addition, blinded physicians’ estimates of the women’s ages decreased significantly: The estimates dropped from an average of 51 years at baseline to an average of 49 years after the women completed the 20 weeks of facial exercises (P = .002), Dr. Alam and his associates reported.
The study was limited by several factors, including its small sample size, the lack of a control group, and a self-selected population that may have been especially motivated to follow the exercise routine, the researchers noted.
However, the results suggest that the cause for improvements in appearance as a result of the exercises “may be exercise-actuated hypertrophy of cheek and other muscles,” they said. “Further research is warranted to isolate the causes and effects of exercise-related changes and to assess the generalizability of these findings,” Dr. Alam and his associates concluded.
The study was supported by research funds from the department of dermatology at Northwestern University. Dr. Alam disclosed serving as a consultant for Amway and Leo Pharma and has served as an investigator on studies supported in part by Allergan, Medicis Pharmaceutical, BioForm Medical, and Ulthera.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Jan 3. doi: 10.1001/jamadermatol.2017.5142
The role of skin laxity and substructural fat and muscle loss in the appearance of facial aging has been recognized already, and there has been interest within the nonmedical community regarding use of facial exercise to improve appearance, Murad Alam, MD, of Northwestern University, Chicago, and his colleagues wrote in a research letter published in JAMA Dermatology.
The researchers recruited healthy women aged 40-65 years with some photodamage to the face and an interest in facial exercises. After two 90-minute, in-person training sessions with a certified instructor, the participants were asked to perform a 30-minute facial exercise session daily for 8 weeks at home, followed by sessions every other day during weeks 9-20. Sixteen patients completed the full 20-week study.
Two blinded physicians used validated assessment scales to compare photographs of the participants taken at the beginning and end of the 20-week period. Facial exercise was associated with an improved mean upper-cheek fullness score, compared with baseline (1.1 vs. 1.8, respectively; P = .003), and an improved mean lower-cheek fullness score, compared with baseline (0.9 vs. 1.6; P = .003).
In addition, blinded physicians’ estimates of the women’s ages decreased significantly: The estimates dropped from an average of 51 years at baseline to an average of 49 years after the women completed the 20 weeks of facial exercises (P = .002), Dr. Alam and his associates reported.
The study was limited by several factors, including its small sample size, the lack of a control group, and a self-selected population that may have been especially motivated to follow the exercise routine, the researchers noted.
However, the results suggest that the cause for improvements in appearance as a result of the exercises “may be exercise-actuated hypertrophy of cheek and other muscles,” they said. “Further research is warranted to isolate the causes and effects of exercise-related changes and to assess the generalizability of these findings,” Dr. Alam and his associates concluded.
The study was supported by research funds from the department of dermatology at Northwestern University. Dr. Alam disclosed serving as a consultant for Amway and Leo Pharma and has served as an investigator on studies supported in part by Allergan, Medicis Pharmaceutical, BioForm Medical, and Ulthera.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Jan 3. doi: 10.1001/jamadermatol.2017.5142
The role of skin laxity and substructural fat and muscle loss in the appearance of facial aging has been recognized already, and there has been interest within the nonmedical community regarding use of facial exercise to improve appearance, Murad Alam, MD, of Northwestern University, Chicago, and his colleagues wrote in a research letter published in JAMA Dermatology.
The researchers recruited healthy women aged 40-65 years with some photodamage to the face and an interest in facial exercises. After two 90-minute, in-person training sessions with a certified instructor, the participants were asked to perform a 30-minute facial exercise session daily for 8 weeks at home, followed by sessions every other day during weeks 9-20. Sixteen patients completed the full 20-week study.
Two blinded physicians used validated assessment scales to compare photographs of the participants taken at the beginning and end of the 20-week period. Facial exercise was associated with an improved mean upper-cheek fullness score, compared with baseline (1.1 vs. 1.8, respectively; P = .003), and an improved mean lower-cheek fullness score, compared with baseline (0.9 vs. 1.6; P = .003).
In addition, blinded physicians’ estimates of the women’s ages decreased significantly: The estimates dropped from an average of 51 years at baseline to an average of 49 years after the women completed the 20 weeks of facial exercises (P = .002), Dr. Alam and his associates reported.
The study was limited by several factors, including its small sample size, the lack of a control group, and a self-selected population that may have been especially motivated to follow the exercise routine, the researchers noted.
However, the results suggest that the cause for improvements in appearance as a result of the exercises “may be exercise-actuated hypertrophy of cheek and other muscles,” they said. “Further research is warranted to isolate the causes and effects of exercise-related changes and to assess the generalizability of these findings,” Dr. Alam and his associates concluded.
The study was supported by research funds from the department of dermatology at Northwestern University. Dr. Alam disclosed serving as a consultant for Amway and Leo Pharma and has served as an investigator on studies supported in part by Allergan, Medicis Pharmaceutical, BioForm Medical, and Ulthera.
SOURCE: Alam M et al. JAMA Dermatol. 2018 Jan 3. doi: 10.1001/jamadermatol.2017.5142
FROM JAMA DERMATOLOGY
Key clinical point: A 20-week program of facial exercise significantly improved facial fullness and perceived age among women aged 40-65 years.
Major finding: Fullness of the upper and lower cheek significantly improved from baseline after the exercise program, based on a validated scale.
Data source: The data come from a study of 27 women aged 40-65 years.
Disclosures: The study was supported by research funds from the department of dermatology at Northwestern University. Dr. Alam disclosed serving as a consultant for Amway and LEO Pharma and has served as an investigator on studies supported in part by Allergan, Medicis Pharmaceutical, BioForm Medical, and Ulthera.
Source: Alam M et al. JAMA Dermatol. 2018 Jan 3. doi: 10.1001/jamadermatol.2017.5142.
Neutrophilic urticarial dermatosis is usually misdiagnosed
GENEVA – Neutrophilic urticarial dermatosis (NUD) in patients with systemic lupus erythematosus (SLE) is “almost always” initially misdiagnosed as a lupus flare and treated inappropriately, Dan Lipsker, MD, PhD, said in a plenary address at the annual congress of the European Academy of Dermatology and Venereology.
“This is a condition that is underdiagnosed and overtreated,” declared Dr. Lipsker, professor of dermatology at the University of Strasbourg (France).
NUD is not rare. Dr. Lipsker estimates it occurs in 1%-2% of patients with SLE. In a retrospective study of seven patients with NUD and SLE, he and his colleagues reported that NUD was initially misdiagnosed as a lupus flare in 4 patients, who were then treated with immunosuppressive drugs (Medicine. 2014 Dec;93[29]:e351]). “That’s quite logical because the patients had a rash, fever, and joint pain,” the dermatologist noted.
However, : It won’t alleviate the symptoms and needlessly exposes the patient to drug toxicities.
The treatment for NUD is not prednisone, mycophenolate mofetil, an antimalarial, or other drugs conventionally prescribed for SLE; it’s a drug that inhibits neutrophil migration, such as dapsone at 50-200 mg per day or colchicine at 0.5-1.0 mg per day. Typically, within just a few days after starting the appropriate therapy, the joint pain and rash of NUD are gone, according to Dr. Lipsker.
Making the diagnosis
The rash of NUD is distinctly different from a classic lupus rash. It consists of pale red macules or slightly raised nonpruritic papules. Individual lesions will disappear spontaneously within 24-48 hours.
The histopathology of NUD is characteristic of a neutrophilic dermatosis. On biopsy, an intense neutrophilic perivascular and interstitial infiltrate with leukocytoclasia is seen. There is no damage to the blood vessel walls, which readily distinguishes NUD from urticarial vasculitis.
Other neutrophilic dermatoses have also been reported with increased frequency in patients with SLE. These include Sweet syndrome, pyoderma gangrenosum, bullous SLE, amicrobial pustulosis of the folds, and palisaded neutrophilic granulomatous dermatitis. Dr. Lipsker lumps them, together with NUD, as neutrophilic cutaneous lupus erythematosus. Affected SLE patients have an exaggerated innate immune response. It is as yet unclear if these neutrophilic dermatoses have prognostic significance in the setting of SLE, he said.
Dr. Lipsker reported having no financial conflicts of interest regarding his presentation.
GENEVA – Neutrophilic urticarial dermatosis (NUD) in patients with systemic lupus erythematosus (SLE) is “almost always” initially misdiagnosed as a lupus flare and treated inappropriately, Dan Lipsker, MD, PhD, said in a plenary address at the annual congress of the European Academy of Dermatology and Venereology.
“This is a condition that is underdiagnosed and overtreated,” declared Dr. Lipsker, professor of dermatology at the University of Strasbourg (France).
NUD is not rare. Dr. Lipsker estimates it occurs in 1%-2% of patients with SLE. In a retrospective study of seven patients with NUD and SLE, he and his colleagues reported that NUD was initially misdiagnosed as a lupus flare in 4 patients, who were then treated with immunosuppressive drugs (Medicine. 2014 Dec;93[29]:e351]). “That’s quite logical because the patients had a rash, fever, and joint pain,” the dermatologist noted.
However, : It won’t alleviate the symptoms and needlessly exposes the patient to drug toxicities.
The treatment for NUD is not prednisone, mycophenolate mofetil, an antimalarial, or other drugs conventionally prescribed for SLE; it’s a drug that inhibits neutrophil migration, such as dapsone at 50-200 mg per day or colchicine at 0.5-1.0 mg per day. Typically, within just a few days after starting the appropriate therapy, the joint pain and rash of NUD are gone, according to Dr. Lipsker.
Making the diagnosis
The rash of NUD is distinctly different from a classic lupus rash. It consists of pale red macules or slightly raised nonpruritic papules. Individual lesions will disappear spontaneously within 24-48 hours.
The histopathology of NUD is characteristic of a neutrophilic dermatosis. On biopsy, an intense neutrophilic perivascular and interstitial infiltrate with leukocytoclasia is seen. There is no damage to the blood vessel walls, which readily distinguishes NUD from urticarial vasculitis.
Other neutrophilic dermatoses have also been reported with increased frequency in patients with SLE. These include Sweet syndrome, pyoderma gangrenosum, bullous SLE, amicrobial pustulosis of the folds, and palisaded neutrophilic granulomatous dermatitis. Dr. Lipsker lumps them, together with NUD, as neutrophilic cutaneous lupus erythematosus. Affected SLE patients have an exaggerated innate immune response. It is as yet unclear if these neutrophilic dermatoses have prognostic significance in the setting of SLE, he said.
Dr. Lipsker reported having no financial conflicts of interest regarding his presentation.
GENEVA – Neutrophilic urticarial dermatosis (NUD) in patients with systemic lupus erythematosus (SLE) is “almost always” initially misdiagnosed as a lupus flare and treated inappropriately, Dan Lipsker, MD, PhD, said in a plenary address at the annual congress of the European Academy of Dermatology and Venereology.
“This is a condition that is underdiagnosed and overtreated,” declared Dr. Lipsker, professor of dermatology at the University of Strasbourg (France).
NUD is not rare. Dr. Lipsker estimates it occurs in 1%-2% of patients with SLE. In a retrospective study of seven patients with NUD and SLE, he and his colleagues reported that NUD was initially misdiagnosed as a lupus flare in 4 patients, who were then treated with immunosuppressive drugs (Medicine. 2014 Dec;93[29]:e351]). “That’s quite logical because the patients had a rash, fever, and joint pain,” the dermatologist noted.
However, : It won’t alleviate the symptoms and needlessly exposes the patient to drug toxicities.
The treatment for NUD is not prednisone, mycophenolate mofetil, an antimalarial, or other drugs conventionally prescribed for SLE; it’s a drug that inhibits neutrophil migration, such as dapsone at 50-200 mg per day or colchicine at 0.5-1.0 mg per day. Typically, within just a few days after starting the appropriate therapy, the joint pain and rash of NUD are gone, according to Dr. Lipsker.
Making the diagnosis
The rash of NUD is distinctly different from a classic lupus rash. It consists of pale red macules or slightly raised nonpruritic papules. Individual lesions will disappear spontaneously within 24-48 hours.
The histopathology of NUD is characteristic of a neutrophilic dermatosis. On biopsy, an intense neutrophilic perivascular and interstitial infiltrate with leukocytoclasia is seen. There is no damage to the blood vessel walls, which readily distinguishes NUD from urticarial vasculitis.
Other neutrophilic dermatoses have also been reported with increased frequency in patients with SLE. These include Sweet syndrome, pyoderma gangrenosum, bullous SLE, amicrobial pustulosis of the folds, and palisaded neutrophilic granulomatous dermatitis. Dr. Lipsker lumps them, together with NUD, as neutrophilic cutaneous lupus erythematosus. Affected SLE patients have an exaggerated innate immune response. It is as yet unclear if these neutrophilic dermatoses have prognostic significance in the setting of SLE, he said.
Dr. Lipsker reported having no financial conflicts of interest regarding his presentation.
EXPERT ANALYSIS FROM THE EADV CONGRESS
In Brazil, few patients get second- and third-line treatment for metastatic RCC
, a retrospective study showed.
Of 3,990 patients with metastatic renal cell carcinoma (mRCC), 79% received an appropriate first-line treatment – mainly a vascular endothelial growth factor agent. But only 20% went on to get a second-line agent, and just 5% received a third-line agent, Paulo G. Bergerot, MD, and his colleagues reported in the Journal of Global Oncology.
Patients in private institutions were significantly more likely to receive appropriate first- and second-line treatment than those in public institutions, although the numbers receiving third-line agents were similarly low, reported Dr. Bergerot of the Federal University of São Paulo and his coauthors.
The study highlights sharp discrepancies between treatment in Brazil and more developed countries, the team noted.
“Previous reports from the International Metastatic Renal Cell Carcinoma Database Consortium suggest that approximately 48% of patients who receive first-line therapy proceed to second-line therapy. In addition, among patients who received first-line therapy in this experience, approximately 21% received third-line therapy,” the investigators wrote.
The reasons behind the differences aren’t entirely clear, but cost and clinicians’ knowledge of emerging study data could be major factors, they suggested.
“In particular, we suspect limited availability and cost of second-line treatments to be a barrier, although our data set did not have the capability of confirming this. Another barrier to receipt of second-line therapy might be educational gaps among practitioners. Emerging data from phase 3 studies supporting the use of agents in the refractory setting may not be widely broadcast. The discordance in receipt of therapies in private and public settings is perhaps the greatest indication that financial and social barriers likely affect treatment paradigms in Brazil,” the authors wrote.
Slow dissemination of clinical knowledge may also be reflected in another of the team’s findings: 240 patients received “nontraditional” first-line cytotoxic treatments, which lacked regulatory approval and had little supporting evidence for treating mRCC, the investigators reported.
Dr. Bergerot had no relevant financial disclosures, although several of his coauthors reported financial relationships with various pharmaceutical companies.
SOURCE: Bergerot et al. J Glob Oncol. 2017 Dec 27. doi: 10.1200/JGO.17.00113.
, a retrospective study showed.
Of 3,990 patients with metastatic renal cell carcinoma (mRCC), 79% received an appropriate first-line treatment – mainly a vascular endothelial growth factor agent. But only 20% went on to get a second-line agent, and just 5% received a third-line agent, Paulo G. Bergerot, MD, and his colleagues reported in the Journal of Global Oncology.
Patients in private institutions were significantly more likely to receive appropriate first- and second-line treatment than those in public institutions, although the numbers receiving third-line agents were similarly low, reported Dr. Bergerot of the Federal University of São Paulo and his coauthors.
The study highlights sharp discrepancies between treatment in Brazil and more developed countries, the team noted.
“Previous reports from the International Metastatic Renal Cell Carcinoma Database Consortium suggest that approximately 48% of patients who receive first-line therapy proceed to second-line therapy. In addition, among patients who received first-line therapy in this experience, approximately 21% received third-line therapy,” the investigators wrote.
The reasons behind the differences aren’t entirely clear, but cost and clinicians’ knowledge of emerging study data could be major factors, they suggested.
“In particular, we suspect limited availability and cost of second-line treatments to be a barrier, although our data set did not have the capability of confirming this. Another barrier to receipt of second-line therapy might be educational gaps among practitioners. Emerging data from phase 3 studies supporting the use of agents in the refractory setting may not be widely broadcast. The discordance in receipt of therapies in private and public settings is perhaps the greatest indication that financial and social barriers likely affect treatment paradigms in Brazil,” the authors wrote.
Slow dissemination of clinical knowledge may also be reflected in another of the team’s findings: 240 patients received “nontraditional” first-line cytotoxic treatments, which lacked regulatory approval and had little supporting evidence for treating mRCC, the investigators reported.
Dr. Bergerot had no relevant financial disclosures, although several of his coauthors reported financial relationships with various pharmaceutical companies.
SOURCE: Bergerot et al. J Glob Oncol. 2017 Dec 27. doi: 10.1200/JGO.17.00113.
, a retrospective study showed.
Of 3,990 patients with metastatic renal cell carcinoma (mRCC), 79% received an appropriate first-line treatment – mainly a vascular endothelial growth factor agent. But only 20% went on to get a second-line agent, and just 5% received a third-line agent, Paulo G. Bergerot, MD, and his colleagues reported in the Journal of Global Oncology.
Patients in private institutions were significantly more likely to receive appropriate first- and second-line treatment than those in public institutions, although the numbers receiving third-line agents were similarly low, reported Dr. Bergerot of the Federal University of São Paulo and his coauthors.
The study highlights sharp discrepancies between treatment in Brazil and more developed countries, the team noted.
“Previous reports from the International Metastatic Renal Cell Carcinoma Database Consortium suggest that approximately 48% of patients who receive first-line therapy proceed to second-line therapy. In addition, among patients who received first-line therapy in this experience, approximately 21% received third-line therapy,” the investigators wrote.
The reasons behind the differences aren’t entirely clear, but cost and clinicians’ knowledge of emerging study data could be major factors, they suggested.
“In particular, we suspect limited availability and cost of second-line treatments to be a barrier, although our data set did not have the capability of confirming this. Another barrier to receipt of second-line therapy might be educational gaps among practitioners. Emerging data from phase 3 studies supporting the use of agents in the refractory setting may not be widely broadcast. The discordance in receipt of therapies in private and public settings is perhaps the greatest indication that financial and social barriers likely affect treatment paradigms in Brazil,” the authors wrote.
Slow dissemination of clinical knowledge may also be reflected in another of the team’s findings: 240 patients received “nontraditional” first-line cytotoxic treatments, which lacked regulatory approval and had little supporting evidence for treating mRCC, the investigators reported.
Dr. Bergerot had no relevant financial disclosures, although several of his coauthors reported financial relationships with various pharmaceutical companies.
SOURCE: Bergerot et al. J Glob Oncol. 2017 Dec 27. doi: 10.1200/JGO.17.00113.
FROM THE JOURNAL OF GLOBAL ONCOLOGY
Key clinical point: Few Brazilians with mRCC receive anything after their first-line treatment.
Major finding: First-line agents were used in 79% of the cohort, but only 20% got second-line treatments and just 5%, third-line treatment.
Study details: A retrospective database study involving 3,990 patients with mRCC.
Disclosures: Dr. Bergerot had no relevant financial disclosures, although several of his coauthors disclosed financial relationships with pharmaceutical companies.
Source: Bergerot et al. J Glob Oncol. 2017 Dec 27. doi: 10.1200/JGO.17.00113.
2017 update to McDonald criteria loosens MS diagnosis somewhat
Updates to the McDonald criteria for diagnosing multiple sclerosis (MS), first introduced in 2010, should allow initiation of therapy earlier in the time point of disease. The changes expand some of the criteria that can be used for diagnosis of disease.
The McDonald criteria should be applied primarily to patients with a typical clinically isolated syndrome – that is, in whom the probability of MS is high. They are best applied to patients 11 years or older, according to first author Alan J. Thompson, MD, and his colleagues on the International Panel on Diagnosis of Multiple Sclerosis. Their update to the 2010 criteria was published online Dec. 21, 2017, in The Lancet Neurology.
The changes include:
• Cerebrospinal fluid-specific oligoclonal bands can now be used to diagnose MS in patients with a typical clinically isolated syndrome in whom MRI or clinical signs point to dissemination in space (DIS), and if there is no other, better explanation for clinical signs.
• Symptomatic or asymptomatic MRI lesions can be used in the determination of DIS or dissemination in time (DIT). An exception is MRI lesions in the optic nerve in patients with optic neuritis, due to insufficient evidence. Specifically, the panel notes that DIS “can be demonstrated by one or more T2-hyperintense lesions [symptomatic or asymptomatic] that are characteristic of multiple sclerosis in two or more of four areas of the CNS: periventricular, cortical or juxtacortical, and infratentorial brain regions, and the spinal cord.” DIT is defined by “the simultaneous presence of gadolinium-enhancing and non-enhancing lesions [symptomatic or asymptomatic] at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI, with reference to a baseline scan, irrespective of the timing of the baseline MRI.”
• In patients experiencing brainstem or spinal cord clinically isolated syndrome, symptomatic lesions are sufficient to determine DIS or DIT.
• Cortical or juxtacortical lesions can be used in determining DIS.
• When MS is diagnosed, physicians should determine disease course (relapsing-remitting, primary progressive, or secondary progressive), whether the disease is active or not, and whether it is progressive, using the clinical history over the previous year.
The update was driven by a range of factors, including ongoing developments in imaging, the performance of the 2010 guidelines in diverse populations, and potential confusion between MS and other conditions with similar imaging characteristics, such as neuromyelitis optica spectrum disorders, which should always be considered because symptoms can overlap with MS. These conditions demand different treatment protocols. In addition, in 2016, the European Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) network suggested changes to the MRI criteria for diagnosing multiple sclerosis.
Updates to the guidelines are hardly finished. The panel called for future examination of optic nerve involvement, diverse populations, advanced imaging techniques, and biomarkers.
Some of the panel members reported financial ties to the pharmaceutical industry.
SOURCE: Thompson A et al., Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422(17)30470-2
Earlier diagnosis and treatment initiation is increasingly important to prevent long-term disability. In recent years, MRI has become a more powerful diagnostic tool. These guidelines present useful improvements, but challenges remain. Due to a lack of data, it is not clear how well the McDonald criteria perform in nonwhite and non-Western populations, as well as in patients with atypical presentation of a clinically isolated syndrome. The guidelines also offer little help in the treatment of asymptomatic patients with radiologically isolated syndromes who eventually develop dissemination in time or space as determined by MRI findings.
Careful application of the new criteria should reduce misdiagnosis between MS and migraine, fibromyalgia, psychiatric disorders, and neuromyelitis optica spectrum disorders, but vigilance is required and clinicians should keep an open mind regarding alternative diagnoses.
Stephen Hauser, MD, and Riley Bove, MD, are with the University of California, San Francisco. Dr. Hauser serves on the board of trustees for Neurona Therapeutics, and scientific advisory boards for Symbiotix, Annexon, Bionure, and Molecular Stethoscope, and he has received travel reimbursement and writing support from F. Hoffmann La Roche. Dr. Bove has received fees from Genzyme-Sanofi, Roche-Genentech, and Novartis. Their comments are derived from an editorial accompanying the 2017 McDonald criteria (Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422[17]30461-1)
Earlier diagnosis and treatment initiation is increasingly important to prevent long-term disability. In recent years, MRI has become a more powerful diagnostic tool. These guidelines present useful improvements, but challenges remain. Due to a lack of data, it is not clear how well the McDonald criteria perform in nonwhite and non-Western populations, as well as in patients with atypical presentation of a clinically isolated syndrome. The guidelines also offer little help in the treatment of asymptomatic patients with radiologically isolated syndromes who eventually develop dissemination in time or space as determined by MRI findings.
Careful application of the new criteria should reduce misdiagnosis between MS and migraine, fibromyalgia, psychiatric disorders, and neuromyelitis optica spectrum disorders, but vigilance is required and clinicians should keep an open mind regarding alternative diagnoses.
Stephen Hauser, MD, and Riley Bove, MD, are with the University of California, San Francisco. Dr. Hauser serves on the board of trustees for Neurona Therapeutics, and scientific advisory boards for Symbiotix, Annexon, Bionure, and Molecular Stethoscope, and he has received travel reimbursement and writing support from F. Hoffmann La Roche. Dr. Bove has received fees from Genzyme-Sanofi, Roche-Genentech, and Novartis. Their comments are derived from an editorial accompanying the 2017 McDonald criteria (Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422[17]30461-1)
Earlier diagnosis and treatment initiation is increasingly important to prevent long-term disability. In recent years, MRI has become a more powerful diagnostic tool. These guidelines present useful improvements, but challenges remain. Due to a lack of data, it is not clear how well the McDonald criteria perform in nonwhite and non-Western populations, as well as in patients with atypical presentation of a clinically isolated syndrome. The guidelines also offer little help in the treatment of asymptomatic patients with radiologically isolated syndromes who eventually develop dissemination in time or space as determined by MRI findings.
Careful application of the new criteria should reduce misdiagnosis between MS and migraine, fibromyalgia, psychiatric disorders, and neuromyelitis optica spectrum disorders, but vigilance is required and clinicians should keep an open mind regarding alternative diagnoses.
Stephen Hauser, MD, and Riley Bove, MD, are with the University of California, San Francisco. Dr. Hauser serves on the board of trustees for Neurona Therapeutics, and scientific advisory boards for Symbiotix, Annexon, Bionure, and Molecular Stethoscope, and he has received travel reimbursement and writing support from F. Hoffmann La Roche. Dr. Bove has received fees from Genzyme-Sanofi, Roche-Genentech, and Novartis. Their comments are derived from an editorial accompanying the 2017 McDonald criteria (Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422[17]30461-1)
Updates to the McDonald criteria for diagnosing multiple sclerosis (MS), first introduced in 2010, should allow initiation of therapy earlier in the time point of disease. The changes expand some of the criteria that can be used for diagnosis of disease.
The McDonald criteria should be applied primarily to patients with a typical clinically isolated syndrome – that is, in whom the probability of MS is high. They are best applied to patients 11 years or older, according to first author Alan J. Thompson, MD, and his colleagues on the International Panel on Diagnosis of Multiple Sclerosis. Their update to the 2010 criteria was published online Dec. 21, 2017, in The Lancet Neurology.
The changes include:
• Cerebrospinal fluid-specific oligoclonal bands can now be used to diagnose MS in patients with a typical clinically isolated syndrome in whom MRI or clinical signs point to dissemination in space (DIS), and if there is no other, better explanation for clinical signs.
• Symptomatic or asymptomatic MRI lesions can be used in the determination of DIS or dissemination in time (DIT). An exception is MRI lesions in the optic nerve in patients with optic neuritis, due to insufficient evidence. Specifically, the panel notes that DIS “can be demonstrated by one or more T2-hyperintense lesions [symptomatic or asymptomatic] that are characteristic of multiple sclerosis in two or more of four areas of the CNS: periventricular, cortical or juxtacortical, and infratentorial brain regions, and the spinal cord.” DIT is defined by “the simultaneous presence of gadolinium-enhancing and non-enhancing lesions [symptomatic or asymptomatic] at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI, with reference to a baseline scan, irrespective of the timing of the baseline MRI.”
• In patients experiencing brainstem or spinal cord clinically isolated syndrome, symptomatic lesions are sufficient to determine DIS or DIT.
• Cortical or juxtacortical lesions can be used in determining DIS.
• When MS is diagnosed, physicians should determine disease course (relapsing-remitting, primary progressive, or secondary progressive), whether the disease is active or not, and whether it is progressive, using the clinical history over the previous year.
The update was driven by a range of factors, including ongoing developments in imaging, the performance of the 2010 guidelines in diverse populations, and potential confusion between MS and other conditions with similar imaging characteristics, such as neuromyelitis optica spectrum disorders, which should always be considered because symptoms can overlap with MS. These conditions demand different treatment protocols. In addition, in 2016, the European Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) network suggested changes to the MRI criteria for diagnosing multiple sclerosis.
Updates to the guidelines are hardly finished. The panel called for future examination of optic nerve involvement, diverse populations, advanced imaging techniques, and biomarkers.
Some of the panel members reported financial ties to the pharmaceutical industry.
SOURCE: Thompson A et al., Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422(17)30470-2
Updates to the McDonald criteria for diagnosing multiple sclerosis (MS), first introduced in 2010, should allow initiation of therapy earlier in the time point of disease. The changes expand some of the criteria that can be used for diagnosis of disease.
The McDonald criteria should be applied primarily to patients with a typical clinically isolated syndrome – that is, in whom the probability of MS is high. They are best applied to patients 11 years or older, according to first author Alan J. Thompson, MD, and his colleagues on the International Panel on Diagnosis of Multiple Sclerosis. Their update to the 2010 criteria was published online Dec. 21, 2017, in The Lancet Neurology.
The changes include:
• Cerebrospinal fluid-specific oligoclonal bands can now be used to diagnose MS in patients with a typical clinically isolated syndrome in whom MRI or clinical signs point to dissemination in space (DIS), and if there is no other, better explanation for clinical signs.
• Symptomatic or asymptomatic MRI lesions can be used in the determination of DIS or dissemination in time (DIT). An exception is MRI lesions in the optic nerve in patients with optic neuritis, due to insufficient evidence. Specifically, the panel notes that DIS “can be demonstrated by one or more T2-hyperintense lesions [symptomatic or asymptomatic] that are characteristic of multiple sclerosis in two or more of four areas of the CNS: periventricular, cortical or juxtacortical, and infratentorial brain regions, and the spinal cord.” DIT is defined by “the simultaneous presence of gadolinium-enhancing and non-enhancing lesions [symptomatic or asymptomatic] at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI, with reference to a baseline scan, irrespective of the timing of the baseline MRI.”
• In patients experiencing brainstem or spinal cord clinically isolated syndrome, symptomatic lesions are sufficient to determine DIS or DIT.
• Cortical or juxtacortical lesions can be used in determining DIS.
• When MS is diagnosed, physicians should determine disease course (relapsing-remitting, primary progressive, or secondary progressive), whether the disease is active or not, and whether it is progressive, using the clinical history over the previous year.
The update was driven by a range of factors, including ongoing developments in imaging, the performance of the 2010 guidelines in diverse populations, and potential confusion between MS and other conditions with similar imaging characteristics, such as neuromyelitis optica spectrum disorders, which should always be considered because symptoms can overlap with MS. These conditions demand different treatment protocols. In addition, in 2016, the European Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) network suggested changes to the MRI criteria for diagnosing multiple sclerosis.
Updates to the guidelines are hardly finished. The panel called for future examination of optic nerve involvement, diverse populations, advanced imaging techniques, and biomarkers.
Some of the panel members reported financial ties to the pharmaceutical industry.
SOURCE: Thompson A et al., Lancet Neurol. 2017 Dec 21. doi: 10.1016/S1474-4422(17)30470-2
FROM THE LANCET NEUROLOGY
Biologic mesh safe, effective for prevention of parastomal hernia recurrence
at 18.9%.
Theadore Hufford, MD, of the University of Illinois at Chicago and his colleagues conducted a study to look at the effects of placement and type of mesh on postop morbidity and recurrence of parastomal hernia (PSH). The study was a retrospective analysis of 58 patients who had undergone local PSH repair with biological mesh between July 2006 and July 2015 at a single medical center.
All procedures were conducted by three board-certified surgeons at a tertiary medical center, and decisions such as the mesh type, placement and incision type were determined by the attending surgeon’s operative preferences.
In the study group, mesh placement (overlay, underlay, or sandwich technique) was found to have a statistically significant effect on recurrence. Of the patients who received an underlay of biologic mesh, 33% had a recurrence, compared with 25% of those who had overlays. The sandwich technique (a combination of overlay and underlay) was found to have the lowest rate of recurrence at 6.7%. The type of mesh (human origin, bovine, or porcine) and type of stoma (colostomy vs. ileostomy) had no statistically significant effect on the rate of recurrence.
Total recurrences in the study patients was 18.9%, a figure consistent with the current literature on parastomal hernia repair, the investigators wrote.
A key factor in recurrence was type of incision. Keyhole incisions had a much lower rate of recurrence than did circular incisions (32% vs. 9.1%; P = .042).
In the study group, “one patient was readmitted for mesh infection within 30 days of the repair and required mesh removal. Even with the biologic mesh in place there was an overlying skin infection that warranted reoperation that resulted in the stoma being moved to a new site altogether,” the investigators wrote.
The limitations of this study include the retrospective nature of the research and the difficulty in diagnosing PSH, which is often asymptomatic, the investigators mentioned. In addition, the techniques for local PSH repair with biologic mesh are not fully standardized. Mesh type and location decisions are often made on a case-by-case basis which limits the applicability of the study data for general PSH repairs.
Dr. Hufford and his associates wrote, “Our results suggest local parastomal hernia repair with biological mesh is both a safe and effective method, especially when used with the sandwich technique for mesh placement, for definitive treatment of parastomal hernias with very low morbidity, and acceptable recurrence rate.”
The investigators reported no disclosures.
at 18.9%.
Theadore Hufford, MD, of the University of Illinois at Chicago and his colleagues conducted a study to look at the effects of placement and type of mesh on postop morbidity and recurrence of parastomal hernia (PSH). The study was a retrospective analysis of 58 patients who had undergone local PSH repair with biological mesh between July 2006 and July 2015 at a single medical center.
All procedures were conducted by three board-certified surgeons at a tertiary medical center, and decisions such as the mesh type, placement and incision type were determined by the attending surgeon’s operative preferences.
In the study group, mesh placement (overlay, underlay, or sandwich technique) was found to have a statistically significant effect on recurrence. Of the patients who received an underlay of biologic mesh, 33% had a recurrence, compared with 25% of those who had overlays. The sandwich technique (a combination of overlay and underlay) was found to have the lowest rate of recurrence at 6.7%. The type of mesh (human origin, bovine, or porcine) and type of stoma (colostomy vs. ileostomy) had no statistically significant effect on the rate of recurrence.
Total recurrences in the study patients was 18.9%, a figure consistent with the current literature on parastomal hernia repair, the investigators wrote.
A key factor in recurrence was type of incision. Keyhole incisions had a much lower rate of recurrence than did circular incisions (32% vs. 9.1%; P = .042).
In the study group, “one patient was readmitted for mesh infection within 30 days of the repair and required mesh removal. Even with the biologic mesh in place there was an overlying skin infection that warranted reoperation that resulted in the stoma being moved to a new site altogether,” the investigators wrote.
The limitations of this study include the retrospective nature of the research and the difficulty in diagnosing PSH, which is often asymptomatic, the investigators mentioned. In addition, the techniques for local PSH repair with biologic mesh are not fully standardized. Mesh type and location decisions are often made on a case-by-case basis which limits the applicability of the study data for general PSH repairs.
Dr. Hufford and his associates wrote, “Our results suggest local parastomal hernia repair with biological mesh is both a safe and effective method, especially when used with the sandwich technique for mesh placement, for definitive treatment of parastomal hernias with very low morbidity, and acceptable recurrence rate.”
The investigators reported no disclosures.
at 18.9%.
Theadore Hufford, MD, of the University of Illinois at Chicago and his colleagues conducted a study to look at the effects of placement and type of mesh on postop morbidity and recurrence of parastomal hernia (PSH). The study was a retrospective analysis of 58 patients who had undergone local PSH repair with biological mesh between July 2006 and July 2015 at a single medical center.
All procedures were conducted by three board-certified surgeons at a tertiary medical center, and decisions such as the mesh type, placement and incision type were determined by the attending surgeon’s operative preferences.
In the study group, mesh placement (overlay, underlay, or sandwich technique) was found to have a statistically significant effect on recurrence. Of the patients who received an underlay of biologic mesh, 33% had a recurrence, compared with 25% of those who had overlays. The sandwich technique (a combination of overlay and underlay) was found to have the lowest rate of recurrence at 6.7%. The type of mesh (human origin, bovine, or porcine) and type of stoma (colostomy vs. ileostomy) had no statistically significant effect on the rate of recurrence.
Total recurrences in the study patients was 18.9%, a figure consistent with the current literature on parastomal hernia repair, the investigators wrote.
A key factor in recurrence was type of incision. Keyhole incisions had a much lower rate of recurrence than did circular incisions (32% vs. 9.1%; P = .042).
In the study group, “one patient was readmitted for mesh infection within 30 days of the repair and required mesh removal. Even with the biologic mesh in place there was an overlying skin infection that warranted reoperation that resulted in the stoma being moved to a new site altogether,” the investigators wrote.
The limitations of this study include the retrospective nature of the research and the difficulty in diagnosing PSH, which is often asymptomatic, the investigators mentioned. In addition, the techniques for local PSH repair with biologic mesh are not fully standardized. Mesh type and location decisions are often made on a case-by-case basis which limits the applicability of the study data for general PSH repairs.
Dr. Hufford and his associates wrote, “Our results suggest local parastomal hernia repair with biological mesh is both a safe and effective method, especially when used with the sandwich technique for mesh placement, for definitive treatment of parastomal hernias with very low morbidity, and acceptable recurrence rate.”
The investigators reported no disclosures.
FROM THE AMERICAN JOURNAL OF SURGERY
Key clinical point: In a comparison of the biologic meshes and placement techniques, the sandwich technique was most successful in preventing recurrence.
Major finding: Rate of recurrence of parastomal hernia was 33% with underlay surgical mesh placement, 25% with overlay placement, and 6.7% with sandwich placement.
Study details: A retrospective analysis of 58 patients who had undergone local parastomal hernia repair with biological mesh at a single medical center.
Disclosures: The investigators reported no disclosures.
Source: Hufford T et al. Am J Surg. 2018 Jan. 215(1):88-90.
Phoenix Children’s Hospital integrates care from ground up
About 4 years ago, officials at Phoenix Children’s Hospital stopped and took a look around. The adult health care landscape was zooming toward value-based models and integrating care so that previously separate components were now working together. The health of whole populations mattered more than ever.
But their hospital, they found, accounted for just 9% of the “care touches” – interactions between a patient and a doctor – of their half-million pediatric population. They were not working closely with primary care doctors and independent specialists. Patients would come to the hospital, get treated, and then – poof, they were gone. The hospital came to a realization that there was a better way to provide care.
They began a process that led to what appears to be a “first-of-its-kind” model, an integrated care network created from the ground up by a hospital venturing out into the community and actively recruiting private primary care doctors and specialists. Now, more than 1,000 physicians from more than 100 practices in the Phoenix metro area are part of the network, joined with the hospital through contracts laden with incentives for meeting care and wellness goals. When good care is being given, the network gets paid, and everyone benefits financially.
“It’s amazing the difference we’re able to provide when we start linking together what used to be very disparate systems,” Mr. Johnson said.
Here are some features of the network:
Every group and practice, including the hospital, is now sharing their data. When a child shows up at the ER, the ER doctor can quickly see things like who the primary care doctor is, allergies, medications, and care history.
- Targets such as asthma control, providing basic wellness exams, and following patients appropriately, are tied to financial rewards.
- Children with complex or special health care needs, and patients who are high utilizers, have a care coordinator assigned to look more closely at their cases.
- A corporate entity created by the hospital and its independent community physician partners has a doctor-heavy board of directors composed of community primary care physicians, specialists, hospital-employed physicians, and hospital administrators.
Some of the care improvements have been dramatic, Mr. Johnson said. One teenager had made 55 ER visits and 21 inpatient visits over 9 months, but the pattern went unnoticed. With new tools – reports drawn from hospital records, insurance records, and records from other doctor visits – the problem became apparent. A care coordinator found that the mother didn’t quite understand how to administer the boy’s medication, prompting repeated medical crises and hundred of thousands of dollars in unnecessary costs. The teenager has since re-enrolled in school and has had no more hospital admissions, Johnson said.
He said that, at first, many community doctors had a “real skepticism” of being too closely tied to a hospital financially, but now doctors are getting in touch with the network about joining.
“There’s a leap of faith that has to happen in the initial stages,” he said. “When you get the insurance companies at the table to really work with you to build the right incentives around truly impactful and quality care, you can really start to move the needle. When you see – with data – that what you’re doing is having success, and they see the additional money coming from the incentives, that really helps.”
Amy Knight, MHA, chief operating officer of the Washington-based Children’s Hospital Association, said that, while other children’s hospitals have migrated toward more integrated care, they either haven’t needed to recruit community physicians as they have in Phoenix, because they already employed many primary care physicians, or market conditions have been such that they haven’t expanded as quickly.
“Phoenix saw a huge opportunity and was very smart about how they approached their own market,” she said. “They are definitely on the front end, the cutting edge of doing that.”
Since its network has expanded, Phoenix Children’s has hosted visitors who hope to draw lessons from their experience, she said.
“I think what most people go away with is: ‘Very interesting, very cool – not sure it would work in our market,’” she said. Still, lessons on thinking about risk and building a governance structure are widely applicable, she said.
“The house may look a little bit different, but some of the things you’re doing inside it may actually all look the same,” Ms. Knight said.
She expects a continued move toward more integrated care networks, despite the on-again, off-again political talk about repealing and replacing the Affordable Care Act.
“There’s probably some people stepping back in hesitancy, but I don’t think that the political discourse right now will necessarily change the trajectory that we’re on.”
About 4 years ago, officials at Phoenix Children’s Hospital stopped and took a look around. The adult health care landscape was zooming toward value-based models and integrating care so that previously separate components were now working together. The health of whole populations mattered more than ever.
But their hospital, they found, accounted for just 9% of the “care touches” – interactions between a patient and a doctor – of their half-million pediatric population. They were not working closely with primary care doctors and independent specialists. Patients would come to the hospital, get treated, and then – poof, they were gone. The hospital came to a realization that there was a better way to provide care.
They began a process that led to what appears to be a “first-of-its-kind” model, an integrated care network created from the ground up by a hospital venturing out into the community and actively recruiting private primary care doctors and specialists. Now, more than 1,000 physicians from more than 100 practices in the Phoenix metro area are part of the network, joined with the hospital through contracts laden with incentives for meeting care and wellness goals. When good care is being given, the network gets paid, and everyone benefits financially.
“It’s amazing the difference we’re able to provide when we start linking together what used to be very disparate systems,” Mr. Johnson said.
Here are some features of the network:
Every group and practice, including the hospital, is now sharing their data. When a child shows up at the ER, the ER doctor can quickly see things like who the primary care doctor is, allergies, medications, and care history.
- Targets such as asthma control, providing basic wellness exams, and following patients appropriately, are tied to financial rewards.
- Children with complex or special health care needs, and patients who are high utilizers, have a care coordinator assigned to look more closely at their cases.
- A corporate entity created by the hospital and its independent community physician partners has a doctor-heavy board of directors composed of community primary care physicians, specialists, hospital-employed physicians, and hospital administrators.
Some of the care improvements have been dramatic, Mr. Johnson said. One teenager had made 55 ER visits and 21 inpatient visits over 9 months, but the pattern went unnoticed. With new tools – reports drawn from hospital records, insurance records, and records from other doctor visits – the problem became apparent. A care coordinator found that the mother didn’t quite understand how to administer the boy’s medication, prompting repeated medical crises and hundred of thousands of dollars in unnecessary costs. The teenager has since re-enrolled in school and has had no more hospital admissions, Johnson said.
He said that, at first, many community doctors had a “real skepticism” of being too closely tied to a hospital financially, but now doctors are getting in touch with the network about joining.
“There’s a leap of faith that has to happen in the initial stages,” he said. “When you get the insurance companies at the table to really work with you to build the right incentives around truly impactful and quality care, you can really start to move the needle. When you see – with data – that what you’re doing is having success, and they see the additional money coming from the incentives, that really helps.”
Amy Knight, MHA, chief operating officer of the Washington-based Children’s Hospital Association, said that, while other children’s hospitals have migrated toward more integrated care, they either haven’t needed to recruit community physicians as they have in Phoenix, because they already employed many primary care physicians, or market conditions have been such that they haven’t expanded as quickly.
“Phoenix saw a huge opportunity and was very smart about how they approached their own market,” she said. “They are definitely on the front end, the cutting edge of doing that.”
Since its network has expanded, Phoenix Children’s has hosted visitors who hope to draw lessons from their experience, she said.
“I think what most people go away with is: ‘Very interesting, very cool – not sure it would work in our market,’” she said. Still, lessons on thinking about risk and building a governance structure are widely applicable, she said.
“The house may look a little bit different, but some of the things you’re doing inside it may actually all look the same,” Ms. Knight said.
She expects a continued move toward more integrated care networks, despite the on-again, off-again political talk about repealing and replacing the Affordable Care Act.
“There’s probably some people stepping back in hesitancy, but I don’t think that the political discourse right now will necessarily change the trajectory that we’re on.”
About 4 years ago, officials at Phoenix Children’s Hospital stopped and took a look around. The adult health care landscape was zooming toward value-based models and integrating care so that previously separate components were now working together. The health of whole populations mattered more than ever.
But their hospital, they found, accounted for just 9% of the “care touches” – interactions between a patient and a doctor – of their half-million pediatric population. They were not working closely with primary care doctors and independent specialists. Patients would come to the hospital, get treated, and then – poof, they were gone. The hospital came to a realization that there was a better way to provide care.
They began a process that led to what appears to be a “first-of-its-kind” model, an integrated care network created from the ground up by a hospital venturing out into the community and actively recruiting private primary care doctors and specialists. Now, more than 1,000 physicians from more than 100 practices in the Phoenix metro area are part of the network, joined with the hospital through contracts laden with incentives for meeting care and wellness goals. When good care is being given, the network gets paid, and everyone benefits financially.
“It’s amazing the difference we’re able to provide when we start linking together what used to be very disparate systems,” Mr. Johnson said.
Here are some features of the network:
Every group and practice, including the hospital, is now sharing their data. When a child shows up at the ER, the ER doctor can quickly see things like who the primary care doctor is, allergies, medications, and care history.
- Targets such as asthma control, providing basic wellness exams, and following patients appropriately, are tied to financial rewards.
- Children with complex or special health care needs, and patients who are high utilizers, have a care coordinator assigned to look more closely at their cases.
- A corporate entity created by the hospital and its independent community physician partners has a doctor-heavy board of directors composed of community primary care physicians, specialists, hospital-employed physicians, and hospital administrators.
Some of the care improvements have been dramatic, Mr. Johnson said. One teenager had made 55 ER visits and 21 inpatient visits over 9 months, but the pattern went unnoticed. With new tools – reports drawn from hospital records, insurance records, and records from other doctor visits – the problem became apparent. A care coordinator found that the mother didn’t quite understand how to administer the boy’s medication, prompting repeated medical crises and hundred of thousands of dollars in unnecessary costs. The teenager has since re-enrolled in school and has had no more hospital admissions, Johnson said.
He said that, at first, many community doctors had a “real skepticism” of being too closely tied to a hospital financially, but now doctors are getting in touch with the network about joining.
“There’s a leap of faith that has to happen in the initial stages,” he said. “When you get the insurance companies at the table to really work with you to build the right incentives around truly impactful and quality care, you can really start to move the needle. When you see – with data – that what you’re doing is having success, and they see the additional money coming from the incentives, that really helps.”
Amy Knight, MHA, chief operating officer of the Washington-based Children’s Hospital Association, said that, while other children’s hospitals have migrated toward more integrated care, they either haven’t needed to recruit community physicians as they have in Phoenix, because they already employed many primary care physicians, or market conditions have been such that they haven’t expanded as quickly.
“Phoenix saw a huge opportunity and was very smart about how they approached their own market,” she said. “They are definitely on the front end, the cutting edge of doing that.”
Since its network has expanded, Phoenix Children’s has hosted visitors who hope to draw lessons from their experience, she said.
“I think what most people go away with is: ‘Very interesting, very cool – not sure it would work in our market,’” she said. Still, lessons on thinking about risk and building a governance structure are widely applicable, she said.
“The house may look a little bit different, but some of the things you’re doing inside it may actually all look the same,” Ms. Knight said.
She expects a continued move toward more integrated care networks, despite the on-again, off-again political talk about repealing and replacing the Affordable Care Act.
“There’s probably some people stepping back in hesitancy, but I don’t think that the political discourse right now will necessarily change the trajectory that we’re on.”
Sexual harassment
Question: A medical assistant alleged that Dr. Y sexually harassed her by sending anonymous gifts and messages such as, “you’re gorgeous,” and “I love your figure.” It was a repeat of Dr. Y’s previous behavior pattern directed at a different worker, who had lodged a complaint with the human resources department. The medical assistant now files a sexual harassment action under Title VII of the federal Civil Rights Act of 1964 against the health care institution, alleging a hostile work environment.
Which of the following is false?
A. Sexual harassment is a form of sexual misconduct regulated by state medical boards.
B. Mere words, without physical action, may suffice to be deemed sexual harassment.
C. A hostile environment arises when offensive conduct is so severe and pervasive as to amount to job discrimination.
D. Sexual harassment is a civil rights violation unique to the workplace.
E. Liability may attach to the supervisor, institution, or the harasser.
Answer: D. This hypothetical is modified from an actual Connecticut case that was recently decided in favor of the plaintiff.1 In that case, which involved a dentist, the federal Second Circuit unanimously rejected the University of Connecticut Health Center’s appeal against a jury’s verdict holding it responsible for its employee’s sexual harassment of a coworker, who was awarded $125,000. It ruled that the health center should have known of its employee’s harassing behavior.
Sexual harassment, a current hot topic, is pervasive, affecting a diversity of individuals in the fields of media, sports, politics, judiciary, education, entertainment, and others. The medical profession is no exception, and studies indicate that sexual harassment affects patients and physicians alike, occurring in hospitals, private offices, and academic centers.
In a large questionnaire study involving 4,501 female physicians, the authors found a prevalence rate of 47.7%. Harassment was more common while in medical school or during internship, residency, or fellowship than in practice.2 Patients may be the harassers. In 599 of the 1,064 licensed female family physicians in Ontario, more than 75% reported sexual harassment by patients at some time during their careers, either in their own offices by their own patients, or in settings such as emergency departments and clinics, where unknown patients presented an even higher risk.3
When physicians sexually harass fellow workers such as nurses, they distract their victims from providing attentive and competent care. In a review of the subject, researchers cited a study of 188 critical care nurses in hospitals, where nearly half (46%) reported experiencing sexual harassment that included “offensive sexual remarks, unwanted physical contact, unwanted nonverbal attention, requests for unwanted dates, sexual propositions, and physical assault.”4 To this list must now be added misconduct via the use of social media. In the study, physicians (82%), coworkers (20%), and immediate supervisors (7%) accounted for most of the incidents.
Neglecting to look seriously into complaints or to monitor and remedy the situation may create a hostile environment and trigger liability.
An example is the recent well-publicized case of Olympics team physician Dr. Larry Nassar, who was also a faculty member at Michigan State University. Olympic gold medalist McKayla Maroney named both the university and the U.S. Olympic Committee as codefendants in a lawsuit alleging that the institutions failed to properly investigate the team doctor’s criminal sexual conduct.
In Anania v. Daubenspeck Chiropractic, two employees of a chiropractor alleged that his patients sexually harassed them, but he did not remedy the situation.5 The trial court initially dismissed their lawsuit, holding that Ohio law did not recognize a cause of action for sexual harassment by a nonemployee patient, and that liability for sexual harassment can only exist in the context of respondeat superior (employer-employee) liability.
However, the court of appeals held that so long as the chiropractor knew or should have known of the harassment, and failed to take corrective action, he could be liable for allowing a hostile environment to exist.
Negligent supervision is another favorite plaintiff’s cause of action. In Doe v. Borromeo, a patient sought to hold the hospital liable for sexual assault by a physician during a medical exam.6 The lower state court had summarily dismissed the case, which was based on vicarious liability, but the state court of appeals reversed, finding the patient’s complaint against the hospital included a negligent supervision claim.
The appeals court reasoned that this was distinguishable from one based upon vicarious liability, so long as the supervising entity had a duty to protect the victim – and such a duty can only be established if the supervising entity knew or should have known of the existence of the harasser’s propensities, if any, to commit criminal and tortious acts.
Sexual harassment is a form of sex discrimination under Title VII of the Civil Rights Act of 1964, which is enforced by the Equal Employment Opportunity Commission. The commission’s website explains the law in clear and simple language:
“It is unlawful to harass a person (an applicant or employee) because of that person’s sex. Harassment can include ‘sexual harassment’ or unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature. Harassment does not have to be of a sexual nature, however, and can include offensive remarks about a person’s sex.
“For example, it is illegal to harass a woman by making offensive comments about women in general. Both victim and the harasser can be either a woman or a man, and the victim and harasser can be the same sex.
“Although the law doesn’t prohibit simple teasing, offhand comments, or isolated incidents that are not very serious, harassment is illegal when it is so frequent or severe that it creates a hostile or offensive work environment or when it results in an adverse employment decision (such as the victim being fired or demoted). The harasser can be the victim’s supervisor, a supervisor in another area, a coworker, or someone who is not an employee of the employer, such as a client or customer.”7
For sexual harassment to occur, the aggrieved party must either show a “hostile environment” or “quid pro quo” situation.
In a hostile environment case, the harassment is serious and persistent, creating unacceptable and offensive work conditions. The plaintiff has to show that the employer knew or should have known of the situation but failed to remedy it.
The “quid pro quo” type of case requires a showing that a person in authority conditioned some aspect of the employee’s employment, such as promotion or retention, upon a sexual favor or relationship.
The U.S. Supreme Court has both clarified and muddied the law’s position on these two previously distinct types of sexual harassment.
In the landmark case of Burlington Industries v. Ellerth, the plaintiff, who was a salesperson, alleged that a supervisor made advances to her and threatened to deny her certain job benefits if she did not cooperate.8 The threats were never carried out, and she was in fact promoted; but her lawsuit alleged that the harassment caused her resignation and amounted to a “constructive” discharge.
Likewise, in Faragher v. City of Boca Raton, the plaintiff, employed as a lifeguard, alleged that her work environment was riddled with crude remarks and obscenities.9 One of the two supervisors reportedly once said to Faragher, “Date me or clean toilets for a year.” Another lifeguard had previously lodged similar complaints. The plaintiff ultimately resigned and brought suit.
The U.S. Supreme Court characterized both of these as “hostile environment” rather than “quid pro quo” cases, because the plaintiffs did not suffer any direct adverse job action. In its decisions, the court defined the scope of liability and affirmative defenses, holding that employers can be subject to vicarious liability when supervisors create actionable hostile work environments.
In other cases, the Supreme Court has ruled for the use of “the reasonable person in the plaintiff’s position” standard in judging the severity of sexual harassment. The court has also held that the genders of the harasser and the harassed employee are not material in determining whether sexual harassment has occurred.
A physician can be accused of harassing an employee, a nurse, an assistant, a fellow worker, a third party, or a patient. Focusing on misconduct within the doctor-patient relationship, the Federation of State Medical Boards adopted in May 2006 a policy entitled “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”10
Although it did not use the term sexual harassment, the policy emphasized that physician sexual misconduct may include behavior that is verbal or physical, and may include expressions of thoughts and feelings or gestures that are sexual. It used the term “sexual impropriety” to denote behavior, gestures, or expressions that are seductive, sexually suggestive, disrespectful of patient privacy, or sexually demeaning to a patient. Together with “sexual violation,” a term the FSMB used when referring to physical sexual contact, they form the basis for disciplinary action by a state medical board.
Caveat: When performing a physical exam, physicians should always use good judgment and sensitivity, relying on the presence of a medical assistant to ensure patient comfort and to alleviate possible embarrassment or anxiety.
Under the federal EEOC rules, the employer rather than the harasser is the defendant. But there are other legal recourses, including tort and criminal actions, that directly target the harasser. Successful plaintiffs may be awarded lost wages, as well as damages for emotional distress, medical expenses, and punitive damages. They may also recover attorney fees.
In one case, a psychiatric nurse was awarded $1.2 million (later reduced to $850,000); in another, a nurse successfully sued a physician’s medical practice and received $150,000 in damages.4 And in an unusual case, a plaintiff was awarded only $1 in damages, but her counsel was paid $41,598 in fees.11 For the practicing doctor, medical board sanction, notoriety, and loss of professional standing and privileges constitute additional costs.
The medical profession is as susceptible as any other – perhaps more so – to allegations of sexual harassment. The magic words for actionable sexual harassment are severe, pervasive, and unwelcome. Although laws in the workplace generally do not prohibit simple teasing, offhand comments, or minor isolated incidents, the line separating these behaviors from bona fide sexual harassment is thin.
Erring on the side of strict and sober professional propriety seems prudent, given the current climate of zero tolerance.
References
1. MacCluskey v. University of Connecticut Health Center, United States Court of Appeals, Second Circuit, No. 17-0807-cv, Dec. 19, 2017.
2. Arch Intern Med. 1998 Feb 23;158(4):352-8.
3. N Engl J Med. 1993 Dec 23;329(26):1936-9.
4. J Nurs Care Qual. 2004 Jul-Sep;19(3):234-41.
5. Anania v. Daubenspeck Chiropractic, 718 N.E. 2d 480 (Ohio 1998).
6. Doe v. Borromeo, Nos. 305162, 305163 (Mich. Ct. App. Sept. 20, 2012).
7. Available at https://www.eeoc.gov/laws/types/sexual_harassment.cfm.
8. Burlington Industries, Inc. v. Ellerth, 524 US 742 (1998).
9. Faragher v. City of Boca Raton, 524 U.S. 775 (1998).
10. Federation of State Medical Boards, “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”
11. J Healthc Risk Manag. 1999 Summer;19(3):14-25.
Question: A medical assistant alleged that Dr. Y sexually harassed her by sending anonymous gifts and messages such as, “you’re gorgeous,” and “I love your figure.” It was a repeat of Dr. Y’s previous behavior pattern directed at a different worker, who had lodged a complaint with the human resources department. The medical assistant now files a sexual harassment action under Title VII of the federal Civil Rights Act of 1964 against the health care institution, alleging a hostile work environment.
Which of the following is false?
A. Sexual harassment is a form of sexual misconduct regulated by state medical boards.
B. Mere words, without physical action, may suffice to be deemed sexual harassment.
C. A hostile environment arises when offensive conduct is so severe and pervasive as to amount to job discrimination.
D. Sexual harassment is a civil rights violation unique to the workplace.
E. Liability may attach to the supervisor, institution, or the harasser.
Answer: D. This hypothetical is modified from an actual Connecticut case that was recently decided in favor of the plaintiff.1 In that case, which involved a dentist, the federal Second Circuit unanimously rejected the University of Connecticut Health Center’s appeal against a jury’s verdict holding it responsible for its employee’s sexual harassment of a coworker, who was awarded $125,000. It ruled that the health center should have known of its employee’s harassing behavior.
Sexual harassment, a current hot topic, is pervasive, affecting a diversity of individuals in the fields of media, sports, politics, judiciary, education, entertainment, and others. The medical profession is no exception, and studies indicate that sexual harassment affects patients and physicians alike, occurring in hospitals, private offices, and academic centers.
In a large questionnaire study involving 4,501 female physicians, the authors found a prevalence rate of 47.7%. Harassment was more common while in medical school or during internship, residency, or fellowship than in practice.2 Patients may be the harassers. In 599 of the 1,064 licensed female family physicians in Ontario, more than 75% reported sexual harassment by patients at some time during their careers, either in their own offices by their own patients, or in settings such as emergency departments and clinics, where unknown patients presented an even higher risk.3
When physicians sexually harass fellow workers such as nurses, they distract their victims from providing attentive and competent care. In a review of the subject, researchers cited a study of 188 critical care nurses in hospitals, where nearly half (46%) reported experiencing sexual harassment that included “offensive sexual remarks, unwanted physical contact, unwanted nonverbal attention, requests for unwanted dates, sexual propositions, and physical assault.”4 To this list must now be added misconduct via the use of social media. In the study, physicians (82%), coworkers (20%), and immediate supervisors (7%) accounted for most of the incidents.
Neglecting to look seriously into complaints or to monitor and remedy the situation may create a hostile environment and trigger liability.
An example is the recent well-publicized case of Olympics team physician Dr. Larry Nassar, who was also a faculty member at Michigan State University. Olympic gold medalist McKayla Maroney named both the university and the U.S. Olympic Committee as codefendants in a lawsuit alleging that the institutions failed to properly investigate the team doctor’s criminal sexual conduct.
In Anania v. Daubenspeck Chiropractic, two employees of a chiropractor alleged that his patients sexually harassed them, but he did not remedy the situation.5 The trial court initially dismissed their lawsuit, holding that Ohio law did not recognize a cause of action for sexual harassment by a nonemployee patient, and that liability for sexual harassment can only exist in the context of respondeat superior (employer-employee) liability.
However, the court of appeals held that so long as the chiropractor knew or should have known of the harassment, and failed to take corrective action, he could be liable for allowing a hostile environment to exist.
Negligent supervision is another favorite plaintiff’s cause of action. In Doe v. Borromeo, a patient sought to hold the hospital liable for sexual assault by a physician during a medical exam.6 The lower state court had summarily dismissed the case, which was based on vicarious liability, but the state court of appeals reversed, finding the patient’s complaint against the hospital included a negligent supervision claim.
The appeals court reasoned that this was distinguishable from one based upon vicarious liability, so long as the supervising entity had a duty to protect the victim – and such a duty can only be established if the supervising entity knew or should have known of the existence of the harasser’s propensities, if any, to commit criminal and tortious acts.
Sexual harassment is a form of sex discrimination under Title VII of the Civil Rights Act of 1964, which is enforced by the Equal Employment Opportunity Commission. The commission’s website explains the law in clear and simple language:
“It is unlawful to harass a person (an applicant or employee) because of that person’s sex. Harassment can include ‘sexual harassment’ or unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature. Harassment does not have to be of a sexual nature, however, and can include offensive remarks about a person’s sex.
“For example, it is illegal to harass a woman by making offensive comments about women in general. Both victim and the harasser can be either a woman or a man, and the victim and harasser can be the same sex.
“Although the law doesn’t prohibit simple teasing, offhand comments, or isolated incidents that are not very serious, harassment is illegal when it is so frequent or severe that it creates a hostile or offensive work environment or when it results in an adverse employment decision (such as the victim being fired or demoted). The harasser can be the victim’s supervisor, a supervisor in another area, a coworker, or someone who is not an employee of the employer, such as a client or customer.”7
For sexual harassment to occur, the aggrieved party must either show a “hostile environment” or “quid pro quo” situation.
In a hostile environment case, the harassment is serious and persistent, creating unacceptable and offensive work conditions. The plaintiff has to show that the employer knew or should have known of the situation but failed to remedy it.
The “quid pro quo” type of case requires a showing that a person in authority conditioned some aspect of the employee’s employment, such as promotion or retention, upon a sexual favor or relationship.
The U.S. Supreme Court has both clarified and muddied the law’s position on these two previously distinct types of sexual harassment.
In the landmark case of Burlington Industries v. Ellerth, the plaintiff, who was a salesperson, alleged that a supervisor made advances to her and threatened to deny her certain job benefits if she did not cooperate.8 The threats were never carried out, and she was in fact promoted; but her lawsuit alleged that the harassment caused her resignation and amounted to a “constructive” discharge.
Likewise, in Faragher v. City of Boca Raton, the plaintiff, employed as a lifeguard, alleged that her work environment was riddled with crude remarks and obscenities.9 One of the two supervisors reportedly once said to Faragher, “Date me or clean toilets for a year.” Another lifeguard had previously lodged similar complaints. The plaintiff ultimately resigned and brought suit.
The U.S. Supreme Court characterized both of these as “hostile environment” rather than “quid pro quo” cases, because the plaintiffs did not suffer any direct adverse job action. In its decisions, the court defined the scope of liability and affirmative defenses, holding that employers can be subject to vicarious liability when supervisors create actionable hostile work environments.
In other cases, the Supreme Court has ruled for the use of “the reasonable person in the plaintiff’s position” standard in judging the severity of sexual harassment. The court has also held that the genders of the harasser and the harassed employee are not material in determining whether sexual harassment has occurred.
A physician can be accused of harassing an employee, a nurse, an assistant, a fellow worker, a third party, or a patient. Focusing on misconduct within the doctor-patient relationship, the Federation of State Medical Boards adopted in May 2006 a policy entitled “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”10
Although it did not use the term sexual harassment, the policy emphasized that physician sexual misconduct may include behavior that is verbal or physical, and may include expressions of thoughts and feelings or gestures that are sexual. It used the term “sexual impropriety” to denote behavior, gestures, or expressions that are seductive, sexually suggestive, disrespectful of patient privacy, or sexually demeaning to a patient. Together with “sexual violation,” a term the FSMB used when referring to physical sexual contact, they form the basis for disciplinary action by a state medical board.
Caveat: When performing a physical exam, physicians should always use good judgment and sensitivity, relying on the presence of a medical assistant to ensure patient comfort and to alleviate possible embarrassment or anxiety.
Under the federal EEOC rules, the employer rather than the harasser is the defendant. But there are other legal recourses, including tort and criminal actions, that directly target the harasser. Successful plaintiffs may be awarded lost wages, as well as damages for emotional distress, medical expenses, and punitive damages. They may also recover attorney fees.
In one case, a psychiatric nurse was awarded $1.2 million (later reduced to $850,000); in another, a nurse successfully sued a physician’s medical practice and received $150,000 in damages.4 And in an unusual case, a plaintiff was awarded only $1 in damages, but her counsel was paid $41,598 in fees.11 For the practicing doctor, medical board sanction, notoriety, and loss of professional standing and privileges constitute additional costs.
The medical profession is as susceptible as any other – perhaps more so – to allegations of sexual harassment. The magic words for actionable sexual harassment are severe, pervasive, and unwelcome. Although laws in the workplace generally do not prohibit simple teasing, offhand comments, or minor isolated incidents, the line separating these behaviors from bona fide sexual harassment is thin.
Erring on the side of strict and sober professional propriety seems prudent, given the current climate of zero tolerance.
References
1. MacCluskey v. University of Connecticut Health Center, United States Court of Appeals, Second Circuit, No. 17-0807-cv, Dec. 19, 2017.
2. Arch Intern Med. 1998 Feb 23;158(4):352-8.
3. N Engl J Med. 1993 Dec 23;329(26):1936-9.
4. J Nurs Care Qual. 2004 Jul-Sep;19(3):234-41.
5. Anania v. Daubenspeck Chiropractic, 718 N.E. 2d 480 (Ohio 1998).
6. Doe v. Borromeo, Nos. 305162, 305163 (Mich. Ct. App. Sept. 20, 2012).
7. Available at https://www.eeoc.gov/laws/types/sexual_harassment.cfm.
8. Burlington Industries, Inc. v. Ellerth, 524 US 742 (1998).
9. Faragher v. City of Boca Raton, 524 U.S. 775 (1998).
10. Federation of State Medical Boards, “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”
11. J Healthc Risk Manag. 1999 Summer;19(3):14-25.
Question: A medical assistant alleged that Dr. Y sexually harassed her by sending anonymous gifts and messages such as, “you’re gorgeous,” and “I love your figure.” It was a repeat of Dr. Y’s previous behavior pattern directed at a different worker, who had lodged a complaint with the human resources department. The medical assistant now files a sexual harassment action under Title VII of the federal Civil Rights Act of 1964 against the health care institution, alleging a hostile work environment.
Which of the following is false?
A. Sexual harassment is a form of sexual misconduct regulated by state medical boards.
B. Mere words, without physical action, may suffice to be deemed sexual harassment.
C. A hostile environment arises when offensive conduct is so severe and pervasive as to amount to job discrimination.
D. Sexual harassment is a civil rights violation unique to the workplace.
E. Liability may attach to the supervisor, institution, or the harasser.
Answer: D. This hypothetical is modified from an actual Connecticut case that was recently decided in favor of the plaintiff.1 In that case, which involved a dentist, the federal Second Circuit unanimously rejected the University of Connecticut Health Center’s appeal against a jury’s verdict holding it responsible for its employee’s sexual harassment of a coworker, who was awarded $125,000. It ruled that the health center should have known of its employee’s harassing behavior.
Sexual harassment, a current hot topic, is pervasive, affecting a diversity of individuals in the fields of media, sports, politics, judiciary, education, entertainment, and others. The medical profession is no exception, and studies indicate that sexual harassment affects patients and physicians alike, occurring in hospitals, private offices, and academic centers.
In a large questionnaire study involving 4,501 female physicians, the authors found a prevalence rate of 47.7%. Harassment was more common while in medical school or during internship, residency, or fellowship than in practice.2 Patients may be the harassers. In 599 of the 1,064 licensed female family physicians in Ontario, more than 75% reported sexual harassment by patients at some time during their careers, either in their own offices by their own patients, or in settings such as emergency departments and clinics, where unknown patients presented an even higher risk.3
When physicians sexually harass fellow workers such as nurses, they distract their victims from providing attentive and competent care. In a review of the subject, researchers cited a study of 188 critical care nurses in hospitals, where nearly half (46%) reported experiencing sexual harassment that included “offensive sexual remarks, unwanted physical contact, unwanted nonverbal attention, requests for unwanted dates, sexual propositions, and physical assault.”4 To this list must now be added misconduct via the use of social media. In the study, physicians (82%), coworkers (20%), and immediate supervisors (7%) accounted for most of the incidents.
Neglecting to look seriously into complaints or to monitor and remedy the situation may create a hostile environment and trigger liability.
An example is the recent well-publicized case of Olympics team physician Dr. Larry Nassar, who was also a faculty member at Michigan State University. Olympic gold medalist McKayla Maroney named both the university and the U.S. Olympic Committee as codefendants in a lawsuit alleging that the institutions failed to properly investigate the team doctor’s criminal sexual conduct.
In Anania v. Daubenspeck Chiropractic, two employees of a chiropractor alleged that his patients sexually harassed them, but he did not remedy the situation.5 The trial court initially dismissed their lawsuit, holding that Ohio law did not recognize a cause of action for sexual harassment by a nonemployee patient, and that liability for sexual harassment can only exist in the context of respondeat superior (employer-employee) liability.
However, the court of appeals held that so long as the chiropractor knew or should have known of the harassment, and failed to take corrective action, he could be liable for allowing a hostile environment to exist.
Negligent supervision is another favorite plaintiff’s cause of action. In Doe v. Borromeo, a patient sought to hold the hospital liable for sexual assault by a physician during a medical exam.6 The lower state court had summarily dismissed the case, which was based on vicarious liability, but the state court of appeals reversed, finding the patient’s complaint against the hospital included a negligent supervision claim.
The appeals court reasoned that this was distinguishable from one based upon vicarious liability, so long as the supervising entity had a duty to protect the victim – and such a duty can only be established if the supervising entity knew or should have known of the existence of the harasser’s propensities, if any, to commit criminal and tortious acts.
Sexual harassment is a form of sex discrimination under Title VII of the Civil Rights Act of 1964, which is enforced by the Equal Employment Opportunity Commission. The commission’s website explains the law in clear and simple language:
“It is unlawful to harass a person (an applicant or employee) because of that person’s sex. Harassment can include ‘sexual harassment’ or unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature. Harassment does not have to be of a sexual nature, however, and can include offensive remarks about a person’s sex.
“For example, it is illegal to harass a woman by making offensive comments about women in general. Both victim and the harasser can be either a woman or a man, and the victim and harasser can be the same sex.
“Although the law doesn’t prohibit simple teasing, offhand comments, or isolated incidents that are not very serious, harassment is illegal when it is so frequent or severe that it creates a hostile or offensive work environment or when it results in an adverse employment decision (such as the victim being fired or demoted). The harasser can be the victim’s supervisor, a supervisor in another area, a coworker, or someone who is not an employee of the employer, such as a client or customer.”7
For sexual harassment to occur, the aggrieved party must either show a “hostile environment” or “quid pro quo” situation.
In a hostile environment case, the harassment is serious and persistent, creating unacceptable and offensive work conditions. The plaintiff has to show that the employer knew or should have known of the situation but failed to remedy it.
The “quid pro quo” type of case requires a showing that a person in authority conditioned some aspect of the employee’s employment, such as promotion or retention, upon a sexual favor or relationship.
The U.S. Supreme Court has both clarified and muddied the law’s position on these two previously distinct types of sexual harassment.
In the landmark case of Burlington Industries v. Ellerth, the plaintiff, who was a salesperson, alleged that a supervisor made advances to her and threatened to deny her certain job benefits if she did not cooperate.8 The threats were never carried out, and she was in fact promoted; but her lawsuit alleged that the harassment caused her resignation and amounted to a “constructive” discharge.
Likewise, in Faragher v. City of Boca Raton, the plaintiff, employed as a lifeguard, alleged that her work environment was riddled with crude remarks and obscenities.9 One of the two supervisors reportedly once said to Faragher, “Date me or clean toilets for a year.” Another lifeguard had previously lodged similar complaints. The plaintiff ultimately resigned and brought suit.
The U.S. Supreme Court characterized both of these as “hostile environment” rather than “quid pro quo” cases, because the plaintiffs did not suffer any direct adverse job action. In its decisions, the court defined the scope of liability and affirmative defenses, holding that employers can be subject to vicarious liability when supervisors create actionable hostile work environments.
In other cases, the Supreme Court has ruled for the use of “the reasonable person in the plaintiff’s position” standard in judging the severity of sexual harassment. The court has also held that the genders of the harasser and the harassed employee are not material in determining whether sexual harassment has occurred.
A physician can be accused of harassing an employee, a nurse, an assistant, a fellow worker, a third party, or a patient. Focusing on misconduct within the doctor-patient relationship, the Federation of State Medical Boards adopted in May 2006 a policy entitled “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”10
Although it did not use the term sexual harassment, the policy emphasized that physician sexual misconduct may include behavior that is verbal or physical, and may include expressions of thoughts and feelings or gestures that are sexual. It used the term “sexual impropriety” to denote behavior, gestures, or expressions that are seductive, sexually suggestive, disrespectful of patient privacy, or sexually demeaning to a patient. Together with “sexual violation,” a term the FSMB used when referring to physical sexual contact, they form the basis for disciplinary action by a state medical board.
Caveat: When performing a physical exam, physicians should always use good judgment and sensitivity, relying on the presence of a medical assistant to ensure patient comfort and to alleviate possible embarrassment or anxiety.
Under the federal EEOC rules, the employer rather than the harasser is the defendant. But there are other legal recourses, including tort and criminal actions, that directly target the harasser. Successful plaintiffs may be awarded lost wages, as well as damages for emotional distress, medical expenses, and punitive damages. They may also recover attorney fees.
In one case, a psychiatric nurse was awarded $1.2 million (later reduced to $850,000); in another, a nurse successfully sued a physician’s medical practice and received $150,000 in damages.4 And in an unusual case, a plaintiff was awarded only $1 in damages, but her counsel was paid $41,598 in fees.11 For the practicing doctor, medical board sanction, notoriety, and loss of professional standing and privileges constitute additional costs.
The medical profession is as susceptible as any other – perhaps more so – to allegations of sexual harassment. The magic words for actionable sexual harassment are severe, pervasive, and unwelcome. Although laws in the workplace generally do not prohibit simple teasing, offhand comments, or minor isolated incidents, the line separating these behaviors from bona fide sexual harassment is thin.
Erring on the side of strict and sober professional propriety seems prudent, given the current climate of zero tolerance.
References
1. MacCluskey v. University of Connecticut Health Center, United States Court of Appeals, Second Circuit, No. 17-0807-cv, Dec. 19, 2017.
2. Arch Intern Med. 1998 Feb 23;158(4):352-8.
3. N Engl J Med. 1993 Dec 23;329(26):1936-9.
4. J Nurs Care Qual. 2004 Jul-Sep;19(3):234-41.
5. Anania v. Daubenspeck Chiropractic, 718 N.E. 2d 480 (Ohio 1998).
6. Doe v. Borromeo, Nos. 305162, 305163 (Mich. Ct. App. Sept. 20, 2012).
7. Available at https://www.eeoc.gov/laws/types/sexual_harassment.cfm.
8. Burlington Industries, Inc. v. Ellerth, 524 US 742 (1998).
9. Faragher v. City of Boca Raton, 524 U.S. 775 (1998).
10. Federation of State Medical Boards, “Addressing Sexual Boundaries: Guidelines for State Medical Boards.”
11. J Healthc Risk Manag. 1999 Summer;19(3):14-25.
Systemic corticosteroids not recommended for long-term treatment of eczema
Systemic corticosteroids (SCSs) should be limited to short courses as a transition to steroid-sparing therapies in patients with atopic dermatitis because of the potential for adverse effects, reported Sherry Yu, MD, of Massachusetts General Hospital, Boston, and her associates.
Another AE is adrenal insufficiency, defined as a cortisol level less than or equal to 500 nmol/L. In a meta-analysis of 74 articles with 3,753 participants, there was a significant increase in absolute risk of adrenal insufficiency with medium term use (1 month to less than 1 year) and long term use (more than 1 year) of SCSs, as well as medium and high doses of SCSs. Adrenal insufficiency can occur in as little as 4 weeks and may be subclinical. This can leave patients vulnerable to infection and stress from surgery. Adrenal insufficiency also can manifest itself as weakness, fatigue, and shock in more severe cases.
Dr. Yu and her colleagues noted that tapering may minimize the risk of adrenal insufficiency and that a single morning dose or alternate dosing strategy may minimize this risk.
Another finding from this study was the adverse effects the SCSs have on pediatric patients. One study showed that 7 of 10 (70%) of children taking maintenance doses of beclomethasone dipropionate had growth impairment after 6 months of therapy. Significant growth disruption also was observed in children who had taken beclomethasone dipropionate only 4 weeks.
Dr. Yu and her colleagues warned that SCS should not be used to treat pediatric AD “because of growth retardation and other AEs.”
In conclusion, Dr. Yu and her colleagues said, “the literature supports short-term use of short courses of oral corticosteroids (less than 3 weeks) to interrupt acute flares, but rebound flaring is commonly observed after discontinuation. If SCSs are used at all, their use should be short term when bridging to other systemic therapies or phototherapy.” Despite the support for short-term courses of SCSs, the “duration of an optimal short course is not well defined” in the literature.
Dr. Yu reported no relevant financial disclosures. The other three authors reported relationships with various companies in the industry.
SOURCE: Yu S et al. J Am Acad Dermatol. 2017 Oct 13. doi: 10.1016/j.jaad.2017.09.074.
Systemic corticosteroids (SCSs) should be limited to short courses as a transition to steroid-sparing therapies in patients with atopic dermatitis because of the potential for adverse effects, reported Sherry Yu, MD, of Massachusetts General Hospital, Boston, and her associates.
Another AE is adrenal insufficiency, defined as a cortisol level less than or equal to 500 nmol/L. In a meta-analysis of 74 articles with 3,753 participants, there was a significant increase in absolute risk of adrenal insufficiency with medium term use (1 month to less than 1 year) and long term use (more than 1 year) of SCSs, as well as medium and high doses of SCSs. Adrenal insufficiency can occur in as little as 4 weeks and may be subclinical. This can leave patients vulnerable to infection and stress from surgery. Adrenal insufficiency also can manifest itself as weakness, fatigue, and shock in more severe cases.
Dr. Yu and her colleagues noted that tapering may minimize the risk of adrenal insufficiency and that a single morning dose or alternate dosing strategy may minimize this risk.
Another finding from this study was the adverse effects the SCSs have on pediatric patients. One study showed that 7 of 10 (70%) of children taking maintenance doses of beclomethasone dipropionate had growth impairment after 6 months of therapy. Significant growth disruption also was observed in children who had taken beclomethasone dipropionate only 4 weeks.
Dr. Yu and her colleagues warned that SCS should not be used to treat pediatric AD “because of growth retardation and other AEs.”
In conclusion, Dr. Yu and her colleagues said, “the literature supports short-term use of short courses of oral corticosteroids (less than 3 weeks) to interrupt acute flares, but rebound flaring is commonly observed after discontinuation. If SCSs are used at all, their use should be short term when bridging to other systemic therapies or phototherapy.” Despite the support for short-term courses of SCSs, the “duration of an optimal short course is not well defined” in the literature.
Dr. Yu reported no relevant financial disclosures. The other three authors reported relationships with various companies in the industry.
SOURCE: Yu S et al. J Am Acad Dermatol. 2017 Oct 13. doi: 10.1016/j.jaad.2017.09.074.
Systemic corticosteroids (SCSs) should be limited to short courses as a transition to steroid-sparing therapies in patients with atopic dermatitis because of the potential for adverse effects, reported Sherry Yu, MD, of Massachusetts General Hospital, Boston, and her associates.
Another AE is adrenal insufficiency, defined as a cortisol level less than or equal to 500 nmol/L. In a meta-analysis of 74 articles with 3,753 participants, there was a significant increase in absolute risk of adrenal insufficiency with medium term use (1 month to less than 1 year) and long term use (more than 1 year) of SCSs, as well as medium and high doses of SCSs. Adrenal insufficiency can occur in as little as 4 weeks and may be subclinical. This can leave patients vulnerable to infection and stress from surgery. Adrenal insufficiency also can manifest itself as weakness, fatigue, and shock in more severe cases.
Dr. Yu and her colleagues noted that tapering may minimize the risk of adrenal insufficiency and that a single morning dose or alternate dosing strategy may minimize this risk.
Another finding from this study was the adverse effects the SCSs have on pediatric patients. One study showed that 7 of 10 (70%) of children taking maintenance doses of beclomethasone dipropionate had growth impairment after 6 months of therapy. Significant growth disruption also was observed in children who had taken beclomethasone dipropionate only 4 weeks.
Dr. Yu and her colleagues warned that SCS should not be used to treat pediatric AD “because of growth retardation and other AEs.”
In conclusion, Dr. Yu and her colleagues said, “the literature supports short-term use of short courses of oral corticosteroids (less than 3 weeks) to interrupt acute flares, but rebound flaring is commonly observed after discontinuation. If SCSs are used at all, their use should be short term when bridging to other systemic therapies or phototherapy.” Despite the support for short-term courses of SCSs, the “duration of an optimal short course is not well defined” in the literature.
Dr. Yu reported no relevant financial disclosures. The other three authors reported relationships with various companies in the industry.
SOURCE: Yu S et al. J Am Acad Dermatol. 2017 Oct 13. doi: 10.1016/j.jaad.2017.09.074.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point:
Major finding: Growth impairment was seen after 6 months in 7 out of 10 children with eczema taking maintenance doses of oral beclomethasone dipropionate.
Study details: A systematic review of 52 reviews and 12 studies concerning systemic corticosteroid use in atopic dermatitis patients from journal databases including PubMed and Medline
Disclosures: Dr. Yu reported no relevant financial disclosures. The other three authors reported relationships with various companies in the industry.
Source: Yu S et al. J Am Acad Dermatol. 2017 Oct 13. doi: 10.1016/j.jaad.2017.09.074.
USPSTF goes neutral on adolescent scoliosis screening
The U.S. Preventive Services Task Force neither recommended for nor recommended against routine screening for adolescent idiopathic scoliosis in new guidelines published Jan. 9 in JAMA.
The determination applies to asymptomatic adolescents 10-18 years old; it does not apply to children and adolescents who present with back pain, breathing difficulties, obvious spine deformities, or abnormal imaging.
Studies since then, however, have shifted the calculus a bit so that the group “no longer has moderate certainty that the harms of treatment outweigh the benefits ... As a result, the USPSTF has determined that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis,” which led the group to issue an “I statement” for “insufficient evidence,” David C. Grossman, MD, MPH, of Kaiser Permanente
Washington Health Research Institute, Seattle, and the other members of the task force wrote.
An I statement means that “if the service is offered, patients should understand the uncertainty about the balance of benefits and harms ... The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation.”
The task force did find that screening using the forward bend test, scoliometer, or both with radiologic confirmation does a good job at detecting scoliosis. It also found a growing body of evidence that bracing can interrupt or slow scoliosis progression; “however, evidence on whether reducing spinal curvature in adolescence has a long-term effect on health in adulthood is inadequate,” and “evidence on the effects of exercise and surgery on health or spinal curvature in childhood or adulthood is insufficient.” Also, the majority of individuals identified through screening will never require treatment, the task force said.
The guidance is based on a review of 448,276 subjects in 14 studies, more than half of which were published after the last guidance.
USPSTF noted that limited new evidence suggests curves “may respond similarly to physiotherapeutic, scoliosis-specific exercise treatment; if confirmed, this may represent a treatment option for mild curves before bracing is recommended.”
Meanwhile, “surgical treatment remains the standard of care for curves that progress to greater than 40-50 degrees; however, there are no controlled studies of surgical [versus] nonsurgical treatment in individuals with lower degrees of curvature,” the task force said in an evidence review that was also published Jan. 9 in JAMA and was led by pediatrician John Dunn, MD, of Kaiser Permanente Washington Health Research Institute, Seattle.
More than half of US states either mandate or recommend school-based screening for scoliosis. The American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the Pediatric Orthopaedic Society of North America, and the American Academy of Pediatrics advocate screening for scoliosis in girls at 10 and 12 years and in male adolescents at either 13 or 14 years as part of medical home preventive services. The United Kingdom National Screening Society does not recommend screening for scoliosis given the uncertainty surrounding the effectiveness of screening and treatment.
The work was funded by the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.
SOURCE: US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):165-72; Dunn J et al. JAMA. 2018;319(2):173-87.
Twenty or more states, including highly populous states such as California, New York, Ohio, and Texas, mandate or strongly recommend school-based screening for scoliosis ... Given the new USPSTF recommendations and the I statement [suggesting insufficient evidence], it would be appropriate for states to advise students and parents of the insufficient data about benefits and harms of screening, while also sharing more recent evidence that bracing and exercise therapies may be helpful if scoliosis is clinically diagnosed in screen-positive youth.
The broad lack of evidence regarding the short-term effect of screening for adolescents and long-term health outcomes in later adolescence and into adulthood is a clear obstacle to moving adolescent idiopathic scoliosis recommendations beyond the I rating. Consequently, the gaps in current understanding serve to highlight immediate opportunities for clinical and health services research. For example, a multisite, multiyear observational study could provide evidence about the association between reduction in spinal curvature in adolescence and long-term health outcomes.
John Sarwark, MD , is head of orthopedic surgery at Ann & Robert H. Lurie Children’s Hospital and a professor of orthopedic surgery at Northwestern University, both in Chicago. Matthew Davis, MD , is head of academic general pediatrics and primary care at Lurie and a pediatrics professor at Northwestern. They made their comments in an editorial published Jan. 9 in JAMA and were not involved with the work ( 2018;319(2):127-129) .
Twenty or more states, including highly populous states such as California, New York, Ohio, and Texas, mandate or strongly recommend school-based screening for scoliosis ... Given the new USPSTF recommendations and the I statement [suggesting insufficient evidence], it would be appropriate for states to advise students and parents of the insufficient data about benefits and harms of screening, while also sharing more recent evidence that bracing and exercise therapies may be helpful if scoliosis is clinically diagnosed in screen-positive youth.
The broad lack of evidence regarding the short-term effect of screening for adolescents and long-term health outcomes in later adolescence and into adulthood is a clear obstacle to moving adolescent idiopathic scoliosis recommendations beyond the I rating. Consequently, the gaps in current understanding serve to highlight immediate opportunities for clinical and health services research. For example, a multisite, multiyear observational study could provide evidence about the association between reduction in spinal curvature in adolescence and long-term health outcomes.
John Sarwark, MD , is head of orthopedic surgery at Ann & Robert H. Lurie Children’s Hospital and a professor of orthopedic surgery at Northwestern University, both in Chicago. Matthew Davis, MD , is head of academic general pediatrics and primary care at Lurie and a pediatrics professor at Northwestern. They made their comments in an editorial published Jan. 9 in JAMA and were not involved with the work ( 2018;319(2):127-129) .
Twenty or more states, including highly populous states such as California, New York, Ohio, and Texas, mandate or strongly recommend school-based screening for scoliosis ... Given the new USPSTF recommendations and the I statement [suggesting insufficient evidence], it would be appropriate for states to advise students and parents of the insufficient data about benefits and harms of screening, while also sharing more recent evidence that bracing and exercise therapies may be helpful if scoliosis is clinically diagnosed in screen-positive youth.
The broad lack of evidence regarding the short-term effect of screening for adolescents and long-term health outcomes in later adolescence and into adulthood is a clear obstacle to moving adolescent idiopathic scoliosis recommendations beyond the I rating. Consequently, the gaps in current understanding serve to highlight immediate opportunities for clinical and health services research. For example, a multisite, multiyear observational study could provide evidence about the association between reduction in spinal curvature in adolescence and long-term health outcomes.
John Sarwark, MD , is head of orthopedic surgery at Ann & Robert H. Lurie Children’s Hospital and a professor of orthopedic surgery at Northwestern University, both in Chicago. Matthew Davis, MD , is head of academic general pediatrics and primary care at Lurie and a pediatrics professor at Northwestern. They made their comments in an editorial published Jan. 9 in JAMA and were not involved with the work ( 2018;319(2):127-129) .
The U.S. Preventive Services Task Force neither recommended for nor recommended against routine screening for adolescent idiopathic scoliosis in new guidelines published Jan. 9 in JAMA.
The determination applies to asymptomatic adolescents 10-18 years old; it does not apply to children and adolescents who present with back pain, breathing difficulties, obvious spine deformities, or abnormal imaging.
Studies since then, however, have shifted the calculus a bit so that the group “no longer has moderate certainty that the harms of treatment outweigh the benefits ... As a result, the USPSTF has determined that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis,” which led the group to issue an “I statement” for “insufficient evidence,” David C. Grossman, MD, MPH, of Kaiser Permanente
Washington Health Research Institute, Seattle, and the other members of the task force wrote.
An I statement means that “if the service is offered, patients should understand the uncertainty about the balance of benefits and harms ... The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation.”
The task force did find that screening using the forward bend test, scoliometer, or both with radiologic confirmation does a good job at detecting scoliosis. It also found a growing body of evidence that bracing can interrupt or slow scoliosis progression; “however, evidence on whether reducing spinal curvature in adolescence has a long-term effect on health in adulthood is inadequate,” and “evidence on the effects of exercise and surgery on health or spinal curvature in childhood or adulthood is insufficient.” Also, the majority of individuals identified through screening will never require treatment, the task force said.
The guidance is based on a review of 448,276 subjects in 14 studies, more than half of which were published after the last guidance.
USPSTF noted that limited new evidence suggests curves “may respond similarly to physiotherapeutic, scoliosis-specific exercise treatment; if confirmed, this may represent a treatment option for mild curves before bracing is recommended.”
Meanwhile, “surgical treatment remains the standard of care for curves that progress to greater than 40-50 degrees; however, there are no controlled studies of surgical [versus] nonsurgical treatment in individuals with lower degrees of curvature,” the task force said in an evidence review that was also published Jan. 9 in JAMA and was led by pediatrician John Dunn, MD, of Kaiser Permanente Washington Health Research Institute, Seattle.
More than half of US states either mandate or recommend school-based screening for scoliosis. The American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the Pediatric Orthopaedic Society of North America, and the American Academy of Pediatrics advocate screening for scoliosis in girls at 10 and 12 years and in male adolescents at either 13 or 14 years as part of medical home preventive services. The United Kingdom National Screening Society does not recommend screening for scoliosis given the uncertainty surrounding the effectiveness of screening and treatment.
The work was funded by the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.
SOURCE: US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):165-72; Dunn J et al. JAMA. 2018;319(2):173-87.
The U.S. Preventive Services Task Force neither recommended for nor recommended against routine screening for adolescent idiopathic scoliosis in new guidelines published Jan. 9 in JAMA.
The determination applies to asymptomatic adolescents 10-18 years old; it does not apply to children and adolescents who present with back pain, breathing difficulties, obvious spine deformities, or abnormal imaging.
Studies since then, however, have shifted the calculus a bit so that the group “no longer has moderate certainty that the harms of treatment outweigh the benefits ... As a result, the USPSTF has determined that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis,” which led the group to issue an “I statement” for “insufficient evidence,” David C. Grossman, MD, MPH, of Kaiser Permanente
Washington Health Research Institute, Seattle, and the other members of the task force wrote.
An I statement means that “if the service is offered, patients should understand the uncertainty about the balance of benefits and harms ... The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or situation.”
The task force did find that screening using the forward bend test, scoliometer, or both with radiologic confirmation does a good job at detecting scoliosis. It also found a growing body of evidence that bracing can interrupt or slow scoliosis progression; “however, evidence on whether reducing spinal curvature in adolescence has a long-term effect on health in adulthood is inadequate,” and “evidence on the effects of exercise and surgery on health or spinal curvature in childhood or adulthood is insufficient.” Also, the majority of individuals identified through screening will never require treatment, the task force said.
The guidance is based on a review of 448,276 subjects in 14 studies, more than half of which were published after the last guidance.
USPSTF noted that limited new evidence suggests curves “may respond similarly to physiotherapeutic, scoliosis-specific exercise treatment; if confirmed, this may represent a treatment option for mild curves before bracing is recommended.”
Meanwhile, “surgical treatment remains the standard of care for curves that progress to greater than 40-50 degrees; however, there are no controlled studies of surgical [versus] nonsurgical treatment in individuals with lower degrees of curvature,” the task force said in an evidence review that was also published Jan. 9 in JAMA and was led by pediatrician John Dunn, MD, of Kaiser Permanente Washington Health Research Institute, Seattle.
More than half of US states either mandate or recommend school-based screening for scoliosis. The American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the Pediatric Orthopaedic Society of North America, and the American Academy of Pediatrics advocate screening for scoliosis in girls at 10 and 12 years and in male adolescents at either 13 or 14 years as part of medical home preventive services. The United Kingdom National Screening Society does not recommend screening for scoliosis given the uncertainty surrounding the effectiveness of screening and treatment.
The work was funded by the Agency for Healthcare Research and Quality. The authors had no relevant disclosures.
SOURCE: US Preventive Services Task Force. JAMA. 2018 Jan 9;319(2):165-72; Dunn J et al. JAMA. 2018;319(2):173-87.
FROM JAMA
Idalopirdine falls short in three phase 3 Alzheimer’s trials
Idalopirdine suffered the final nail in its coffin with the complete release of its phase 3 data detailing its failure to improve cognitive outcomes in patients with mild to moderate Alzheimer’s disease.
The 5-HT6 receptor antagonist idalopirdine was given on a background of stable cholinesterase inhibitor therapy in three Lundbeck-sponsored phase 3 trials: STARSHINE, STARBEAM, and STARBRIGHT. But none of the STAR studies reproduced the results of idalopirdine’s modestly successful phase 2 study, LADDER, wrote Alireza Atri, MD, PhD, and his colleagues. The report appears Jan. 9 in JAMA.
STARSHINE, STARBEAM, and STARBRIGHT were all 24-week, fixed-dose, randomized placebo-controlled studies with the same endpoint: change on the Alzheimer’s Disease Cooperative Scale–cognitive (ADAS-cog) measure. Together, they enrolled 2,525 patients with mild to moderate AD. Patients were a mean of 74 years old, with a mean Mini Mental State Exam Score of 17-18 and a mean baseline ADAS-cog of 26.
Study 1 (STARSHINE) randomized patients to background donepezil plus placebo, or idalopirdine 30 mg or 60 mg. Study 2 (STARBEAM) randomized patients to background donepezil plus placebo or idalopirdine 10 mg or 30 mg. Study 3 (STARBRIGHT) randomized patients to background donepezil, rivastigmine, or galantamine plus placebo or 60 mg idalopirdine.
Cohort retention was good in all three studies, with about a 9% dropout rate for those taking placebo, 10% for those taking 10 mg or 30 mg idalopirdine, and 11% for those taking the 60-mg dose. The adverse event profile was also acceptable. However, there were no statistically significant cognitive improvements in any study.
In study 1, the mean 24-week change in ADAS-cog total score was 0.37 for the 60-mg group, 0.61 for the 30-mg group, and 0.41 for the placebo group. Compared with placebo, the mean difference in ADAS-cog score change was 0.05 for the 60-mg dose group and 0.33 for the 30-mg group.
In study 2, the mean 24-week change in ADAS-cog score was 1.01 for the 30-mg group, 0.53 for the 10-mg group, and 0.56 for the placebo group. Compared with placebo, the adjusted mean difference in ADAS-cog was 0.63 for the 30-mg group and −0.09 for the 10-mg group.
In study 3, the mean ADAS-cog change was 0.38 for the 60-mg group and 0.82 for the placebo group. Compared with placebo, the mean difference was –0.55.
Adverse events were similar across the studies. The most common treatment-related adverse events were accidental overdose (idalopirdine treatment groups: 5%-11%; placebo: 9%-12%). Falls were the next most common (idalopirdine treatment groups: 4%-6%; placebo: 3%-6%). Cholinergic adverse events were also more common among those taking the study drug, with nausea and vomiting occurring in up to 4% of patients. About 5%-7% of patients taking idalopirdine discontinued because of a treatment-emergent adverse event, compared with 3%-5% of those taking placebo.
Five patients taking idalopirdine and three taking placebo died during the study; no death was related to the study drug. There was no indication of suicidal ideation or behavior associated with idalopirdine.
One striking difference between the modestly successful phase 2 and the clearly negative phase 3 studies was dosage, Dr. Atri noted. LADDER tested 90 mg of idalopirdine, split into three 30-mg doses each day. The STAR-series opted for a lower dose because PET studies on healthy volunteers showed high binding on the 5-HT6 receptors (more than 80%) at both the 30- and 60-mg doses.
“Although there is an approximate 40% decrease in 5-HT6 receptor expression among patients with Alzheimer disease compared with healthy individuals, there are also potential limitations in translating occupancy data from healthy individuals to those with a diseased brain,” the authors noted.
Based on the soundly negative data, and disappointing results with idalopirdine’s close competitor, intepirdine, it may be time to retire this area of investigation entirely, Dr. Atri concluded.
“Placing the results of this study in the broader context of the 5-HT6 antagonism adjunctive to cholinesterase inhibitor therapy mechanism of action suggests a lack of efficacy for this approach in the treatment of Alzheimer disease. In the phase 3 MINDSET study, intepirdine (another 5-HT6 antagonist) was administered at a dose of 35 mg daily added to background donepezil therapy in patients with mild to moderate Alzheimer disease and it failed to meet cognitive and functional efficacy outcomes.”
As if on cue with the idalopirdine data, Axovant Life Sciences, the New York company developing intepirdine, announced on Jan. 8 that it would shelve that drug. The announcement came on the heels of negative findings in its last best-hope studies aimed at patients with Lewy body dementia.
In the HEADWAY Lewy body dementia study, neither 35 mg nor 70 mg of intepirdine significantly improved cognition, compared with placebo. The 70-mg dose was associated with a small but insignificant improvement in motor function, but the 35-mg dose was associated with a 2-point worsening.
In a phase 2 study of intepirdine in patients with dementia and gait impairment, 35 mg of intepirdine did not improve gait speed.
“Based on the totality of intepirdine data to date, there is no evidence to support its further development. We are incredibly disappointed and saddened for the millions of people living with these difficult conditions, and are deeply grateful to the patients, caregivers and investigators who participated in our trials,” David Hung, MD, chief executive officer of Axovant, said in a press statement.
Dr. Atri reported financial relationships with numerous pharmaceutical companies, including Lundbeck, which sponsored the STAR trials.
This article was updated 1/12/18.
Idalopirdine’s failure is an all-too-familiar theme in Alzheimer’s research: a drug with a rational therapeutic target, which performed reasonable well in early clinical trials, but fell apart in large phase 3 studies, David Bennett, MD, wrote in an accompanying editorial (JAMA. 2018;319:123-4).
“Over the past 15 years, more than 400 clinical trials of therapeutics for Alzheimer’s disease have been registered, with a failure rate of nearly 100%. ... The lack of progress in the treatment and prevention of Alzheimer disease is frustrating for patients, families, physicians, researchers, industry, funders, and policy makers. Understanding the causes for these failures is essential for informing future trials.”
This task, however, is daunting. Researchers continue to unfold the complexity of Alzheimer’s disease, which is increasingly acknowledged as much more than a load of sticky protein in the brain, Dr. Bennett wrote.
“Clinical and pathological findings from community-based studies that incorporate brain autopsy find that clinically evident Alzheimer disease dementia is a function of multiple pathological abnormalities adding to and interacting with multiple resilience factors (e.g., synaptic proteins), further complicating strategies for clinical trial design and drug discovery. Some studies suggest that the comorbid pathological abnormalities account for an equal amount of dementia, perhaps even more than Alzheimer disease pathology, collectively ... These data suggest that much of the age-related loss of cognition and dementia is unexplained. Thus, treatments that affect any single pathology are unlikely to have a major effect on the occurrence of clinically diagnosed Alzheimer disease dementia.”
Nevertheless, Dr. Bennett predicts that researchers will ultimately succeed in finding an effective treatment for Alzheimer’s.
“Given the series of failures in rigorous attempts to develop an effective treatment for Alzheimer disease, it may seem difficult to be optimistic, yet lessons from the past century paint a different picture.”
He likened the current research situation to the early days of President Nixon’s “War on Cancer,” launched in the early 1970s. Once that public commitment was made, funding opportunities followed, research surged, and successes followed.
“Since then, numerous treatments for cancer are now available that were unimaginable 45 years ago.”
The 2011 National Alzheimer’s Project Act is even now fostering a similar research environment, Dr. Bennett said. Federal funding for Alzheimer’s research topped out at $1.4 billion in 2017 – a new high.
“This is a worldwide effort with many countries creating plans to counteract dementia and both governments and industry increasing research funding in this area. In addition, despite the complexity of the disease, the field is generating new knowledge at an unprecedented pace. It is just a matter of time before that knowledge is translated into effective strategies for the treatment and prevention of Alzheimer disease dementia.”
Dr. Bennett is the Robert C. Borwell Professor of Neurological Science and director of the Rush Alzheimer’s Disease Center, Rush University, Chicago. He reported serving on study committees for Takeda and AbbVie.
Idalopirdine’s failure is an all-too-familiar theme in Alzheimer’s research: a drug with a rational therapeutic target, which performed reasonable well in early clinical trials, but fell apart in large phase 3 studies, David Bennett, MD, wrote in an accompanying editorial (JAMA. 2018;319:123-4).
“Over the past 15 years, more than 400 clinical trials of therapeutics for Alzheimer’s disease have been registered, with a failure rate of nearly 100%. ... The lack of progress in the treatment and prevention of Alzheimer disease is frustrating for patients, families, physicians, researchers, industry, funders, and policy makers. Understanding the causes for these failures is essential for informing future trials.”
This task, however, is daunting. Researchers continue to unfold the complexity of Alzheimer’s disease, which is increasingly acknowledged as much more than a load of sticky protein in the brain, Dr. Bennett wrote.
“Clinical and pathological findings from community-based studies that incorporate brain autopsy find that clinically evident Alzheimer disease dementia is a function of multiple pathological abnormalities adding to and interacting with multiple resilience factors (e.g., synaptic proteins), further complicating strategies for clinical trial design and drug discovery. Some studies suggest that the comorbid pathological abnormalities account for an equal amount of dementia, perhaps even more than Alzheimer disease pathology, collectively ... These data suggest that much of the age-related loss of cognition and dementia is unexplained. Thus, treatments that affect any single pathology are unlikely to have a major effect on the occurrence of clinically diagnosed Alzheimer disease dementia.”
Nevertheless, Dr. Bennett predicts that researchers will ultimately succeed in finding an effective treatment for Alzheimer’s.
“Given the series of failures in rigorous attempts to develop an effective treatment for Alzheimer disease, it may seem difficult to be optimistic, yet lessons from the past century paint a different picture.”
He likened the current research situation to the early days of President Nixon’s “War on Cancer,” launched in the early 1970s. Once that public commitment was made, funding opportunities followed, research surged, and successes followed.
“Since then, numerous treatments for cancer are now available that were unimaginable 45 years ago.”
The 2011 National Alzheimer’s Project Act is even now fostering a similar research environment, Dr. Bennett said. Federal funding for Alzheimer’s research topped out at $1.4 billion in 2017 – a new high.
“This is a worldwide effort with many countries creating plans to counteract dementia and both governments and industry increasing research funding in this area. In addition, despite the complexity of the disease, the field is generating new knowledge at an unprecedented pace. It is just a matter of time before that knowledge is translated into effective strategies for the treatment and prevention of Alzheimer disease dementia.”
Dr. Bennett is the Robert C. Borwell Professor of Neurological Science and director of the Rush Alzheimer’s Disease Center, Rush University, Chicago. He reported serving on study committees for Takeda and AbbVie.
Idalopirdine’s failure is an all-too-familiar theme in Alzheimer’s research: a drug with a rational therapeutic target, which performed reasonable well in early clinical trials, but fell apart in large phase 3 studies, David Bennett, MD, wrote in an accompanying editorial (JAMA. 2018;319:123-4).
“Over the past 15 years, more than 400 clinical trials of therapeutics for Alzheimer’s disease have been registered, with a failure rate of nearly 100%. ... The lack of progress in the treatment and prevention of Alzheimer disease is frustrating for patients, families, physicians, researchers, industry, funders, and policy makers. Understanding the causes for these failures is essential for informing future trials.”
This task, however, is daunting. Researchers continue to unfold the complexity of Alzheimer’s disease, which is increasingly acknowledged as much more than a load of sticky protein in the brain, Dr. Bennett wrote.
“Clinical and pathological findings from community-based studies that incorporate brain autopsy find that clinically evident Alzheimer disease dementia is a function of multiple pathological abnormalities adding to and interacting with multiple resilience factors (e.g., synaptic proteins), further complicating strategies for clinical trial design and drug discovery. Some studies suggest that the comorbid pathological abnormalities account for an equal amount of dementia, perhaps even more than Alzheimer disease pathology, collectively ... These data suggest that much of the age-related loss of cognition and dementia is unexplained. Thus, treatments that affect any single pathology are unlikely to have a major effect on the occurrence of clinically diagnosed Alzheimer disease dementia.”
Nevertheless, Dr. Bennett predicts that researchers will ultimately succeed in finding an effective treatment for Alzheimer’s.
“Given the series of failures in rigorous attempts to develop an effective treatment for Alzheimer disease, it may seem difficult to be optimistic, yet lessons from the past century paint a different picture.”
He likened the current research situation to the early days of President Nixon’s “War on Cancer,” launched in the early 1970s. Once that public commitment was made, funding opportunities followed, research surged, and successes followed.
“Since then, numerous treatments for cancer are now available that were unimaginable 45 years ago.”
The 2011 National Alzheimer’s Project Act is even now fostering a similar research environment, Dr. Bennett said. Federal funding for Alzheimer’s research topped out at $1.4 billion in 2017 – a new high.
“This is a worldwide effort with many countries creating plans to counteract dementia and both governments and industry increasing research funding in this area. In addition, despite the complexity of the disease, the field is generating new knowledge at an unprecedented pace. It is just a matter of time before that knowledge is translated into effective strategies for the treatment and prevention of Alzheimer disease dementia.”
Dr. Bennett is the Robert C. Borwell Professor of Neurological Science and director of the Rush Alzheimer’s Disease Center, Rush University, Chicago. He reported serving on study committees for Takeda and AbbVie.
Idalopirdine suffered the final nail in its coffin with the complete release of its phase 3 data detailing its failure to improve cognitive outcomes in patients with mild to moderate Alzheimer’s disease.
The 5-HT6 receptor antagonist idalopirdine was given on a background of stable cholinesterase inhibitor therapy in three Lundbeck-sponsored phase 3 trials: STARSHINE, STARBEAM, and STARBRIGHT. But none of the STAR studies reproduced the results of idalopirdine’s modestly successful phase 2 study, LADDER, wrote Alireza Atri, MD, PhD, and his colleagues. The report appears Jan. 9 in JAMA.
STARSHINE, STARBEAM, and STARBRIGHT were all 24-week, fixed-dose, randomized placebo-controlled studies with the same endpoint: change on the Alzheimer’s Disease Cooperative Scale–cognitive (ADAS-cog) measure. Together, they enrolled 2,525 patients with mild to moderate AD. Patients were a mean of 74 years old, with a mean Mini Mental State Exam Score of 17-18 and a mean baseline ADAS-cog of 26.
Study 1 (STARSHINE) randomized patients to background donepezil plus placebo, or idalopirdine 30 mg or 60 mg. Study 2 (STARBEAM) randomized patients to background donepezil plus placebo or idalopirdine 10 mg or 30 mg. Study 3 (STARBRIGHT) randomized patients to background donepezil, rivastigmine, or galantamine plus placebo or 60 mg idalopirdine.
Cohort retention was good in all three studies, with about a 9% dropout rate for those taking placebo, 10% for those taking 10 mg or 30 mg idalopirdine, and 11% for those taking the 60-mg dose. The adverse event profile was also acceptable. However, there were no statistically significant cognitive improvements in any study.
In study 1, the mean 24-week change in ADAS-cog total score was 0.37 for the 60-mg group, 0.61 for the 30-mg group, and 0.41 for the placebo group. Compared with placebo, the mean difference in ADAS-cog score change was 0.05 for the 60-mg dose group and 0.33 for the 30-mg group.
In study 2, the mean 24-week change in ADAS-cog score was 1.01 for the 30-mg group, 0.53 for the 10-mg group, and 0.56 for the placebo group. Compared with placebo, the adjusted mean difference in ADAS-cog was 0.63 for the 30-mg group and −0.09 for the 10-mg group.
In study 3, the mean ADAS-cog change was 0.38 for the 60-mg group and 0.82 for the placebo group. Compared with placebo, the mean difference was –0.55.
Adverse events were similar across the studies. The most common treatment-related adverse events were accidental overdose (idalopirdine treatment groups: 5%-11%; placebo: 9%-12%). Falls were the next most common (idalopirdine treatment groups: 4%-6%; placebo: 3%-6%). Cholinergic adverse events were also more common among those taking the study drug, with nausea and vomiting occurring in up to 4% of patients. About 5%-7% of patients taking idalopirdine discontinued because of a treatment-emergent adverse event, compared with 3%-5% of those taking placebo.
Five patients taking idalopirdine and three taking placebo died during the study; no death was related to the study drug. There was no indication of suicidal ideation or behavior associated with idalopirdine.
One striking difference between the modestly successful phase 2 and the clearly negative phase 3 studies was dosage, Dr. Atri noted. LADDER tested 90 mg of idalopirdine, split into three 30-mg doses each day. The STAR-series opted for a lower dose because PET studies on healthy volunteers showed high binding on the 5-HT6 receptors (more than 80%) at both the 30- and 60-mg doses.
“Although there is an approximate 40% decrease in 5-HT6 receptor expression among patients with Alzheimer disease compared with healthy individuals, there are also potential limitations in translating occupancy data from healthy individuals to those with a diseased brain,” the authors noted.
Based on the soundly negative data, and disappointing results with idalopirdine’s close competitor, intepirdine, it may be time to retire this area of investigation entirely, Dr. Atri concluded.
“Placing the results of this study in the broader context of the 5-HT6 antagonism adjunctive to cholinesterase inhibitor therapy mechanism of action suggests a lack of efficacy for this approach in the treatment of Alzheimer disease. In the phase 3 MINDSET study, intepirdine (another 5-HT6 antagonist) was administered at a dose of 35 mg daily added to background donepezil therapy in patients with mild to moderate Alzheimer disease and it failed to meet cognitive and functional efficacy outcomes.”
As if on cue with the idalopirdine data, Axovant Life Sciences, the New York company developing intepirdine, announced on Jan. 8 that it would shelve that drug. The announcement came on the heels of negative findings in its last best-hope studies aimed at patients with Lewy body dementia.
In the HEADWAY Lewy body dementia study, neither 35 mg nor 70 mg of intepirdine significantly improved cognition, compared with placebo. The 70-mg dose was associated with a small but insignificant improvement in motor function, but the 35-mg dose was associated with a 2-point worsening.
In a phase 2 study of intepirdine in patients with dementia and gait impairment, 35 mg of intepirdine did not improve gait speed.
“Based on the totality of intepirdine data to date, there is no evidence to support its further development. We are incredibly disappointed and saddened for the millions of people living with these difficult conditions, and are deeply grateful to the patients, caregivers and investigators who participated in our trials,” David Hung, MD, chief executive officer of Axovant, said in a press statement.
Dr. Atri reported financial relationships with numerous pharmaceutical companies, including Lundbeck, which sponsored the STAR trials.
This article was updated 1/12/18.
Idalopirdine suffered the final nail in its coffin with the complete release of its phase 3 data detailing its failure to improve cognitive outcomes in patients with mild to moderate Alzheimer’s disease.
The 5-HT6 receptor antagonist idalopirdine was given on a background of stable cholinesterase inhibitor therapy in three Lundbeck-sponsored phase 3 trials: STARSHINE, STARBEAM, and STARBRIGHT. But none of the STAR studies reproduced the results of idalopirdine’s modestly successful phase 2 study, LADDER, wrote Alireza Atri, MD, PhD, and his colleagues. The report appears Jan. 9 in JAMA.
STARSHINE, STARBEAM, and STARBRIGHT were all 24-week, fixed-dose, randomized placebo-controlled studies with the same endpoint: change on the Alzheimer’s Disease Cooperative Scale–cognitive (ADAS-cog) measure. Together, they enrolled 2,525 patients with mild to moderate AD. Patients were a mean of 74 years old, with a mean Mini Mental State Exam Score of 17-18 and a mean baseline ADAS-cog of 26.
Study 1 (STARSHINE) randomized patients to background donepezil plus placebo, or idalopirdine 30 mg or 60 mg. Study 2 (STARBEAM) randomized patients to background donepezil plus placebo or idalopirdine 10 mg or 30 mg. Study 3 (STARBRIGHT) randomized patients to background donepezil, rivastigmine, or galantamine plus placebo or 60 mg idalopirdine.
Cohort retention was good in all three studies, with about a 9% dropout rate for those taking placebo, 10% for those taking 10 mg or 30 mg idalopirdine, and 11% for those taking the 60-mg dose. The adverse event profile was also acceptable. However, there were no statistically significant cognitive improvements in any study.
In study 1, the mean 24-week change in ADAS-cog total score was 0.37 for the 60-mg group, 0.61 for the 30-mg group, and 0.41 for the placebo group. Compared with placebo, the mean difference in ADAS-cog score change was 0.05 for the 60-mg dose group and 0.33 for the 30-mg group.
In study 2, the mean 24-week change in ADAS-cog score was 1.01 for the 30-mg group, 0.53 for the 10-mg group, and 0.56 for the placebo group. Compared with placebo, the adjusted mean difference in ADAS-cog was 0.63 for the 30-mg group and −0.09 for the 10-mg group.
In study 3, the mean ADAS-cog change was 0.38 for the 60-mg group and 0.82 for the placebo group. Compared with placebo, the mean difference was –0.55.
Adverse events were similar across the studies. The most common treatment-related adverse events were accidental overdose (idalopirdine treatment groups: 5%-11%; placebo: 9%-12%). Falls were the next most common (idalopirdine treatment groups: 4%-6%; placebo: 3%-6%). Cholinergic adverse events were also more common among those taking the study drug, with nausea and vomiting occurring in up to 4% of patients. About 5%-7% of patients taking idalopirdine discontinued because of a treatment-emergent adverse event, compared with 3%-5% of those taking placebo.
Five patients taking idalopirdine and three taking placebo died during the study; no death was related to the study drug. There was no indication of suicidal ideation or behavior associated with idalopirdine.
One striking difference between the modestly successful phase 2 and the clearly negative phase 3 studies was dosage, Dr. Atri noted. LADDER tested 90 mg of idalopirdine, split into three 30-mg doses each day. The STAR-series opted for a lower dose because PET studies on healthy volunteers showed high binding on the 5-HT6 receptors (more than 80%) at both the 30- and 60-mg doses.
“Although there is an approximate 40% decrease in 5-HT6 receptor expression among patients with Alzheimer disease compared with healthy individuals, there are also potential limitations in translating occupancy data from healthy individuals to those with a diseased brain,” the authors noted.
Based on the soundly negative data, and disappointing results with idalopirdine’s close competitor, intepirdine, it may be time to retire this area of investigation entirely, Dr. Atri concluded.
“Placing the results of this study in the broader context of the 5-HT6 antagonism adjunctive to cholinesterase inhibitor therapy mechanism of action suggests a lack of efficacy for this approach in the treatment of Alzheimer disease. In the phase 3 MINDSET study, intepirdine (another 5-HT6 antagonist) was administered at a dose of 35 mg daily added to background donepezil therapy in patients with mild to moderate Alzheimer disease and it failed to meet cognitive and functional efficacy outcomes.”
As if on cue with the idalopirdine data, Axovant Life Sciences, the New York company developing intepirdine, announced on Jan. 8 that it would shelve that drug. The announcement came on the heels of negative findings in its last best-hope studies aimed at patients with Lewy body dementia.
In the HEADWAY Lewy body dementia study, neither 35 mg nor 70 mg of intepirdine significantly improved cognition, compared with placebo. The 70-mg dose was associated with a small but insignificant improvement in motor function, but the 35-mg dose was associated with a 2-point worsening.
In a phase 2 study of intepirdine in patients with dementia and gait impairment, 35 mg of intepirdine did not improve gait speed.
“Based on the totality of intepirdine data to date, there is no evidence to support its further development. We are incredibly disappointed and saddened for the millions of people living with these difficult conditions, and are deeply grateful to the patients, caregivers and investigators who participated in our trials,” David Hung, MD, chief executive officer of Axovant, said in a press statement.
Dr. Atri reported financial relationships with numerous pharmaceutical companies, including Lundbeck, which sponsored the STAR trials.
This article was updated 1/12/18.
FROM JAMA
Key clinical point:
Major finding: None of the trio of phase 3 trials showed any cognitive benefit associated with the drug.
Study details: The studies randomized more than 2,000 patients to placebo plus idalopirdine 10, 30, or 60 mg on background cholinesterase inhibitor medication.
Disclosures: Dr. Atri disclosed financial relationships with numerous pharmaceutical companies, including Lundbeck, which sponsored the trials.
Source: Atri A et al., JAMA. 2018;319(2):130-42