User login
Rituximab does not improve fatigue symptoms of ME/CFS
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
The RituxME trial’s results weaken the case for the use of rituximab to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but there are opportunities to test other treatments targeting immunologic abnormalities in ME/CFS, Peter C. Rowe, MD, of Johns Hopkins University, Baltimore, wrote in a related editorial.
“Persons with ME/CFS often meet criteria for several comorbid conditions, each of which could flare during a trial, possibly obscuring a true beneficial effect of an intervention,” Dr. Rowe wrote.
Trials with open treatment periods, in which ME/CFS patients all receive rituximab and then are grouped based on nontargeted conditions, could be warranted to “allow better control” of these conditions. Other trial designs could include randomizing patients to continue or discontinue therapy for responders, he added.
“The profound level of impaired function of affected individuals warrants a new commitment to hypothesis-driven clinical trials that incorporate and expand on the methodological sophistication of the rituximab trial,” Dr. Rowe wrote.
Dr. Rowe is with Johns Hopkins University, Baltimore. These comments summarize his editorial in response to Fluge et al. (Ann Intern Med. 2019 Apr 1. doi: 10.7326/M19-0643). Dr. Rowe reported receiving grants from the National Institutes of Health and is a scientific advisory board member for Solve ME/CFS, all outside the submitted work.
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
according to results from the phase 3 RituxME trial.
“The lack of clinical effect of B-cell depletion in this trial weakens the case for an important role of B lymphocytes in ME/CFS but does not exclude an immunologic basis,” Øystein Fluge, MD, PhD, of the department of oncology and medical physics at Haukeland University Hospital in Bergen, Norway, and his colleagues wrote April 1 in Annals of Internal Medicine.
The investigators noted that the basis for testing the effects of a B-cell–depleting intervention on clinical symptoms in patients with ME/CFS came from observations of its potential benefit in a subgroup of patients in previous studies. Dr. Fluge and his colleagues performed a three-patient case series in their own group that found benefit for patients who received rituximab for treatment of CFS (BMC Neurol. 2009 May 8;9:28. doi: 10.1186/1471-2377-9-28). A phase 2 trial of 30 patients with CFS also performed by his own group found improved fatigue scores in 66.7% of patients in the rituximab group, compared with placebo (PLOS One. 2011 Oct 19. doi: 10.1371/journal.pone.0026358).
In the double-blinded RituxME trial, 151 patients with ME/CFS from four university hospitals and one general hospital in Norway were recruited and randomized to receive infusions of rituximab (n = 77) or placebo (n = 74). The patients were aged 18-65 years old and had the disease ranging from 2 years to 15 years. Patients reported and rated their ME/CFS symptoms at baseline as well as completed forms for the SF-36, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, and modified DePaul Symptom Questionnaire out to 24 months. The rituximab group received two infusions at 500 mg/m2 across body surface area at 2 weeks apart. They then received 500-mg maintenance infusions at 3 months, 6 months, 9 months, and 12 months where they also self-reported changes in ME/CFS symptoms.
There were no significant differences between groups regarding fatigue score at any follow-up period, with an average between-group difference of 0.02 at 24 months (95% confidence interval, –0.27 to 0.31). The overall response rate was 26% with rituximab and 35% with placebo. Dr. Fluge and his colleagues also noted no significant differences regarding SF-36 scores, function level, and fatigue severity between groups.
Adverse event rates were higher in the rituximab group (63 patients; 82%) than in the placebo group (48 patients; 65%), and these were more often attributed to treatment for those taking rituximab (26 patients [34%]) than for placebo (12 patients [16%]). Adverse events requiring hospitalization also occurred more often among those taking rituximab (31 events in 20 patients [26%]) than for those who took placebo (16 events in 14 patients [19%]).
Some of the weaknesses of the trial included its use of self-referral and self-reported symptom scores, which might have been subject to recall bias. In commenting on the difference in outcome between the phase 3 trial and others, Dr. Fluge and his associates said the discrepancy could potentially be high expectations in the placebo group, unknown factors surrounding symptom variation in ME/CFS patients, and unknown patient selection effects.
“[T]he negative outcome of RituxME should spur research to assess patient subgroups and further elucidate disease mechanisms, of which recently disclosed impairment of energy metabolism may be important,” Dr. Fluge and his coauthors wrote.
The trial was funded by grants to the researchers from the Norwegian Research Council, the Norwegian Regional Health Trusts, the MEandYou Foundation, the Norwegian ME Association, and the legacy of Torstein Hereid.
SOURCE: Fluge Ø et al. Ann Intern Med. 2019 Apr 1. doi: 10.7326/M18-1451
FROM ANNALS OF INTERNAL MEDICINE
Future of NASH care means multiple targets, multiple providers, expert says
PHILADELPHIA – While current treatment options are limited for patients with nonalcoholic steatohepatitis (NASH), a number of potential agents in clinical trials, Zobair M. Younossi, MD, MPH, said here at the 6th annual Digestive Diseases: New Advances conference.
With agents currently available and those to come, the future will be focused on long-term management of NASH as a chronic disease in specialized centers, according to Dr. Younossi, chairman in the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System, both in Falls Church, Va.
“We are not going to be able to cure NASH – we need to manage it,” Dr. Younossi said in a podium presentation. “NASH will be managed like type 2 diabetes. It’s not going to be treated like hepatitis C.”
Current treatment options are limited, with no Food and Drug Administration–approved options, and just two agents, vitamin E and pioglitazone, supported by guidance from the American Association for the Study of Liver Diseases (AASLD), Dr. Younossi said.
Public health interventions are needed to address the obesity and type 2 diabetes that are “the root of this disease,” Dr. Younossi said at the meeting, which was jointly provided by Rutgers and Global Academy for Medical Education.
Current AASLD guidance is based on studies suggesting that weight loss in the 3%-5% range may improve steatosis, and a 7%-10% weight loss can improve most histologic features of NASH, including fibrosis.
“The problem is that this is very hard to achieve,” Dr. Younossi said, adding that it is also hard to maintain. In a 2011 meta-analysis of clinical trials for reduction in nonalcoholic fatty liver disease, only a small minority of patients were able to maintain weight loss.
Bariatric surgery may be “very effective” for weight loss in the right patients, with some trials showing a proportion of patients maintaining improvement at 5-year follow-up, he said.
Exercise alone might prevent or reduce steatosis, but its effects on other aspects of liver histology, such as fibrosis, remain unknown, Dr. Younossi said.
Pioglitazone improves liver histology in patients with biopsy-proven NASH, although the benefits and risks, including potential adverse effects such as bone loss, diastolic dysfunction, or weight gain, should be discussed with each individual patient, he said.
Dr. Younossi highlighted randomized phase 3 trials for several agents that could figure into the treatment paradigm of NASH in the future by targeting different promoters of NASH and fibrosis progression. One of those was elafibranor, which targets the PPAR alpha/gamma pathways and is being evaluated versus placebo in NASH patients in the phase 3 RESOLVE-IT study. In a post hoc analysis of a previous randomized trial, the treatment resolved NASH without fibrosis worsening.
Other agents being evaluated in phase 3 trials include the CCR2/CCR5 receptor blocker cenicriviroc, the FXR agonist obeticholic acid, and the ASK-1 inhibitor selonsertib, Dr. Younossi said.
Optimal NASH care in the future may be based on targeting multiple such pathways, with patients increasingly treated at specialized centers that incorporate not only hepatologists, but also diabetes experts, dietitians, and exercise specialists.
“My own belief is that you have to treat this in the long term and also in a multidisciplinary sort of approach,” he said.
Dr. Younossi indicated that he is a consultant for Gilead, Intercept, Bristol-Myers Squibb, Novo Nordisk, Viking, Terms, Shionogi, AbbVie, Merck, and Novartis.
Global Academy and this news organization are owned by the same parent company.
PHILADELPHIA – While current treatment options are limited for patients with nonalcoholic steatohepatitis (NASH), a number of potential agents in clinical trials, Zobair M. Younossi, MD, MPH, said here at the 6th annual Digestive Diseases: New Advances conference.
With agents currently available and those to come, the future will be focused on long-term management of NASH as a chronic disease in specialized centers, according to Dr. Younossi, chairman in the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System, both in Falls Church, Va.
“We are not going to be able to cure NASH – we need to manage it,” Dr. Younossi said in a podium presentation. “NASH will be managed like type 2 diabetes. It’s not going to be treated like hepatitis C.”
Current treatment options are limited, with no Food and Drug Administration–approved options, and just two agents, vitamin E and pioglitazone, supported by guidance from the American Association for the Study of Liver Diseases (AASLD), Dr. Younossi said.
Public health interventions are needed to address the obesity and type 2 diabetes that are “the root of this disease,” Dr. Younossi said at the meeting, which was jointly provided by Rutgers and Global Academy for Medical Education.
Current AASLD guidance is based on studies suggesting that weight loss in the 3%-5% range may improve steatosis, and a 7%-10% weight loss can improve most histologic features of NASH, including fibrosis.
“The problem is that this is very hard to achieve,” Dr. Younossi said, adding that it is also hard to maintain. In a 2011 meta-analysis of clinical trials for reduction in nonalcoholic fatty liver disease, only a small minority of patients were able to maintain weight loss.
Bariatric surgery may be “very effective” for weight loss in the right patients, with some trials showing a proportion of patients maintaining improvement at 5-year follow-up, he said.
Exercise alone might prevent or reduce steatosis, but its effects on other aspects of liver histology, such as fibrosis, remain unknown, Dr. Younossi said.
Pioglitazone improves liver histology in patients with biopsy-proven NASH, although the benefits and risks, including potential adverse effects such as bone loss, diastolic dysfunction, or weight gain, should be discussed with each individual patient, he said.
Dr. Younossi highlighted randomized phase 3 trials for several agents that could figure into the treatment paradigm of NASH in the future by targeting different promoters of NASH and fibrosis progression. One of those was elafibranor, which targets the PPAR alpha/gamma pathways and is being evaluated versus placebo in NASH patients in the phase 3 RESOLVE-IT study. In a post hoc analysis of a previous randomized trial, the treatment resolved NASH without fibrosis worsening.
Other agents being evaluated in phase 3 trials include the CCR2/CCR5 receptor blocker cenicriviroc, the FXR agonist obeticholic acid, and the ASK-1 inhibitor selonsertib, Dr. Younossi said.
Optimal NASH care in the future may be based on targeting multiple such pathways, with patients increasingly treated at specialized centers that incorporate not only hepatologists, but also diabetes experts, dietitians, and exercise specialists.
“My own belief is that you have to treat this in the long term and also in a multidisciplinary sort of approach,” he said.
Dr. Younossi indicated that he is a consultant for Gilead, Intercept, Bristol-Myers Squibb, Novo Nordisk, Viking, Terms, Shionogi, AbbVie, Merck, and Novartis.
Global Academy and this news organization are owned by the same parent company.
PHILADELPHIA – While current treatment options are limited for patients with nonalcoholic steatohepatitis (NASH), a number of potential agents in clinical trials, Zobair M. Younossi, MD, MPH, said here at the 6th annual Digestive Diseases: New Advances conference.
With agents currently available and those to come, the future will be focused on long-term management of NASH as a chronic disease in specialized centers, according to Dr. Younossi, chairman in the department of medicine at Inova Fairfax Hospital and vice president for research at Inova Health System, both in Falls Church, Va.
“We are not going to be able to cure NASH – we need to manage it,” Dr. Younossi said in a podium presentation. “NASH will be managed like type 2 diabetes. It’s not going to be treated like hepatitis C.”
Current treatment options are limited, with no Food and Drug Administration–approved options, and just two agents, vitamin E and pioglitazone, supported by guidance from the American Association for the Study of Liver Diseases (AASLD), Dr. Younossi said.
Public health interventions are needed to address the obesity and type 2 diabetes that are “the root of this disease,” Dr. Younossi said at the meeting, which was jointly provided by Rutgers and Global Academy for Medical Education.
Current AASLD guidance is based on studies suggesting that weight loss in the 3%-5% range may improve steatosis, and a 7%-10% weight loss can improve most histologic features of NASH, including fibrosis.
“The problem is that this is very hard to achieve,” Dr. Younossi said, adding that it is also hard to maintain. In a 2011 meta-analysis of clinical trials for reduction in nonalcoholic fatty liver disease, only a small minority of patients were able to maintain weight loss.
Bariatric surgery may be “very effective” for weight loss in the right patients, with some trials showing a proportion of patients maintaining improvement at 5-year follow-up, he said.
Exercise alone might prevent or reduce steatosis, but its effects on other aspects of liver histology, such as fibrosis, remain unknown, Dr. Younossi said.
Pioglitazone improves liver histology in patients with biopsy-proven NASH, although the benefits and risks, including potential adverse effects such as bone loss, diastolic dysfunction, or weight gain, should be discussed with each individual patient, he said.
Dr. Younossi highlighted randomized phase 3 trials for several agents that could figure into the treatment paradigm of NASH in the future by targeting different promoters of NASH and fibrosis progression. One of those was elafibranor, which targets the PPAR alpha/gamma pathways and is being evaluated versus placebo in NASH patients in the phase 3 RESOLVE-IT study. In a post hoc analysis of a previous randomized trial, the treatment resolved NASH without fibrosis worsening.
Other agents being evaluated in phase 3 trials include the CCR2/CCR5 receptor blocker cenicriviroc, the FXR agonist obeticholic acid, and the ASK-1 inhibitor selonsertib, Dr. Younossi said.
Optimal NASH care in the future may be based on targeting multiple such pathways, with patients increasingly treated at specialized centers that incorporate not only hepatologists, but also diabetes experts, dietitians, and exercise specialists.
“My own belief is that you have to treat this in the long term and also in a multidisciplinary sort of approach,” he said.
Dr. Younossi indicated that he is a consultant for Gilead, Intercept, Bristol-Myers Squibb, Novo Nordisk, Viking, Terms, Shionogi, AbbVie, Merck, and Novartis.
Global Academy and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Cerebellar volume may predict disability in patients with relapsing-remitting MS
DALLAS – Among patients with relapsing-remitting multiple sclerosis (MS), cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test, according to a retrospective analysis of data from a phase 3 trial. Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months, researchers reported at ACTRIMS Forum 2019, the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Investigators have found that demyelination in MS tends to occur in the cerebellum, and cerebellar atrophy contributes to clinical impairment in patients with the disease. In addition, cerebellar volume loss over one year may predict disease worsening in patients with progressive MS, said Maria Petracca, MD, PhD, a postdoctoral fellow at Icahn School of Medicine at Mount Sinai, New York, and her research colleagues. Prior studies, however, had not tested in a large group of patients whether baseline cerebellar volume predicts disability in relapsing-remitting MS.
To examine this question, Dr. Petracca and her colleagues analyzed MRI data from 838 of 1,008 patients in the phase 3 CombiRx trial. Patients in the multicenter, randomized trial had relapsing-remitting MS and received immunomodulatory treatment with glatiramer acetate, interferon beta-1a, or both. The researchers used an MRI analysis package to measure whole brain and cerebellar T2 and gadolinium-enhancing lesions, and they used statistical parametric mapping to measure gray matter fraction and cerebellar volume. Expanded Disability Status Scale (EDSS) scores and scores on the Multiple Sclerosis Functional Composite (MSFC) and its subcomponents were assessed at baseline and 36 months. The investigators assessed changes in clinical scores using repeated measure analysis of variance. They examined the relationship between MRI metrics and clinical disability at baseline and follow-up using ordinal and hierarchical multiple linear regression analysis.
At baseline, patients had a mean age of 37.7, and 72% were female. Median EDSS score was 2, and average cerebellar gray matter volume was 109.78 mL.
A regression model that included T2 and gadolinium-enhancing lesion volume, supratentorial gray matter volume, and cerebellar gray matter volume explained about 15% of the variance in EDSS and MSFC scores at baseline. Cerebellar volume was a significant predictor of MSFC (beta = 0.188).
The 25-foot walk test was the only clinical score that significantly worsened during follow-up – from an average of 4.94 seconds at baseline to 5.09 seconds at follow-up. “Baseline cerebellar gray matter volume was the only MRI metric to significantly predict 25-foot walk test scores at follow-up (beta = –0.172),” the researchers reported. “These results suggest that cerebellar volume is an independent predictor of clinical disability in MS patients as measured by 25-foot walk test.”
The researchers had no disclosures.
[email protected]
SOURCE: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.
DALLAS – Among patients with relapsing-remitting multiple sclerosis (MS), cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test, according to a retrospective analysis of data from a phase 3 trial. Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months, researchers reported at ACTRIMS Forum 2019, the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Investigators have found that demyelination in MS tends to occur in the cerebellum, and cerebellar atrophy contributes to clinical impairment in patients with the disease. In addition, cerebellar volume loss over one year may predict disease worsening in patients with progressive MS, said Maria Petracca, MD, PhD, a postdoctoral fellow at Icahn School of Medicine at Mount Sinai, New York, and her research colleagues. Prior studies, however, had not tested in a large group of patients whether baseline cerebellar volume predicts disability in relapsing-remitting MS.
To examine this question, Dr. Petracca and her colleagues analyzed MRI data from 838 of 1,008 patients in the phase 3 CombiRx trial. Patients in the multicenter, randomized trial had relapsing-remitting MS and received immunomodulatory treatment with glatiramer acetate, interferon beta-1a, or both. The researchers used an MRI analysis package to measure whole brain and cerebellar T2 and gadolinium-enhancing lesions, and they used statistical parametric mapping to measure gray matter fraction and cerebellar volume. Expanded Disability Status Scale (EDSS) scores and scores on the Multiple Sclerosis Functional Composite (MSFC) and its subcomponents were assessed at baseline and 36 months. The investigators assessed changes in clinical scores using repeated measure analysis of variance. They examined the relationship between MRI metrics and clinical disability at baseline and follow-up using ordinal and hierarchical multiple linear regression analysis.
At baseline, patients had a mean age of 37.7, and 72% were female. Median EDSS score was 2, and average cerebellar gray matter volume was 109.78 mL.
A regression model that included T2 and gadolinium-enhancing lesion volume, supratentorial gray matter volume, and cerebellar gray matter volume explained about 15% of the variance in EDSS and MSFC scores at baseline. Cerebellar volume was a significant predictor of MSFC (beta = 0.188).
The 25-foot walk test was the only clinical score that significantly worsened during follow-up – from an average of 4.94 seconds at baseline to 5.09 seconds at follow-up. “Baseline cerebellar gray matter volume was the only MRI metric to significantly predict 25-foot walk test scores at follow-up (beta = –0.172),” the researchers reported. “These results suggest that cerebellar volume is an independent predictor of clinical disability in MS patients as measured by 25-foot walk test.”
The researchers had no disclosures.
[email protected]
SOURCE: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.
DALLAS – Among patients with relapsing-remitting multiple sclerosis (MS), cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test, according to a retrospective analysis of data from a phase 3 trial. Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months, researchers reported at ACTRIMS Forum 2019, the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Investigators have found that demyelination in MS tends to occur in the cerebellum, and cerebellar atrophy contributes to clinical impairment in patients with the disease. In addition, cerebellar volume loss over one year may predict disease worsening in patients with progressive MS, said Maria Petracca, MD, PhD, a postdoctoral fellow at Icahn School of Medicine at Mount Sinai, New York, and her research colleagues. Prior studies, however, had not tested in a large group of patients whether baseline cerebellar volume predicts disability in relapsing-remitting MS.
To examine this question, Dr. Petracca and her colleagues analyzed MRI data from 838 of 1,008 patients in the phase 3 CombiRx trial. Patients in the multicenter, randomized trial had relapsing-remitting MS and received immunomodulatory treatment with glatiramer acetate, interferon beta-1a, or both. The researchers used an MRI analysis package to measure whole brain and cerebellar T2 and gadolinium-enhancing lesions, and they used statistical parametric mapping to measure gray matter fraction and cerebellar volume. Expanded Disability Status Scale (EDSS) scores and scores on the Multiple Sclerosis Functional Composite (MSFC) and its subcomponents were assessed at baseline and 36 months. The investigators assessed changes in clinical scores using repeated measure analysis of variance. They examined the relationship between MRI metrics and clinical disability at baseline and follow-up using ordinal and hierarchical multiple linear regression analysis.
At baseline, patients had a mean age of 37.7, and 72% were female. Median EDSS score was 2, and average cerebellar gray matter volume was 109.78 mL.
A regression model that included T2 and gadolinium-enhancing lesion volume, supratentorial gray matter volume, and cerebellar gray matter volume explained about 15% of the variance in EDSS and MSFC scores at baseline. Cerebellar volume was a significant predictor of MSFC (beta = 0.188).
The 25-foot walk test was the only clinical score that significantly worsened during follow-up – from an average of 4.94 seconds at baseline to 5.09 seconds at follow-up. “Baseline cerebellar gray matter volume was the only MRI metric to significantly predict 25-foot walk test scores at follow-up (beta = –0.172),” the researchers reported. “These results suggest that cerebellar volume is an independent predictor of clinical disability in MS patients as measured by 25-foot walk test.”
The researchers had no disclosures.
[email protected]
SOURCE: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.
REPORTING FROM ACTRIMS FORUM 2019
Key clinical point: In patients with relapsing-remitting MS, cerebellar volume may independently predict clinical disability as measured by the 25-foot walk test.
Major finding: Baseline cerebellar gray matter volume was the only MRI metric that significantly predicted 25-foot walk test results at 36 months (Beta = –0.172).
Study details: A retrospective analysis of MRI data from 838 patients in the phase 3 CombiRx trial.
Disclosures: The researchers had no disclosures.
Source: Petracca M et al. ACTRIMS Forum 2019, Abstract 160.
AI will change the practice of medicine
Remembering the importance of caring
As artificial intelligence (AI) takes on more and more tasks in medical care that mimic human cognition, hospitalists and other physicians will need to adapt to a changing role.
Today AI can identify tuberculosis infections in chest radiographs with almost complete accuracy, diagnose melanoma from images of skin lesions more accurately than dermatologists can, and identify metastatic cells in images of lymph node tissue more accurately than pathologists can. The next 20 years are likely to see further acceleration in the capabilities, according to a recent article by S. Claiborne Johnston, MD, PhD.
“AI will change the practice of medicine. The art of medicine, including all the humanistic components, will only become more important over time. As dean of a medical school, I’m training students who will be practicing in 2065,” Dr. Johnston said. “If I’m not thinking about the future, I’m failing my students and the society they will serve.”
The contributions of AI will shift the emphasis for human caregivers to the caring. Studies have shown that the skills of caring are associated with improved patient outcomes, but most medical schools allocate substantial time in the curriculum to memorization and analysis – tasks that will become less demanding as artificial intelligence improves. The art of caring – communication, empathy, shared decision making, leadership, and team building – is usually a minor part of the medical school curriculum.
Effective leadership and creativity are distant aspirations for artificial intelligence but are growing needs in a system of care that is ever more complex.
At Dr. Johnston’s school, the Dell Medical School at the University of Texas at Austin, they have reduced the duration of basic science instruction to 12 months and emphasized group problem solving, while deemphasizing memorization. This has freed up additional time for instruction in the art of caring, leadership, and creativity.
“Hospitalists should acknowledge the value of caring,” Dr. Johnston said. “They do it every day with every patient. It is important today, and will be more important tomorrow.”
Reference
Johnston SC. Anticipating and training the physician of the future: The importance of caring in an age of artificial intelligence. Acad Med. 2018;93(8):1105-6. doi: 10.1097/ACM.0000000000002175.
Remembering the importance of caring
Remembering the importance of caring
As artificial intelligence (AI) takes on more and more tasks in medical care that mimic human cognition, hospitalists and other physicians will need to adapt to a changing role.
Today AI can identify tuberculosis infections in chest radiographs with almost complete accuracy, diagnose melanoma from images of skin lesions more accurately than dermatologists can, and identify metastatic cells in images of lymph node tissue more accurately than pathologists can. The next 20 years are likely to see further acceleration in the capabilities, according to a recent article by S. Claiborne Johnston, MD, PhD.
“AI will change the practice of medicine. The art of medicine, including all the humanistic components, will only become more important over time. As dean of a medical school, I’m training students who will be practicing in 2065,” Dr. Johnston said. “If I’m not thinking about the future, I’m failing my students and the society they will serve.”
The contributions of AI will shift the emphasis for human caregivers to the caring. Studies have shown that the skills of caring are associated with improved patient outcomes, but most medical schools allocate substantial time in the curriculum to memorization and analysis – tasks that will become less demanding as artificial intelligence improves. The art of caring – communication, empathy, shared decision making, leadership, and team building – is usually a minor part of the medical school curriculum.
Effective leadership and creativity are distant aspirations for artificial intelligence but are growing needs in a system of care that is ever more complex.
At Dr. Johnston’s school, the Dell Medical School at the University of Texas at Austin, they have reduced the duration of basic science instruction to 12 months and emphasized group problem solving, while deemphasizing memorization. This has freed up additional time for instruction in the art of caring, leadership, and creativity.
“Hospitalists should acknowledge the value of caring,” Dr. Johnston said. “They do it every day with every patient. It is important today, and will be more important tomorrow.”
Reference
Johnston SC. Anticipating and training the physician of the future: The importance of caring in an age of artificial intelligence. Acad Med. 2018;93(8):1105-6. doi: 10.1097/ACM.0000000000002175.
As artificial intelligence (AI) takes on more and more tasks in medical care that mimic human cognition, hospitalists and other physicians will need to adapt to a changing role.
Today AI can identify tuberculosis infections in chest radiographs with almost complete accuracy, diagnose melanoma from images of skin lesions more accurately than dermatologists can, and identify metastatic cells in images of lymph node tissue more accurately than pathologists can. The next 20 years are likely to see further acceleration in the capabilities, according to a recent article by S. Claiborne Johnston, MD, PhD.
“AI will change the practice of medicine. The art of medicine, including all the humanistic components, will only become more important over time. As dean of a medical school, I’m training students who will be practicing in 2065,” Dr. Johnston said. “If I’m not thinking about the future, I’m failing my students and the society they will serve.”
The contributions of AI will shift the emphasis for human caregivers to the caring. Studies have shown that the skills of caring are associated with improved patient outcomes, but most medical schools allocate substantial time in the curriculum to memorization and analysis – tasks that will become less demanding as artificial intelligence improves. The art of caring – communication, empathy, shared decision making, leadership, and team building – is usually a minor part of the medical school curriculum.
Effective leadership and creativity are distant aspirations for artificial intelligence but are growing needs in a system of care that is ever more complex.
At Dr. Johnston’s school, the Dell Medical School at the University of Texas at Austin, they have reduced the duration of basic science instruction to 12 months and emphasized group problem solving, while deemphasizing memorization. This has freed up additional time for instruction in the art of caring, leadership, and creativity.
“Hospitalists should acknowledge the value of caring,” Dr. Johnston said. “They do it every day with every patient. It is important today, and will be more important tomorrow.”
Reference
Johnston SC. Anticipating and training the physician of the future: The importance of caring in an age of artificial intelligence. Acad Med. 2018;93(8):1105-6. doi: 10.1097/ACM.0000000000002175.
Studies link TMAO to microbiome, reveal new heart disease target
MIAMI – Researchers are one step closer to developing “drugs for bugs” – agents that target the gut microbiome to prevent and treat cardiometabolic diseases, Stanley L. Hazen, MD, PhD, said at the 2019 Gut Microbiota for Health World Summit.
“Each person experiences a meal differently through the filter of their gut microbiome, which helps explain individual differences in susceptibility to disease,” said Dr. Hazen of Cleveland Clinic. “In the future, our medicine cabinets will have drugs in them that not only affect us, but also target the microbial enzymes that affect levels of metabolites like TMAO.”
Trimethylamine N-oxide (TMAO) is produced by gut bacteria. High levels (in one study, approximately 6.2 micromolar) significantly increase the risk of major adverse cardiovascular events even after controlling for traditional demographic and clinical risk factors. Studies indicate that TMAO alters cholesterol and bile acid metabolism, upregulates inflammatory pathways, and promotes foam cell formation, all of which worsen atherosclerosis. In addition, TMAO increases clotting risk by enhancing platelet reactivity.
“Reducing the amount of animal products in one’s diet helps reduce TMAO levels,” said Dr. Hazen. Certain fish – mainly those found in deep, cold water, such as cod – are high in TMAO. However, a bigger culprit in the United States is red meat, which contains two major TMAO precursors – choline and carnitine. In a recent study, Dr. Hazen and his associates gave 113 healthy volunteers three isocaloric diets in random order based on red meat, white meat, or plant-based protein. After 4 weeks, eating the daily equivalent of 8 ounces of steak or two quarter-pound beef patties nearly tripled plasma TMAO levels (P less than .05) from baseline. The white meat and vegetarian diets showed no such effect.
Crucially, the effect of red meat was reversible – TMAO levels fell significantly within 4 weeks after participants stopped consuming red meat. Eating red meat low in saturated fat did not prevent TMAO levels from rising, Dr. Hazen noted at the meeting at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.
In a second study, Dr. Hazen and his associates identified a two-step process by which gut bacteria metabolize carnitine to TMAO. The second step was greatly enhanced in individuals who eat red meat, suggesting a possible therapeutic target. In a third study, they found that high TMAO levels in mice fell significantly with a single oral dose of a second-generation inhibitor of trimethylamine lyase, the enzyme used by gut bacteria to convert choline to TMAO. The inhibitory effect was irreversible, did not reduce the viability of commensal microorganisms, and significantly lowered platelet hyperreactivity and clot formation.
Such results are exciting, but “drugs for bugs” will exhibit varying effects depending on which gut species are present at baseline, Dr. Hazen explained. Investigators will need to understand and account for these differences before therapies for the microbiome can enter the clinic. For now, a blood test for TMAO is available and can help clinicians tailor their suggestions on what to eat.
Dr. Hazen disclosed a consulting relationship with Proctor & Gamble, royalties for patents from Proctor & Gamble, Cleveland Heart Lab, and Quest Diagnostics, and research support from AstraZeneca, Pfizer, Roche Diagnostics, and Proctor & Gamble.
MIAMI – Researchers are one step closer to developing “drugs for bugs” – agents that target the gut microbiome to prevent and treat cardiometabolic diseases, Stanley L. Hazen, MD, PhD, said at the 2019 Gut Microbiota for Health World Summit.
“Each person experiences a meal differently through the filter of their gut microbiome, which helps explain individual differences in susceptibility to disease,” said Dr. Hazen of Cleveland Clinic. “In the future, our medicine cabinets will have drugs in them that not only affect us, but also target the microbial enzymes that affect levels of metabolites like TMAO.”
Trimethylamine N-oxide (TMAO) is produced by gut bacteria. High levels (in one study, approximately 6.2 micromolar) significantly increase the risk of major adverse cardiovascular events even after controlling for traditional demographic and clinical risk factors. Studies indicate that TMAO alters cholesterol and bile acid metabolism, upregulates inflammatory pathways, and promotes foam cell formation, all of which worsen atherosclerosis. In addition, TMAO increases clotting risk by enhancing platelet reactivity.
“Reducing the amount of animal products in one’s diet helps reduce TMAO levels,” said Dr. Hazen. Certain fish – mainly those found in deep, cold water, such as cod – are high in TMAO. However, a bigger culprit in the United States is red meat, which contains two major TMAO precursors – choline and carnitine. In a recent study, Dr. Hazen and his associates gave 113 healthy volunteers three isocaloric diets in random order based on red meat, white meat, or plant-based protein. After 4 weeks, eating the daily equivalent of 8 ounces of steak or two quarter-pound beef patties nearly tripled plasma TMAO levels (P less than .05) from baseline. The white meat and vegetarian diets showed no such effect.
Crucially, the effect of red meat was reversible – TMAO levels fell significantly within 4 weeks after participants stopped consuming red meat. Eating red meat low in saturated fat did not prevent TMAO levels from rising, Dr. Hazen noted at the meeting at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.
In a second study, Dr. Hazen and his associates identified a two-step process by which gut bacteria metabolize carnitine to TMAO. The second step was greatly enhanced in individuals who eat red meat, suggesting a possible therapeutic target. In a third study, they found that high TMAO levels in mice fell significantly with a single oral dose of a second-generation inhibitor of trimethylamine lyase, the enzyme used by gut bacteria to convert choline to TMAO. The inhibitory effect was irreversible, did not reduce the viability of commensal microorganisms, and significantly lowered platelet hyperreactivity and clot formation.
Such results are exciting, but “drugs for bugs” will exhibit varying effects depending on which gut species are present at baseline, Dr. Hazen explained. Investigators will need to understand and account for these differences before therapies for the microbiome can enter the clinic. For now, a blood test for TMAO is available and can help clinicians tailor their suggestions on what to eat.
Dr. Hazen disclosed a consulting relationship with Proctor & Gamble, royalties for patents from Proctor & Gamble, Cleveland Heart Lab, and Quest Diagnostics, and research support from AstraZeneca, Pfizer, Roche Diagnostics, and Proctor & Gamble.
MIAMI – Researchers are one step closer to developing “drugs for bugs” – agents that target the gut microbiome to prevent and treat cardiometabolic diseases, Stanley L. Hazen, MD, PhD, said at the 2019 Gut Microbiota for Health World Summit.
“Each person experiences a meal differently through the filter of their gut microbiome, which helps explain individual differences in susceptibility to disease,” said Dr. Hazen of Cleveland Clinic. “In the future, our medicine cabinets will have drugs in them that not only affect us, but also target the microbial enzymes that affect levels of metabolites like TMAO.”
Trimethylamine N-oxide (TMAO) is produced by gut bacteria. High levels (in one study, approximately 6.2 micromolar) significantly increase the risk of major adverse cardiovascular events even after controlling for traditional demographic and clinical risk factors. Studies indicate that TMAO alters cholesterol and bile acid metabolism, upregulates inflammatory pathways, and promotes foam cell formation, all of which worsen atherosclerosis. In addition, TMAO increases clotting risk by enhancing platelet reactivity.
“Reducing the amount of animal products in one’s diet helps reduce TMAO levels,” said Dr. Hazen. Certain fish – mainly those found in deep, cold water, such as cod – are high in TMAO. However, a bigger culprit in the United States is red meat, which contains two major TMAO precursors – choline and carnitine. In a recent study, Dr. Hazen and his associates gave 113 healthy volunteers three isocaloric diets in random order based on red meat, white meat, or plant-based protein. After 4 weeks, eating the daily equivalent of 8 ounces of steak or two quarter-pound beef patties nearly tripled plasma TMAO levels (P less than .05) from baseline. The white meat and vegetarian diets showed no such effect.
Crucially, the effect of red meat was reversible – TMAO levels fell significantly within 4 weeks after participants stopped consuming red meat. Eating red meat low in saturated fat did not prevent TMAO levels from rising, Dr. Hazen noted at the meeting at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.
In a second study, Dr. Hazen and his associates identified a two-step process by which gut bacteria metabolize carnitine to TMAO. The second step was greatly enhanced in individuals who eat red meat, suggesting a possible therapeutic target. In a third study, they found that high TMAO levels in mice fell significantly with a single oral dose of a second-generation inhibitor of trimethylamine lyase, the enzyme used by gut bacteria to convert choline to TMAO. The inhibitory effect was irreversible, did not reduce the viability of commensal microorganisms, and significantly lowered platelet hyperreactivity and clot formation.
Such results are exciting, but “drugs for bugs” will exhibit varying effects depending on which gut species are present at baseline, Dr. Hazen explained. Investigators will need to understand and account for these differences before therapies for the microbiome can enter the clinic. For now, a blood test for TMAO is available and can help clinicians tailor their suggestions on what to eat.
Dr. Hazen disclosed a consulting relationship with Proctor & Gamble, royalties for patents from Proctor & Gamble, Cleveland Heart Lab, and Quest Diagnostics, and research support from AstraZeneca, Pfizer, Roche Diagnostics, and Proctor & Gamble.
REPORTING FROM GMFH 2019
Measles: Latest weekly count is the highest of the year
according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.
according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.
according to the Centers for Disease Control and Prevention.

The 73 new cases of measles reported to the CDC during the week ending March 28 – more than any other single week so far in 2019 – brings the total number of cases for the year to 387, the CDC reported April 1. That surpasses the 372 reported in 2018 and is now the highest annual count since 667 cases were reported in 2014.
The ongoing outbreak in Rockland County, N.Y., which resulted in 6 new cases there last week and 52 for the year, prompted County Executive Ed Day to declare a state of emergency effective March 27 that bars unvaccinated individuals under age 18 years from public places for the next 30 days unless they receive an MMR vaccination.
“As this outbreak has continued our inspectors have begun to meet resistance from those they are trying to protect. They have been hung up on or told not to call again. They’ve been told ‘we’re not discussing this, do not come back,’ when visiting the homes of infected individuals as part of their investigations. This type of response is unacceptable and irresponsible. It endangers the health and well-being of others and displays a shocking lack of responsibility and concern for others in our community,” Mr. Day said in a written statement.
In addition to Rockland County, the CDC is currently tracking five other outbreaks: New York City, mainly Brooklyn (33 new cases last week); Washington state (74 cases for the year, but no new cases in the last week); New Jersey (10 total cases, with 8 related to an outbreak in Ocean and Monmouth Counties); and two in California (16 total cases, with 11 related to the outbreaks). One of the California outbreaks and the New Jersey outbreak are new, but the CDC is no longer reporting outbreaks in Texas and Illinois, so the total stays at six nationwide.
In related news from California, state Sen. Richard Pan (D), a pediatrician, and Assemblywoman Lorena Gonzalez (D) introduced a bill to monitor vaccine exemptions “by requiring the state health department to vet each medical exemption form written by physicians [and to] maintain a database of exemptions that would allow officials to monitor which doctors are granting the exemptions,” the Los Angeles Times reported.
Thoughts for Thursday
Email Marie-Eileen Onieal, PhD, CPNP, FAANP, at: [email protected]
Email Randy D. Danielsen, PhD, DFAAPA, PA-C Emeritus, at: [email protected]
Email Marie-Eileen Onieal, PhD, CPNP, FAANP, at: [email protected]
Email Randy D. Danielsen, PhD, DFAAPA, PA-C Emeritus, at: [email protected]
Email Marie-Eileen Onieal, PhD, CPNP, FAANP, at: [email protected]
Email Randy D. Danielsen, PhD, DFAAPA, PA-C Emeritus, at: [email protected]
Renal denervation reduced BP in sham-controlled trials, meta-analysis shows
although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Renal sympathetic denervation significantly reduced blood pressure in randomized, sham-controlled trials.
Major finding: In second-generation trials of renal sympathetic denervation for hypertension therapy, 24-hour ambulatory blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham.
Study details: Renal sympathetic denervation for treating hypertension was tested in six randomized, sham-controlled trials of 24-hour ambulatory, daytime ambulatory, and blood pressure office measurements including a total of 977 participants.
Disclosures: Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
Source: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
Society of Gynecologic Surgeons 2019 meeting: Daily reporting from Fellow Scholar
WEDNESDAY, 4/3/2019. DAY 4 OF SGS.
Sadly, the annual Society of Gynecologic Surgeons meeting is wrapping up, and we will soon be leaving sunny Tucson! The last morning of conference proceedings was jam-packed with more outstanding oral and video presentations. We heard about topics such as the burden of postoperative catheterization, dietary patterns associated with postoperative defecatory symptoms, and more surgical tips and tricks to take back to our own institutions. At the end of the morning, the Distinguished Surgeon award was presented to the talented and deserving J. Marion Sims Endowed Chair of Obstetrics and Gynecology at UAB Medicine in Birmingham Dr. Holly E. Richter. The SGS Presidential Gavel was then passed from current SGS President Dr. Rajiv Gala to the incoming 46th President Dr. Peter Rosenblatt, Director of the Urogynecology and Pelvic Reconstructive Surgery Division at Mount Auburn Hospital in Cambridge, Massachusetts.
#SGS2019 was an amazingly successful conference! Beautiful surroundings, emerging science and education, and respectful inquiry was plentiful. I enjoyed all of the networking, reconnecting, and relaxing, and could not ask for a better community of GYN surgeons to have shared this with. I can’t wait to return to Pittsburgh to implement all the new things that I have learned. Thanks to the Society of Gynecologic Surgeons, OBG MANAGEMENT, and all the sponsors of the Fellows Scholar Program for supporting each of the scholars and this blog!
If you were at all intrigued by the happenings reported here, please consider attending the SGS meeting in 2020! The conference will be located in Jacksonville, Florida! See you there!
Thanks for following along! #SGS2019 out.
Continue to: TUESDAY, 4/2/19. DAY 3...
TUESDAY, 4/2/19. DAY 3.
The third day of the annual meeting of the Society of Gynecologic Surgeons started off with several academic roundtables hosted by experts in the field. The general session got underway with more fantastic oral and video presentations and, as usual, plenty of lively discussion and education ensued! The 45th SGS President Dr. Rajiv Gala (@rgala_nola) gave his presidential address, where he spoke so genuinely about how SGS is looking forward in our field. After all, the best way to predict your future is to create it! Be on the lookout on Twitter for Dr. Gala’s selfie with his “SGS Family” that he took during his address!
This year’s Telinde Lecture was given by Dr. Marcela G. del Carmen, titled “Health Care Disparities in Gynecologic Oncology Surgery.” She gave an informative and eye-opening lecture on the disparities that still exist in our field, specifically in patients with cancer. The morning session was rounded out with a mentoring panel, featuring Drs. B. Star Hampton, Bobby Shull, Peggy Norton, Tom Nolan, and Deborah Myers. Plenty of sage advice was offered. Thanks to Dr. Shull for reminding us to “be gracious; kindness never goes out of style,” and to be “a citizen of the world.”
Conference goers took the afternoon to enjoy leisure activities in the beautiful Arizona surroundings, including mountain biking, yoga, golf, and poolside lounging. The evening was filled with the excitement of the annual “SGS Got Talent” show! Fabulous performances and delicious food and drinks were just half of the fun, though. The life-size play on hungry, hungry hippos—“Hungry, Hungry Surgeons”—competition was the hit of the night!
Tomorrow is the last day of #SGS2019. Be sure to follow along for the final day of coverage!
Continue to: MONDAY, 4/1/19. DAY 2...
MONDAY, 4/1/19. DAY 2.
The first day of the general sessions started off with a cleverly titled breakfast symposium, “Postmenopausal sexuality: A bit dry but a must-have conversation,” by the brilliant and entertaining duo of Cheryl Iglesia (@cheryliglesia) and Sheryl Kingsberg (@SherylKingsburg) #CherylandSheryl.
Cheryl Iglesia, MD
The new members of the Society of Gynecologic Surgeons were recognized, and there were several outstanding oral and video presentations throughout the morning. A range of topics were discussed, including vaginal surgery education, patient perspectives on adverse events, and postoperative pain management. In addition, Dr. Gary Dunnington (@GLDunnington), Chair of Surgery at Indiana University School of Medicine in Indianapolis, gave the keynote lecture on “Measuring and improving performance in surgical training,” reminding us to continually strive for change.
After a brief lunch and stroll around the exhibit hall, the afternoon session kicked off with a special guest lecture on vaginal rejuvenation and energy-based therapies for female genital cosmetic surgery by Cheryl Iglesia (@cheryliglesia). Next, a distinguished panel of experts from all gynecologic subspecialties gave their opinions on “Working together to shape the future of gynecologic surgery.” What a treat to see such important topics discussed by all the giants of our field sitting in one room: Society of Gynecologic Surgeons President Rajiv Gala, MD; ACOG President Elect Ted Anderson, MD; American Urogynecologic Society President Geoffrey W. Cundiff, MD; Society of Gynecologic Oncology President Elect Warner Huh, MD; Society of Reproductive Surgeons Immediate Past President Samantha Pfeifer, MD; and AAGL President Marie Fidela R. Paraiso, MD.
Supplemented by popcorn, the Videofest featured a series of informative and impressive videos—from management of removal of the Essure hysteroscopic contraceptive device to tips and tricks to navigate a pelvic kidney. The Fellows’ Pelvic Research Network (FPRN), a network of fellows from both minimally invasive gynecologic surgery and urogynecology programs that facilitates multicenter research, met and discussed ongoing and upcoming studies. Exciting work is coming your way thanks to the collaboration of the FPRN!
We concluded an excellent first day of general sessions with an awards ceremony and President’s reception. It was an evening filled with networking, catching up with old colleagues, and meeting new friends. I look forward to another day of scholarship and education tomorrow! Follow @lauraknewcomb, @GynSurgery, and @MDedgeObGyn on Twitter for updates.
Continue to: SUNDAY, 3/31/19. DAY 1 AT SGS...
SUNDAY, 3/31/19. DAY 1 AT SGS.
Hello from Tucson! I woke up to a beautiful Arizona sunrise, with cacti as far as the eye can see; a great start to what is surely going to be an educational scientific conference of the Society of Gynecologic Surgeons! Be sure to follow me on Twitter to stay in the loop real-time: @lauraknewcomb. And don’t forget to check out our conference hashtag #SGS2019.
Postgrad courses kick off
Quality improvement bootcamp
Dr. Bob Flora (@RFFlora) gave a great “Teach the Teacher” session, reviewing different methods for performing quality improvement projects in your own workspace, including the Institute for Healthcare Improvement (IHI) Model for Improvement (www.IHI.org). We also had the opportunity to learn and play with QI Macros (KnowWare International Inc) and Lucid Chart (Lucid Software Inc) programs—which are excellent tools to assist in quality improvement data analysis and presentation. Try them out if you have never used them before!
Sex and surgery
The sex and surgery postgraduate course was a lively discussion centering on:
- the links between gynecologic surgery and sexual function
- how to measure sexual function and incorporate discussion into our pre- and post-operative counseling
- how to approach the patient with postoperative sexual concerns.
As surgeons, we admitted that an anatomic approach with surgery will not always be successful in treating sexual complaints, as sexuality encompasses psychological, social/cultural, interpersonal, and biological aspects. We agreed that further studies are needed to examine the issue, using sexual function as a primary endpoint, because the concern is of critical importance to our patients.
Social media workshop
The talented SGS Social Media Committee, including influencers Dr. Mireille Truong (@MIS_MDT) and Dr. Elisa Jorgensen (@ejiorgensenmd) gave us the run-down on how to host a successful Twitter journal club and how to be a responsible and influential influencer on various social media avenues. They encouraged us to take advantage of the virtual space that connects so many more people than we could interact with without it!
Hands-on laparoscopic suturing simulation
This course was an excellent comprehensive laparoscopic suturing course. It began with a detailed outline of basic principles and slowly built on these concepts until we were performing laparoscopic myomectomies on a high-fidelity model. We can’t wait to implement these principles in the operating room next week! Thanks to the talented faculty who taught all the tips and tricks of the experts!
Conservative and definitive surgical strategies for fibroid management
Drs. Megan Wasson (@WassonMegan), Arnold Advincula (@arnieadvincula), and others taught all the nuances of managing fibroids and difficult surgical cases. Participants learned several tips, tricks, and techniques to use to manage fibroids—for example the “bow and arrow” and “push and tuck” techniques when performing a hysteroscopic myomectomy with a resectoscope.
Women’s leadership forum
During the evening women’s leadership forum, Drs. Catherine Matthews and Kimberly Kenton (@KimKenton1) highlighted the differences between mentorship and sponsorship. While most female physicians identify meaningful mentorship relationships, women lack sponsorship to advance their careers. Furthermore, more women-to-women sponsorship relationships are needed to improve and achieve gender equality.
Lastly, we all enjoyed the Arizona sunset with a welcome reception on the lawn. It was a great first day and we are all looking forward to an exciting general session on Monday! Stay tuned for more!

#SGS2019 attendees enjoying the welcome reception
WEDNESDAY, 4/3/2019. DAY 4 OF SGS.
Sadly, the annual Society of Gynecologic Surgeons meeting is wrapping up, and we will soon be leaving sunny Tucson! The last morning of conference proceedings was jam-packed with more outstanding oral and video presentations. We heard about topics such as the burden of postoperative catheterization, dietary patterns associated with postoperative defecatory symptoms, and more surgical tips and tricks to take back to our own institutions. At the end of the morning, the Distinguished Surgeon award was presented to the talented and deserving J. Marion Sims Endowed Chair of Obstetrics and Gynecology at UAB Medicine in Birmingham Dr. Holly E. Richter. The SGS Presidential Gavel was then passed from current SGS President Dr. Rajiv Gala to the incoming 46th President Dr. Peter Rosenblatt, Director of the Urogynecology and Pelvic Reconstructive Surgery Division at Mount Auburn Hospital in Cambridge, Massachusetts.
#SGS2019 was an amazingly successful conference! Beautiful surroundings, emerging science and education, and respectful inquiry was plentiful. I enjoyed all of the networking, reconnecting, and relaxing, and could not ask for a better community of GYN surgeons to have shared this with. I can’t wait to return to Pittsburgh to implement all the new things that I have learned. Thanks to the Society of Gynecologic Surgeons, OBG MANAGEMENT, and all the sponsors of the Fellows Scholar Program for supporting each of the scholars and this blog!
If you were at all intrigued by the happenings reported here, please consider attending the SGS meeting in 2020! The conference will be located in Jacksonville, Florida! See you there!
Thanks for following along! #SGS2019 out.
Continue to: TUESDAY, 4/2/19. DAY 3...
TUESDAY, 4/2/19. DAY 3.
The third day of the annual meeting of the Society of Gynecologic Surgeons started off with several academic roundtables hosted by experts in the field. The general session got underway with more fantastic oral and video presentations and, as usual, plenty of lively discussion and education ensued! The 45th SGS President Dr. Rajiv Gala (@rgala_nola) gave his presidential address, where he spoke so genuinely about how SGS is looking forward in our field. After all, the best way to predict your future is to create it! Be on the lookout on Twitter for Dr. Gala’s selfie with his “SGS Family” that he took during his address!
This year’s Telinde Lecture was given by Dr. Marcela G. del Carmen, titled “Health Care Disparities in Gynecologic Oncology Surgery.” She gave an informative and eye-opening lecture on the disparities that still exist in our field, specifically in patients with cancer. The morning session was rounded out with a mentoring panel, featuring Drs. B. Star Hampton, Bobby Shull, Peggy Norton, Tom Nolan, and Deborah Myers. Plenty of sage advice was offered. Thanks to Dr. Shull for reminding us to “be gracious; kindness never goes out of style,” and to be “a citizen of the world.”
Conference goers took the afternoon to enjoy leisure activities in the beautiful Arizona surroundings, including mountain biking, yoga, golf, and poolside lounging. The evening was filled with the excitement of the annual “SGS Got Talent” show! Fabulous performances and delicious food and drinks were just half of the fun, though. The life-size play on hungry, hungry hippos—“Hungry, Hungry Surgeons”—competition was the hit of the night!
Tomorrow is the last day of #SGS2019. Be sure to follow along for the final day of coverage!
Continue to: MONDAY, 4/1/19. DAY 2...
MONDAY, 4/1/19. DAY 2.
The first day of the general sessions started off with a cleverly titled breakfast symposium, “Postmenopausal sexuality: A bit dry but a must-have conversation,” by the brilliant and entertaining duo of Cheryl Iglesia (@cheryliglesia) and Sheryl Kingsberg (@SherylKingsburg) #CherylandSheryl.
Cheryl Iglesia, MD
The new members of the Society of Gynecologic Surgeons were recognized, and there were several outstanding oral and video presentations throughout the morning. A range of topics were discussed, including vaginal surgery education, patient perspectives on adverse events, and postoperative pain management. In addition, Dr. Gary Dunnington (@GLDunnington), Chair of Surgery at Indiana University School of Medicine in Indianapolis, gave the keynote lecture on “Measuring and improving performance in surgical training,” reminding us to continually strive for change.
After a brief lunch and stroll around the exhibit hall, the afternoon session kicked off with a special guest lecture on vaginal rejuvenation and energy-based therapies for female genital cosmetic surgery by Cheryl Iglesia (@cheryliglesia). Next, a distinguished panel of experts from all gynecologic subspecialties gave their opinions on “Working together to shape the future of gynecologic surgery.” What a treat to see such important topics discussed by all the giants of our field sitting in one room: Society of Gynecologic Surgeons President Rajiv Gala, MD; ACOG President Elect Ted Anderson, MD; American Urogynecologic Society President Geoffrey W. Cundiff, MD; Society of Gynecologic Oncology President Elect Warner Huh, MD; Society of Reproductive Surgeons Immediate Past President Samantha Pfeifer, MD; and AAGL President Marie Fidela R. Paraiso, MD.
Supplemented by popcorn, the Videofest featured a series of informative and impressive videos—from management of removal of the Essure hysteroscopic contraceptive device to tips and tricks to navigate a pelvic kidney. The Fellows’ Pelvic Research Network (FPRN), a network of fellows from both minimally invasive gynecologic surgery and urogynecology programs that facilitates multicenter research, met and discussed ongoing and upcoming studies. Exciting work is coming your way thanks to the collaboration of the FPRN!
We concluded an excellent first day of general sessions with an awards ceremony and President’s reception. It was an evening filled with networking, catching up with old colleagues, and meeting new friends. I look forward to another day of scholarship and education tomorrow! Follow @lauraknewcomb, @GynSurgery, and @MDedgeObGyn on Twitter for updates.
Continue to: SUNDAY, 3/31/19. DAY 1 AT SGS...
SUNDAY, 3/31/19. DAY 1 AT SGS.
Hello from Tucson! I woke up to a beautiful Arizona sunrise, with cacti as far as the eye can see; a great start to what is surely going to be an educational scientific conference of the Society of Gynecologic Surgeons! Be sure to follow me on Twitter to stay in the loop real-time: @lauraknewcomb. And don’t forget to check out our conference hashtag #SGS2019.
Postgrad courses kick off
Quality improvement bootcamp
Dr. Bob Flora (@RFFlora) gave a great “Teach the Teacher” session, reviewing different methods for performing quality improvement projects in your own workspace, including the Institute for Healthcare Improvement (IHI) Model for Improvement (www.IHI.org). We also had the opportunity to learn and play with QI Macros (KnowWare International Inc) and Lucid Chart (Lucid Software Inc) programs—which are excellent tools to assist in quality improvement data analysis and presentation. Try them out if you have never used them before!
Sex and surgery
The sex and surgery postgraduate course was a lively discussion centering on:
- the links between gynecologic surgery and sexual function
- how to measure sexual function and incorporate discussion into our pre- and post-operative counseling
- how to approach the patient with postoperative sexual concerns.
As surgeons, we admitted that an anatomic approach with surgery will not always be successful in treating sexual complaints, as sexuality encompasses psychological, social/cultural, interpersonal, and biological aspects. We agreed that further studies are needed to examine the issue, using sexual function as a primary endpoint, because the concern is of critical importance to our patients.
Social media workshop
The talented SGS Social Media Committee, including influencers Dr. Mireille Truong (@MIS_MDT) and Dr. Elisa Jorgensen (@ejiorgensenmd) gave us the run-down on how to host a successful Twitter journal club and how to be a responsible and influential influencer on various social media avenues. They encouraged us to take advantage of the virtual space that connects so many more people than we could interact with without it!
Hands-on laparoscopic suturing simulation
This course was an excellent comprehensive laparoscopic suturing course. It began with a detailed outline of basic principles and slowly built on these concepts until we were performing laparoscopic myomectomies on a high-fidelity model. We can’t wait to implement these principles in the operating room next week! Thanks to the talented faculty who taught all the tips and tricks of the experts!
Conservative and definitive surgical strategies for fibroid management
Drs. Megan Wasson (@WassonMegan), Arnold Advincula (@arnieadvincula), and others taught all the nuances of managing fibroids and difficult surgical cases. Participants learned several tips, tricks, and techniques to use to manage fibroids—for example the “bow and arrow” and “push and tuck” techniques when performing a hysteroscopic myomectomy with a resectoscope.
Women’s leadership forum
During the evening women’s leadership forum, Drs. Catherine Matthews and Kimberly Kenton (@KimKenton1) highlighted the differences between mentorship and sponsorship. While most female physicians identify meaningful mentorship relationships, women lack sponsorship to advance their careers. Furthermore, more women-to-women sponsorship relationships are needed to improve and achieve gender equality.
Lastly, we all enjoyed the Arizona sunset with a welcome reception on the lawn. It was a great first day and we are all looking forward to an exciting general session on Monday! Stay tuned for more!

#SGS2019 attendees enjoying the welcome reception
WEDNESDAY, 4/3/2019. DAY 4 OF SGS.
Sadly, the annual Society of Gynecologic Surgeons meeting is wrapping up, and we will soon be leaving sunny Tucson! The last morning of conference proceedings was jam-packed with more outstanding oral and video presentations. We heard about topics such as the burden of postoperative catheterization, dietary patterns associated with postoperative defecatory symptoms, and more surgical tips and tricks to take back to our own institutions. At the end of the morning, the Distinguished Surgeon award was presented to the talented and deserving J. Marion Sims Endowed Chair of Obstetrics and Gynecology at UAB Medicine in Birmingham Dr. Holly E. Richter. The SGS Presidential Gavel was then passed from current SGS President Dr. Rajiv Gala to the incoming 46th President Dr. Peter Rosenblatt, Director of the Urogynecology and Pelvic Reconstructive Surgery Division at Mount Auburn Hospital in Cambridge, Massachusetts.
#SGS2019 was an amazingly successful conference! Beautiful surroundings, emerging science and education, and respectful inquiry was plentiful. I enjoyed all of the networking, reconnecting, and relaxing, and could not ask for a better community of GYN surgeons to have shared this with. I can’t wait to return to Pittsburgh to implement all the new things that I have learned. Thanks to the Society of Gynecologic Surgeons, OBG MANAGEMENT, and all the sponsors of the Fellows Scholar Program for supporting each of the scholars and this blog!
If you were at all intrigued by the happenings reported here, please consider attending the SGS meeting in 2020! The conference will be located in Jacksonville, Florida! See you there!
Thanks for following along! #SGS2019 out.
Continue to: TUESDAY, 4/2/19. DAY 3...
TUESDAY, 4/2/19. DAY 3.
The third day of the annual meeting of the Society of Gynecologic Surgeons started off with several academic roundtables hosted by experts in the field. The general session got underway with more fantastic oral and video presentations and, as usual, plenty of lively discussion and education ensued! The 45th SGS President Dr. Rajiv Gala (@rgala_nola) gave his presidential address, where he spoke so genuinely about how SGS is looking forward in our field. After all, the best way to predict your future is to create it! Be on the lookout on Twitter for Dr. Gala’s selfie with his “SGS Family” that he took during his address!
This year’s Telinde Lecture was given by Dr. Marcela G. del Carmen, titled “Health Care Disparities in Gynecologic Oncology Surgery.” She gave an informative and eye-opening lecture on the disparities that still exist in our field, specifically in patients with cancer. The morning session was rounded out with a mentoring panel, featuring Drs. B. Star Hampton, Bobby Shull, Peggy Norton, Tom Nolan, and Deborah Myers. Plenty of sage advice was offered. Thanks to Dr. Shull for reminding us to “be gracious; kindness never goes out of style,” and to be “a citizen of the world.”
Conference goers took the afternoon to enjoy leisure activities in the beautiful Arizona surroundings, including mountain biking, yoga, golf, and poolside lounging. The evening was filled with the excitement of the annual “SGS Got Talent” show! Fabulous performances and delicious food and drinks were just half of the fun, though. The life-size play on hungry, hungry hippos—“Hungry, Hungry Surgeons”—competition was the hit of the night!
Tomorrow is the last day of #SGS2019. Be sure to follow along for the final day of coverage!
Continue to: MONDAY, 4/1/19. DAY 2...
MONDAY, 4/1/19. DAY 2.
The first day of the general sessions started off with a cleverly titled breakfast symposium, “Postmenopausal sexuality: A bit dry but a must-have conversation,” by the brilliant and entertaining duo of Cheryl Iglesia (@cheryliglesia) and Sheryl Kingsberg (@SherylKingsburg) #CherylandSheryl.
Cheryl Iglesia, MD
The new members of the Society of Gynecologic Surgeons were recognized, and there were several outstanding oral and video presentations throughout the morning. A range of topics were discussed, including vaginal surgery education, patient perspectives on adverse events, and postoperative pain management. In addition, Dr. Gary Dunnington (@GLDunnington), Chair of Surgery at Indiana University School of Medicine in Indianapolis, gave the keynote lecture on “Measuring and improving performance in surgical training,” reminding us to continually strive for change.
After a brief lunch and stroll around the exhibit hall, the afternoon session kicked off with a special guest lecture on vaginal rejuvenation and energy-based therapies for female genital cosmetic surgery by Cheryl Iglesia (@cheryliglesia). Next, a distinguished panel of experts from all gynecologic subspecialties gave their opinions on “Working together to shape the future of gynecologic surgery.” What a treat to see such important topics discussed by all the giants of our field sitting in one room: Society of Gynecologic Surgeons President Rajiv Gala, MD; ACOG President Elect Ted Anderson, MD; American Urogynecologic Society President Geoffrey W. Cundiff, MD; Society of Gynecologic Oncology President Elect Warner Huh, MD; Society of Reproductive Surgeons Immediate Past President Samantha Pfeifer, MD; and AAGL President Marie Fidela R. Paraiso, MD.
Supplemented by popcorn, the Videofest featured a series of informative and impressive videos—from management of removal of the Essure hysteroscopic contraceptive device to tips and tricks to navigate a pelvic kidney. The Fellows’ Pelvic Research Network (FPRN), a network of fellows from both minimally invasive gynecologic surgery and urogynecology programs that facilitates multicenter research, met and discussed ongoing and upcoming studies. Exciting work is coming your way thanks to the collaboration of the FPRN!
We concluded an excellent first day of general sessions with an awards ceremony and President’s reception. It was an evening filled with networking, catching up with old colleagues, and meeting new friends. I look forward to another day of scholarship and education tomorrow! Follow @lauraknewcomb, @GynSurgery, and @MDedgeObGyn on Twitter for updates.
Continue to: SUNDAY, 3/31/19. DAY 1 AT SGS...
SUNDAY, 3/31/19. DAY 1 AT SGS.
Hello from Tucson! I woke up to a beautiful Arizona sunrise, with cacti as far as the eye can see; a great start to what is surely going to be an educational scientific conference of the Society of Gynecologic Surgeons! Be sure to follow me on Twitter to stay in the loop real-time: @lauraknewcomb. And don’t forget to check out our conference hashtag #SGS2019.
Postgrad courses kick off
Quality improvement bootcamp
Dr. Bob Flora (@RFFlora) gave a great “Teach the Teacher” session, reviewing different methods for performing quality improvement projects in your own workspace, including the Institute for Healthcare Improvement (IHI) Model for Improvement (www.IHI.org). We also had the opportunity to learn and play with QI Macros (KnowWare International Inc) and Lucid Chart (Lucid Software Inc) programs—which are excellent tools to assist in quality improvement data analysis and presentation. Try them out if you have never used them before!
Sex and surgery
The sex and surgery postgraduate course was a lively discussion centering on:
- the links between gynecologic surgery and sexual function
- how to measure sexual function and incorporate discussion into our pre- and post-operative counseling
- how to approach the patient with postoperative sexual concerns.
As surgeons, we admitted that an anatomic approach with surgery will not always be successful in treating sexual complaints, as sexuality encompasses psychological, social/cultural, interpersonal, and biological aspects. We agreed that further studies are needed to examine the issue, using sexual function as a primary endpoint, because the concern is of critical importance to our patients.
Social media workshop
The talented SGS Social Media Committee, including influencers Dr. Mireille Truong (@MIS_MDT) and Dr. Elisa Jorgensen (@ejiorgensenmd) gave us the run-down on how to host a successful Twitter journal club and how to be a responsible and influential influencer on various social media avenues. They encouraged us to take advantage of the virtual space that connects so many more people than we could interact with without it!
Hands-on laparoscopic suturing simulation
This course was an excellent comprehensive laparoscopic suturing course. It began with a detailed outline of basic principles and slowly built on these concepts until we were performing laparoscopic myomectomies on a high-fidelity model. We can’t wait to implement these principles in the operating room next week! Thanks to the talented faculty who taught all the tips and tricks of the experts!
Conservative and definitive surgical strategies for fibroid management
Drs. Megan Wasson (@WassonMegan), Arnold Advincula (@arnieadvincula), and others taught all the nuances of managing fibroids and difficult surgical cases. Participants learned several tips, tricks, and techniques to use to manage fibroids—for example the “bow and arrow” and “push and tuck” techniques when performing a hysteroscopic myomectomy with a resectoscope.
Women’s leadership forum
During the evening women’s leadership forum, Drs. Catherine Matthews and Kimberly Kenton (@KimKenton1) highlighted the differences between mentorship and sponsorship. While most female physicians identify meaningful mentorship relationships, women lack sponsorship to advance their careers. Furthermore, more women-to-women sponsorship relationships are needed to improve and achieve gender equality.
Lastly, we all enjoyed the Arizona sunset with a welcome reception on the lawn. It was a great first day and we are all looking forward to an exciting general session on Monday! Stay tuned for more!

#SGS2019 attendees enjoying the welcome reception
Novel microbiome signature may detect NAFLD-cirrhosis
according to results from a study published in Nature Communications.
“Limited data exist concerning the diagnostic accuracy of gut microbiome–derived signatures for detecting NAFLD-cirrhosis,” wrote Cyrielle Caussy, MD, PhD, of the University of California, San Diego, along with her colleagues.
The researchers conducted a cross-sectional analysis of 203 patients with NAFLD. Data was collected from a twin and family cohort with a total of 98 probands that included the complete spectrum of the disease. In addition, 105 first-degree relatives of the probands were also included.
The team analyzed stool samples of participants using MRI and assessed whether the novel signature could accurately identify cirrhosis in NAFLD.
After analysis, the researchers found that in a specific cohort of probands, the microbial biomarker showed strong diagnostic accuracy for identifying cirrhosis in patients with NAFLD (area under the ROC curve, 0.92). These findings were validated in another cohort of first-degree relatives of the proband group (AUROC, 0.87).
The authors acknowledged that a key limitation of the analysis was that it was only a single-center study. As a result, the widespread generalizability of the findings could be restricted.
“This conveniently assessed microbial biomarker could present an adjunct tool to current invasive approaches to determine stage of liver disease,” they concluded.
The study was supported by funding from the National Institutes of Health and Janssen. The authors reported financial affiliations with the American Gastroenterological Association, Atlantic Philanthropies, the John A. Hartford Foundation, and the Association of Specialty Professors.
SOURCE: Caussy C et al. Nat Commun. 2019 Mar 29. doi: 10.1038/s41467-019-09455-9.
according to results from a study published in Nature Communications.
“Limited data exist concerning the diagnostic accuracy of gut microbiome–derived signatures for detecting NAFLD-cirrhosis,” wrote Cyrielle Caussy, MD, PhD, of the University of California, San Diego, along with her colleagues.
The researchers conducted a cross-sectional analysis of 203 patients with NAFLD. Data was collected from a twin and family cohort with a total of 98 probands that included the complete spectrum of the disease. In addition, 105 first-degree relatives of the probands were also included.
The team analyzed stool samples of participants using MRI and assessed whether the novel signature could accurately identify cirrhosis in NAFLD.
After analysis, the researchers found that in a specific cohort of probands, the microbial biomarker showed strong diagnostic accuracy for identifying cirrhosis in patients with NAFLD (area under the ROC curve, 0.92). These findings were validated in another cohort of first-degree relatives of the proband group (AUROC, 0.87).
The authors acknowledged that a key limitation of the analysis was that it was only a single-center study. As a result, the widespread generalizability of the findings could be restricted.
“This conveniently assessed microbial biomarker could present an adjunct tool to current invasive approaches to determine stage of liver disease,” they concluded.
The study was supported by funding from the National Institutes of Health and Janssen. The authors reported financial affiliations with the American Gastroenterological Association, Atlantic Philanthropies, the John A. Hartford Foundation, and the Association of Specialty Professors.
SOURCE: Caussy C et al. Nat Commun. 2019 Mar 29. doi: 10.1038/s41467-019-09455-9.
according to results from a study published in Nature Communications.
“Limited data exist concerning the diagnostic accuracy of gut microbiome–derived signatures for detecting NAFLD-cirrhosis,” wrote Cyrielle Caussy, MD, PhD, of the University of California, San Diego, along with her colleagues.
The researchers conducted a cross-sectional analysis of 203 patients with NAFLD. Data was collected from a twin and family cohort with a total of 98 probands that included the complete spectrum of the disease. In addition, 105 first-degree relatives of the probands were also included.
The team analyzed stool samples of participants using MRI and assessed whether the novel signature could accurately identify cirrhosis in NAFLD.
After analysis, the researchers found that in a specific cohort of probands, the microbial biomarker showed strong diagnostic accuracy for identifying cirrhosis in patients with NAFLD (area under the ROC curve, 0.92). These findings were validated in another cohort of first-degree relatives of the proband group (AUROC, 0.87).
The authors acknowledged that a key limitation of the analysis was that it was only a single-center study. As a result, the widespread generalizability of the findings could be restricted.
“This conveniently assessed microbial biomarker could present an adjunct tool to current invasive approaches to determine stage of liver disease,” they concluded.
The study was supported by funding from the National Institutes of Health and Janssen. The authors reported financial affiliations with the American Gastroenterological Association, Atlantic Philanthropies, the John A. Hartford Foundation, and the Association of Specialty Professors.
SOURCE: Caussy C et al. Nat Commun. 2019 Mar 29. doi: 10.1038/s41467-019-09455-9.
FROM NATURE COMMUNICATIONS








