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Greater travel distance reduces rates of abortion
Travel distance is an important determinant of access to abortion care in the United States, new findings show.
Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.
The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.
Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).
Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.
Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.
Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.
“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”
As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”
However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
Study details
About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.
Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.
They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.
Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.
There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).
When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.
A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.
They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
Solutions are feasible
Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.
“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”
What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”
However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”
The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”
But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.
Another expert also weighed in and agreed that these two solutions can potentially be implemented.
“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.
“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”
Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”
As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”
The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.
Travel distance is an important determinant of access to abortion care in the United States, new findings show.
Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.
The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.
Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).
Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.
Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.
Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.
“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”
As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”
However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
Study details
About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.
Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.
They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.
Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.
There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).
When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.
A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.
They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
Solutions are feasible
Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.
“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”
What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”
However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”
The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”
But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.
Another expert also weighed in and agreed that these two solutions can potentially be implemented.
“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.
“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”
Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”
As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”
The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.
Travel distance is an important determinant of access to abortion care in the United States, new findings show.
Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.
The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.
Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).
Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.
Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.
Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.
“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”
As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”
However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
Study details
About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.
Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.
They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.
Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.
There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).
When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.
A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.
They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
Solutions are feasible
Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.
“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”
What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”
However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”
The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”
But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.
Another expert also weighed in and agreed that these two solutions can potentially be implemented.
“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.
“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”
Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”
As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”
The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.
FROM JAMA NETWORK OPEN
Do you plan to incorporate dynamic ultrasonography (use of the vaginal probe to help examine a patient, for pelvic pain for instance) into your practice?
[polldaddy:10873738]
[polldaddy:10873738]
[polldaddy:10873738]
Huge trial casts doubt on bisphosphonates for breast cancer
say researchers reporting new results from a phase 3 trial with almost 3,000 women.
Current guidelines call for 3-5 years of bisphosphonate therapy on the theory that these drugs might reduce breast cancer recurrence as well as treatment-related bone problems.
However, the new results show no difference in disease-free survival, distant disease-free survival, and overall survival – regardless of menopausal status – between the 1,540 women who received intravenous zoledronate over a 5-year period and 1,447 women who received such therapy over a 2-year period.
What they did find was a substantially higher risk for adverse events with prolonged bisphosphonate treatment, including risks for grade 3/4 events, bone pain, bone fractures, arthralgia, and jaw necrosis, a rare but well- recognized possibility with bisphosphonates.
Lead investigator Thomas Friedl, PhD, a statistician at University Hospital Ulm (Germany), and colleagues concluded that the current duration of treatment can be reduced and that, short of good reason to use bisphosphonates longer, such as decreased bone density, “treatment with zoledronate for 5 years should not be considered in patients with early breast cancer.”
The study was published online on June 24 in JAMA Oncology.
An accompanying editorial went even further, stating not only that “shorter duration of treatment is sufficient” but also that the whole idea of bisphosphonates for breast cancer is in doubt.
With “the modest outcomes of bisphosphonates, compared with no bone-targeted therapy, in historical trials” and the low rates of recurrence with modern treatment – less than 10% in the trial – “what, if any, is the benefit from adjuvant bisphosphonates? It’s time to reevaluate the guidelines,” said the editorialists, led by Alexandra Desnoyers, MD, a breast cancer fellow at the University of Toronto.
“We suggest that zoledronate or other amino-bisphosphonates should not be given as standard adjuvant therapy for unselected women with breast cancer,” they wrote.
Risk for necrosis with 5 years of zoledronate
The women in the trial had primary invasive breast cancer and were at high risk for recurrence. They had either positive nodes or high-risk features, including age (median, 53 years). They were treated at 250 centers in Germany.
The first part of the trial was to see whether use of gemcitabine improved outcomes when added to docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide adjuvant therapy following surgery. It did not, and the authors reported in 2020 that adjuvant gemcitabine should not be used in the treatment of high-risk early breast cancer.
The next phase of the trial involved zoledronate. Women were randomly assigned to receive zoledronate for 2 or 5 years after surgery and after undergoing chemotherapy. Dosing was 4 mg IV every 3 months for 2 years. The women in the 5-year group went on to receive 4 mg IV every 6 months for another 3 years.
At a mean of 5 years’ follow-up after the first zoledronate dose, there was no difference in any of the survival measures between the two dosage groups.
There was also no difference in rates of bone recurrence or in circulating tumor cells, which the bisphosphonates theory would have predicted. For instance, 10.5% of women in the 5-year group had one or more circulating tumor cells on follow-up versus 7.2% in the 2-year group.
Almost half of the women in the 5-year treatment group experienced adverse events with zoledronate – including 7.6% with grade 3/4 events – versus just over a quarter in the 2-year arm and only 5.1% with grade 3/4 events.
In the 5-year group, 8.3% of patients experienced bone pain and 5.1% experienced arthralgia versus 3.7% and 3.1%, respectively, in the 2-year arm.
Atypical fractures, such as femoral spiral fractures, are another concern with bisphosphonates. Although this trial did not report on fracture type, fractures were reported in 14 women in the 5-year group but in only 3 in the 2-year arm.
Jaw necrosis, another known adverse effect of bisphosphonates, was reported in 11 women in the 5-year group and in 5 in the 2-year group.
The study was funded by several pharmaceutical companies, including Novartis, the maker of zoledronate. The investigators have numerous industry ties. Dr. Friedl has received payments from Novartis.
A version of this article first appeared on Medscape.com.
say researchers reporting new results from a phase 3 trial with almost 3,000 women.
Current guidelines call for 3-5 years of bisphosphonate therapy on the theory that these drugs might reduce breast cancer recurrence as well as treatment-related bone problems.
However, the new results show no difference in disease-free survival, distant disease-free survival, and overall survival – regardless of menopausal status – between the 1,540 women who received intravenous zoledronate over a 5-year period and 1,447 women who received such therapy over a 2-year period.
What they did find was a substantially higher risk for adverse events with prolonged bisphosphonate treatment, including risks for grade 3/4 events, bone pain, bone fractures, arthralgia, and jaw necrosis, a rare but well- recognized possibility with bisphosphonates.
Lead investigator Thomas Friedl, PhD, a statistician at University Hospital Ulm (Germany), and colleagues concluded that the current duration of treatment can be reduced and that, short of good reason to use bisphosphonates longer, such as decreased bone density, “treatment with zoledronate for 5 years should not be considered in patients with early breast cancer.”
The study was published online on June 24 in JAMA Oncology.
An accompanying editorial went even further, stating not only that “shorter duration of treatment is sufficient” but also that the whole idea of bisphosphonates for breast cancer is in doubt.
With “the modest outcomes of bisphosphonates, compared with no bone-targeted therapy, in historical trials” and the low rates of recurrence with modern treatment – less than 10% in the trial – “what, if any, is the benefit from adjuvant bisphosphonates? It’s time to reevaluate the guidelines,” said the editorialists, led by Alexandra Desnoyers, MD, a breast cancer fellow at the University of Toronto.
“We suggest that zoledronate or other amino-bisphosphonates should not be given as standard adjuvant therapy for unselected women with breast cancer,” they wrote.
Risk for necrosis with 5 years of zoledronate
The women in the trial had primary invasive breast cancer and were at high risk for recurrence. They had either positive nodes or high-risk features, including age (median, 53 years). They were treated at 250 centers in Germany.
The first part of the trial was to see whether use of gemcitabine improved outcomes when added to docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide adjuvant therapy following surgery. It did not, and the authors reported in 2020 that adjuvant gemcitabine should not be used in the treatment of high-risk early breast cancer.
The next phase of the trial involved zoledronate. Women were randomly assigned to receive zoledronate for 2 or 5 years after surgery and after undergoing chemotherapy. Dosing was 4 mg IV every 3 months for 2 years. The women in the 5-year group went on to receive 4 mg IV every 6 months for another 3 years.
At a mean of 5 years’ follow-up after the first zoledronate dose, there was no difference in any of the survival measures between the two dosage groups.
There was also no difference in rates of bone recurrence or in circulating tumor cells, which the bisphosphonates theory would have predicted. For instance, 10.5% of women in the 5-year group had one or more circulating tumor cells on follow-up versus 7.2% in the 2-year group.
Almost half of the women in the 5-year treatment group experienced adverse events with zoledronate – including 7.6% with grade 3/4 events – versus just over a quarter in the 2-year arm and only 5.1% with grade 3/4 events.
In the 5-year group, 8.3% of patients experienced bone pain and 5.1% experienced arthralgia versus 3.7% and 3.1%, respectively, in the 2-year arm.
Atypical fractures, such as femoral spiral fractures, are another concern with bisphosphonates. Although this trial did not report on fracture type, fractures were reported in 14 women in the 5-year group but in only 3 in the 2-year arm.
Jaw necrosis, another known adverse effect of bisphosphonates, was reported in 11 women in the 5-year group and in 5 in the 2-year group.
The study was funded by several pharmaceutical companies, including Novartis, the maker of zoledronate. The investigators have numerous industry ties. Dr. Friedl has received payments from Novartis.
A version of this article first appeared on Medscape.com.
say researchers reporting new results from a phase 3 trial with almost 3,000 women.
Current guidelines call for 3-5 years of bisphosphonate therapy on the theory that these drugs might reduce breast cancer recurrence as well as treatment-related bone problems.
However, the new results show no difference in disease-free survival, distant disease-free survival, and overall survival – regardless of menopausal status – between the 1,540 women who received intravenous zoledronate over a 5-year period and 1,447 women who received such therapy over a 2-year period.
What they did find was a substantially higher risk for adverse events with prolonged bisphosphonate treatment, including risks for grade 3/4 events, bone pain, bone fractures, arthralgia, and jaw necrosis, a rare but well- recognized possibility with bisphosphonates.
Lead investigator Thomas Friedl, PhD, a statistician at University Hospital Ulm (Germany), and colleagues concluded that the current duration of treatment can be reduced and that, short of good reason to use bisphosphonates longer, such as decreased bone density, “treatment with zoledronate for 5 years should not be considered in patients with early breast cancer.”
The study was published online on June 24 in JAMA Oncology.
An accompanying editorial went even further, stating not only that “shorter duration of treatment is sufficient” but also that the whole idea of bisphosphonates for breast cancer is in doubt.
With “the modest outcomes of bisphosphonates, compared with no bone-targeted therapy, in historical trials” and the low rates of recurrence with modern treatment – less than 10% in the trial – “what, if any, is the benefit from adjuvant bisphosphonates? It’s time to reevaluate the guidelines,” said the editorialists, led by Alexandra Desnoyers, MD, a breast cancer fellow at the University of Toronto.
“We suggest that zoledronate or other amino-bisphosphonates should not be given as standard adjuvant therapy for unselected women with breast cancer,” they wrote.
Risk for necrosis with 5 years of zoledronate
The women in the trial had primary invasive breast cancer and were at high risk for recurrence. They had either positive nodes or high-risk features, including age (median, 53 years). They were treated at 250 centers in Germany.
The first part of the trial was to see whether use of gemcitabine improved outcomes when added to docetaxel after standard fluorouracil, epirubicin, and cyclophosphamide adjuvant therapy following surgery. It did not, and the authors reported in 2020 that adjuvant gemcitabine should not be used in the treatment of high-risk early breast cancer.
The next phase of the trial involved zoledronate. Women were randomly assigned to receive zoledronate for 2 or 5 years after surgery and after undergoing chemotherapy. Dosing was 4 mg IV every 3 months for 2 years. The women in the 5-year group went on to receive 4 mg IV every 6 months for another 3 years.
At a mean of 5 years’ follow-up after the first zoledronate dose, there was no difference in any of the survival measures between the two dosage groups.
There was also no difference in rates of bone recurrence or in circulating tumor cells, which the bisphosphonates theory would have predicted. For instance, 10.5% of women in the 5-year group had one or more circulating tumor cells on follow-up versus 7.2% in the 2-year group.
Almost half of the women in the 5-year treatment group experienced adverse events with zoledronate – including 7.6% with grade 3/4 events – versus just over a quarter in the 2-year arm and only 5.1% with grade 3/4 events.
In the 5-year group, 8.3% of patients experienced bone pain and 5.1% experienced arthralgia versus 3.7% and 3.1%, respectively, in the 2-year arm.
Atypical fractures, such as femoral spiral fractures, are another concern with bisphosphonates. Although this trial did not report on fracture type, fractures were reported in 14 women in the 5-year group but in only 3 in the 2-year arm.
Jaw necrosis, another known adverse effect of bisphosphonates, was reported in 11 women in the 5-year group and in 5 in the 2-year group.
The study was funded by several pharmaceutical companies, including Novartis, the maker of zoledronate. The investigators have numerous industry ties. Dr. Friedl has received payments from Novartis.
A version of this article first appeared on Medscape.com.
Small uptick in children’s COVID vaccinations can’t change overall decline
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
Is walking speed following stroke a good predictor of recovery?
, suggests new research backed by imaging data.
In secondary analysis of a previous study, training enabled both “good” and “limited” walkers to increase travel distance during a 2-minute walk. However, for “dual-task” walking, good walkers improved their distance by approximately 10 m after training, whereas limited walkers improved by only 1 m. Brain imaging showed increased brain activity in the limited walkers, which could reduce cognitive resources available for performing a second task while walking.
These findings, which were published online May 30 in Clinical Rehabilitation, may explain the apparent lack of superiority, shown previously, of dual-task training compared with single-task training for patients with stroke and impaired walking ability, researchers noted.
“Imaging data were consistent with our hypothesis that walking automaticity might explain these results,” said lead author Johnny Collett, PhD, senior clinical research fellow at Oxford Brookes University, United Kingdom.
At baseline, participants who walked slowly had increased resting state connectivity between contralesional M1 and cortical areas associated with conscious gait control.
“In response to the intervention, we found increased connectivity with the precuneus in those who walked slowly at baseline, an adaptation that might support walking in more complex situations,” Dr. Collett said.
Benefits questioned
After stroke, many patients have difficulty walking while performing a second task, such as holding a conversation. Training in dual-task walking has provided uncertain benefits, according to clinical research.
In healthy individuals, walking is believed to be a largely automatic process that requires minimal executive resources. Previous studies have suggested that a certain minimum walking speed is required to enable automatic control of walking in the brain.
“We know that those with better walking ability after stroke are better able to cope with additional cognitive loads while walking,” said Dr. Collett. “Here, we proposed that increased automatic gait control may provide a mechanism whereby executive resources are freed up to attend to additional tasks,” he added.
The investigators further hypothesized that greater walking speed is required for automatic gait control. To test these hypotheses, they analyzed data from a previously conducted randomized trial of single- and dual-task walking interventions.
Trial participants were aged 18 years or older, had survived a stroke that had occurred at least 6 months before enrollment, had reduced 2-minute walk distance relative to their peers, and had no comorbid neurologic or psychologic disorders.
Over 10 weeks, participants underwent 20 sessions that included 30 minutes of walking on a treadmill. They were randomly assigned to undergo single-task walking or dual-task walking. The latter incorporated cognitive tasks as distractions.
Good versus limited walkers
In the current study, investigators analyzed various assessments that had been conducted at baseline and after completion of the training sessions, including distance on 2-minute walks with and without a distracting task. In addition, participants underwent imaging with functional near-infrared spectroscopy (fNIRS) and fMRI.
Using previous research as a basis, the researchers defined good walking speed as 0.8 m/sec. They categorized all participants, regardless of their intervention assignments, as having good walking capacity (0.8 m/sec or more) or limited walking capacity (less than 0.79 m/sec).
A total of 50 participants enrolled in the study (mean age, 62 years), and 45 completed the interventions. Of those who completed the interventions, 22 were randomly assigned to undergo single-task training, and 23 were assigned to dual-task training.
The researchers categorized 21 participants as having good walking capacity and 24 as having limited walking capacity. Participants in each category were divided approximately evenly between treatment assignments.
Barthel index score, which assesses functional independence, was higher in the group of good walkers.
Increased travel distance
Results showed that after the interventions, distance traveled during the single-task 2-minute walk increased by 8.9 m for good walkers and by 5.3 m for limited walkers. For the dual-task 2-minute walk, the distance traveled increased by 10.4 m among good walkers and by 1.3 m for limited walkers. Change from baseline on the dual-task walk was not significant for limited walkers.
There was no significant difference between good walkers and limited walkers in their perceptions of participation in community walking. Neither group increased its walking activity significantly following the interventions.
At baseline, limited walkers, in comparison with good walkers, had significantly greater activation in the contralesional hemisphere during dual-task walking, which consisted of incorporating a planning task.
In contrast, for many good walkers, there was a decrease in activation during dual-task walking. Activation in the contralesional hemisphere correlated negatively with dual-task 2-minute walk distance.
The researchers also found a negative correlation between activation and dual-task 2-minute walk distance when the second task was the Stroop task.
Initial step
“The original trial was never designed or powered to compare groups formed by walking speed or test our automaticity hypothesis, and the results need to be viewed within this context,” said Dr. Collett. The small sample size did not allow the researchers to detect small effects of the intervention, especially in the imaging data, he added.
It also prevented the investigators from comparing limited walking and good walking groups according to whether they underwent the single-task or dual-task intervention, “which would be a superior way to investigate our hypotheses,” Dr. Collett said.
“The result of this study should be seen as exploratory, with further investigation needed,” he noted.
Helping stroke survivors to walk in the community is challenging, and new interventions that enable them to navigate complex surroundings need to be designed, said Dr. Collett. “Research is required to better understand the conscious and automatic contribution to gait control, especially with neurological impairment,” he added.
Overall, “our results suggest that improving automatic walking may be an initial step to improve capacity to respond to more complex walking interventions. However, [future] trials are required to test this,” he concluded.
The next frontier?
Commenting on the findings, Louis R. Caplan, MD, professor of neurology at Harvard University and senior neurologist at Beth Israel Deaconess Medical Center, Boston, said that “recovery and rehab are going to be the next frontier in stroke neurology, because there has to be a limitation in the present emphasis on acute care.”
Some patients do not receive acute care on time, and current treatment is not curative, added Dr. Caplan, who was not involved with the research.
Little scientific attention has been paid to how doctors can enhance recovery after stroke, what interventions delay recovery, and what the natural history of recovery is, he said. “This is a very nice study about that.”
Although the study’s methodology was sound, there were some limitations, including that strokes and underlying brain lesions were heterogeneous and that the study population was relatively small, Dr. Caplan said.
He added that “it’s a difficult study to do” and that it is difficult to organize participants into homogeneous groups.
Another limitation cited was lack of long-term follow-up that could indicate whether training provided sustained improvements in walking.
“It would be nice to revisit the same people later and see if their walking has improved, if they’re doing it differently, and if their subjective responses are different,” said Dr. Caplan.
In addition, the study did not examine whether the interventions made it easier for participants to walk with other people or to socialize more. “It may be that it really requires some time for them to gain confidence and for them to integrate that into their social network,” Dr. Caplan said.
“I would call it a proof-of-principle study, not a final study,” he noted. “It’s a study that shows that you can scientifically study rehab” and indicates the possible methodology that could be used.
The study was funded by the Stroke Association. Dr. Collett and Dr. Caplan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, suggests new research backed by imaging data.
In secondary analysis of a previous study, training enabled both “good” and “limited” walkers to increase travel distance during a 2-minute walk. However, for “dual-task” walking, good walkers improved their distance by approximately 10 m after training, whereas limited walkers improved by only 1 m. Brain imaging showed increased brain activity in the limited walkers, which could reduce cognitive resources available for performing a second task while walking.
These findings, which were published online May 30 in Clinical Rehabilitation, may explain the apparent lack of superiority, shown previously, of dual-task training compared with single-task training for patients with stroke and impaired walking ability, researchers noted.
“Imaging data were consistent with our hypothesis that walking automaticity might explain these results,” said lead author Johnny Collett, PhD, senior clinical research fellow at Oxford Brookes University, United Kingdom.
At baseline, participants who walked slowly had increased resting state connectivity between contralesional M1 and cortical areas associated with conscious gait control.
“In response to the intervention, we found increased connectivity with the precuneus in those who walked slowly at baseline, an adaptation that might support walking in more complex situations,” Dr. Collett said.
Benefits questioned
After stroke, many patients have difficulty walking while performing a second task, such as holding a conversation. Training in dual-task walking has provided uncertain benefits, according to clinical research.
In healthy individuals, walking is believed to be a largely automatic process that requires minimal executive resources. Previous studies have suggested that a certain minimum walking speed is required to enable automatic control of walking in the brain.
“We know that those with better walking ability after stroke are better able to cope with additional cognitive loads while walking,” said Dr. Collett. “Here, we proposed that increased automatic gait control may provide a mechanism whereby executive resources are freed up to attend to additional tasks,” he added.
The investigators further hypothesized that greater walking speed is required for automatic gait control. To test these hypotheses, they analyzed data from a previously conducted randomized trial of single- and dual-task walking interventions.
Trial participants were aged 18 years or older, had survived a stroke that had occurred at least 6 months before enrollment, had reduced 2-minute walk distance relative to their peers, and had no comorbid neurologic or psychologic disorders.
Over 10 weeks, participants underwent 20 sessions that included 30 minutes of walking on a treadmill. They were randomly assigned to undergo single-task walking or dual-task walking. The latter incorporated cognitive tasks as distractions.
Good versus limited walkers
In the current study, investigators analyzed various assessments that had been conducted at baseline and after completion of the training sessions, including distance on 2-minute walks with and without a distracting task. In addition, participants underwent imaging with functional near-infrared spectroscopy (fNIRS) and fMRI.
Using previous research as a basis, the researchers defined good walking speed as 0.8 m/sec. They categorized all participants, regardless of their intervention assignments, as having good walking capacity (0.8 m/sec or more) or limited walking capacity (less than 0.79 m/sec).
A total of 50 participants enrolled in the study (mean age, 62 years), and 45 completed the interventions. Of those who completed the interventions, 22 were randomly assigned to undergo single-task training, and 23 were assigned to dual-task training.
The researchers categorized 21 participants as having good walking capacity and 24 as having limited walking capacity. Participants in each category were divided approximately evenly between treatment assignments.
Barthel index score, which assesses functional independence, was higher in the group of good walkers.
Increased travel distance
Results showed that after the interventions, distance traveled during the single-task 2-minute walk increased by 8.9 m for good walkers and by 5.3 m for limited walkers. For the dual-task 2-minute walk, the distance traveled increased by 10.4 m among good walkers and by 1.3 m for limited walkers. Change from baseline on the dual-task walk was not significant for limited walkers.
There was no significant difference between good walkers and limited walkers in their perceptions of participation in community walking. Neither group increased its walking activity significantly following the interventions.
At baseline, limited walkers, in comparison with good walkers, had significantly greater activation in the contralesional hemisphere during dual-task walking, which consisted of incorporating a planning task.
In contrast, for many good walkers, there was a decrease in activation during dual-task walking. Activation in the contralesional hemisphere correlated negatively with dual-task 2-minute walk distance.
The researchers also found a negative correlation between activation and dual-task 2-minute walk distance when the second task was the Stroop task.
Initial step
“The original trial was never designed or powered to compare groups formed by walking speed or test our automaticity hypothesis, and the results need to be viewed within this context,” said Dr. Collett. The small sample size did not allow the researchers to detect small effects of the intervention, especially in the imaging data, he added.
It also prevented the investigators from comparing limited walking and good walking groups according to whether they underwent the single-task or dual-task intervention, “which would be a superior way to investigate our hypotheses,” Dr. Collett said.
“The result of this study should be seen as exploratory, with further investigation needed,” he noted.
Helping stroke survivors to walk in the community is challenging, and new interventions that enable them to navigate complex surroundings need to be designed, said Dr. Collett. “Research is required to better understand the conscious and automatic contribution to gait control, especially with neurological impairment,” he added.
Overall, “our results suggest that improving automatic walking may be an initial step to improve capacity to respond to more complex walking interventions. However, [future] trials are required to test this,” he concluded.
The next frontier?
Commenting on the findings, Louis R. Caplan, MD, professor of neurology at Harvard University and senior neurologist at Beth Israel Deaconess Medical Center, Boston, said that “recovery and rehab are going to be the next frontier in stroke neurology, because there has to be a limitation in the present emphasis on acute care.”
Some patients do not receive acute care on time, and current treatment is not curative, added Dr. Caplan, who was not involved with the research.
Little scientific attention has been paid to how doctors can enhance recovery after stroke, what interventions delay recovery, and what the natural history of recovery is, he said. “This is a very nice study about that.”
Although the study’s methodology was sound, there were some limitations, including that strokes and underlying brain lesions were heterogeneous and that the study population was relatively small, Dr. Caplan said.
He added that “it’s a difficult study to do” and that it is difficult to organize participants into homogeneous groups.
Another limitation cited was lack of long-term follow-up that could indicate whether training provided sustained improvements in walking.
“It would be nice to revisit the same people later and see if their walking has improved, if they’re doing it differently, and if their subjective responses are different,” said Dr. Caplan.
In addition, the study did not examine whether the interventions made it easier for participants to walk with other people or to socialize more. “It may be that it really requires some time for them to gain confidence and for them to integrate that into their social network,” Dr. Caplan said.
“I would call it a proof-of-principle study, not a final study,” he noted. “It’s a study that shows that you can scientifically study rehab” and indicates the possible methodology that could be used.
The study was funded by the Stroke Association. Dr. Collett and Dr. Caplan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, suggests new research backed by imaging data.
In secondary analysis of a previous study, training enabled both “good” and “limited” walkers to increase travel distance during a 2-minute walk. However, for “dual-task” walking, good walkers improved their distance by approximately 10 m after training, whereas limited walkers improved by only 1 m. Brain imaging showed increased brain activity in the limited walkers, which could reduce cognitive resources available for performing a second task while walking.
These findings, which were published online May 30 in Clinical Rehabilitation, may explain the apparent lack of superiority, shown previously, of dual-task training compared with single-task training for patients with stroke and impaired walking ability, researchers noted.
“Imaging data were consistent with our hypothesis that walking automaticity might explain these results,” said lead author Johnny Collett, PhD, senior clinical research fellow at Oxford Brookes University, United Kingdom.
At baseline, participants who walked slowly had increased resting state connectivity between contralesional M1 and cortical areas associated with conscious gait control.
“In response to the intervention, we found increased connectivity with the precuneus in those who walked slowly at baseline, an adaptation that might support walking in more complex situations,” Dr. Collett said.
Benefits questioned
After stroke, many patients have difficulty walking while performing a second task, such as holding a conversation. Training in dual-task walking has provided uncertain benefits, according to clinical research.
In healthy individuals, walking is believed to be a largely automatic process that requires minimal executive resources. Previous studies have suggested that a certain minimum walking speed is required to enable automatic control of walking in the brain.
“We know that those with better walking ability after stroke are better able to cope with additional cognitive loads while walking,” said Dr. Collett. “Here, we proposed that increased automatic gait control may provide a mechanism whereby executive resources are freed up to attend to additional tasks,” he added.
The investigators further hypothesized that greater walking speed is required for automatic gait control. To test these hypotheses, they analyzed data from a previously conducted randomized trial of single- and dual-task walking interventions.
Trial participants were aged 18 years or older, had survived a stroke that had occurred at least 6 months before enrollment, had reduced 2-minute walk distance relative to their peers, and had no comorbid neurologic or psychologic disorders.
Over 10 weeks, participants underwent 20 sessions that included 30 minutes of walking on a treadmill. They were randomly assigned to undergo single-task walking or dual-task walking. The latter incorporated cognitive tasks as distractions.
Good versus limited walkers
In the current study, investigators analyzed various assessments that had been conducted at baseline and after completion of the training sessions, including distance on 2-minute walks with and without a distracting task. In addition, participants underwent imaging with functional near-infrared spectroscopy (fNIRS) and fMRI.
Using previous research as a basis, the researchers defined good walking speed as 0.8 m/sec. They categorized all participants, regardless of their intervention assignments, as having good walking capacity (0.8 m/sec or more) or limited walking capacity (less than 0.79 m/sec).
A total of 50 participants enrolled in the study (mean age, 62 years), and 45 completed the interventions. Of those who completed the interventions, 22 were randomly assigned to undergo single-task training, and 23 were assigned to dual-task training.
The researchers categorized 21 participants as having good walking capacity and 24 as having limited walking capacity. Participants in each category were divided approximately evenly between treatment assignments.
Barthel index score, which assesses functional independence, was higher in the group of good walkers.
Increased travel distance
Results showed that after the interventions, distance traveled during the single-task 2-minute walk increased by 8.9 m for good walkers and by 5.3 m for limited walkers. For the dual-task 2-minute walk, the distance traveled increased by 10.4 m among good walkers and by 1.3 m for limited walkers. Change from baseline on the dual-task walk was not significant for limited walkers.
There was no significant difference between good walkers and limited walkers in their perceptions of participation in community walking. Neither group increased its walking activity significantly following the interventions.
At baseline, limited walkers, in comparison with good walkers, had significantly greater activation in the contralesional hemisphere during dual-task walking, which consisted of incorporating a planning task.
In contrast, for many good walkers, there was a decrease in activation during dual-task walking. Activation in the contralesional hemisphere correlated negatively with dual-task 2-minute walk distance.
The researchers also found a negative correlation between activation and dual-task 2-minute walk distance when the second task was the Stroop task.
Initial step
“The original trial was never designed or powered to compare groups formed by walking speed or test our automaticity hypothesis, and the results need to be viewed within this context,” said Dr. Collett. The small sample size did not allow the researchers to detect small effects of the intervention, especially in the imaging data, he added.
It also prevented the investigators from comparing limited walking and good walking groups according to whether they underwent the single-task or dual-task intervention, “which would be a superior way to investigate our hypotheses,” Dr. Collett said.
“The result of this study should be seen as exploratory, with further investigation needed,” he noted.
Helping stroke survivors to walk in the community is challenging, and new interventions that enable them to navigate complex surroundings need to be designed, said Dr. Collett. “Research is required to better understand the conscious and automatic contribution to gait control, especially with neurological impairment,” he added.
Overall, “our results suggest that improving automatic walking may be an initial step to improve capacity to respond to more complex walking interventions. However, [future] trials are required to test this,” he concluded.
The next frontier?
Commenting on the findings, Louis R. Caplan, MD, professor of neurology at Harvard University and senior neurologist at Beth Israel Deaconess Medical Center, Boston, said that “recovery and rehab are going to be the next frontier in stroke neurology, because there has to be a limitation in the present emphasis on acute care.”
Some patients do not receive acute care on time, and current treatment is not curative, added Dr. Caplan, who was not involved with the research.
Little scientific attention has been paid to how doctors can enhance recovery after stroke, what interventions delay recovery, and what the natural history of recovery is, he said. “This is a very nice study about that.”
Although the study’s methodology was sound, there were some limitations, including that strokes and underlying brain lesions were heterogeneous and that the study population was relatively small, Dr. Caplan said.
He added that “it’s a difficult study to do” and that it is difficult to organize participants into homogeneous groups.
Another limitation cited was lack of long-term follow-up that could indicate whether training provided sustained improvements in walking.
“It would be nice to revisit the same people later and see if their walking has improved, if they’re doing it differently, and if their subjective responses are different,” said Dr. Caplan.
In addition, the study did not examine whether the interventions made it easier for participants to walk with other people or to socialize more. “It may be that it really requires some time for them to gain confidence and for them to integrate that into their social network,” Dr. Caplan said.
“I would call it a proof-of-principle study, not a final study,” he noted. “It’s a study that shows that you can scientifically study rehab” and indicates the possible methodology that could be used.
The study was funded by the Stroke Association. Dr. Collett and Dr. Caplan have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
From Clinical Rehabilitation
Antimicrobial resistance threat continues during COVID-19
The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.
For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.
“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.
“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.
The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.
The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
A ‘terrifying’ personal experience
Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.
“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.
A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.
Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.
“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”
The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.
“Ultimately, I had eight surgeries in 2 weeks,” she said.
“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.
When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.
“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
Incentivizing new antimicrobial agents
A lack of new antimicrobials in development is not a new story.
“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”
One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.
Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.
Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.
“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.
Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
Everyone’s concern
AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.
“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.
Furthermore, consumers are partially to blame as well, Dr. Fowler noted.
“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.
“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
Reasons for optimism
Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.
“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.
For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.
Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.
Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.
When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
Patient outcomes
The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.
“But his life is forever changed,” he added.
Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.
“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”
A version of this article first appeared on WebMD.com.
The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.
For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.
“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.
“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.
The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.
The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
A ‘terrifying’ personal experience
Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.
“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.
A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.
Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.
“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”
The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.
“Ultimately, I had eight surgeries in 2 weeks,” she said.
“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.
When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.
“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
Incentivizing new antimicrobial agents
A lack of new antimicrobials in development is not a new story.
“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”
One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.
Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.
Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.
“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.
Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
Everyone’s concern
AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.
“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.
Furthermore, consumers are partially to blame as well, Dr. Fowler noted.
“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.
“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
Reasons for optimism
Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.
“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.
For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.
Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.
Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.
When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
Patient outcomes
The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.
“But his life is forever changed,” he added.
Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.
“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”
A version of this article first appeared on WebMD.com.
The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.
For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.
“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.
“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.
The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.
The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
A ‘terrifying’ personal experience
Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.
“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.
A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.
Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.
“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”
The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.
“Ultimately, I had eight surgeries in 2 weeks,” she said.
“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.
When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.
“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
Incentivizing new antimicrobial agents
A lack of new antimicrobials in development is not a new story.
“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”
One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.
Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.
Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.
“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.
Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
Everyone’s concern
AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.
“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.
Furthermore, consumers are partially to blame as well, Dr. Fowler noted.
“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.
“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
Reasons for optimism
Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.
“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.
For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.
Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.
Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.
When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
Patient outcomes
The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.
“But his life is forever changed,” he added.
Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.
“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”
A version of this article first appeared on WebMD.com.
Asymptomatic C. diff carriers have increased risk of symptomatic infection
Background: C. difficile infections (CDI) are significant with more than 400,000 cases and almost 30,000 deaths annually. However, there is uncertainty regarding asymptomatic C. difficile carriers and whether they have higher rates of progression to symptomatic infections.
Study design: Prospective cohort study.
Setting: Large university hospital in the New York from July 2017 through March 2018.
Synopsis: Patients admitted were screened, enrolled, and tested to include an adequate sample of nursing facility residents because of prior studies that showed nursing facility residents with a higher prevalence of carriage. Patients underwent perirectal swabbing and stool swabbing if available. Test swab soilage, noted as any visible material on the swab, was noted and recorded. Two stool-testing methods were used to test for carriage. A C. difficile carrier was defined as any patient with a positive test without diarrhea. Patients were followed for 6 months or until death; 220 patients were enrolled, with 21 patients (9.6%) asymptomatic C. difficile carriers. Having a soiled swab was the only statistically significant characteristic, including previous antibiotic exposure within the past 90 days, to be associated with carriage; 8 of 21 (38.1%) carriage patients progressed to CDI within 6 months versus 4 of 199 (2.0%) noncarriage patients. Most carriers that progressed to CDI did so within 2 weeks of enrollment. Limitations included lower numbers of expected carriage patients, diarrhea diagnosing variability, and perirectal swabbing was used rather than rectal swabbing/stool testing.
Bottom line: Asymptomatic carriage of C. difficile has increased risk of progression to symptomatic CDI and could present an opportunity for screening to reduce CDI in the inpatient setting.
Citation: Baron SW et al. Screening of Clostridioides difficile carriers in an urban academic medical center: Understanding implications of disease. Infect Control Hosp Epidemiol. 2020;41(2):149-53.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Background: C. difficile infections (CDI) are significant with more than 400,000 cases and almost 30,000 deaths annually. However, there is uncertainty regarding asymptomatic C. difficile carriers and whether they have higher rates of progression to symptomatic infections.
Study design: Prospective cohort study.
Setting: Large university hospital in the New York from July 2017 through March 2018.
Synopsis: Patients admitted were screened, enrolled, and tested to include an adequate sample of nursing facility residents because of prior studies that showed nursing facility residents with a higher prevalence of carriage. Patients underwent perirectal swabbing and stool swabbing if available. Test swab soilage, noted as any visible material on the swab, was noted and recorded. Two stool-testing methods were used to test for carriage. A C. difficile carrier was defined as any patient with a positive test without diarrhea. Patients were followed for 6 months or until death; 220 patients were enrolled, with 21 patients (9.6%) asymptomatic C. difficile carriers. Having a soiled swab was the only statistically significant characteristic, including previous antibiotic exposure within the past 90 days, to be associated with carriage; 8 of 21 (38.1%) carriage patients progressed to CDI within 6 months versus 4 of 199 (2.0%) noncarriage patients. Most carriers that progressed to CDI did so within 2 weeks of enrollment. Limitations included lower numbers of expected carriage patients, diarrhea diagnosing variability, and perirectal swabbing was used rather than rectal swabbing/stool testing.
Bottom line: Asymptomatic carriage of C. difficile has increased risk of progression to symptomatic CDI and could present an opportunity for screening to reduce CDI in the inpatient setting.
Citation: Baron SW et al. Screening of Clostridioides difficile carriers in an urban academic medical center: Understanding implications of disease. Infect Control Hosp Epidemiol. 2020;41(2):149-53.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Background: C. difficile infections (CDI) are significant with more than 400,000 cases and almost 30,000 deaths annually. However, there is uncertainty regarding asymptomatic C. difficile carriers and whether they have higher rates of progression to symptomatic infections.
Study design: Prospective cohort study.
Setting: Large university hospital in the New York from July 2017 through March 2018.
Synopsis: Patients admitted were screened, enrolled, and tested to include an adequate sample of nursing facility residents because of prior studies that showed nursing facility residents with a higher prevalence of carriage. Patients underwent perirectal swabbing and stool swabbing if available. Test swab soilage, noted as any visible material on the swab, was noted and recorded. Two stool-testing methods were used to test for carriage. A C. difficile carrier was defined as any patient with a positive test without diarrhea. Patients were followed for 6 months or until death; 220 patients were enrolled, with 21 patients (9.6%) asymptomatic C. difficile carriers. Having a soiled swab was the only statistically significant characteristic, including previous antibiotic exposure within the past 90 days, to be associated with carriage; 8 of 21 (38.1%) carriage patients progressed to CDI within 6 months versus 4 of 199 (2.0%) noncarriage patients. Most carriers that progressed to CDI did so within 2 weeks of enrollment. Limitations included lower numbers of expected carriage patients, diarrhea diagnosing variability, and perirectal swabbing was used rather than rectal swabbing/stool testing.
Bottom line: Asymptomatic carriage of C. difficile has increased risk of progression to symptomatic CDI and could present an opportunity for screening to reduce CDI in the inpatient setting.
Citation: Baron SW et al. Screening of Clostridioides difficile carriers in an urban academic medical center: Understanding implications of disease. Infect Control Hosp Epidemiol. 2020;41(2):149-53.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Default EMR settings can influence opioid prescribing
Background: The opioid crisis is in the forefront as a public health emergency and there are concerns regarding addiction stemming from opioid prescriptions written in the acute setting, such as the ED and hospitals.
Study design: Quality improvement project, randomized.
Setting: Two large EDs in San Francisco and Oakland, Calif.
Synopsis: In five 4-week blocks, the prepopulated opioid dispense quantities were altered on a block randomized treatment schedule without prior knowledge by the prescribing practitioners with the default dispense quantities of 5, 10, 15, and null (prescriber determined dispense quantity). Opiates included oxycodone, oxycodone/acetaminophen, and hydrocodone/acetaminophen. The primary outcome was number of opioid tablets prescribed at discharge from the ED. In this study, a total of 104 health care professionals issued 4,320 opioid study prescriptions. With use of linear regression, an increase of 0.19 tablets prescribed was found for each tablet increase in default quantity. When comparing default pairs – that is, 5 versus 15 tablets – a lower default was associated with a lower number of pills prescribed in more than half of the comparisons. Limitations of this study include a small sample of EDs, and local prescribing patterns can vary greatly for opioid prescriptions written. In addition, the reasons for the prescriptions were not noted.
Bottom line: Default EMR opioid quantity settings can be used to decrease the quantity of opioids prescribed.
Citation: Montoy JCC et al. Association of default electronic medical record settings with health care professional patterns of opioid prescribing in emergency departments: A randomized quality improvement study. JAMA Intern Med. 2020;180(4):487-93.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Background: The opioid crisis is in the forefront as a public health emergency and there are concerns regarding addiction stemming from opioid prescriptions written in the acute setting, such as the ED and hospitals.
Study design: Quality improvement project, randomized.
Setting: Two large EDs in San Francisco and Oakland, Calif.
Synopsis: In five 4-week blocks, the prepopulated opioid dispense quantities were altered on a block randomized treatment schedule without prior knowledge by the prescribing practitioners with the default dispense quantities of 5, 10, 15, and null (prescriber determined dispense quantity). Opiates included oxycodone, oxycodone/acetaminophen, and hydrocodone/acetaminophen. The primary outcome was number of opioid tablets prescribed at discharge from the ED. In this study, a total of 104 health care professionals issued 4,320 opioid study prescriptions. With use of linear regression, an increase of 0.19 tablets prescribed was found for each tablet increase in default quantity. When comparing default pairs – that is, 5 versus 15 tablets – a lower default was associated with a lower number of pills prescribed in more than half of the comparisons. Limitations of this study include a small sample of EDs, and local prescribing patterns can vary greatly for opioid prescriptions written. In addition, the reasons for the prescriptions were not noted.
Bottom line: Default EMR opioid quantity settings can be used to decrease the quantity of opioids prescribed.
Citation: Montoy JCC et al. Association of default electronic medical record settings with health care professional patterns of opioid prescribing in emergency departments: A randomized quality improvement study. JAMA Intern Med. 2020;180(4):487-93.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Background: The opioid crisis is in the forefront as a public health emergency and there are concerns regarding addiction stemming from opioid prescriptions written in the acute setting, such as the ED and hospitals.
Study design: Quality improvement project, randomized.
Setting: Two large EDs in San Francisco and Oakland, Calif.
Synopsis: In five 4-week blocks, the prepopulated opioid dispense quantities were altered on a block randomized treatment schedule without prior knowledge by the prescribing practitioners with the default dispense quantities of 5, 10, 15, and null (prescriber determined dispense quantity). Opiates included oxycodone, oxycodone/acetaminophen, and hydrocodone/acetaminophen. The primary outcome was number of opioid tablets prescribed at discharge from the ED. In this study, a total of 104 health care professionals issued 4,320 opioid study prescriptions. With use of linear regression, an increase of 0.19 tablets prescribed was found for each tablet increase in default quantity. When comparing default pairs – that is, 5 versus 15 tablets – a lower default was associated with a lower number of pills prescribed in more than half of the comparisons. Limitations of this study include a small sample of EDs, and local prescribing patterns can vary greatly for opioid prescriptions written. In addition, the reasons for the prescriptions were not noted.
Bottom line: Default EMR opioid quantity settings can be used to decrease the quantity of opioids prescribed.
Citation: Montoy JCC et al. Association of default electronic medical record settings with health care professional patterns of opioid prescribing in emergency departments: A randomized quality improvement study. JAMA Intern Med. 2020;180(4):487-93.
Dr. Wang is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.
Drug effective in treating symptoms of postpartum depression
Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.
Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.
Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.
“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”
Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.
Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.
Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.
Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.
By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.
Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.
Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.
“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”
When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”
In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.
“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.
Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.
Dr. Deligiannidis and Dr. Tanner had no financial disclosures.
Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.
Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.
Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.
“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”
Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.
Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.
Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.
Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.
By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.
Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.
Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.
“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”
When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”
In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.
“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.
Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.
Dr. Deligiannidis and Dr. Tanner had no financial disclosures.
Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.
Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.
Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.
“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”
Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.
Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.
Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.
Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.
By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.
Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.
Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.
“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”
When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”
In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.
“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.
Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.
Dr. Deligiannidis and Dr. Tanner had no financial disclosures.
FROM JAMA PSYCHIATRY
Infusion centers may best EDs for treating sickle cell crises
At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.
“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”
To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.
The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.
The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs.
Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.
The investigators used propensity score methodology to balance patient characteristics in the study groups.
Quick, effective pain reduction is beneficial
The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write.
Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.
The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note.
“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write.
“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.
Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote.
The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study.
“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
Infusion centers are scarce
“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.
“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.”
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.
“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”
To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.
The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.
The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs.
Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.
The investigators used propensity score methodology to balance patient characteristics in the study groups.
Quick, effective pain reduction is beneficial
The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write.
Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.
The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note.
“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write.
“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.
Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote.
The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study.
“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
Infusion centers are scarce
“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.
“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.”
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At infusion centers, patients received pain medication an average of 70 minutes faster compared with patients treated in EDs (62 vs. 132 minutes), according to a study published online in the Annals of Internal Medicine. In addition, patients at infusion centers were 3.8 times more likely to have their pain reassessed within 30 minutes of the first dose. And they were 4 times more likely to be discharged home, the researchers found.
“It’s not that the emergency room doctors don’t want to do the right thing,” study author Sophie Lanzkron, MD, said in an interview. “They do, but they aren’t experts in sickle cell disease. They work in an emergency room, which is an incredibly busy, stressful place where they see trauma and heart attacks and strokes and all of these things that need emergency care. And so it just is not the right setting to treat people with sickle cell disease.”
To assess whether care at specialty infusion centers or EDs leads to better outcomes for patients with sickle cell disease with uncomplicated vaso-occlusive crises, Dr. Lanzkron, director of the Sickle Cell Center for Adults at the Johns Hopkins Hospital, Baltimore, and colleagues conducted the ESCAPED (Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital) study.
The trial included 483 adults with sickle cell disease who lived within 60 miles of an infusion center in four U.S. cities: Baltimore, Maryland; Cleveland, Ohio; Milwaukee, Wisconsin; and Baton Rouge, Louisiana. Investigators recruited patients between April 2015 and December 2016 and followed them for 18 months after enrollment.
The present analysis focused on data from 269 participants who had infusion center visits or ED visits that occurred during weekdays when infusion centers were open. Two sites had infusion centers solely for adults with sickle cell disease (Baltimore and Milwaukee), and two infusion centers shared infusion space with other hematology-oncology patients. All four sites were in hospitals that also had EDs.
Although participants may have received comprehensive care at one of the sites with an infusion center, those who lived farther from an infusion center were likely to receive care for acute pain at an ED closer to home, the authors explain in the article.
The investigators used propensity score methodology to balance patient characteristics in the study groups.
Quick, effective pain reduction is beneficial
The results suggest that infusion centers “are more likely to provide guideline-based care than EDs,” and this care “can improve overall outcomes,” the authors write.
Although the specialty infusion centers the researchers studied used various models, similar outcomes were seen at all of them.
The study did not include patients who had complications of sickle cell disease in addition to vaso-occlusive crisis, the researchers note.
“[Because] the magnitude of the treatment effects estimated in our study is large and we have captured most of the important potential confounders, an unmeasured confounder that can nullify the treatment effect is unlikely to exist,” the authors write.
“Sickle cell disease is a complicated condition that affects multiple organs. Patients who present with acute pain will have better outcomes being treated under providers who know and understand the disease,” commented Julie Kanter, MD, director of the adult sickle cell disease program and codirector of the Comprehensive Sickle Cell Center at the University of Alabama at Birmingham. “Specialized infusion centers offer the opportunity to both improve outcomes and decrease the cost of care. Most importantly, it is better for the individual with sickle cell disease,” she said.
Dr. Kanter wrote an accompanying editorial about the ESCAPED findings. The editorialist notes that “opioid medications are the only option to reduce the pain caused by microvascular injury” in patients with sickle cell crisis, although these treatments do not reduce the underlying damage and have substantial side effects and risks. Nevertheless, “quick and effective reduction of pain can allow patients to more easily move, stretch, and breathe ... important to increase oxygenation and restore blood flow, which will eventually abate the crisis,” Dr. Kanter wrote.
The study shows that the infusion center treatment approach can benefit patients across different settings, commented John J. Strouse, MD, PhD, medical director of the adult sickle cell program at Duke University Sickle Cell Center, Durham, N.C., who was not involved in the study.
“They show that they can definitely get closer to the recommendations of guidelines for acute pain management and sickle cell disease” in a setting that is focused on one problem, he said. “The other piece that is really important is that people are much more likely to go home if you follow the guideline.”
Infusion centers are scarce
“These systems need to be built,” Dr. Lanzkron said. “In most places, patients don’t have access to the infusion center model for their care. And in some places, it is not going to be practical.” Still, there may be ways to establish infusion locations, such as at oncology centers. And while there are challenges to delivering sickle cell disease care in EDs, “emergency rooms need to try to meet the needs of this patient population as best as they can,” Dr. Lanzkron said.
“Structural racism has played a role in the quality of care delivered” to patients with sickle cell disease, Dr. Lanzkron said. “The big message is [that] there is a better way to do this.”
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Lanzkron’s disclosures included grants or contracts with government agencies and companies that are paid to her institution, as well as consulting fees from Bluebird Bio, Novo Nordisk, and Pfizer. Coauthors have disclosed working with sickle cell organizations and various medical companies. Dr. Kanter and Dr. Strouse have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.