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One-fifth of Medicaid kids receive mental health diagnoses
Twenty percent of children insured by Medicaid received a psychiatric diagnosis before 8 years of age, according to data from more than 35,000 Medicaid-insured children in a mid-Atlantic state.
Previous cross-sectional studies have addressed trends in psychiatric treatment of children. “However, little is known about the longitudinal patterns of pediatric use of psychiatric services,” wrote Dinci Pennap, MPH, of the University of Maryland, Baltimore, and her colleagues.
By the age of 8 years, 20% of the children had received a psychiatric diagnosis; 58% of these diagnoses were behavioral. The most common psychiatric diagnoses were ADHD (44%) and learning disorder (32%).
In addition, 10% (2,196) of children had received psychotropic medications. Of those receiving psychotropic medications, 81% received a single medication, 16% received two medications, and 4% received three medications for 60 days or more, the researchers said. Girls were significantly more likely than boys to be diagnosed with adjustment disorder (22% vs. 15%, respectively) or anxiety disorder (7% vs. 4%, respectively). Boys were significantly more likely than girls to be diagnosed with ADHD (30% vs. 22%).
the researchers said.
The study findings were limited by several factors, including the use of clinician-reported diagnoses rather than research-identified diagnoses and the possible lack of generalizability to Medicaid populations in other regions or to privately insured children, the researchers noted. However, the results captured long-term psychotropic use and “highlight the need for safety and outcomes research, particularly for health outcomes such as metabolic imbalance, weight gain, and sleep disturbances after initiation of psychotropic medication for very young children.”
Dr. Pennap had no financial conflicts to disclose. One of the study coauthors disclosed research grants from the National Institutes of Health.
SOURCE: Pennap D et al. JAMA Pediatr. 2018. doi: 10.1001/jamapediatrics.2018.0240.
Twenty percent of children insured by Medicaid received a psychiatric diagnosis before 8 years of age, according to data from more than 35,000 Medicaid-insured children in a mid-Atlantic state.
Previous cross-sectional studies have addressed trends in psychiatric treatment of children. “However, little is known about the longitudinal patterns of pediatric use of psychiatric services,” wrote Dinci Pennap, MPH, of the University of Maryland, Baltimore, and her colleagues.
By the age of 8 years, 20% of the children had received a psychiatric diagnosis; 58% of these diagnoses were behavioral. The most common psychiatric diagnoses were ADHD (44%) and learning disorder (32%).
In addition, 10% (2,196) of children had received psychotropic medications. Of those receiving psychotropic medications, 81% received a single medication, 16% received two medications, and 4% received three medications for 60 days or more, the researchers said. Girls were significantly more likely than boys to be diagnosed with adjustment disorder (22% vs. 15%, respectively) or anxiety disorder (7% vs. 4%, respectively). Boys were significantly more likely than girls to be diagnosed with ADHD (30% vs. 22%).
the researchers said.
The study findings were limited by several factors, including the use of clinician-reported diagnoses rather than research-identified diagnoses and the possible lack of generalizability to Medicaid populations in other regions or to privately insured children, the researchers noted. However, the results captured long-term psychotropic use and “highlight the need for safety and outcomes research, particularly for health outcomes such as metabolic imbalance, weight gain, and sleep disturbances after initiation of psychotropic medication for very young children.”
Dr. Pennap had no financial conflicts to disclose. One of the study coauthors disclosed research grants from the National Institutes of Health.
SOURCE: Pennap D et al. JAMA Pediatr. 2018. doi: 10.1001/jamapediatrics.2018.0240.
Twenty percent of children insured by Medicaid received a psychiatric diagnosis before 8 years of age, according to data from more than 35,000 Medicaid-insured children in a mid-Atlantic state.
Previous cross-sectional studies have addressed trends in psychiatric treatment of children. “However, little is known about the longitudinal patterns of pediatric use of psychiatric services,” wrote Dinci Pennap, MPH, of the University of Maryland, Baltimore, and her colleagues.
By the age of 8 years, 20% of the children had received a psychiatric diagnosis; 58% of these diagnoses were behavioral. The most common psychiatric diagnoses were ADHD (44%) and learning disorder (32%).
In addition, 10% (2,196) of children had received psychotropic medications. Of those receiving psychotropic medications, 81% received a single medication, 16% received two medications, and 4% received three medications for 60 days or more, the researchers said. Girls were significantly more likely than boys to be diagnosed with adjustment disorder (22% vs. 15%, respectively) or anxiety disorder (7% vs. 4%, respectively). Boys were significantly more likely than girls to be diagnosed with ADHD (30% vs. 22%).
the researchers said.
The study findings were limited by several factors, including the use of clinician-reported diagnoses rather than research-identified diagnoses and the possible lack of generalizability to Medicaid populations in other regions or to privately insured children, the researchers noted. However, the results captured long-term psychotropic use and “highlight the need for safety and outcomes research, particularly for health outcomes such as metabolic imbalance, weight gain, and sleep disturbances after initiation of psychotropic medication for very young children.”
Dr. Pennap had no financial conflicts to disclose. One of the study coauthors disclosed research grants from the National Institutes of Health.
SOURCE: Pennap D et al. JAMA Pediatr. 2018. doi: 10.1001/jamapediatrics.2018.0240.
FROM JAMA PEDIATRICS
Key clinical point: More safety and outcome data are needed for young children receiving psychiatric medications.
Major finding: Twenty percent of Medicaid-insured children in a mid-Atlantic state were diagnosed with a psychiatric disorder before 8 years of age.
Study details: The data come from a longitudinal study of 35,244 children insured with Medicaid born in 2007 in a mid-Atlantic state.
Disclosures: Dr. Pennap had no financial conflicts to disclose. One of the study coauthors disclosed research grants from the National Institutes of Health.
Source: Pennap D et al. JAMA Pediatr. 2018. doi: 10.1001/jamapediatrics.2018.0240.
Use these two questions to simplify H. pylori treatment choice
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
Recent clinical guidelines have expanded not only the pool of patients who should be tested for Helicobacter pylori infection, but also the number of first-line treatment strategies clinicians should consider.
The American College of Gastroenterology guidelines from 2007 recommended just two treatments: clarithromycin-based triple therapy or bismuth-based quadruple therapy.
The 2017 update to ACG guidelines adds five additional recommended treatment possibilities, not all of which have been well studied in U.S. clinical practice, Colin W. Howden, MD, AGAF, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are a variety of options, and unfortunately for us as practitioners, antibiotic sensitivity testing is not routinely or easily available in contemporary U.S. practice,” said Dr. Howden, professor of medicine–gastroenterology at the University of Tennessee Health Sciences Center, Memphis.
Dr. Howden, a coauthor of the latest ACG guidelines, said asking two pointed questions outlined in the document can help simplify the treatment decision:
- Is there a penicillin allergy?
- Has there been previous macrolide exposure?
“The ideal situation is that the patient is not penicillin allergic, and they’ve never had a macrolide before,” Dr. Howden said. In that case, bismuth-based quadruple therapy would be an appropriate choice.
“Bismuth quadruple therapy is never the wrong answer,” he added.
Clarithromycin-based triple therapy might be considered, according to Dr. Howden, if the local rate of resistance to H. pylori is known to be low.
Bismuth-based quadruple therapy consists of a proton pump inhibitor (PPI) or H2 blocker, bismuth, tetracycline, and metronidazole for 10-14 days, while clarithromycin triple therapy consists of a PPI, clarithromycin, and amoxicillin or metronidazole for 10-14 days.
Several other options recently added to the guidelines have been tried in this scenario, he noted, including concomitant therapy, which consists of a PPI, clarithromycin, amoxicillin, and metronidazole for 10-14 days.
If there has been previous macrolide use but the patient is not penicillin allergic, bismuth quadruple therapy is again recommended, Dr. Howden said, and an additional approach might be the introduction of a levofloxacin-based regimen, as outlined in the guidelines.
Conversely, if there has been no previous macrolide use but the patient is confirmed to be penicillin allergic, the current guideline-recommended options are limited to bismuth quadruple therapy, or clarithromycin triple therapy with metronidazole instead of amoxicillin, Dr. Howden said at the meeting.
Finally, for penicillin-allergic patients with previous macrolide use, recommended options are whittled down to just bismuth-based quadruple therapy. “Again, it’s never the wrong answer,” Dr. Howden said.
Global Academy and this news organization are owned by the same parent company.
Dr. Howden reported disclosures related to Horizon, Otsuka, Allergan, Aralaez, EndoStim, Ironwood, Pfizer, and SynteractHCR.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Reduced intensity conditioning doesn’t protect fertility
SALT LAKE CITY – Both male and female recipients of childhood hematopoietic stem cell transplantation (HSCT) were very likely to have severely decreased fertility potential, even in the setting of preserved puberty, according to a recent study of adolescent and young adult HSCT recipients.
A reduced intensity conditioning regimen did not protect this cohort from decreased fertility, a finding that surprised the study’s lead author.
“We had hypothesized that, as compared to myeloablative conditioning, reduced intensity conditioning in children who received HSCT would lower the risk of infertility and lessen gonadal failure,” said Helen Oquendo del Toro, MD. In fact, Dr. Oquendo del Toro and her collaborators found that more than 90% of semen samples available for analysis had results that indicated infertility or severely impaired fertility, regardless of the type of pretransplant conditioning the patient had received.
The study highlights the need for fertility preservation when possible before HSCT, and makes clear that “normal puberty does not equate to normal fertility,” said Dr. Oquendo del Toro, of Cincinnati Children’s Hospital Medical Center.
Dr. Oquendo del Toro presented results of an observational cohort study of late effects of HSCT that included individuals aged 1-40 years old who received a single HSCT at, or after, 1 year of age.
Twenty-one males in the study had semen available for analysis. Of the 10 males who received myeloablative conditioning (MAC), 8 had azoospermia, and 2 more had oligoteratospermia (low sperm count with abnormal morphology). For the 11 males who received reduced intensity conditioning (RIC), eight had azoospermia, two had semen samples that showed oligoteratospermia, and one had a normal semen analysis.
The median age at transplant for these males was 14.5 years, and patients were a median of 19 years old at follow-up, Dr. Oquendo del Toro said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
For females in the study, low levels of anti-Müllerian hormone (AMH) – generally considered the best surrogate lab value for ovarian reserve – were nearly as common. Of 14 females receiving MAC, 13 (93%) had low AMH, as did 6 of 8 (75%) female patients who received RIC.
Individuals with more than one HSCT were excluded, as were those with Fanconi anemia, which itself carries a risk of gonadal failure. The study’s two aims were to investigate gonadal function as well as fertility potential after receipt of either RIC or MAC for HSCT.
Patients were seen by an endocrinologist who assessed testicular volume and assigned a Tanner stage. At age 11 and older, patients’ gonadal function was assessed on an annual basis by obtaining levels of luteinizing hormone and follicle stimulating hormone for all patients; female estradiol levels were tracked, as were male testosterone levels.
Assessment of fertility potential required additional laboratory testing: For females, the investigators obtained AMH levels, while for males, semen analysis was coupled with serum levels of inhibin B, an indicator of Sertoli cell function.
A total of 72 males were more than 1 year post-HSCT in the cohort, and of these, 41 were at least 11 years old and had achieved pubertal status according to laboratory evaluation. In all, 22 of the male patients received RIC, and 19 received MAC.
Males receiving MAC were a median 20 years old at their follow-up evaluation, and a median 6 years post-HSCT, while the RIC group were a median of 18.5 years old and 5.5 years out from their transplant.
Of the 50 females who were more than 1 year post-HSCT, 25 were pubertal and 11 years old or older. Nine of the female patients received RIC, and 16 received MAC.
Females who received MAC were a median 12.1 years old and 4.1 years post-HSCT at their follow-up evaluation. Females receiving RIC were a median 16 years old, and 6.5 years post-HSCT at the time of evaluation.
Patients received their transplants for a variety of malignant and nonmalignant conditions.
“We saw relatively normal gonadotropins after both reduced intensity and myeloablative conditioning in males,” Dr. Oquendo del Toro said. Of the MAC group, 4 of 15 (27%) had elevated follicle stimulating hormone levels, as did 2 of 17 (12%) of the RIC group. Elevated luteinizing hormone levels were seen in 2 of 15 (13%) of the MAC group and 1 of 17 (6%) of the RIC group. Four patients in each group had abnormally low testosterone levels.
However, when the investigators looked at inhibin B levels in males, they found abnormally low levels in 9 of 15 (60%) of those who received MAC, and in 6 of 15 (40%) of those who received RIC. These results meshed with the severely abnormal semen analyses investigators found from those participants for whom a sample was available, Dr. Oquendo del Toro said.
For females, estradiol levels were significantly lower for those who had received MAC, with 7 of 11 (64%) of that group having abnormally low estradiol levels. The levels approached 0 pg/mL for many, said Dr. Oquendo del Toro. None of the eight patients who had received RIC had abnormally low estradiol levels (P = .0008).
“Male puberty is relatively well preserved after both myeloablative and reduced intensity conditioning, but there is a greater than 90% risk of male infertility associated with both reduced intensity and myeloablative conditioning for HSCT,” Dr. Oquendo del Toro said.
For females, the study paints a different picture. “We saw decreased premature ovarian failure after reduced intensity conditioning … but the fertility potential as assessed by anti-Müllerian hormone was decreased” after both conditioning regimens, she said.
Dr. Oquendo del Toro reported having no conflicts of interest.
SOURCE: Oquendo del Toro H et al. The 2018 BMT Tandem Meetings, Abstract 88.
SALT LAKE CITY – Both male and female recipients of childhood hematopoietic stem cell transplantation (HSCT) were very likely to have severely decreased fertility potential, even in the setting of preserved puberty, according to a recent study of adolescent and young adult HSCT recipients.
A reduced intensity conditioning regimen did not protect this cohort from decreased fertility, a finding that surprised the study’s lead author.
“We had hypothesized that, as compared to myeloablative conditioning, reduced intensity conditioning in children who received HSCT would lower the risk of infertility and lessen gonadal failure,” said Helen Oquendo del Toro, MD. In fact, Dr. Oquendo del Toro and her collaborators found that more than 90% of semen samples available for analysis had results that indicated infertility or severely impaired fertility, regardless of the type of pretransplant conditioning the patient had received.
The study highlights the need for fertility preservation when possible before HSCT, and makes clear that “normal puberty does not equate to normal fertility,” said Dr. Oquendo del Toro, of Cincinnati Children’s Hospital Medical Center.
Dr. Oquendo del Toro presented results of an observational cohort study of late effects of HSCT that included individuals aged 1-40 years old who received a single HSCT at, or after, 1 year of age.
Twenty-one males in the study had semen available for analysis. Of the 10 males who received myeloablative conditioning (MAC), 8 had azoospermia, and 2 more had oligoteratospermia (low sperm count with abnormal morphology). For the 11 males who received reduced intensity conditioning (RIC), eight had azoospermia, two had semen samples that showed oligoteratospermia, and one had a normal semen analysis.
The median age at transplant for these males was 14.5 years, and patients were a median of 19 years old at follow-up, Dr. Oquendo del Toro said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
For females in the study, low levels of anti-Müllerian hormone (AMH) – generally considered the best surrogate lab value for ovarian reserve – were nearly as common. Of 14 females receiving MAC, 13 (93%) had low AMH, as did 6 of 8 (75%) female patients who received RIC.
Individuals with more than one HSCT were excluded, as were those with Fanconi anemia, which itself carries a risk of gonadal failure. The study’s two aims were to investigate gonadal function as well as fertility potential after receipt of either RIC or MAC for HSCT.
Patients were seen by an endocrinologist who assessed testicular volume and assigned a Tanner stage. At age 11 and older, patients’ gonadal function was assessed on an annual basis by obtaining levels of luteinizing hormone and follicle stimulating hormone for all patients; female estradiol levels were tracked, as were male testosterone levels.
Assessment of fertility potential required additional laboratory testing: For females, the investigators obtained AMH levels, while for males, semen analysis was coupled with serum levels of inhibin B, an indicator of Sertoli cell function.
A total of 72 males were more than 1 year post-HSCT in the cohort, and of these, 41 were at least 11 years old and had achieved pubertal status according to laboratory evaluation. In all, 22 of the male patients received RIC, and 19 received MAC.
Males receiving MAC were a median 20 years old at their follow-up evaluation, and a median 6 years post-HSCT, while the RIC group were a median of 18.5 years old and 5.5 years out from their transplant.
Of the 50 females who were more than 1 year post-HSCT, 25 were pubertal and 11 years old or older. Nine of the female patients received RIC, and 16 received MAC.
Females who received MAC were a median 12.1 years old and 4.1 years post-HSCT at their follow-up evaluation. Females receiving RIC were a median 16 years old, and 6.5 years post-HSCT at the time of evaluation.
Patients received their transplants for a variety of malignant and nonmalignant conditions.
“We saw relatively normal gonadotropins after both reduced intensity and myeloablative conditioning in males,” Dr. Oquendo del Toro said. Of the MAC group, 4 of 15 (27%) had elevated follicle stimulating hormone levels, as did 2 of 17 (12%) of the RIC group. Elevated luteinizing hormone levels were seen in 2 of 15 (13%) of the MAC group and 1 of 17 (6%) of the RIC group. Four patients in each group had abnormally low testosterone levels.
However, when the investigators looked at inhibin B levels in males, they found abnormally low levels in 9 of 15 (60%) of those who received MAC, and in 6 of 15 (40%) of those who received RIC. These results meshed with the severely abnormal semen analyses investigators found from those participants for whom a sample was available, Dr. Oquendo del Toro said.
For females, estradiol levels were significantly lower for those who had received MAC, with 7 of 11 (64%) of that group having abnormally low estradiol levels. The levels approached 0 pg/mL for many, said Dr. Oquendo del Toro. None of the eight patients who had received RIC had abnormally low estradiol levels (P = .0008).
“Male puberty is relatively well preserved after both myeloablative and reduced intensity conditioning, but there is a greater than 90% risk of male infertility associated with both reduced intensity and myeloablative conditioning for HSCT,” Dr. Oquendo del Toro said.
For females, the study paints a different picture. “We saw decreased premature ovarian failure after reduced intensity conditioning … but the fertility potential as assessed by anti-Müllerian hormone was decreased” after both conditioning regimens, she said.
Dr. Oquendo del Toro reported having no conflicts of interest.
SOURCE: Oquendo del Toro H et al. The 2018 BMT Tandem Meetings, Abstract 88.
SALT LAKE CITY – Both male and female recipients of childhood hematopoietic stem cell transplantation (HSCT) were very likely to have severely decreased fertility potential, even in the setting of preserved puberty, according to a recent study of adolescent and young adult HSCT recipients.
A reduced intensity conditioning regimen did not protect this cohort from decreased fertility, a finding that surprised the study’s lead author.
“We had hypothesized that, as compared to myeloablative conditioning, reduced intensity conditioning in children who received HSCT would lower the risk of infertility and lessen gonadal failure,” said Helen Oquendo del Toro, MD. In fact, Dr. Oquendo del Toro and her collaborators found that more than 90% of semen samples available for analysis had results that indicated infertility or severely impaired fertility, regardless of the type of pretransplant conditioning the patient had received.
The study highlights the need for fertility preservation when possible before HSCT, and makes clear that “normal puberty does not equate to normal fertility,” said Dr. Oquendo del Toro, of Cincinnati Children’s Hospital Medical Center.
Dr. Oquendo del Toro presented results of an observational cohort study of late effects of HSCT that included individuals aged 1-40 years old who received a single HSCT at, or after, 1 year of age.
Twenty-one males in the study had semen available for analysis. Of the 10 males who received myeloablative conditioning (MAC), 8 had azoospermia, and 2 more had oligoteratospermia (low sperm count with abnormal morphology). For the 11 males who received reduced intensity conditioning (RIC), eight had azoospermia, two had semen samples that showed oligoteratospermia, and one had a normal semen analysis.
The median age at transplant for these males was 14.5 years, and patients were a median of 19 years old at follow-up, Dr. Oquendo del Toro said at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
For females in the study, low levels of anti-Müllerian hormone (AMH) – generally considered the best surrogate lab value for ovarian reserve – were nearly as common. Of 14 females receiving MAC, 13 (93%) had low AMH, as did 6 of 8 (75%) female patients who received RIC.
Individuals with more than one HSCT were excluded, as were those with Fanconi anemia, which itself carries a risk of gonadal failure. The study’s two aims were to investigate gonadal function as well as fertility potential after receipt of either RIC or MAC for HSCT.
Patients were seen by an endocrinologist who assessed testicular volume and assigned a Tanner stage. At age 11 and older, patients’ gonadal function was assessed on an annual basis by obtaining levels of luteinizing hormone and follicle stimulating hormone for all patients; female estradiol levels were tracked, as were male testosterone levels.
Assessment of fertility potential required additional laboratory testing: For females, the investigators obtained AMH levels, while for males, semen analysis was coupled with serum levels of inhibin B, an indicator of Sertoli cell function.
A total of 72 males were more than 1 year post-HSCT in the cohort, and of these, 41 were at least 11 years old and had achieved pubertal status according to laboratory evaluation. In all, 22 of the male patients received RIC, and 19 received MAC.
Males receiving MAC were a median 20 years old at their follow-up evaluation, and a median 6 years post-HSCT, while the RIC group were a median of 18.5 years old and 5.5 years out from their transplant.
Of the 50 females who were more than 1 year post-HSCT, 25 were pubertal and 11 years old or older. Nine of the female patients received RIC, and 16 received MAC.
Females who received MAC were a median 12.1 years old and 4.1 years post-HSCT at their follow-up evaluation. Females receiving RIC were a median 16 years old, and 6.5 years post-HSCT at the time of evaluation.
Patients received their transplants for a variety of malignant and nonmalignant conditions.
“We saw relatively normal gonadotropins after both reduced intensity and myeloablative conditioning in males,” Dr. Oquendo del Toro said. Of the MAC group, 4 of 15 (27%) had elevated follicle stimulating hormone levels, as did 2 of 17 (12%) of the RIC group. Elevated luteinizing hormone levels were seen in 2 of 15 (13%) of the MAC group and 1 of 17 (6%) of the RIC group. Four patients in each group had abnormally low testosterone levels.
However, when the investigators looked at inhibin B levels in males, they found abnormally low levels in 9 of 15 (60%) of those who received MAC, and in 6 of 15 (40%) of those who received RIC. These results meshed with the severely abnormal semen analyses investigators found from those participants for whom a sample was available, Dr. Oquendo del Toro said.
For females, estradiol levels were significantly lower for those who had received MAC, with 7 of 11 (64%) of that group having abnormally low estradiol levels. The levels approached 0 pg/mL for many, said Dr. Oquendo del Toro. None of the eight patients who had received RIC had abnormally low estradiol levels (P = .0008).
“Male puberty is relatively well preserved after both myeloablative and reduced intensity conditioning, but there is a greater than 90% risk of male infertility associated with both reduced intensity and myeloablative conditioning for HSCT,” Dr. Oquendo del Toro said.
For females, the study paints a different picture. “We saw decreased premature ovarian failure after reduced intensity conditioning … but the fertility potential as assessed by anti-Müllerian hormone was decreased” after both conditioning regimens, she said.
Dr. Oquendo del Toro reported having no conflicts of interest.
SOURCE: Oquendo del Toro H et al. The 2018 BMT Tandem Meetings, Abstract 88.
REPORTING FROM THE 2018 BMT TANDEM MEETINGS
Key clinical point:
Major finding: Of 21 males receiving reduced intensity conditioning or myeloablative conditioning, all but one had azoospermia or oligoteratospermia.
Study details: Observational cohort study of 41 males and 25 females receiving pediatric HSCT.
Disclosures: Dr. Oquendo del Toro reported having no conflicts of interest.
Source: Oquendo del Toro H et al. The 2018 BMT Tandem Meetings, Abstract 88.
Women’s representation in CV drug trials still lagging
Although women have been well represented recently in certain types of cardiovascular drug trials, they remain underrepresented in studies of heart failure, coronary artery disease, and acute coronary syndrome, a recent study authored by Food and Drug Administration researchers has revealed.
However, representation of women fell below an acceptable participation-to-prevalence ratio in those other trial types that were evaluated, according to researchers, including lead author Pamela E. Scott, PhD, of the FDA’s Office of Women’s Health.
“As we move into the era of precision medicine – that is, assessing the impact of a wide range of patient and disease characteristics on drug effects – it is imperative that clinical trial participants represent the full spectrum of patients for whom the drug will be prescribed,” Dr. Scott and her colleagues said in the report.
To quantify the participation of women in clinical trials, Dr. Scott and coinvestigators reviewed publicly available FDA reviews from 2005 to 2015 supporting the approval of 36 drugs.
They used a metric called the participation-to-prevalence ratio (PPR) to compare representation of women in a study relative to the representation of women in the disease population being studied. The range of PPR of 0.8-1.2 represented similar representation of women in the study and disease population.
Participation of women in drug trials varied widely – from a low of 22% to a high of 81% – with a mean of 46%, they found.
The PPR was within the desirable range for hypertension, at 0.9, and atrial fibrillation trials, at 0.8-1.1, while participation for pulmonary arterial hypertension trials was above the desirable range, at 1.4, according to the report.
However, a PPR of less than 0.8 was found for coronary artery disease trials, at 0.6; acute coronary syndrome/myocardial infarction trials, also at 0.6; and heart failure trials, at 0.5 to 0.6.
Few clinically meaningful gender differences were found in efficacy or safety, they added, noting that such differences were discussed in the prescribing information for four different drugs.
To ensure that representative patient populations are enrolled in drug trials, clinical researchers, patient advocacy groups, federal agencies, and the industry as a whole should work together, Dr. Scott and her colleagues said.
“These steps will move us closer toward the goal of providing the best information possible about the use of drugs for every patient,” they wrote.
Dr. Scott and coauthors reported that they had no relationships relevant to their study.
SOURCE: Scott PE et al. J Am Coll Cardiol. 2018 May 18;71:1960-9.
Any optimism for results of this study by FDA authors are dampened significantly by the continued under-representation of women in heart failure and ischemic heart disease.
Even though progress has been made toward a higher participation of women in pivotal clinical trials, it still is not time to rest on our laurels.
One key contributor to the persistently low representation of women is the eligibility criteria of clinical trials. Those criteria often describe a male pattern of disease, particularly in drug trials for ischemic heart disease and heart failure.
As an example, heart failure trials have included eligibility criteria that consistently exclude women, such as a glomerular filtration rate less than 30 mL/min per 1.73 m2, and an ejection fraction of 40% or less.
The inclusion criteria in randomized, controlled trials impose homogeneous clinical characteristics for men and women and may be responsible for the lack of sex differences in efficacy outcomes.
Thus, the current analysis exposes not only successes but also failings of clinical trial design for FDA approval. We are still far from providing equitable cardiovascular health care for women.
Louise Pilote, MD, MPH, PhD, and Valeria Raparelli, MD, PhD, are both affiliated with McGill University Health Centre, Montreal. These comments are derived from their editorial in the Journal of the American College of Cardiology . Both reported that they had no relationships relevant to the contents of their editorial.
Any optimism for results of this study by FDA authors are dampened significantly by the continued under-representation of women in heart failure and ischemic heart disease.
Even though progress has been made toward a higher participation of women in pivotal clinical trials, it still is not time to rest on our laurels.
One key contributor to the persistently low representation of women is the eligibility criteria of clinical trials. Those criteria often describe a male pattern of disease, particularly in drug trials for ischemic heart disease and heart failure.
As an example, heart failure trials have included eligibility criteria that consistently exclude women, such as a glomerular filtration rate less than 30 mL/min per 1.73 m2, and an ejection fraction of 40% or less.
The inclusion criteria in randomized, controlled trials impose homogeneous clinical characteristics for men and women and may be responsible for the lack of sex differences in efficacy outcomes.
Thus, the current analysis exposes not only successes but also failings of clinical trial design for FDA approval. We are still far from providing equitable cardiovascular health care for women.
Louise Pilote, MD, MPH, PhD, and Valeria Raparelli, MD, PhD, are both affiliated with McGill University Health Centre, Montreal. These comments are derived from their editorial in the Journal of the American College of Cardiology . Both reported that they had no relationships relevant to the contents of their editorial.
Any optimism for results of this study by FDA authors are dampened significantly by the continued under-representation of women in heart failure and ischemic heart disease.
Even though progress has been made toward a higher participation of women in pivotal clinical trials, it still is not time to rest on our laurels.
One key contributor to the persistently low representation of women is the eligibility criteria of clinical trials. Those criteria often describe a male pattern of disease, particularly in drug trials for ischemic heart disease and heart failure.
As an example, heart failure trials have included eligibility criteria that consistently exclude women, such as a glomerular filtration rate less than 30 mL/min per 1.73 m2, and an ejection fraction of 40% or less.
The inclusion criteria in randomized, controlled trials impose homogeneous clinical characteristics for men and women and may be responsible for the lack of sex differences in efficacy outcomes.
Thus, the current analysis exposes not only successes but also failings of clinical trial design for FDA approval. We are still far from providing equitable cardiovascular health care for women.
Louise Pilote, MD, MPH, PhD, and Valeria Raparelli, MD, PhD, are both affiliated with McGill University Health Centre, Montreal. These comments are derived from their editorial in the Journal of the American College of Cardiology . Both reported that they had no relationships relevant to the contents of their editorial.
Although women have been well represented recently in certain types of cardiovascular drug trials, they remain underrepresented in studies of heart failure, coronary artery disease, and acute coronary syndrome, a recent study authored by Food and Drug Administration researchers has revealed.
However, representation of women fell below an acceptable participation-to-prevalence ratio in those other trial types that were evaluated, according to researchers, including lead author Pamela E. Scott, PhD, of the FDA’s Office of Women’s Health.
“As we move into the era of precision medicine – that is, assessing the impact of a wide range of patient and disease characteristics on drug effects – it is imperative that clinical trial participants represent the full spectrum of patients for whom the drug will be prescribed,” Dr. Scott and her colleagues said in the report.
To quantify the participation of women in clinical trials, Dr. Scott and coinvestigators reviewed publicly available FDA reviews from 2005 to 2015 supporting the approval of 36 drugs.
They used a metric called the participation-to-prevalence ratio (PPR) to compare representation of women in a study relative to the representation of women in the disease population being studied. The range of PPR of 0.8-1.2 represented similar representation of women in the study and disease population.
Participation of women in drug trials varied widely – from a low of 22% to a high of 81% – with a mean of 46%, they found.
The PPR was within the desirable range for hypertension, at 0.9, and atrial fibrillation trials, at 0.8-1.1, while participation for pulmonary arterial hypertension trials was above the desirable range, at 1.4, according to the report.
However, a PPR of less than 0.8 was found for coronary artery disease trials, at 0.6; acute coronary syndrome/myocardial infarction trials, also at 0.6; and heart failure trials, at 0.5 to 0.6.
Few clinically meaningful gender differences were found in efficacy or safety, they added, noting that such differences were discussed in the prescribing information for four different drugs.
To ensure that representative patient populations are enrolled in drug trials, clinical researchers, patient advocacy groups, federal agencies, and the industry as a whole should work together, Dr. Scott and her colleagues said.
“These steps will move us closer toward the goal of providing the best information possible about the use of drugs for every patient,” they wrote.
Dr. Scott and coauthors reported that they had no relationships relevant to their study.
SOURCE: Scott PE et al. J Am Coll Cardiol. 2018 May 18;71:1960-9.
Although women have been well represented recently in certain types of cardiovascular drug trials, they remain underrepresented in studies of heart failure, coronary artery disease, and acute coronary syndrome, a recent study authored by Food and Drug Administration researchers has revealed.
However, representation of women fell below an acceptable participation-to-prevalence ratio in those other trial types that were evaluated, according to researchers, including lead author Pamela E. Scott, PhD, of the FDA’s Office of Women’s Health.
“As we move into the era of precision medicine – that is, assessing the impact of a wide range of patient and disease characteristics on drug effects – it is imperative that clinical trial participants represent the full spectrum of patients for whom the drug will be prescribed,” Dr. Scott and her colleagues said in the report.
To quantify the participation of women in clinical trials, Dr. Scott and coinvestigators reviewed publicly available FDA reviews from 2005 to 2015 supporting the approval of 36 drugs.
They used a metric called the participation-to-prevalence ratio (PPR) to compare representation of women in a study relative to the representation of women in the disease population being studied. The range of PPR of 0.8-1.2 represented similar representation of women in the study and disease population.
Participation of women in drug trials varied widely – from a low of 22% to a high of 81% – with a mean of 46%, they found.
The PPR was within the desirable range for hypertension, at 0.9, and atrial fibrillation trials, at 0.8-1.1, while participation for pulmonary arterial hypertension trials was above the desirable range, at 1.4, according to the report.
However, a PPR of less than 0.8 was found for coronary artery disease trials, at 0.6; acute coronary syndrome/myocardial infarction trials, also at 0.6; and heart failure trials, at 0.5 to 0.6.
Few clinically meaningful gender differences were found in efficacy or safety, they added, noting that such differences were discussed in the prescribing information for four different drugs.
To ensure that representative patient populations are enrolled in drug trials, clinical researchers, patient advocacy groups, federal agencies, and the industry as a whole should work together, Dr. Scott and her colleagues said.
“These steps will move us closer toward the goal of providing the best information possible about the use of drugs for every patient,” they wrote.
Dr. Scott and coauthors reported that they had no relationships relevant to their study.
SOURCE: Scott PE et al. J Am Coll Cardiol. 2018 May 18;71:1960-9.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Although women are well represented in clinical trials for hypertension, atrial fibrillation, and pulmonary arterial hypertension, they are not well represented in other trial types.
Major finding: The participation-to-prevalence ratio fell below 0.8 (that is, the bottom end of the range reflecting a similar representation of women) for coronary artery disease, acute coronary syndrome, and heart failure.
Study details: An assessment of publicly available FDA data from 2005 to 2015 on enrollment of women in clinical trials representing 36 drug approvals.
Disclosures: Authors reported that they had no relationships relevant to their report.
Source: Scott PE et al. J Am Coll Cardiol. 2018 May 18;71:1960-9.
Wearing lateral wedge insoles reduces osteoarthritis knee pain
LIVERPOOL, ENGLAND – Lateral wedge insoles reduced osteoarthritis knee pain to a greater extent than did wearing neutral insoles in a randomized, controlled, crossover trial.
An overall significant treatment difference of 0.7 points on a 0-10 numerical rating scale global pain score was observed when patients with painful medial osteoarthritis (OA) wore lateral wedge insoles compared with when they wore neutral insoles in their own shoes (95% confidence interval [CI], 0.1-1.2 points; P = .02).
The study’s findings are in contrast to previous research that has found no benefit of lateral wedge insoles in patients with medial compartment knee OA (JAMA. 2013;310[7]:722-30) because patients were specifically prescreened to find those who would be biomechanical responders, David T. Felson, MD, said at the World Congress on Osteoarthritis.
“There is increased medial load in medial knee OA, and that is thought to cause pain and medial joint damage,” Dr. Felson, of Boston University, said at the congress, sponsored by the Osteoarthritis Research Society International.
There is evidence, however, that by moving the center of pressure laterally during walking with the use of lateral wedge insoles, the external knee adduction movement (KAM) can be reduced by around 5%-6%, which in turn can reduce the load across the medial component.
“We asked the following question: ‘If patients were screened to remove those with painful patellofemoral OA and those who did not show a biomechanical response to lateral wedge insoles, would lateral wedge insoles actually reduce pain?’ ” Dr. Felson noted.
For inclusion in the trial, patients needed to be aged between 40 and 80 years and have x-rays showing Kellgren-Lawrence grade 2-4 OA with definite medial and no lateral joint space narrowing in the last 2 years. They then also needed to have experienced knee pain that was rated at least 4 or more on a 0-10 numerical rating scale in the last week. Patients then had to be examined by an experienced physiotherapist or have x-rays to exclude patellofemoral OA and inflammatory arthritis.
All patients then underwent biomechanical assessment which consisted of motion analysis screening. Patients who did not show at least a 2% decrease in KAM after wearing the lateral wedge insoles versus the neutral insoles were excluded.
Of 112 subjects who were screened for the study, there remained 62 with a mean age of 64 years and body mass index of 28 kg/m2 who could be randomized. The subjects, 73% of whom were male, were randomized to first wear either neutral insoles or insoles with a lateral five-degree wedge for 8 weeks and then, after an 8-week washout period, to wear the other type of insole for a further 8 weeks. Participants wore the insoles for at least 4 hours a day and for a median of 7 hours per day.
Results showed that the lateral wedge insoles reduced KAM by 7.5% versus their own shoes and by 6.6% versus a neutral insole, and of the 62 patients randomized, 56 completed the trial. Two patients in each group stopped participating in the trial because of adverse events, which with lateral wedge insoles were cramps in the calf and foot and increased pain in the knee, and with the neutral insoles included a blister and increased pain in knee and foot.
At baseline, the mean global knee pain score in the last week was 5.46. After use of the lateral wedge or neutral insoles, this fell to a respective 4.2 and 4.9.
Patients were asked to report on the pain experience during a nominated activity. The baseline value for pain was 6.18, which decreased to 4.9 and 5.8 in the two groups, respectively, with an overall treatment difference of 0.9 (P = .001) favoring the use of the lateral wedge insoles.
There was improvement in knee pain assessed by the Knee injury and Osteoarthritis Outcomes Score from a baseline of 55 points to a score of 60.6 for lateral wedge and 58.9 for the neutral insoles, a between group difference of –1.7 (P = .45).
“Lateral wedge insoles reduce knee pain in selected subjects with painful medial OA, those without patellofemoral OA, and those who are biomechanical responders to these insoles,” Dr. Felson said.
“I think the importance of this study is that it opens the door to a treatment that we were frustrated wasn’t working,” Dr. Felson said. Insoles are inexpensive, safe, and potentially widely useful, and the research paves the way for further study of these insoles and for perhaps for shoes that could modify knee loads.
The findings open the door to “stratified approaches to knee OA that may also offer us an avenue toward success in developing treatments,” he added.
The National Institute for Health Research, Arthritis Research U.K., and the National Institutes of Health sponsored the study. Dr. Felson had no disclosures.
SOURCE: Felson D et al. Osteoarthritis Cartilage. 2018:26(1):S17. Abstract 14.
LIVERPOOL, ENGLAND – Lateral wedge insoles reduced osteoarthritis knee pain to a greater extent than did wearing neutral insoles in a randomized, controlled, crossover trial.
An overall significant treatment difference of 0.7 points on a 0-10 numerical rating scale global pain score was observed when patients with painful medial osteoarthritis (OA) wore lateral wedge insoles compared with when they wore neutral insoles in their own shoes (95% confidence interval [CI], 0.1-1.2 points; P = .02).
The study’s findings are in contrast to previous research that has found no benefit of lateral wedge insoles in patients with medial compartment knee OA (JAMA. 2013;310[7]:722-30) because patients were specifically prescreened to find those who would be biomechanical responders, David T. Felson, MD, said at the World Congress on Osteoarthritis.
“There is increased medial load in medial knee OA, and that is thought to cause pain and medial joint damage,” Dr. Felson, of Boston University, said at the congress, sponsored by the Osteoarthritis Research Society International.
There is evidence, however, that by moving the center of pressure laterally during walking with the use of lateral wedge insoles, the external knee adduction movement (KAM) can be reduced by around 5%-6%, which in turn can reduce the load across the medial component.
“We asked the following question: ‘If patients were screened to remove those with painful patellofemoral OA and those who did not show a biomechanical response to lateral wedge insoles, would lateral wedge insoles actually reduce pain?’ ” Dr. Felson noted.
For inclusion in the trial, patients needed to be aged between 40 and 80 years and have x-rays showing Kellgren-Lawrence grade 2-4 OA with definite medial and no lateral joint space narrowing in the last 2 years. They then also needed to have experienced knee pain that was rated at least 4 or more on a 0-10 numerical rating scale in the last week. Patients then had to be examined by an experienced physiotherapist or have x-rays to exclude patellofemoral OA and inflammatory arthritis.
All patients then underwent biomechanical assessment which consisted of motion analysis screening. Patients who did not show at least a 2% decrease in KAM after wearing the lateral wedge insoles versus the neutral insoles were excluded.
Of 112 subjects who were screened for the study, there remained 62 with a mean age of 64 years and body mass index of 28 kg/m2 who could be randomized. The subjects, 73% of whom were male, were randomized to first wear either neutral insoles or insoles with a lateral five-degree wedge for 8 weeks and then, after an 8-week washout period, to wear the other type of insole for a further 8 weeks. Participants wore the insoles for at least 4 hours a day and for a median of 7 hours per day.
Results showed that the lateral wedge insoles reduced KAM by 7.5% versus their own shoes and by 6.6% versus a neutral insole, and of the 62 patients randomized, 56 completed the trial. Two patients in each group stopped participating in the trial because of adverse events, which with lateral wedge insoles were cramps in the calf and foot and increased pain in the knee, and with the neutral insoles included a blister and increased pain in knee and foot.
At baseline, the mean global knee pain score in the last week was 5.46. After use of the lateral wedge or neutral insoles, this fell to a respective 4.2 and 4.9.
Patients were asked to report on the pain experience during a nominated activity. The baseline value for pain was 6.18, which decreased to 4.9 and 5.8 in the two groups, respectively, with an overall treatment difference of 0.9 (P = .001) favoring the use of the lateral wedge insoles.
There was improvement in knee pain assessed by the Knee injury and Osteoarthritis Outcomes Score from a baseline of 55 points to a score of 60.6 for lateral wedge and 58.9 for the neutral insoles, a between group difference of –1.7 (P = .45).
“Lateral wedge insoles reduce knee pain in selected subjects with painful medial OA, those without patellofemoral OA, and those who are biomechanical responders to these insoles,” Dr. Felson said.
“I think the importance of this study is that it opens the door to a treatment that we were frustrated wasn’t working,” Dr. Felson said. Insoles are inexpensive, safe, and potentially widely useful, and the research paves the way for further study of these insoles and for perhaps for shoes that could modify knee loads.
The findings open the door to “stratified approaches to knee OA that may also offer us an avenue toward success in developing treatments,” he added.
The National Institute for Health Research, Arthritis Research U.K., and the National Institutes of Health sponsored the study. Dr. Felson had no disclosures.
SOURCE: Felson D et al. Osteoarthritis Cartilage. 2018:26(1):S17. Abstract 14.
LIVERPOOL, ENGLAND – Lateral wedge insoles reduced osteoarthritis knee pain to a greater extent than did wearing neutral insoles in a randomized, controlled, crossover trial.
An overall significant treatment difference of 0.7 points on a 0-10 numerical rating scale global pain score was observed when patients with painful medial osteoarthritis (OA) wore lateral wedge insoles compared with when they wore neutral insoles in their own shoes (95% confidence interval [CI], 0.1-1.2 points; P = .02).
The study’s findings are in contrast to previous research that has found no benefit of lateral wedge insoles in patients with medial compartment knee OA (JAMA. 2013;310[7]:722-30) because patients were specifically prescreened to find those who would be biomechanical responders, David T. Felson, MD, said at the World Congress on Osteoarthritis.
“There is increased medial load in medial knee OA, and that is thought to cause pain and medial joint damage,” Dr. Felson, of Boston University, said at the congress, sponsored by the Osteoarthritis Research Society International.
There is evidence, however, that by moving the center of pressure laterally during walking with the use of lateral wedge insoles, the external knee adduction movement (KAM) can be reduced by around 5%-6%, which in turn can reduce the load across the medial component.
“We asked the following question: ‘If patients were screened to remove those with painful patellofemoral OA and those who did not show a biomechanical response to lateral wedge insoles, would lateral wedge insoles actually reduce pain?’ ” Dr. Felson noted.
For inclusion in the trial, patients needed to be aged between 40 and 80 years and have x-rays showing Kellgren-Lawrence grade 2-4 OA with definite medial and no lateral joint space narrowing in the last 2 years. They then also needed to have experienced knee pain that was rated at least 4 or more on a 0-10 numerical rating scale in the last week. Patients then had to be examined by an experienced physiotherapist or have x-rays to exclude patellofemoral OA and inflammatory arthritis.
All patients then underwent biomechanical assessment which consisted of motion analysis screening. Patients who did not show at least a 2% decrease in KAM after wearing the lateral wedge insoles versus the neutral insoles were excluded.
Of 112 subjects who were screened for the study, there remained 62 with a mean age of 64 years and body mass index of 28 kg/m2 who could be randomized. The subjects, 73% of whom were male, were randomized to first wear either neutral insoles or insoles with a lateral five-degree wedge for 8 weeks and then, after an 8-week washout period, to wear the other type of insole for a further 8 weeks. Participants wore the insoles for at least 4 hours a day and for a median of 7 hours per day.
Results showed that the lateral wedge insoles reduced KAM by 7.5% versus their own shoes and by 6.6% versus a neutral insole, and of the 62 patients randomized, 56 completed the trial. Two patients in each group stopped participating in the trial because of adverse events, which with lateral wedge insoles were cramps in the calf and foot and increased pain in the knee, and with the neutral insoles included a blister and increased pain in knee and foot.
At baseline, the mean global knee pain score in the last week was 5.46. After use of the lateral wedge or neutral insoles, this fell to a respective 4.2 and 4.9.
Patients were asked to report on the pain experience during a nominated activity. The baseline value for pain was 6.18, which decreased to 4.9 and 5.8 in the two groups, respectively, with an overall treatment difference of 0.9 (P = .001) favoring the use of the lateral wedge insoles.
There was improvement in knee pain assessed by the Knee injury and Osteoarthritis Outcomes Score from a baseline of 55 points to a score of 60.6 for lateral wedge and 58.9 for the neutral insoles, a between group difference of –1.7 (P = .45).
“Lateral wedge insoles reduce knee pain in selected subjects with painful medial OA, those without patellofemoral OA, and those who are biomechanical responders to these insoles,” Dr. Felson said.
“I think the importance of this study is that it opens the door to a treatment that we were frustrated wasn’t working,” Dr. Felson said. Insoles are inexpensive, safe, and potentially widely useful, and the research paves the way for further study of these insoles and for perhaps for shoes that could modify knee loads.
The findings open the door to “stratified approaches to knee OA that may also offer us an avenue toward success in developing treatments,” he added.
The National Institute for Health Research, Arthritis Research U.K., and the National Institutes of Health sponsored the study. Dr. Felson had no disclosures.
SOURCE: Felson D et al. Osteoarthritis Cartilage. 2018:26(1):S17. Abstract 14.
REPORTING FROM OARSI 2018
Key clinical point:
Major finding: There was a mean treatment difference of 0.7 points in a global pain score favoring lateral wedge over neutral insoles (P = .02).
Study details: Randomized, controlled, crossover study of 62 patients with painful medial knee OA.
Disclosures: The National Institute for Health Research, Arthritis Research U.K., and the National Institutes of Health sponsored the study. Dr. Felson had no disclosures.
Source: Felson D et al. Osteoarthritis Cartilage. 2018:26(1):S17. Abstract 14.
Hep B therapy: Indefinite or FINITE for e-negative patients?
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
LAS VEGAS – Current guidelines recommend indefinite continuation of antiviral therapy in chronic hepatitis B patients who are hepatitis B e-antigen (HBeAg)-negative. But emerging data suggest that this may not always be the case.
“It’s very provocative data, though not at the guideline level,” W. Ray Kim, MD, said in a presentation at the inaugural Perspectives in Digestive Diseases meeting held by Global Academy for Medical Education.
“There are patients who really have begged to go off treatment because they are sick of taking the medication for year after year after year,” said Dr. Kim, professor of medicine, gastroenterology and hepatology, Stanford (Calif.) University.
In light of new data, taking them off medication might be “something to consider” in noncirrhotic patients if they are completely suppressed, have normal ALT, and have a low level of quantitative hepatitis B surface antigen (HBsAg), Dr. Kim told attendees.
The most current Association for the Advancement of the Study of Liver Diseases guidelines state that unless there is a competing rationale, antiviral therapy should be continued indefinitely for noncirrhotic adults with HBeAg‐negative immune‐active chronic hepatitis B.
They do also say that treatment discontinuation “may be considered” for individuals with proven loss of HBsAg. “However, there is currently insufficient evidence to definitively guide treatment decisions for such persons,” the guidelines say.
Evidence has emerged since those guideline statements were written. Most recently, German investigators published results of the FINITE study showing some long-term responses after stopping tenofovir disoproxil fumarate (TDF) in noncirrhotic, HBeAg-negative patients.
In that prospective, controlled study, 62% of patients who stopped TDF therapy (n = 13) stayed off therapy to week 144 of treatment follow-up. Four of the patients achieved HBsAg loss, and median HBsAg change was –0.59log10IU/mL vs. 0.21log10IU/mL in patients who stayed on TDF therapy.
Investigators said that result demonstrated the potential of stopping long-term TDF treatment and seeing either HBsAg loss or sustained virologic response.
Before that, a retrospective study from investigators in Taiwan showed that age plus level of HBsAg were associated with HBV relapse after entecavir treatment in HBeAg-negative patients. According to investigators, those results suggested HBsAg levels could be used to guide timing of entecavir cessation.
If antiviral therapy is stopped in an HBeAg-negative patient, that patient should be monitored every 3 month for a year for recurrent viremia, ALT flares, and hepatic decompensation, Dr. Kim said at the meeting.
Even before stopping, “there are a number of factors to consider, including biological relapse, flare, hepatic decompensation,” he said.
On the other hand, there is the burden of continued therapy, financial concerns of continuing treatment due not only to medication costs but also long-term monitoring, as well as patient and provider preference, he noted in his presentation.
Global Academy and this news organization are owned by the same parent company.
Dr. Kim reported serving as a consultant to Gilead.
EXPERT ANALYSIS FROM PERSPECTIVES IN DIGESTIVE DISEASES
Merkel Cell Carcinoma: Presentation, Pathogenesis, and Spontaneous Regression
Cathepsin K inhibitor exhibits bone protecting effects in osteoarthritis
LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.
The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.
MIV-711 also produced rapid and sustained reductions in the bone biomarkers CTX-I and CTX-II, study investigator Philip Conaghan, MBBS, PhD, reported at the World Congress on Osteoarthritis.
The primary endpoint of the trial – the change in average knee pain over 26 weeks assessed using an 11-point numerical rating scale (NRS) – was not met, however, with no differences between MIV-711 treatment and placebo.
While there were also no statistical differences in Western Ontario and McMaster Universities Osteoarthritis Index pain scores, one of several secondary endpoints assessed, there was a trend for less pain with MIV-711 than with placebo.
“The lack of symptom benefits may reflect that the study duration was not sufficient to see symptom reduction following structure modification,” Dr. Conaghan and his coauthors stated in their abstract.
“That’s something we’re seeing with all the drugs that are trying to get DMOAD [disease modifying osteoarthritis drug] licenses at present,“ Dr. Conaghan said at the Congress, sponsored by the Osteoarthritis Research Society International.
Dr. Conaghan, who is professor of musculoskeletal medicine and director of the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine, noted: “Cathepsin K is a cysteine protease that degrades the collagen matrix and stops bone resorption, so it’s got a number of potential actions,” in the development of OA.
MIV-711 is a potent, selective, and reversible inhibitor of cathepsin K, he added, which has previously been shown to have bone structure–modifying properties in preclinical models. It also has been shown to reduce CTX-I and CTX-II in healthy volunteers.
The current randomized, double-blind, placebo-controlled phase 2a study included two active treatment (100 mg and 200 mg, once daily) arms and one placebo arm. For inclusion, patients had to have knee pain rated as 4 or higher on an 11-point NRS and Kellgren-Lawrence grade 2 or 3 knee OA.
Patients also were allowed to remain on any analgesic medication they were currently taking, provided this was stable. “That enables recruitment as a trialist, and it’s more like my usual practice as it’s unlikely I’d stop an analgesic before starting a new one,” Dr. Conaghan said.
In all, 240 patients were enrolled at six European sites. They had a mean age of 62 years, a body mass index of 32 kg/m2, and 77% were women. MRIs were assessed at baseline and at week 26, with additional clinic visits scheduled at 2, 4, 8, 14, and 20 weeks.
“Overall, there are not any great safety signals,” Dr. Conaghan said. The placebo, 100-mg, and 200-mg MIV-117 arms had similar rates of any adverse event (55%, 54.9%, and 52.4%) or treatment-related adverse events (21.2%, 20.7%, and 24.4%). There were more serious adverse events in the 100-mg and 200-mg MIV-711 treatment arms (3.7% and 2.4%) than in the placebo arm (1.3%), and more discontinuations (7.3%, 4.9%, and 3.8%).
“The primary endpoint of knee pain was not met, but there was a consistent trend, and it looks like there’s a benefit, but the statistically endpoint was not achieved,” Dr. Conaghan summarized.
“MRI measures do show structural modification in terms of bone shape and probably an effect on cartilage,” although the study was not powered to show an effect on the latter, Dr. Conaghan noted.
“The overall data, and from what we’ve seen regarding structural effects, do warrant this drug moving forward into further trials,” he added.
The study was sponsored by Medivir. Dr. Conaghan disclosed being a member of the speaker’s bureau for Kolon TissueGene and Samumed and on advisory boards for AbbVie, Centrexion, Flexion Therapeutics, Medivir, Novartis, and ONO Pharmaceutical.
SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.
The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.
MIV-711 also produced rapid and sustained reductions in the bone biomarkers CTX-I and CTX-II, study investigator Philip Conaghan, MBBS, PhD, reported at the World Congress on Osteoarthritis.
The primary endpoint of the trial – the change in average knee pain over 26 weeks assessed using an 11-point numerical rating scale (NRS) – was not met, however, with no differences between MIV-711 treatment and placebo.
While there were also no statistical differences in Western Ontario and McMaster Universities Osteoarthritis Index pain scores, one of several secondary endpoints assessed, there was a trend for less pain with MIV-711 than with placebo.
“The lack of symptom benefits may reflect that the study duration was not sufficient to see symptom reduction following structure modification,” Dr. Conaghan and his coauthors stated in their abstract.
“That’s something we’re seeing with all the drugs that are trying to get DMOAD [disease modifying osteoarthritis drug] licenses at present,“ Dr. Conaghan said at the Congress, sponsored by the Osteoarthritis Research Society International.
Dr. Conaghan, who is professor of musculoskeletal medicine and director of the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine, noted: “Cathepsin K is a cysteine protease that degrades the collagen matrix and stops bone resorption, so it’s got a number of potential actions,” in the development of OA.
MIV-711 is a potent, selective, and reversible inhibitor of cathepsin K, he added, which has previously been shown to have bone structure–modifying properties in preclinical models. It also has been shown to reduce CTX-I and CTX-II in healthy volunteers.
The current randomized, double-blind, placebo-controlled phase 2a study included two active treatment (100 mg and 200 mg, once daily) arms and one placebo arm. For inclusion, patients had to have knee pain rated as 4 or higher on an 11-point NRS and Kellgren-Lawrence grade 2 or 3 knee OA.
Patients also were allowed to remain on any analgesic medication they were currently taking, provided this was stable. “That enables recruitment as a trialist, and it’s more like my usual practice as it’s unlikely I’d stop an analgesic before starting a new one,” Dr. Conaghan said.
In all, 240 patients were enrolled at six European sites. They had a mean age of 62 years, a body mass index of 32 kg/m2, and 77% were women. MRIs were assessed at baseline and at week 26, with additional clinic visits scheduled at 2, 4, 8, 14, and 20 weeks.
“Overall, there are not any great safety signals,” Dr. Conaghan said. The placebo, 100-mg, and 200-mg MIV-117 arms had similar rates of any adverse event (55%, 54.9%, and 52.4%) or treatment-related adverse events (21.2%, 20.7%, and 24.4%). There were more serious adverse events in the 100-mg and 200-mg MIV-711 treatment arms (3.7% and 2.4%) than in the placebo arm (1.3%), and more discontinuations (7.3%, 4.9%, and 3.8%).
“The primary endpoint of knee pain was not met, but there was a consistent trend, and it looks like there’s a benefit, but the statistically endpoint was not achieved,” Dr. Conaghan summarized.
“MRI measures do show structural modification in terms of bone shape and probably an effect on cartilage,” although the study was not powered to show an effect on the latter, Dr. Conaghan noted.
“The overall data, and from what we’ve seen regarding structural effects, do warrant this drug moving forward into further trials,” he added.
The study was sponsored by Medivir. Dr. Conaghan disclosed being a member of the speaker’s bureau for Kolon TissueGene and Samumed and on advisory boards for AbbVie, Centrexion, Flexion Therapeutics, Medivir, Novartis, and ONO Pharmaceutical.
SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
LIVERPOOL, ENGLAND – The investigational cathepsin K inhibitor MIV-711 had positive effects on both bone and cartilage at 6 months in patients with knee osteoarthritis (OA) in a phase 2a study.
The MRI measures of the “area of bone in the medial femur region” and “average cartilage thickness” showed reduced progression with MIV-711 versus placebo.
MIV-711 also produced rapid and sustained reductions in the bone biomarkers CTX-I and CTX-II, study investigator Philip Conaghan, MBBS, PhD, reported at the World Congress on Osteoarthritis.
The primary endpoint of the trial – the change in average knee pain over 26 weeks assessed using an 11-point numerical rating scale (NRS) – was not met, however, with no differences between MIV-711 treatment and placebo.
While there were also no statistical differences in Western Ontario and McMaster Universities Osteoarthritis Index pain scores, one of several secondary endpoints assessed, there was a trend for less pain with MIV-711 than with placebo.
“The lack of symptom benefits may reflect that the study duration was not sufficient to see symptom reduction following structure modification,” Dr. Conaghan and his coauthors stated in their abstract.
“That’s something we’re seeing with all the drugs that are trying to get DMOAD [disease modifying osteoarthritis drug] licenses at present,“ Dr. Conaghan said at the Congress, sponsored by the Osteoarthritis Research Society International.
Dr. Conaghan, who is professor of musculoskeletal medicine and director of the Leeds (England) Institute of Rheumatic and Musculoskeletal Medicine, noted: “Cathepsin K is a cysteine protease that degrades the collagen matrix and stops bone resorption, so it’s got a number of potential actions,” in the development of OA.
MIV-711 is a potent, selective, and reversible inhibitor of cathepsin K, he added, which has previously been shown to have bone structure–modifying properties in preclinical models. It also has been shown to reduce CTX-I and CTX-II in healthy volunteers.
The current randomized, double-blind, placebo-controlled phase 2a study included two active treatment (100 mg and 200 mg, once daily) arms and one placebo arm. For inclusion, patients had to have knee pain rated as 4 or higher on an 11-point NRS and Kellgren-Lawrence grade 2 or 3 knee OA.
Patients also were allowed to remain on any analgesic medication they were currently taking, provided this was stable. “That enables recruitment as a trialist, and it’s more like my usual practice as it’s unlikely I’d stop an analgesic before starting a new one,” Dr. Conaghan said.
In all, 240 patients were enrolled at six European sites. They had a mean age of 62 years, a body mass index of 32 kg/m2, and 77% were women. MRIs were assessed at baseline and at week 26, with additional clinic visits scheduled at 2, 4, 8, 14, and 20 weeks.
“Overall, there are not any great safety signals,” Dr. Conaghan said. The placebo, 100-mg, and 200-mg MIV-117 arms had similar rates of any adverse event (55%, 54.9%, and 52.4%) or treatment-related adverse events (21.2%, 20.7%, and 24.4%). There were more serious adverse events in the 100-mg and 200-mg MIV-711 treatment arms (3.7% and 2.4%) than in the placebo arm (1.3%), and more discontinuations (7.3%, 4.9%, and 3.8%).
“The primary endpoint of knee pain was not met, but there was a consistent trend, and it looks like there’s a benefit, but the statistically endpoint was not achieved,” Dr. Conaghan summarized.
“MRI measures do show structural modification in terms of bone shape and probably an effect on cartilage,” although the study was not powered to show an effect on the latter, Dr. Conaghan noted.
“The overall data, and from what we’ve seen regarding structural effects, do warrant this drug moving forward into further trials,” he added.
The study was sponsored by Medivir. Dr. Conaghan disclosed being a member of the speaker’s bureau for Kolon TissueGene and Samumed and on advisory boards for AbbVie, Centrexion, Flexion Therapeutics, Medivir, Novartis, and ONO Pharmaceutical.
SOURCE: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
REPORTING FROM OARSI 2018
Key clinical point:
Major finding: A 63%-66% reduction in the medial femur bone area was observed with MIV-711, compared with placebo.
Study details: Randomized, double-blind, placebo-controlled phase 2a study of 240 patients with osteoarthritis knee pain.
Disclosures: The study was sponsored by Medivir. Dr. Conaghan disclosed being a member of the speakers bureau for Kolon TissueGene and Samumed and on advisory boards for AbbVie, Centrexion, Flexion Therapeutics, Medivir, Novartis, and ONO Pharmaceutical.
Source: Conaghan P et al. Osteoarthritis Cartilage. 2018 Apr 16:26(1):S25-26. Abstract 29.
VIDEO: Postpartum care gets a new look
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
AUSTIN, TEX. – While women may have a plethora of options for care during pregnancy, attention given to women after birth is seriously lacking, with detrimental effect.
Currently, postpartum care is limited to a follow-up appointment 6 weeks after pregnancy, but according to Alison Stuebe, MD, medical director of lactation services at the University of North Carolina, Chapel Hill, there is too much going on in those 6 weeks to continue this model.
To address preferred changes to this system of care, the .
“What we’d like to do with the new committee opinion is move from this one-off visit at 6 weeks where we tell people ‘you’re good to go, you can have sex, get out of my office,’ to a much more comprehensive approach that reaches out to moms in the first couple of weeks,” explained Dr. Stuebe. “Whether that’s by phone, by asynchronous communication, by in-person visit, [the physician] finds out what’s going on, and then makes appropriate recommendations to help her rather than waiting to see what’s left after 6 weeks,” she said at ACOG’s annual clinical and scientific meeting.
Paying for these services is a big barrier right now, said Dr. Stuebe, but some solutions have already shown signs of being cost effective.
One example, in Dr. Stuebe’s hometown of Durham County, N.C., is a program called Durham Connect, which puts nurses in contact with women at 3 weeks postpartum to make assessments of what care the mother needs, and then offers service referrals to help with those needs.
According to Dr. Stuebe, studies have found every dollar invested in the program would save $3 in emergency department visits for children.
As postpartum care evolves, the most important thing is to remember that when it comes to pregnancy and birth, just because the baby is out doesn’t mean the mother can be ignored, she said.
“When we think about the way postpartum care exists today, you think about the mom being the candy wrapper and the baby being the candy; when the candy’s out of the wrapper, we toss the wrapper,” said Dr. Stuebe. “What these new guidelines are saying is this wrapper is actually pretty important.”
The revised committee opinion states: “The comprehensive postpartum visit should include a full assessment of physical, social, and psychological well-being, including the following domains: mood and emotional well-being; infant care and feeding; sexuality, contraception, and birth spacing; sleep and fatigue; physical recovery from birth; chronic disease management; and health maintenance.”
Dr. Stuebe receives support from Janssen.
REPORTING FROM ACOG 2018
Prompt palliative care cut hospital costs in pooled study
For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.
In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.
In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.
About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.
The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).
The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”
Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.
SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.
For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.
In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.
In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.
About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.
The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).
The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”
Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.
SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.
For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.
In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.
In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.
About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.
The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).
The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”
Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.
SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.
FROM JAMA INTERNAL MEDICINE
Key clinical point:
Major finding: Average cost savings per admission were $3,237 overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P-values less than .001).
Study details: Systematic review and meta-analysis of six cohort studies of 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease.
Disclosures: Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.
Source: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.