User login
Plecanatide safe, effective for chronic constipation
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
“Many patents are still very dissatisfied” with existing drugs, said Satish Rao, MD, PhD, director of the Digestive Health Center at the Medical College of Georgia, Augusta, who presented one of the posters.
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
“Many patents are still very dissatisfied” with existing drugs, said Satish Rao, MD, PhD, director of the Digestive Health Center at the Medical College of Georgia, Augusta, who presented one of the posters.
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
LAS VEGAS – Two new studies suggest that the peptide plecanatide is safe and effective in the treatment of chronic idiopathic constipation. The drug had a low rate of diarrhea, about 7.1%.
The research, presented in two posters at the annual meeting of the American College of Gastroenterology, includes a pooled efficacy and safety analysis from two previous phase III clinical trials, as well as an open-label extension study.
“Many patents are still very dissatisfied” with existing drugs, said Satish Rao, MD, PhD, director of the Digestive Health Center at the Medical College of Georgia, Augusta, who presented one of the posters.
The drug is a derivative of uroguanylin, a peptide found in the gastrointestinal tract. Like the native peptide, plecanatide stimulates digestive fluid movement in the proximal small intestine, which in turn encourages regular bowel function. “I think because it is so much closer to the innate uroguanylin molecule, it will have better tolerability,” said Dr. Rao in an interview.
The open-label study followed 2,370 patients who received 3-mg or 6-mg doses of plecanatide once daily for up to 72 weeks. The most common adverse events were diarrhea (7.1%) and urinary tract infection (2.2%), and these were the only adverse events that occurred at a frequency above 2%.
About 5% of patients discontinued due to adverse events, 3.1% because of diarrhea. Patients were also asked to score their satisfaction with the drug and their willingness to continue on it, and the median values to those answers corresponded to quite satisfied and quite likely to continue.
The other study was a pooled analysis of two previously presented double-blind, placebo-controlled phase III trials of plecanatide. These studies included 2,791 patients with chronic idiopathic constipation who were treated over the course of 12 weeks, with 3- and 6-mg doses. Both groups showed significant improvements in the rate of durable overall complete spontaneous bowel movements: 20.5% in the 3-mg group and 19.8% in the 6-mg group, compared with 11.5% in the placebo group (P less than .001 for both comparisons).
Patients experienced improvements as early as the first week of treatment (31.6% in the 3-mg group versus 16.1% in placebo, P less than .001), and improvements were maintained through the end of the treatment period. There were also significant improvements in secondary endpoints, including stool consistency, straining, and bloating.
Adverse events occurred in 30.6% of subjects taking the 3-mg dose and 31.1% of those taking 6 mg, compared with 28.7% in the placebo group. As with the long-term study, the most common adverse event was diarrhea (4.6% in 3 mg and 5.1% in 6 mg, compared with 1.3% in placebo). Of those in the 3-mg group, 4.1% discontinued, as did 4.5% in the 6-mg group, and 2.2% in the placebo group.
“I think these are very exciting results. They clearly show a benefit of plecanatide in patients with chronic constipation. These are really methodologically rigorous, large clinical trials that should provide doctors and patients with confidence that the drug will provide benefits,” commented William D. Chey, MD, a professor of medicine at the University of Michigan, Ann Arbor.
Plecanatide is also being developed for irritable bowel syndrome with constipation, and has finished recruitment for two phase III clinical trials, which Synergy expects to report on later this year.
Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood and Synergy.
AT ACG 2016
Key clinical point: Plecanatide is safe and effective in the treatment of idiopathic chronic constipation.
Major finding: A long-term study and an analysis of two phase III clinical trials show the drug is effective at reducing constipation and has low rates of adverse events and discontinuation.
Data source: Open-label extension trial and randomized, placebo-controlled, clinical trials.
Disclosures: Dr. Rao is a member of an advisory committee for Forest Laboratories, Hollister, In Control Medical, Ironwood, Sucampo, and Vibrant. Dr. Chey is a consultant for Ironwood.
Lyme disease spirochete helps babesiosis gain a foothold
BOSTON – The spirochete that causes Lyme disease in humans may be lending a helping hand to the weaker protozoan that causes babesiosis, escalating the rate of human babesiosis cases in regions where both are endemic.
Peter Krause, MD, a research scientist in epidemiology, medicine, and pediatrics at Yale University School of Public Health, New Haven, Conn., reviewed what’s known about babesiosis–Lyme disease coinfections at the annual meeting of the American Society for Microbiology.
Understanding the entire cycle is necessary, he said, because the effects of coinfection will be different depending on the stage of the cycle, and upon the coinfection pathogens.
Over the course of many years, Dr. Krause and his collaborators have used an interdisciplinary, multi-modal approach to try to understand the interplay between these pathogens, their hosts, and environmental, demographic, and ecologic factors.
One arm of their research has taken them to the lab, where they have modeled coinfection and transmission of Borrelia burgdorferi and Babesia microti from their reservoir host, the white-footed mouse (Peromyscus leucopus), to the vector, the deer tick (Ixodes scapularis), which can transmit both diseases to humans.
In an experimental design that mimicked the natural reservoir-vector ecology, Dr. Krause and his collaborators first infected mice with 5 to 10 nymphal ticks, to approximate the average number of ticks that feed on an individual mouse in the wild. The researchers then tracked the effect of coinfection on transmission of each pathogen to ticks during the larval feeds, finding that B. burgdorferi increased B. microti parasitemia in mice who were coinfected. Coinfection also increases B. microti transmission from mice to ticks. This effect happens at least partly because of the increased parasitemia, Dr. Krause said.
The downstream effect on humans is to increase the risk of babesiosis for those who live in regions where both B. microti and B. burgdorferi are endemic, Dr. Krause said.
B. microti is less “ecologically fit” than B. burgdorferi, Dr. Krause said, noting that there are more ticks and humans infected with the latter, as well as more reservoir mice carrying B. burgdorferi. Also, the rate of geographic expansion is more rapid for B. burgdorferi. “B. microti is only endemic in areas where B. burgdorferi is already endemic; it may not be ‘fit’ enough to establish endemic sites on its own,” Dr. Krause said.
The increased rate of B. microti transmission via ticks from mice, if the mice are coinfected with B. burgdorferi, may help explain the greater-than-expected rate of babesiosis in humans in areas of New England where coinfection is common. “This paradox might be explained by the enhancement of B. microti survival and spread by the coinfecting presence of Borrelia burgdorferi,” Dr. Krause said.
This naturalistic experiment has ecological implications in terms of the human impact as well: “Coinfection may help enhance geographic spread of B. microti to new areas,” Dr. Krause said.
Clinicians in geographic areas where both pathogens are endemic should maintain a high level of suspicion for coinfection, especially for the most ill patients. “Anaplasmosis and/or babesiosis coinfection increases the severity of Lyme disease,” Dr. Krause said. “Health care workers should consider anaplasmosis and/or babesiosis coinfection in Lyme disease patients who have more severe illness or who do not respond to antibiotic therapy.”
Understanding the complex interspecies interplay will be increasingly important as more cases of tick-borne illness are seen, Dr. Krause concluded. “Research on coinfections acquired from Ixodes scapularis has just begun.”
Dr. Krause reported no relevant conflicts of interest.
[email protected]
On Twitter @karioakes
BOSTON – The spirochete that causes Lyme disease in humans may be lending a helping hand to the weaker protozoan that causes babesiosis, escalating the rate of human babesiosis cases in regions where both are endemic.
Peter Krause, MD, a research scientist in epidemiology, medicine, and pediatrics at Yale University School of Public Health, New Haven, Conn., reviewed what’s known about babesiosis–Lyme disease coinfections at the annual meeting of the American Society for Microbiology.
Understanding the entire cycle is necessary, he said, because the effects of coinfection will be different depending on the stage of the cycle, and upon the coinfection pathogens.
Over the course of many years, Dr. Krause and his collaborators have used an interdisciplinary, multi-modal approach to try to understand the interplay between these pathogens, their hosts, and environmental, demographic, and ecologic factors.
One arm of their research has taken them to the lab, where they have modeled coinfection and transmission of Borrelia burgdorferi and Babesia microti from their reservoir host, the white-footed mouse (Peromyscus leucopus), to the vector, the deer tick (Ixodes scapularis), which can transmit both diseases to humans.
In an experimental design that mimicked the natural reservoir-vector ecology, Dr. Krause and his collaborators first infected mice with 5 to 10 nymphal ticks, to approximate the average number of ticks that feed on an individual mouse in the wild. The researchers then tracked the effect of coinfection on transmission of each pathogen to ticks during the larval feeds, finding that B. burgdorferi increased B. microti parasitemia in mice who were coinfected. Coinfection also increases B. microti transmission from mice to ticks. This effect happens at least partly because of the increased parasitemia, Dr. Krause said.
The downstream effect on humans is to increase the risk of babesiosis for those who live in regions where both B. microti and B. burgdorferi are endemic, Dr. Krause said.
B. microti is less “ecologically fit” than B. burgdorferi, Dr. Krause said, noting that there are more ticks and humans infected with the latter, as well as more reservoir mice carrying B. burgdorferi. Also, the rate of geographic expansion is more rapid for B. burgdorferi. “B. microti is only endemic in areas where B. burgdorferi is already endemic; it may not be ‘fit’ enough to establish endemic sites on its own,” Dr. Krause said.
The increased rate of B. microti transmission via ticks from mice, if the mice are coinfected with B. burgdorferi, may help explain the greater-than-expected rate of babesiosis in humans in areas of New England where coinfection is common. “This paradox might be explained by the enhancement of B. microti survival and spread by the coinfecting presence of Borrelia burgdorferi,” Dr. Krause said.
This naturalistic experiment has ecological implications in terms of the human impact as well: “Coinfection may help enhance geographic spread of B. microti to new areas,” Dr. Krause said.
Clinicians in geographic areas where both pathogens are endemic should maintain a high level of suspicion for coinfection, especially for the most ill patients. “Anaplasmosis and/or babesiosis coinfection increases the severity of Lyme disease,” Dr. Krause said. “Health care workers should consider anaplasmosis and/or babesiosis coinfection in Lyme disease patients who have more severe illness or who do not respond to antibiotic therapy.”
Understanding the complex interspecies interplay will be increasingly important as more cases of tick-borne illness are seen, Dr. Krause concluded. “Research on coinfections acquired from Ixodes scapularis has just begun.”
Dr. Krause reported no relevant conflicts of interest.
[email protected]
On Twitter @karioakes
BOSTON – The spirochete that causes Lyme disease in humans may be lending a helping hand to the weaker protozoan that causes babesiosis, escalating the rate of human babesiosis cases in regions where both are endemic.
Peter Krause, MD, a research scientist in epidemiology, medicine, and pediatrics at Yale University School of Public Health, New Haven, Conn., reviewed what’s known about babesiosis–Lyme disease coinfections at the annual meeting of the American Society for Microbiology.
Understanding the entire cycle is necessary, he said, because the effects of coinfection will be different depending on the stage of the cycle, and upon the coinfection pathogens.
Over the course of many years, Dr. Krause and his collaborators have used an interdisciplinary, multi-modal approach to try to understand the interplay between these pathogens, their hosts, and environmental, demographic, and ecologic factors.
One arm of their research has taken them to the lab, where they have modeled coinfection and transmission of Borrelia burgdorferi and Babesia microti from their reservoir host, the white-footed mouse (Peromyscus leucopus), to the vector, the deer tick (Ixodes scapularis), which can transmit both diseases to humans.
In an experimental design that mimicked the natural reservoir-vector ecology, Dr. Krause and his collaborators first infected mice with 5 to 10 nymphal ticks, to approximate the average number of ticks that feed on an individual mouse in the wild. The researchers then tracked the effect of coinfection on transmission of each pathogen to ticks during the larval feeds, finding that B. burgdorferi increased B. microti parasitemia in mice who were coinfected. Coinfection also increases B. microti transmission from mice to ticks. This effect happens at least partly because of the increased parasitemia, Dr. Krause said.
The downstream effect on humans is to increase the risk of babesiosis for those who live in regions where both B. microti and B. burgdorferi are endemic, Dr. Krause said.
B. microti is less “ecologically fit” than B. burgdorferi, Dr. Krause said, noting that there are more ticks and humans infected with the latter, as well as more reservoir mice carrying B. burgdorferi. Also, the rate of geographic expansion is more rapid for B. burgdorferi. “B. microti is only endemic in areas where B. burgdorferi is already endemic; it may not be ‘fit’ enough to establish endemic sites on its own,” Dr. Krause said.
The increased rate of B. microti transmission via ticks from mice, if the mice are coinfected with B. burgdorferi, may help explain the greater-than-expected rate of babesiosis in humans in areas of New England where coinfection is common. “This paradox might be explained by the enhancement of B. microti survival and spread by the coinfecting presence of Borrelia burgdorferi,” Dr. Krause said.
This naturalistic experiment has ecological implications in terms of the human impact as well: “Coinfection may help enhance geographic spread of B. microti to new areas,” Dr. Krause said.
Clinicians in geographic areas where both pathogens are endemic should maintain a high level of suspicion for coinfection, especially for the most ill patients. “Anaplasmosis and/or babesiosis coinfection increases the severity of Lyme disease,” Dr. Krause said. “Health care workers should consider anaplasmosis and/or babesiosis coinfection in Lyme disease patients who have more severe illness or who do not respond to antibiotic therapy.”
Understanding the complex interspecies interplay will be increasingly important as more cases of tick-borne illness are seen, Dr. Krause concluded. “Research on coinfections acquired from Ixodes scapularis has just begun.”
Dr. Krause reported no relevant conflicts of interest.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM ASM 2016
HIV hospitalizations continue to decline
The total number of HIV hospitalizations fell by a third during 2000-2013, even though the number of people living with HIV increased by more than 50%, according to an investigation by the Agency for Healthcare Research and Quality.
“To some extent, the considerable reduction in hospital utilization by persons with HIV disease may be attributed to the diffusion of new antiretroviral medications and the enhanced ability of clinicians to control viral replication,” wrote investigator Fred Hellinger, PhD, of AHRQ’s Center for Delivery, Organization, and Markets (Med Care. 2016 Jun;54[6]:639-44).
Dr. Hellinger used his agency’s State Inpatient Database to collect data on all HIV-related hospital admissions from California, Florida, New Jersey, New York, and South Carolina during 2000-2013. Overall, people with HIV were 64% less likely to be hospitalized in 2013 than they were in 2000; there was also a slight drop in length of stay.
Meanwhile, the average age of hospitalized HIV patients has risen from 41 to 49 years, and the average number of diagnoses from 6 to more than 12. That’s in part because HIV patients are living longer, and “older patients are generally sicker and have more chronic illnesses ... As HIV patients age, they are being hospitalized for conditions that are not closely related to HIV infection,” Dr. Hellinger said.
“Indeed, the principal diagnosis for almost two-thirds of the HIV patients hospitalized in 2013 in our sample was not HIV infection, and as time passes, the mix of diagnoses recorded for hospitalized patients with HIV is likely to resemble the mix of diagnoses found in the general population of hospitalized patients,” he wrote.
U.S. HIV spending continues to go up, but while the number of patients covered by Medicaid has fallen, the number treated by Medicare has risen 50%, reflecting the increase in average life span.
There has not been much demographic change among HIV inpatients. About half are black, a quarter white, and slightly less than one-fifth Hispanic. One-third are women. More than 1.1 million Americans are living with HIV, and 50,000 are newly infected each year.
Dr. Hellinger had no conflicts of interest.
The total number of HIV hospitalizations fell by a third during 2000-2013, even though the number of people living with HIV increased by more than 50%, according to an investigation by the Agency for Healthcare Research and Quality.
“To some extent, the considerable reduction in hospital utilization by persons with HIV disease may be attributed to the diffusion of new antiretroviral medications and the enhanced ability of clinicians to control viral replication,” wrote investigator Fred Hellinger, PhD, of AHRQ’s Center for Delivery, Organization, and Markets (Med Care. 2016 Jun;54[6]:639-44).
Dr. Hellinger used his agency’s State Inpatient Database to collect data on all HIV-related hospital admissions from California, Florida, New Jersey, New York, and South Carolina during 2000-2013. Overall, people with HIV were 64% less likely to be hospitalized in 2013 than they were in 2000; there was also a slight drop in length of stay.
Meanwhile, the average age of hospitalized HIV patients has risen from 41 to 49 years, and the average number of diagnoses from 6 to more than 12. That’s in part because HIV patients are living longer, and “older patients are generally sicker and have more chronic illnesses ... As HIV patients age, they are being hospitalized for conditions that are not closely related to HIV infection,” Dr. Hellinger said.
“Indeed, the principal diagnosis for almost two-thirds of the HIV patients hospitalized in 2013 in our sample was not HIV infection, and as time passes, the mix of diagnoses recorded for hospitalized patients with HIV is likely to resemble the mix of diagnoses found in the general population of hospitalized patients,” he wrote.
U.S. HIV spending continues to go up, but while the number of patients covered by Medicaid has fallen, the number treated by Medicare has risen 50%, reflecting the increase in average life span.
There has not been much demographic change among HIV inpatients. About half are black, a quarter white, and slightly less than one-fifth Hispanic. One-third are women. More than 1.1 million Americans are living with HIV, and 50,000 are newly infected each year.
Dr. Hellinger had no conflicts of interest.
The total number of HIV hospitalizations fell by a third during 2000-2013, even though the number of people living with HIV increased by more than 50%, according to an investigation by the Agency for Healthcare Research and Quality.
“To some extent, the considerable reduction in hospital utilization by persons with HIV disease may be attributed to the diffusion of new antiretroviral medications and the enhanced ability of clinicians to control viral replication,” wrote investigator Fred Hellinger, PhD, of AHRQ’s Center for Delivery, Organization, and Markets (Med Care. 2016 Jun;54[6]:639-44).
Dr. Hellinger used his agency’s State Inpatient Database to collect data on all HIV-related hospital admissions from California, Florida, New Jersey, New York, and South Carolina during 2000-2013. Overall, people with HIV were 64% less likely to be hospitalized in 2013 than they were in 2000; there was also a slight drop in length of stay.
Meanwhile, the average age of hospitalized HIV patients has risen from 41 to 49 years, and the average number of diagnoses from 6 to more than 12. That’s in part because HIV patients are living longer, and “older patients are generally sicker and have more chronic illnesses ... As HIV patients age, they are being hospitalized for conditions that are not closely related to HIV infection,” Dr. Hellinger said.
“Indeed, the principal diagnosis for almost two-thirds of the HIV patients hospitalized in 2013 in our sample was not HIV infection, and as time passes, the mix of diagnoses recorded for hospitalized patients with HIV is likely to resemble the mix of diagnoses found in the general population of hospitalized patients,” he wrote.
U.S. HIV spending continues to go up, but while the number of patients covered by Medicaid has fallen, the number treated by Medicare has risen 50%, reflecting the increase in average life span.
There has not been much demographic change among HIV inpatients. About half are black, a quarter white, and slightly less than one-fifth Hispanic. One-third are women. More than 1.1 million Americans are living with HIV, and 50,000 are newly infected each year.
Dr. Hellinger had no conflicts of interest.
FROM MEDICAL CARE
Key clinical point:
Major finding: People with HIV were 64% less likely to be hospitalized in 2013 than they were in 2000.
Data source: Review of HIV-related hospitalizations in five U.S. states.
Disclosures: The Agency for Healthcare Research and Quality funded the work. The investigator had no disclosures.
Speaker says use the best regimen ASAP in MM
NEW YORK—It’s important to use the best possible regimen as soon as possible when treating patients with multiple myeloma (MM), according to a speaker at Lymphoma & Myeloma 2016.
Antonio Palumbo, MD, of the University of Torino in Italy, explained that the urgency, from a biological point of view, is because myeloma accumulates genetic mutations that change the disease in a “dramatic way.”
“At diagnosis, you might have 5000 mutations, and, at first relapse, there are 12,000 mutations,” he said. “They are completely different tumors. So the first thing that we have to recognize is that, with time, myeloma is not the same. It’s becoming different tumors.”
Dr Palumbo noted that early intervention is important because genetic and epigenetic abnormalities increase as the disease progresses and becomes more resistant.
For example, if 100 patients receive first-line treatment, 40 of them will not reach the second line. Only 60 patients will receive second-line therapy, and only 35 patients will receive third-line treatment. By the fifth line, only 10 patients, or 10%, will receive it.
“If you have very good genomic stability, you can become sensitive to different treatments,” Dr Palumbo said. “But if you become a different disease, you will not be able to receive the next therapy. That’s why it’s so important . . . to use the best possible regimen as soon as possible.”
Best regimens
The triplet bortezomib-lenalidomide-dexamethasone is the “best possible regimen today,” Dr Palumbo said, “followed by continuous therapy.”
The 2-drug combination of lenalidomide and dexamethasone is probably more suitable for the elderly and the frail.
Alternative regimens include carfilzomib-cyclophosphamide-dexamethasone and ixazomib-lenalidomide-dexamethasone.
Continuous therapy
Continuous therapy has been “one of the major achievements” in the treatment of MM, Dr Palumbo said. Without continuous therapy, patients in complete response remain so for about 1 year when treated with conventional chemotherapy.
Investigators found that maintenance therapy significantly prolongs progression-free survival and overall survival (P=0.02). They recommend intensification with maintenance to optimize treatment efficacy and prolong survival.
Immunomodulatory drugs such as lenalidomide are the backbone of continuous therapy today.
However, ixazomib represents another option. Ixazomib maintenance has been shown to produce durable responses for a median of more than 2 years in previously untreated patients not undergoing autologous stem cell transplant.
Salvage therapy
Seven combinations are now available for salvage therapy, including those with proteasome inhibitors, monoclonal antibodies, pomalidomide, and histone deacetylase inhibitors.
Included in some of these combinations are the newer agents ixazomib, elotuzumab, and daratumumab, “which many might consider the new rituximab,” Dr Palumbo said.
Risk stratification
Dr Palumbo stressed the importance of risk stratification—both in clinical trials and in practice.
“[T]he moment you under-treat a patient, you transform a good-risk patient into a high-risk patient . . . ,” he said.
And if trials comparing treatments are not conducted within risk categories, researchers are comparing apples to oranges—good risk with high risk
The Revised International Staging System (R-ISS) for MM effectively stratifies newly diagnosed patients by combining the original ISS, chromosomal abnormalities, and serum lactate dehydrogenase levels to evaluate prognosis.
The R-ISS defines 3 new, distinct categories that researchers believe effectively define patients’ relative risk with respect to their survival.
Age and frailty
MM patients generally fall into 3 age categories: 25-64, 65-74, and 75-101.
The youngest group can receive autologous transplant, the fit patients ages 65 to 74 can receive full-dose chemotherapy, and the oldest, frailer patients should receive reduced-dose chemotherapy.
“It’s important to differentiate fit from frail,” Dr Palumbo said, “because we cannot give the same treatment schema to a 55-year-old versus 65 or 85. At 85, that schema would create a lot of toxicities.”
In frail patients, it’s always important to check which comorbidities are present using the Charlson comorbidity scale, Dr Palumbo said.
“Remember, when we put together age, chromosome abnormalities, and frailty, frailty is the most relevant prognostic factor when you add everything together,” he said.
“Two drugs versus 3 drugs doesn’t make much difference when you are starting to introduce treatment to these very frail patients with comorbidities.”
Minimal residual disease
Dr Palumbo indicated that a combination of MRI and PET-CT should be used for a more accurate indication of minimal residual disease.
“[W]e hope to have cure, [but] I don’t think, today, myeloma is a curable disease,” he said.
He clarified this by saying that patients who are in complete response and minimal residual disease-negative at 3 years do well, but, by 7 years, “something is happening.”
And at 10 years, progression-free survival has dropped off significantly, “telling us that cure is probably not yet there.” 
NEW YORK—It’s important to use the best possible regimen as soon as possible when treating patients with multiple myeloma (MM), according to a speaker at Lymphoma & Myeloma 2016.
Antonio Palumbo, MD, of the University of Torino in Italy, explained that the urgency, from a biological point of view, is because myeloma accumulates genetic mutations that change the disease in a “dramatic way.”
“At diagnosis, you might have 5000 mutations, and, at first relapse, there are 12,000 mutations,” he said. “They are completely different tumors. So the first thing that we have to recognize is that, with time, myeloma is not the same. It’s becoming different tumors.”
Dr Palumbo noted that early intervention is important because genetic and epigenetic abnormalities increase as the disease progresses and becomes more resistant.
For example, if 100 patients receive first-line treatment, 40 of them will not reach the second line. Only 60 patients will receive second-line therapy, and only 35 patients will receive third-line treatment. By the fifth line, only 10 patients, or 10%, will receive it.
“If you have very good genomic stability, you can become sensitive to different treatments,” Dr Palumbo said. “But if you become a different disease, you will not be able to receive the next therapy. That’s why it’s so important . . . to use the best possible regimen as soon as possible.”
Best regimens
The triplet bortezomib-lenalidomide-dexamethasone is the “best possible regimen today,” Dr Palumbo said, “followed by continuous therapy.”
The 2-drug combination of lenalidomide and dexamethasone is probably more suitable for the elderly and the frail.
Alternative regimens include carfilzomib-cyclophosphamide-dexamethasone and ixazomib-lenalidomide-dexamethasone.
Continuous therapy
Continuous therapy has been “one of the major achievements” in the treatment of MM, Dr Palumbo said. Without continuous therapy, patients in complete response remain so for about 1 year when treated with conventional chemotherapy.
Investigators found that maintenance therapy significantly prolongs progression-free survival and overall survival (P=0.02). They recommend intensification with maintenance to optimize treatment efficacy and prolong survival.
Immunomodulatory drugs such as lenalidomide are the backbone of continuous therapy today.
However, ixazomib represents another option. Ixazomib maintenance has been shown to produce durable responses for a median of more than 2 years in previously untreated patients not undergoing autologous stem cell transplant.
Salvage therapy
Seven combinations are now available for salvage therapy, including those with proteasome inhibitors, monoclonal antibodies, pomalidomide, and histone deacetylase inhibitors.
Included in some of these combinations are the newer agents ixazomib, elotuzumab, and daratumumab, “which many might consider the new rituximab,” Dr Palumbo said.
Risk stratification
Dr Palumbo stressed the importance of risk stratification—both in clinical trials and in practice.
“[T]he moment you under-treat a patient, you transform a good-risk patient into a high-risk patient . . . ,” he said.
And if trials comparing treatments are not conducted within risk categories, researchers are comparing apples to oranges—good risk with high risk
The Revised International Staging System (R-ISS) for MM effectively stratifies newly diagnosed patients by combining the original ISS, chromosomal abnormalities, and serum lactate dehydrogenase levels to evaluate prognosis.
The R-ISS defines 3 new, distinct categories that researchers believe effectively define patients’ relative risk with respect to their survival.
Age and frailty
MM patients generally fall into 3 age categories: 25-64, 65-74, and 75-101.
The youngest group can receive autologous transplant, the fit patients ages 65 to 74 can receive full-dose chemotherapy, and the oldest, frailer patients should receive reduced-dose chemotherapy.
“It’s important to differentiate fit from frail,” Dr Palumbo said, “because we cannot give the same treatment schema to a 55-year-old versus 65 or 85. At 85, that schema would create a lot of toxicities.”
In frail patients, it’s always important to check which comorbidities are present using the Charlson comorbidity scale, Dr Palumbo said.
“Remember, when we put together age, chromosome abnormalities, and frailty, frailty is the most relevant prognostic factor when you add everything together,” he said.
“Two drugs versus 3 drugs doesn’t make much difference when you are starting to introduce treatment to these very frail patients with comorbidities.”
Minimal residual disease
Dr Palumbo indicated that a combination of MRI and PET-CT should be used for a more accurate indication of minimal residual disease.
“[W]e hope to have cure, [but] I don’t think, today, myeloma is a curable disease,” he said.
He clarified this by saying that patients who are in complete response and minimal residual disease-negative at 3 years do well, but, by 7 years, “something is happening.”
And at 10 years, progression-free survival has dropped off significantly, “telling us that cure is probably not yet there.”
NEW YORK—It’s important to use the best possible regimen as soon as possible when treating patients with multiple myeloma (MM), according to a speaker at Lymphoma & Myeloma 2016.
Antonio Palumbo, MD, of the University of Torino in Italy, explained that the urgency, from a biological point of view, is because myeloma accumulates genetic mutations that change the disease in a “dramatic way.”
“At diagnosis, you might have 5000 mutations, and, at first relapse, there are 12,000 mutations,” he said. “They are completely different tumors. So the first thing that we have to recognize is that, with time, myeloma is not the same. It’s becoming different tumors.”
Dr Palumbo noted that early intervention is important because genetic and epigenetic abnormalities increase as the disease progresses and becomes more resistant.
For example, if 100 patients receive first-line treatment, 40 of them will not reach the second line. Only 60 patients will receive second-line therapy, and only 35 patients will receive third-line treatment. By the fifth line, only 10 patients, or 10%, will receive it.
“If you have very good genomic stability, you can become sensitive to different treatments,” Dr Palumbo said. “But if you become a different disease, you will not be able to receive the next therapy. That’s why it’s so important . . . to use the best possible regimen as soon as possible.”
Best regimens
The triplet bortezomib-lenalidomide-dexamethasone is the “best possible regimen today,” Dr Palumbo said, “followed by continuous therapy.”
The 2-drug combination of lenalidomide and dexamethasone is probably more suitable for the elderly and the frail.
Alternative regimens include carfilzomib-cyclophosphamide-dexamethasone and ixazomib-lenalidomide-dexamethasone.
Continuous therapy
Continuous therapy has been “one of the major achievements” in the treatment of MM, Dr Palumbo said. Without continuous therapy, patients in complete response remain so for about 1 year when treated with conventional chemotherapy.
Investigators found that maintenance therapy significantly prolongs progression-free survival and overall survival (P=0.02). They recommend intensification with maintenance to optimize treatment efficacy and prolong survival.
Immunomodulatory drugs such as lenalidomide are the backbone of continuous therapy today.
However, ixazomib represents another option. Ixazomib maintenance has been shown to produce durable responses for a median of more than 2 years in previously untreated patients not undergoing autologous stem cell transplant.
Salvage therapy
Seven combinations are now available for salvage therapy, including those with proteasome inhibitors, monoclonal antibodies, pomalidomide, and histone deacetylase inhibitors.
Included in some of these combinations are the newer agents ixazomib, elotuzumab, and daratumumab, “which many might consider the new rituximab,” Dr Palumbo said.
Risk stratification
Dr Palumbo stressed the importance of risk stratification—both in clinical trials and in practice.
“[T]he moment you under-treat a patient, you transform a good-risk patient into a high-risk patient . . . ,” he said.
And if trials comparing treatments are not conducted within risk categories, researchers are comparing apples to oranges—good risk with high risk
The Revised International Staging System (R-ISS) for MM effectively stratifies newly diagnosed patients by combining the original ISS, chromosomal abnormalities, and serum lactate dehydrogenase levels to evaluate prognosis.
The R-ISS defines 3 new, distinct categories that researchers believe effectively define patients’ relative risk with respect to their survival.
Age and frailty
MM patients generally fall into 3 age categories: 25-64, 65-74, and 75-101.
The youngest group can receive autologous transplant, the fit patients ages 65 to 74 can receive full-dose chemotherapy, and the oldest, frailer patients should receive reduced-dose chemotherapy.
“It’s important to differentiate fit from frail,” Dr Palumbo said, “because we cannot give the same treatment schema to a 55-year-old versus 65 or 85. At 85, that schema would create a lot of toxicities.”
In frail patients, it’s always important to check which comorbidities are present using the Charlson comorbidity scale, Dr Palumbo said.
“Remember, when we put together age, chromosome abnormalities, and frailty, frailty is the most relevant prognostic factor when you add everything together,” he said.
“Two drugs versus 3 drugs doesn’t make much difference when you are starting to introduce treatment to these very frail patients with comorbidities.”
Minimal residual disease
Dr Palumbo indicated that a combination of MRI and PET-CT should be used for a more accurate indication of minimal residual disease.
“[W]e hope to have cure, [but] I don’t think, today, myeloma is a curable disease,” he said.
He clarified this by saying that patients who are in complete response and minimal residual disease-negative at 3 years do well, but, by 7 years, “something is happening.”
And at 10 years, progression-free survival has dropped off significantly, “telling us that cure is probably not yet there.”
ACIP approves changes to HPV, Tdap, DTaP, MenB vaccination guidance
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose. 
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose.
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose.
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
FROM AN ACIP MEETING
Resveratrol cut androgen levels in small PCOS trial
SALT LAKE CITY – Resveratrol significantly decreased androgen levels and insulin resistance among women with polycystic ovary syndrome (PCOS), according to a first-in-kind randomized, double-blind placebo-controlled trial of 30 patients.
After 3 months of daily oral treatment with 1.5 g of the antioxidant polyphenol, testosterone levels fell an average of 23%, dehydroepiandrosterone sulfate (DHEAS) levels dropped 22%, fasting insulin levels decreased by 32%, and insulin sensitivity improved by 66%, Antoni Duleba, MD, said at the annual meeting of the American Society for Reproductive Medicine. No such improvements occurred in the placebo group, he and his coinvestigators reported simultaneously in the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2016-1858).
Past work has found that resveratrol inhibits mRNA expression of Cyp17a1 and reduces androgen production by ovarian theca-interstitial cells. To build on those findings, Dr. Duleba worked with researchers at Poznan (Poland) University of Medical Sciences to enroll 30 women with PCOS based on the Rotterdam criteria. Treatment and placebo groups resembled each other at baseline in terms of age, body mass index, androgen levels, lipid profiles, and levels of follicle-stimulating hormone, luteinizing hormone, prolactin, sex hormone–binding globulin, fasting glucose, and insulin, as well as scores on an insulin sensitivity index.
For the primary outcome measure – total testosterone level – the resveratrol group averaged 0.53 ng/mL at baseline and 0.41 ng/mL at 3-month follow-up, a statistically significant decrease (P = .01). In contrast, testosterone levels in the placebo group remained essentially unchanged, averaging 0.48 ng/mL at baseline and 0.49 ng/mL at follow-up. The difference in effect between the resveratrol and placebo groups was statistically significant (P = .04).
Similarly, average DHEAS levels dropped from 8.1 to 6.3 micromol/L in the resveratrol group (a 22% decline), but increased by 10% in the placebo group.
Resveratrol did not significantly affect progesterone levels, which is consistent with prior findings, Dr. Duleba said. Nor was resveratrol associated with significant changes in body mass index, lipid profile, markers of inflammation or endothelial function, ovarian volume, or gonadotropins.
“We were disappointed that we didn’t see gross changes in ovarian morphology on ultrasound,” he added. Whether those changes might occur with longer treatment is unknown, but for now, “we can only be sure of declining androgen and insulin levels, and improvements in insulin sensitivity.”
The study won a Scientific Congress Prize from ASRM.
RevGenetics provided the resveratrol for the study. Dr. Duleba reported having no relevant financial disclosures.
SALT LAKE CITY – Resveratrol significantly decreased androgen levels and insulin resistance among women with polycystic ovary syndrome (PCOS), according to a first-in-kind randomized, double-blind placebo-controlled trial of 30 patients.
After 3 months of daily oral treatment with 1.5 g of the antioxidant polyphenol, testosterone levels fell an average of 23%, dehydroepiandrosterone sulfate (DHEAS) levels dropped 22%, fasting insulin levels decreased by 32%, and insulin sensitivity improved by 66%, Antoni Duleba, MD, said at the annual meeting of the American Society for Reproductive Medicine. No such improvements occurred in the placebo group, he and his coinvestigators reported simultaneously in the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2016-1858).
Past work has found that resveratrol inhibits mRNA expression of Cyp17a1 and reduces androgen production by ovarian theca-interstitial cells. To build on those findings, Dr. Duleba worked with researchers at Poznan (Poland) University of Medical Sciences to enroll 30 women with PCOS based on the Rotterdam criteria. Treatment and placebo groups resembled each other at baseline in terms of age, body mass index, androgen levels, lipid profiles, and levels of follicle-stimulating hormone, luteinizing hormone, prolactin, sex hormone–binding globulin, fasting glucose, and insulin, as well as scores on an insulin sensitivity index.
For the primary outcome measure – total testosterone level – the resveratrol group averaged 0.53 ng/mL at baseline and 0.41 ng/mL at 3-month follow-up, a statistically significant decrease (P = .01). In contrast, testosterone levels in the placebo group remained essentially unchanged, averaging 0.48 ng/mL at baseline and 0.49 ng/mL at follow-up. The difference in effect between the resveratrol and placebo groups was statistically significant (P = .04).
Similarly, average DHEAS levels dropped from 8.1 to 6.3 micromol/L in the resveratrol group (a 22% decline), but increased by 10% in the placebo group.
Resveratrol did not significantly affect progesterone levels, which is consistent with prior findings, Dr. Duleba said. Nor was resveratrol associated with significant changes in body mass index, lipid profile, markers of inflammation or endothelial function, ovarian volume, or gonadotropins.
“We were disappointed that we didn’t see gross changes in ovarian morphology on ultrasound,” he added. Whether those changes might occur with longer treatment is unknown, but for now, “we can only be sure of declining androgen and insulin levels, and improvements in insulin sensitivity.”
The study won a Scientific Congress Prize from ASRM.
RevGenetics provided the resveratrol for the study. Dr. Duleba reported having no relevant financial disclosures.
SALT LAKE CITY – Resveratrol significantly decreased androgen levels and insulin resistance among women with polycystic ovary syndrome (PCOS), according to a first-in-kind randomized, double-blind placebo-controlled trial of 30 patients.
After 3 months of daily oral treatment with 1.5 g of the antioxidant polyphenol, testosterone levels fell an average of 23%, dehydroepiandrosterone sulfate (DHEAS) levels dropped 22%, fasting insulin levels decreased by 32%, and insulin sensitivity improved by 66%, Antoni Duleba, MD, said at the annual meeting of the American Society for Reproductive Medicine. No such improvements occurred in the placebo group, he and his coinvestigators reported simultaneously in the Journal of Clinical Endocrinology & Metabolism (doi: 10.1210/jc.2016-1858).
Past work has found that resveratrol inhibits mRNA expression of Cyp17a1 and reduces androgen production by ovarian theca-interstitial cells. To build on those findings, Dr. Duleba worked with researchers at Poznan (Poland) University of Medical Sciences to enroll 30 women with PCOS based on the Rotterdam criteria. Treatment and placebo groups resembled each other at baseline in terms of age, body mass index, androgen levels, lipid profiles, and levels of follicle-stimulating hormone, luteinizing hormone, prolactin, sex hormone–binding globulin, fasting glucose, and insulin, as well as scores on an insulin sensitivity index.
For the primary outcome measure – total testosterone level – the resveratrol group averaged 0.53 ng/mL at baseline and 0.41 ng/mL at 3-month follow-up, a statistically significant decrease (P = .01). In contrast, testosterone levels in the placebo group remained essentially unchanged, averaging 0.48 ng/mL at baseline and 0.49 ng/mL at follow-up. The difference in effect between the resveratrol and placebo groups was statistically significant (P = .04).
Similarly, average DHEAS levels dropped from 8.1 to 6.3 micromol/L in the resveratrol group (a 22% decline), but increased by 10% in the placebo group.
Resveratrol did not significantly affect progesterone levels, which is consistent with prior findings, Dr. Duleba said. Nor was resveratrol associated with significant changes in body mass index, lipid profile, markers of inflammation or endothelial function, ovarian volume, or gonadotropins.
“We were disappointed that we didn’t see gross changes in ovarian morphology on ultrasound,” he added. Whether those changes might occur with longer treatment is unknown, but for now, “we can only be sure of declining androgen and insulin levels, and improvements in insulin sensitivity.”
The study won a Scientific Congress Prize from ASRM.
RevGenetics provided the resveratrol for the study. Dr. Duleba reported having no relevant financial disclosures.
AT 2016 ASRM
Key clinical point:
Major finding: Average total testosterone levels dropped 23% in the treatment group and remained unchanged in the placebo group (P = .04).
Data source: A single-center, double-blind, randomized controlled trial of 30 women with polycystic ovary syndrome.
Disclosures: RevGenetics provided the resveratrol for the study. Dr. Duleba reported having no relevant financial disclosures.
Ketamine augmentation doesn’t boost ECT outcomes
VIENNA – Low-dose ketamine provided no benefit as adjunctive anesthesia for severely depressed patients undergoing electroconvulsive therapy in the randomized, multicenter U.K. Ketamine-ECT Study, Ian Anderson, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The hope was that ketamine would lessen the cognitive impairment that is a prominent side effect of ECT. It’s thought that this cognitive impairment results from treatment-induced excessive stimulation of glutamate receptors, and ketamine is a glutamate antagonist, explained Dr. Anderson of the University of Manchester (England).
He and his coinvestigators had also hypothesized that ketamine might result in more rapid improvement in depression in patients undergoing ECT, since a single intravenous infusion of the drug has been shown to produce an extremely rapid, albeit temporary, antidepressant effect. But this was not borne out in the Ketamine-ECT Study.
Dr. Anderson reported on 70 severely depressed patients who were randomized to ketamine at 0.5 mg/kg or saline as an adjunct to standard propofol anesthesia for their course of weekly ECT sessions at seven U.K. mental health centers.
The primary study endpoint was the delayed verbal recall score on the Hopkins Verbal Learning Test–Revised after four ECT sessions, which was midway through the full course of treatment. Blinded assessors found no significant difference between the ketamine and placebo groups then. Nor were significant differences evident at prespecified further assessments 1 and 4 months after conclusion of the treatment program.
Secondary outcomes comprised of cognitive measures of verbal fluency, and autobiographical, working, and visual memory also proved similar in the two study arms, as did assessments of quality of life, safety, and tolerability.
At the end of the full course of ECT, 39% of the ketamine group were categorized as being in remission based upon at least a 50% drop from their baseline score on the Montgomery-Åsberg Depression Rating Scale (MADRS) with a final score of 10 or less, as were 35% of controls. Forty-nine percent of the ketamine group and 60% of controls were categorized as treatment responders, meaning their MADRS score dropped by at least 50% but their final score was greater than 10.
No serious adverse reactions to ketamine occurred.
The study was funded by the United Kingdom's National Institute for Health Research and the Medical Research Council. Dr. Anderson reported having no relevant financial conflicts.
VIENNA – Low-dose ketamine provided no benefit as adjunctive anesthesia for severely depressed patients undergoing electroconvulsive therapy in the randomized, multicenter U.K. Ketamine-ECT Study, Ian Anderson, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The hope was that ketamine would lessen the cognitive impairment that is a prominent side effect of ECT. It’s thought that this cognitive impairment results from treatment-induced excessive stimulation of glutamate receptors, and ketamine is a glutamate antagonist, explained Dr. Anderson of the University of Manchester (England).
He and his coinvestigators had also hypothesized that ketamine might result in more rapid improvement in depression in patients undergoing ECT, since a single intravenous infusion of the drug has been shown to produce an extremely rapid, albeit temporary, antidepressant effect. But this was not borne out in the Ketamine-ECT Study.
Dr. Anderson reported on 70 severely depressed patients who were randomized to ketamine at 0.5 mg/kg or saline as an adjunct to standard propofol anesthesia for their course of weekly ECT sessions at seven U.K. mental health centers.
The primary study endpoint was the delayed verbal recall score on the Hopkins Verbal Learning Test–Revised after four ECT sessions, which was midway through the full course of treatment. Blinded assessors found no significant difference between the ketamine and placebo groups then. Nor were significant differences evident at prespecified further assessments 1 and 4 months after conclusion of the treatment program.
Secondary outcomes comprised of cognitive measures of verbal fluency, and autobiographical, working, and visual memory also proved similar in the two study arms, as did assessments of quality of life, safety, and tolerability.
At the end of the full course of ECT, 39% of the ketamine group were categorized as being in remission based upon at least a 50% drop from their baseline score on the Montgomery-Åsberg Depression Rating Scale (MADRS) with a final score of 10 or less, as were 35% of controls. Forty-nine percent of the ketamine group and 60% of controls were categorized as treatment responders, meaning their MADRS score dropped by at least 50% but their final score was greater than 10.
No serious adverse reactions to ketamine occurred.
The study was funded by the United Kingdom's National Institute for Health Research and the Medical Research Council. Dr. Anderson reported having no relevant financial conflicts.
VIENNA – Low-dose ketamine provided no benefit as adjunctive anesthesia for severely depressed patients undergoing electroconvulsive therapy in the randomized, multicenter U.K. Ketamine-ECT Study, Ian Anderson, MD, reported at the annual congress of the European College of Neuropsychopharmacology.
The hope was that ketamine would lessen the cognitive impairment that is a prominent side effect of ECT. It’s thought that this cognitive impairment results from treatment-induced excessive stimulation of glutamate receptors, and ketamine is a glutamate antagonist, explained Dr. Anderson of the University of Manchester (England).
He and his coinvestigators had also hypothesized that ketamine might result in more rapid improvement in depression in patients undergoing ECT, since a single intravenous infusion of the drug has been shown to produce an extremely rapid, albeit temporary, antidepressant effect. But this was not borne out in the Ketamine-ECT Study.
Dr. Anderson reported on 70 severely depressed patients who were randomized to ketamine at 0.5 mg/kg or saline as an adjunct to standard propofol anesthesia for their course of weekly ECT sessions at seven U.K. mental health centers.
The primary study endpoint was the delayed verbal recall score on the Hopkins Verbal Learning Test–Revised after four ECT sessions, which was midway through the full course of treatment. Blinded assessors found no significant difference between the ketamine and placebo groups then. Nor were significant differences evident at prespecified further assessments 1 and 4 months after conclusion of the treatment program.
Secondary outcomes comprised of cognitive measures of verbal fluency, and autobiographical, working, and visual memory also proved similar in the two study arms, as did assessments of quality of life, safety, and tolerability.
At the end of the full course of ECT, 39% of the ketamine group were categorized as being in remission based upon at least a 50% drop from their baseline score on the Montgomery-Åsberg Depression Rating Scale (MADRS) with a final score of 10 or less, as were 35% of controls. Forty-nine percent of the ketamine group and 60% of controls were categorized as treatment responders, meaning their MADRS score dropped by at least 50% but their final score was greater than 10.
No serious adverse reactions to ketamine occurred.
The study was funded by the United Kingdom's National Institute for Health Research and the Medical Research Council. Dr. Anderson reported having no relevant financial conflicts.
AT THE ECNP CONGRESS
Key clinical point:
Major finding: Cognitive impairment as measured by delayed verbal recall on the Hopkins Verbal Learning Task–Revised was not reduced by the use of ketamine as an adjunctive anesthetic agent for ECT.
Data source: This randomized, multicenter trial featuring blinded assessments included 70 severely depressed patients who received either ketamine or saline in addition to standard anesthesia during their ECT sessions.
Disclosures: The Ketamine-ECT Study was funded by the U.K. National Institute for Health Research and the Medical Research Council. The presenter reported having no conflicts of interest.
Zika increase slows slightly in pregnant women
The total number of pregnant women in the United States and its territories with laboratory evidence of Zika infection rose by 142 for the week ending Oct. 13 – the smallest increase since early September, according to the Centers for Disease Control and Prevention.
There were 121 new cases of Zika virus infection in pregnant women reported in the U.S. territories and 21 new cases in the states and the District of Columbia, bringing the corresponding totals for the year to 1,927 cases in the territories and 899 in the states/D.C. – a total of 2,826 pregnant women with Zika in the United States, the CDC reported Oct. 20.
The Zika caseload among all Americans was 31,418 as of Oct. 19. An additional 80 cases reported from Oct. 14 through Oct. 19 brought the state/D.C. total to 4,016, and 1,447 new cases for the week brings the territorial total to 27,402 for 2015-2016, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
The total number of pregnant women in the United States and its territories with laboratory evidence of Zika infection rose by 142 for the week ending Oct. 13 – the smallest increase since early September, according to the Centers for Disease Control and Prevention.
There were 121 new cases of Zika virus infection in pregnant women reported in the U.S. territories and 21 new cases in the states and the District of Columbia, bringing the corresponding totals for the year to 1,927 cases in the territories and 899 in the states/D.C. – a total of 2,826 pregnant women with Zika in the United States, the CDC reported Oct. 20.
The Zika caseload among all Americans was 31,418 as of Oct. 19. An additional 80 cases reported from Oct. 14 through Oct. 19 brought the state/D.C. total to 4,016, and 1,447 new cases for the week brings the territorial total to 27,402 for 2015-2016, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
The total number of pregnant women in the United States and its territories with laboratory evidence of Zika infection rose by 142 for the week ending Oct. 13 – the smallest increase since early September, according to the Centers for Disease Control and Prevention.
There were 121 new cases of Zika virus infection in pregnant women reported in the U.S. territories and 21 new cases in the states and the District of Columbia, bringing the corresponding totals for the year to 1,927 cases in the territories and 899 in the states/D.C. – a total of 2,826 pregnant women with Zika in the United States, the CDC reported Oct. 20.
The Zika caseload among all Americans was 31,418 as of Oct. 19. An additional 80 cases reported from Oct. 14 through Oct. 19 brought the state/D.C. total to 4,016, and 1,447 new cases for the week brings the territorial total to 27,402 for 2015-2016, the CDC reported.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
The pregnancy-related figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.
Webcast: Contraceptive considerations for women with headache and migraine
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Access Dr. Burkman's Webcasts on contraception:
- Hormonal contraception and risk of venous thromboembolism
- Oral contraceptives and breast cancer: What’s the risk?
- Factors that contribute to overall contraceptive efficacy and risks
- Obesity and contraceptive efficacy and risks
- How to use the CDC's online tools to manage complex cases in contraception
Helpful resources for your practice:
- Book recommendation: Allen RH, Cwiak CA, eds. Contraception for the medically challenging patient. New York, New York: Springer New York; 2014.
- United States Medical Eligibility Criteria for Contraceptive Use, 2016
- United States Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2010
- Summary Chart of US Medical Eligibility for Contraceptive Use
Voice recognition software errors: Often silly, sometimes serious
How much is 15%?
Not that much, on paper. With any drug, at least 15% of people will get some kind of side effect. Usually they all list dizziness and headaches at the top.
Could the same be true of a seemingly harmless technology?
Voice recognition software has become pretty commonplace in modern medicine but is far from perfect. I try to be pretty careful about proofreading my dictations, but many docs, especially those in emergency room, don’t have the time to. So VR errors slip by, persisting in 71% of notes.
Most of these errors are just silly and obvious for what they are. But a recent study at a level I ER found that 15% of dictations contained one or more errors deemed as “critical,” with the potential to adversely affect patient care (Int J Med Inform. 2016 Sep;93:70-3).
Communication among doctors, nurses, and all the other key players in the hospital environment is one of the most critical areas in modern medicine. So many people often rely on the initial dictation for an idea of what’s going on that a critical error can affect the way they think about the case from the get-go.
Another issue, sadly, in today’s hospital is that no one takes (or has) the time to get a patient’s past medical history. It’s commonplace to pull the history out of previous admission notes. (Admittedly, sometimes in a demented or unconscious patient you don’t have a choice.) As a result, errors of this sort tend to propagate down the line, from an admission, to the consults, to the discharge summary, and into the next admission.
So let’s get back to that 15%.
I have to assume that 15% of people being admitted aren’t having catastrophic events from medical errors, hopefully because the doctors and nurses handling patient care are thinking for themselves, recognizing dictation errors, and addressing them appropriately.
But even if we dial it down to a tenth of that, say 1.5%, it’s still a serious concern. Bad outcomes in medicine are never entirely avoidable. That’s the nature of the job.
But bad outcomes caused by too much trust in a still-faulty technology are avoidable.
If 15% of people had a serious outcome from a medication, you’d be very cautious about using it. We need to treat these technological gadgets with the same concerns we extend to drugs and procedures. Avoidable bad outcomes, regardless of cause, are never good.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
How much is 15%?
Not that much, on paper. With any drug, at least 15% of people will get some kind of side effect. Usually they all list dizziness and headaches at the top.
Could the same be true of a seemingly harmless technology?
Voice recognition software has become pretty commonplace in modern medicine but is far from perfect. I try to be pretty careful about proofreading my dictations, but many docs, especially those in emergency room, don’t have the time to. So VR errors slip by, persisting in 71% of notes.
Most of these errors are just silly and obvious for what they are. But a recent study at a level I ER found that 15% of dictations contained one or more errors deemed as “critical,” with the potential to adversely affect patient care (Int J Med Inform. 2016 Sep;93:70-3).
Communication among doctors, nurses, and all the other key players in the hospital environment is one of the most critical areas in modern medicine. So many people often rely on the initial dictation for an idea of what’s going on that a critical error can affect the way they think about the case from the get-go.
Another issue, sadly, in today’s hospital is that no one takes (or has) the time to get a patient’s past medical history. It’s commonplace to pull the history out of previous admission notes. (Admittedly, sometimes in a demented or unconscious patient you don’t have a choice.) As a result, errors of this sort tend to propagate down the line, from an admission, to the consults, to the discharge summary, and into the next admission.
So let’s get back to that 15%.
I have to assume that 15% of people being admitted aren’t having catastrophic events from medical errors, hopefully because the doctors and nurses handling patient care are thinking for themselves, recognizing dictation errors, and addressing them appropriately.
But even if we dial it down to a tenth of that, say 1.5%, it’s still a serious concern. Bad outcomes in medicine are never entirely avoidable. That’s the nature of the job.
But bad outcomes caused by too much trust in a still-faulty technology are avoidable.
If 15% of people had a serious outcome from a medication, you’d be very cautious about using it. We need to treat these technological gadgets with the same concerns we extend to drugs and procedures. Avoidable bad outcomes, regardless of cause, are never good.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
How much is 15%?
Not that much, on paper. With any drug, at least 15% of people will get some kind of side effect. Usually they all list dizziness and headaches at the top.
Could the same be true of a seemingly harmless technology?
Voice recognition software has become pretty commonplace in modern medicine but is far from perfect. I try to be pretty careful about proofreading my dictations, but many docs, especially those in emergency room, don’t have the time to. So VR errors slip by, persisting in 71% of notes.
Most of these errors are just silly and obvious for what they are. But a recent study at a level I ER found that 15% of dictations contained one or more errors deemed as “critical,” with the potential to adversely affect patient care (Int J Med Inform. 2016 Sep;93:70-3).
Communication among doctors, nurses, and all the other key players in the hospital environment is one of the most critical areas in modern medicine. So many people often rely on the initial dictation for an idea of what’s going on that a critical error can affect the way they think about the case from the get-go.
Another issue, sadly, in today’s hospital is that no one takes (or has) the time to get a patient’s past medical history. It’s commonplace to pull the history out of previous admission notes. (Admittedly, sometimes in a demented or unconscious patient you don’t have a choice.) As a result, errors of this sort tend to propagate down the line, from an admission, to the consults, to the discharge summary, and into the next admission.
So let’s get back to that 15%.
I have to assume that 15% of people being admitted aren’t having catastrophic events from medical errors, hopefully because the doctors and nurses handling patient care are thinking for themselves, recognizing dictation errors, and addressing them appropriately.
But even if we dial it down to a tenth of that, say 1.5%, it’s still a serious concern. Bad outcomes in medicine are never entirely avoidable. That’s the nature of the job.
But bad outcomes caused by too much trust in a still-faulty technology are avoidable.
If 15% of people had a serious outcome from a medication, you’d be very cautious about using it. We need to treat these technological gadgets with the same concerns we extend to drugs and procedures. Avoidable bad outcomes, regardless of cause, are never good.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.