Beware the risks associated with greater saphenous vein thrombosis

Article Type
Changed
Fri, 01/04/2019 - 10:11

 

Isolated greater saphenous vein thrombosis is not as benign as generally thought, according to the results of a single institution retrospective study of 61 patients (67 limbs) with isolated GSVT.

Instead, patients had a significant risk of persistent symptoms, recurrence, deep vein thrombosis (DVT), and pulmonary embolism (PE), according to a report published in the Annals of Vascular Surgery by Elizabeth Kudlaty, MD, Ohio State University, Columbus, and her colleagues.

Yale Rosen/Wikimedia Commons
The average age of the patients was 55.5 years and 52.5% of the patients were women.

Location of the GSVT within 5 cm of the saphenous vein junction (SVJ; 32 patients) as compared with GSVT greater than 5 cm from the SVJ (29 patients) was significantly associated with malignancy (37.5% vs. 6.9%, respectively; P = .01), in-patient status (71.9% vs. 41.4%; P = .02), and diabetes (37.5% vs. 10.3%; P = .02). PE also was significantly greater in patients with GSVT within 5 cm of the SVJ (18.8% vs. 0.0%; P = .02). Patients with GSVT greater than 5 cm from the SVJ showed significantly more GSVT propagation/new saphenous vein thrombosis (0% vs. 31.3%, P = .048). There was a nonsignificant trend toward greater mortality for patients with GSVT within 5 cm of the SVJ (P = .052).

Dr. Kudlaty and her colleagues found that the different management options used, including anticoagulation, observation, and aspirin use, did not significantly affect outcomes (Ann Vasc Surg. 2017 Nov;45:154-9).

“Isolated GSVT can be viewed as a marker of more serious systemic diseases, notably diabetes and cancer, and leaves patients at high risk for thromboembolic events, recurrence, and persistent symptoms, despite a variety of managements,” the researchers concluded.

The authors reported that they had no conflicts of interest and that there were no outside funding sources.

Publications
Topics
Sections

 

Isolated greater saphenous vein thrombosis is not as benign as generally thought, according to the results of a single institution retrospective study of 61 patients (67 limbs) with isolated GSVT.

Instead, patients had a significant risk of persistent symptoms, recurrence, deep vein thrombosis (DVT), and pulmonary embolism (PE), according to a report published in the Annals of Vascular Surgery by Elizabeth Kudlaty, MD, Ohio State University, Columbus, and her colleagues.

Yale Rosen/Wikimedia Commons
The average age of the patients was 55.5 years and 52.5% of the patients were women.

Location of the GSVT within 5 cm of the saphenous vein junction (SVJ; 32 patients) as compared with GSVT greater than 5 cm from the SVJ (29 patients) was significantly associated with malignancy (37.5% vs. 6.9%, respectively; P = .01), in-patient status (71.9% vs. 41.4%; P = .02), and diabetes (37.5% vs. 10.3%; P = .02). PE also was significantly greater in patients with GSVT within 5 cm of the SVJ (18.8% vs. 0.0%; P = .02). Patients with GSVT greater than 5 cm from the SVJ showed significantly more GSVT propagation/new saphenous vein thrombosis (0% vs. 31.3%, P = .048). There was a nonsignificant trend toward greater mortality for patients with GSVT within 5 cm of the SVJ (P = .052).

Dr. Kudlaty and her colleagues found that the different management options used, including anticoagulation, observation, and aspirin use, did not significantly affect outcomes (Ann Vasc Surg. 2017 Nov;45:154-9).

“Isolated GSVT can be viewed as a marker of more serious systemic diseases, notably diabetes and cancer, and leaves patients at high risk for thromboembolic events, recurrence, and persistent symptoms, despite a variety of managements,” the researchers concluded.

The authors reported that they had no conflicts of interest and that there were no outside funding sources.

 

Isolated greater saphenous vein thrombosis is not as benign as generally thought, according to the results of a single institution retrospective study of 61 patients (67 limbs) with isolated GSVT.

Instead, patients had a significant risk of persistent symptoms, recurrence, deep vein thrombosis (DVT), and pulmonary embolism (PE), according to a report published in the Annals of Vascular Surgery by Elizabeth Kudlaty, MD, Ohio State University, Columbus, and her colleagues.

Yale Rosen/Wikimedia Commons
The average age of the patients was 55.5 years and 52.5% of the patients were women.

Location of the GSVT within 5 cm of the saphenous vein junction (SVJ; 32 patients) as compared with GSVT greater than 5 cm from the SVJ (29 patients) was significantly associated with malignancy (37.5% vs. 6.9%, respectively; P = .01), in-patient status (71.9% vs. 41.4%; P = .02), and diabetes (37.5% vs. 10.3%; P = .02). PE also was significantly greater in patients with GSVT within 5 cm of the SVJ (18.8% vs. 0.0%; P = .02). Patients with GSVT greater than 5 cm from the SVJ showed significantly more GSVT propagation/new saphenous vein thrombosis (0% vs. 31.3%, P = .048). There was a nonsignificant trend toward greater mortality for patients with GSVT within 5 cm of the SVJ (P = .052).

Dr. Kudlaty and her colleagues found that the different management options used, including anticoagulation, observation, and aspirin use, did not significantly affect outcomes (Ann Vasc Surg. 2017 Nov;45:154-9).

“Isolated GSVT can be viewed as a marker of more serious systemic diseases, notably diabetes and cancer, and leaves patients at high risk for thromboembolic events, recurrence, and persistent symptoms, despite a variety of managements,” the researchers concluded.

The authors reported that they had no conflicts of interest and that there were no outside funding sources.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE ANNALS OF VASCULAR SURGERY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Isolated greater saphenous vein thrombosis may be a marker for diabetes and cancer, as well as a risk for other thromboembolic events.

Major finding: Patients with GSVT show a significant risk of persistent symptoms, recurrence, deep vein thrombosis, and pulmonary embolism.

Data source: A retrospective review of all 61 patients with isolated GSVT at a single institution between 2008 and 2014.

Disclosures: The authors reported that they had no conflicts of interest and that there were no outside funding sources.

Disqus Comments
Default

The Diagnostic Value of 2010 McDonald Criteria Versus 2016 MAGNIMS Guidelines for Special MS Populations

Article Type
Changed
Wed, 01/16/2019 - 15:41
For patients with CIS and progressive MS, established diagnostic criteria may not be adequate.

PARIS—When faced with patients with clinically isolated syndrome (CIS) or primary progressive multiple sclerosis (PPMS), diagnosis can be challenging. The 2010 McDonald criteria and the 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria offer sound guidance for relapsing-remitting multiple sclerosis (MS), but for special patient populations, these criteria may fall short. At the Seventh Joint ECTRIMS–ACTRIMS Meeting, two studies looked at the suitability of diagnostic criteria for special MS populations.

Clinically Isolated Syndrome

The recently proposed MAGNIMS dissemination in space criteria include lesions in the optic nerve, cortex, and symptomatic region, in addition to an increase in the required number of periventricular lesions from one to three. Raquel Lamas Pérez, MD, and colleagues aimed to compare the diagnostic performance of the 2010 McDonald and 2016 MAGNIMS MRI criteria for dissemination in space in predicting the conversion to clinically definite MS in patients with CIS. Dr. Lamas Pérez is affiliated with the Hospital Universitario Virgen del Rocío in Sevilla, Spain.

Study inclusion criteria included CIS suggestive of CNS demyelination (since 2008), clinical assessment and baseline brain MRI within six months of CIS onset, availability of spinal cord MRI if patients presented with spinal cord syndrome, and clinical follow-up of at least 24 months.

The researchers included 161 patients with CIS (113 women) with a mean age at onset of 34. After a mean follow-up of 58 months, 102 (63.4%) patients had a diagnosis of MS according to the 2010 McDonald criteria. The overall conversion rate to clinically definite MS was 48.4%. Forty-six (45%) patients initiated a disease-modifying treatment before the second clinical event. The 2010 McDonald dissemination in space criteria were met in 100 (62.1%) and the 2016 MAGNIMS dissemination in space criteria in 95 (59%) patients with CIS. Six patients with one periventricular lesion fulfilled the 2010 McDonald criteria but not the 2016 MAGNIMS criteria. In contrast, when symptomatic infratentorial or spinal cord lesions were included, two more patients met the 2016 dissemination in space criteria than met the 2010 McDonald criteria. The sensitivity, specificity, and positive and negative predictive values of 2010 McDonald criteria were 80.7%, 55.4%, 63%, and 75.4%, respectively, and those for the 2016 MAGNIMS criteria were 75.6%, 56.6%, 62.1%, and 71.2%, respectively. Both dissemination in space criteria identified a subset of patients with CIS who were at high early risk of developing clinically definite MS (hazard ratio: 2.17 for McDonald and 2.07 for MAGNIMS).

“In our CIS patient cohort, 2016 MAGNIMS MRI criteria for dissemination in space showed lower sensitivity with similar specificity than 2010 McDonald criteria in predicting conversion to clinically definite MS, probably related to the increase in the required number of periventricular lesions,” Dr. Lamas Pérez said. “Because disease-modifying therapy can delay or prevent the conversion to clinically definite MS, the high number of patients that initiated these therapies before the second relapse would explain the intermediate specificity values obtained with both MRI criteria.”

Primary Progressive MS

The 2010 McDonald criteria for PPMS have not been fully validated, while 2016 MAGNIMS MRI guidelines have not been studied in PPMS yet.

To assess the sensitivity and specificity of 2010 McDonald and 2016 MAGNIMS criteria for patients with PPMS, Alberto Gajofatto, MD, PhD, Assistant Professor in Neurology in the Department of Neurological and Movement Sciences at the University of Verona in Italy, and colleagues applied the criteria to two retrospective cohorts.

Patients who were seen at the University of California San Francisco and Verona University MS Centers for suspected PPMS were retrospectively identified from existing databases between November 2015 and October 2016. Data were obtained from review of patient charts with adequate documentation of clinical, MRI, and CSF status to determine the fulfillment of 2010 McDonald criteria for PPMS and 2016 MAGNIMS guidelines for dissemination in space at first visit at study centers. PPMS diagnosis was confirmed at last available visit using stringent criteria (ie, dissemination in space according to 2005 McDonald criteria, dissemination in time according to 2001 McDonald criteria, and exclusion of a better explanation).

Dr. Gajofatto and colleagues included 108 patients with a mean follow-up duration of 10.1 years. The 2010 McDonald criteria had a sensitivity for PPMS of 92.1% and a specificity of 57.9%. The highest combined values of sensitivity and specificity (91.8% and 72.2%) were achieved by combining 2016 MAGNIMS dissemination in space criteria and the presence of oligoclonal bands or increased IgG index in the CSF.

“Our findings suggest that 2010 McDonald criteria for PPMS diagnosis have high sensitivity, while specificity appears to be modest,” Dr. Gajofatto said. “The substitution of 2016 MAGNIMS criteria for dissemination in space plus the incorporation of CSF status increased specificity without compromising sensitivity.”

Meeting/Event
Publications
Topics
Legacy Keywords
Neurology Reviews, MS, McDonald Criteria, MAGNIMS Guidelines for Special MS Populations, Raquel Lamas Pérez
Sections
Meeting/Event
Meeting/Event
For patients with CIS and progressive MS, established diagnostic criteria may not be adequate.
For patients with CIS and progressive MS, established diagnostic criteria may not be adequate.

PARIS—When faced with patients with clinically isolated syndrome (CIS) or primary progressive multiple sclerosis (PPMS), diagnosis can be challenging. The 2010 McDonald criteria and the 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria offer sound guidance for relapsing-remitting multiple sclerosis (MS), but for special patient populations, these criteria may fall short. At the Seventh Joint ECTRIMS–ACTRIMS Meeting, two studies looked at the suitability of diagnostic criteria for special MS populations.

Clinically Isolated Syndrome

The recently proposed MAGNIMS dissemination in space criteria include lesions in the optic nerve, cortex, and symptomatic region, in addition to an increase in the required number of periventricular lesions from one to three. Raquel Lamas Pérez, MD, and colleagues aimed to compare the diagnostic performance of the 2010 McDonald and 2016 MAGNIMS MRI criteria for dissemination in space in predicting the conversion to clinically definite MS in patients with CIS. Dr. Lamas Pérez is affiliated with the Hospital Universitario Virgen del Rocío in Sevilla, Spain.

Study inclusion criteria included CIS suggestive of CNS demyelination (since 2008), clinical assessment and baseline brain MRI within six months of CIS onset, availability of spinal cord MRI if patients presented with spinal cord syndrome, and clinical follow-up of at least 24 months.

The researchers included 161 patients with CIS (113 women) with a mean age at onset of 34. After a mean follow-up of 58 months, 102 (63.4%) patients had a diagnosis of MS according to the 2010 McDonald criteria. The overall conversion rate to clinically definite MS was 48.4%. Forty-six (45%) patients initiated a disease-modifying treatment before the second clinical event. The 2010 McDonald dissemination in space criteria were met in 100 (62.1%) and the 2016 MAGNIMS dissemination in space criteria in 95 (59%) patients with CIS. Six patients with one periventricular lesion fulfilled the 2010 McDonald criteria but not the 2016 MAGNIMS criteria. In contrast, when symptomatic infratentorial or spinal cord lesions were included, two more patients met the 2016 dissemination in space criteria than met the 2010 McDonald criteria. The sensitivity, specificity, and positive and negative predictive values of 2010 McDonald criteria were 80.7%, 55.4%, 63%, and 75.4%, respectively, and those for the 2016 MAGNIMS criteria were 75.6%, 56.6%, 62.1%, and 71.2%, respectively. Both dissemination in space criteria identified a subset of patients with CIS who were at high early risk of developing clinically definite MS (hazard ratio: 2.17 for McDonald and 2.07 for MAGNIMS).

“In our CIS patient cohort, 2016 MAGNIMS MRI criteria for dissemination in space showed lower sensitivity with similar specificity than 2010 McDonald criteria in predicting conversion to clinically definite MS, probably related to the increase in the required number of periventricular lesions,” Dr. Lamas Pérez said. “Because disease-modifying therapy can delay or prevent the conversion to clinically definite MS, the high number of patients that initiated these therapies before the second relapse would explain the intermediate specificity values obtained with both MRI criteria.”

Primary Progressive MS

The 2010 McDonald criteria for PPMS have not been fully validated, while 2016 MAGNIMS MRI guidelines have not been studied in PPMS yet.

To assess the sensitivity and specificity of 2010 McDonald and 2016 MAGNIMS criteria for patients with PPMS, Alberto Gajofatto, MD, PhD, Assistant Professor in Neurology in the Department of Neurological and Movement Sciences at the University of Verona in Italy, and colleagues applied the criteria to two retrospective cohorts.

Patients who were seen at the University of California San Francisco and Verona University MS Centers for suspected PPMS were retrospectively identified from existing databases between November 2015 and October 2016. Data were obtained from review of patient charts with adequate documentation of clinical, MRI, and CSF status to determine the fulfillment of 2010 McDonald criteria for PPMS and 2016 MAGNIMS guidelines for dissemination in space at first visit at study centers. PPMS diagnosis was confirmed at last available visit using stringent criteria (ie, dissemination in space according to 2005 McDonald criteria, dissemination in time according to 2001 McDonald criteria, and exclusion of a better explanation).

Dr. Gajofatto and colleagues included 108 patients with a mean follow-up duration of 10.1 years. The 2010 McDonald criteria had a sensitivity for PPMS of 92.1% and a specificity of 57.9%. The highest combined values of sensitivity and specificity (91.8% and 72.2%) were achieved by combining 2016 MAGNIMS dissemination in space criteria and the presence of oligoclonal bands or increased IgG index in the CSF.

“Our findings suggest that 2010 McDonald criteria for PPMS diagnosis have high sensitivity, while specificity appears to be modest,” Dr. Gajofatto said. “The substitution of 2016 MAGNIMS criteria for dissemination in space plus the incorporation of CSF status increased specificity without compromising sensitivity.”

PARIS—When faced with patients with clinically isolated syndrome (CIS) or primary progressive multiple sclerosis (PPMS), diagnosis can be challenging. The 2010 McDonald criteria and the 2016 Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) criteria offer sound guidance for relapsing-remitting multiple sclerosis (MS), but for special patient populations, these criteria may fall short. At the Seventh Joint ECTRIMS–ACTRIMS Meeting, two studies looked at the suitability of diagnostic criteria for special MS populations.

Clinically Isolated Syndrome

The recently proposed MAGNIMS dissemination in space criteria include lesions in the optic nerve, cortex, and symptomatic region, in addition to an increase in the required number of periventricular lesions from one to three. Raquel Lamas Pérez, MD, and colleagues aimed to compare the diagnostic performance of the 2010 McDonald and 2016 MAGNIMS MRI criteria for dissemination in space in predicting the conversion to clinically definite MS in patients with CIS. Dr. Lamas Pérez is affiliated with the Hospital Universitario Virgen del Rocío in Sevilla, Spain.

Study inclusion criteria included CIS suggestive of CNS demyelination (since 2008), clinical assessment and baseline brain MRI within six months of CIS onset, availability of spinal cord MRI if patients presented with spinal cord syndrome, and clinical follow-up of at least 24 months.

The researchers included 161 patients with CIS (113 women) with a mean age at onset of 34. After a mean follow-up of 58 months, 102 (63.4%) patients had a diagnosis of MS according to the 2010 McDonald criteria. The overall conversion rate to clinically definite MS was 48.4%. Forty-six (45%) patients initiated a disease-modifying treatment before the second clinical event. The 2010 McDonald dissemination in space criteria were met in 100 (62.1%) and the 2016 MAGNIMS dissemination in space criteria in 95 (59%) patients with CIS. Six patients with one periventricular lesion fulfilled the 2010 McDonald criteria but not the 2016 MAGNIMS criteria. In contrast, when symptomatic infratentorial or spinal cord lesions were included, two more patients met the 2016 dissemination in space criteria than met the 2010 McDonald criteria. The sensitivity, specificity, and positive and negative predictive values of 2010 McDonald criteria were 80.7%, 55.4%, 63%, and 75.4%, respectively, and those for the 2016 MAGNIMS criteria were 75.6%, 56.6%, 62.1%, and 71.2%, respectively. Both dissemination in space criteria identified a subset of patients with CIS who were at high early risk of developing clinically definite MS (hazard ratio: 2.17 for McDonald and 2.07 for MAGNIMS).

“In our CIS patient cohort, 2016 MAGNIMS MRI criteria for dissemination in space showed lower sensitivity with similar specificity than 2010 McDonald criteria in predicting conversion to clinically definite MS, probably related to the increase in the required number of periventricular lesions,” Dr. Lamas Pérez said. “Because disease-modifying therapy can delay or prevent the conversion to clinically definite MS, the high number of patients that initiated these therapies before the second relapse would explain the intermediate specificity values obtained with both MRI criteria.”

Primary Progressive MS

The 2010 McDonald criteria for PPMS have not been fully validated, while 2016 MAGNIMS MRI guidelines have not been studied in PPMS yet.

To assess the sensitivity and specificity of 2010 McDonald and 2016 MAGNIMS criteria for patients with PPMS, Alberto Gajofatto, MD, PhD, Assistant Professor in Neurology in the Department of Neurological and Movement Sciences at the University of Verona in Italy, and colleagues applied the criteria to two retrospective cohorts.

Patients who were seen at the University of California San Francisco and Verona University MS Centers for suspected PPMS were retrospectively identified from existing databases between November 2015 and October 2016. Data were obtained from review of patient charts with adequate documentation of clinical, MRI, and CSF status to determine the fulfillment of 2010 McDonald criteria for PPMS and 2016 MAGNIMS guidelines for dissemination in space at first visit at study centers. PPMS diagnosis was confirmed at last available visit using stringent criteria (ie, dissemination in space according to 2005 McDonald criteria, dissemination in time according to 2001 McDonald criteria, and exclusion of a better explanation).

Dr. Gajofatto and colleagues included 108 patients with a mean follow-up duration of 10.1 years. The 2010 McDonald criteria had a sensitivity for PPMS of 92.1% and a specificity of 57.9%. The highest combined values of sensitivity and specificity (91.8% and 72.2%) were achieved by combining 2016 MAGNIMS dissemination in space criteria and the presence of oligoclonal bands or increased IgG index in the CSF.

“Our findings suggest that 2010 McDonald criteria for PPMS diagnosis have high sensitivity, while specificity appears to be modest,” Dr. Gajofatto said. “The substitution of 2016 MAGNIMS criteria for dissemination in space plus the incorporation of CSF status increased specificity without compromising sensitivity.”

Publications
Publications
Topics
Article Type
Legacy Keywords
Neurology Reviews, MS, McDonald Criteria, MAGNIMS Guidelines for Special MS Populations, Raquel Lamas Pérez
Legacy Keywords
Neurology Reviews, MS, McDonald Criteria, MAGNIMS Guidelines for Special MS Populations, Raquel Lamas Pérez
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Research projects aid clinical knowledge

Article Type
Changed
Fri, 09/14/2018 - 11:56
Student researcher appreciates clinical pearls

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

One of my favorite aspects of research is how reading a paper or working on a project will inevitably augment my clinical knowledge as well.

Cole Hirschfeld
By working on my current research project I’ve learned some valuable clinical pearls that I can utilize when I head back to the wards. For instance, working on this project has required me to read published guidelines on osteomyelitis and has helped me grow my understanding of the diagnosis and management of the disease. I also feel more confident in deciding which patients would benefit most from image-guided bone biopsies, and I also have a better understanding of the expected diagnostic yield from that procedure.

In terms of my current project, I am pleased to say that I am on track to complete it within the dedicated ten week time period. I am now in writing mode, typing away furiously to complete an abstract to showcase my work, and eventually a manuscript to publish in an academic journal. I believe careful planning and prioritization has helped me stay on track with such a short deadline.

The one problem I have faced in the last couple of weeks has been figuring out how to display my data graphically. Unfortunately, the nature of the data lends itself to tables rather than figurers. Although a figure by itself won’t change the results, I personally enjoy reading papers with interesting figures more than those without them. However, I also don’t want to create meaningless figures just for the sake of having them, so it’s been a challenge figuring out how to display data in a way that will assist readers in interpreting the data.

Overall, this experience has encouraged me to participate in future research projects. I now know the importance of mentors in guiding a successful research project, and the impact preparation and planning can have on the outcome of the project. I am enthusiastic about incorporating clinical research into my medical career.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

Publications
Topics
Sections
Student researcher appreciates clinical pearls
Student researcher appreciates clinical pearls

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

One of my favorite aspects of research is how reading a paper or working on a project will inevitably augment my clinical knowledge as well.

Cole Hirschfeld
By working on my current research project I’ve learned some valuable clinical pearls that I can utilize when I head back to the wards. For instance, working on this project has required me to read published guidelines on osteomyelitis and has helped me grow my understanding of the diagnosis and management of the disease. I also feel more confident in deciding which patients would benefit most from image-guided bone biopsies, and I also have a better understanding of the expected diagnostic yield from that procedure.

In terms of my current project, I am pleased to say that I am on track to complete it within the dedicated ten week time period. I am now in writing mode, typing away furiously to complete an abstract to showcase my work, and eventually a manuscript to publish in an academic journal. I believe careful planning and prioritization has helped me stay on track with such a short deadline.

The one problem I have faced in the last couple of weeks has been figuring out how to display my data graphically. Unfortunately, the nature of the data lends itself to tables rather than figurers. Although a figure by itself won’t change the results, I personally enjoy reading papers with interesting figures more than those without them. However, I also don’t want to create meaningless figures just for the sake of having them, so it’s been a challenge figuring out how to display data in a way that will assist readers in interpreting the data.

Overall, this experience has encouraged me to participate in future research projects. I now know the importance of mentors in guiding a successful research project, and the impact preparation and planning can have on the outcome of the project. I am enthusiastic about incorporating clinical research into my medical career.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

 

Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-18 year, offering two options for students to receive funding and engage in scholarly work during their 1st, 2nd, and 3rd years of medical school. As a part of the program, recipients are required to write about their experience on a biweekly basis.

One of my favorite aspects of research is how reading a paper or working on a project will inevitably augment my clinical knowledge as well.

Cole Hirschfeld
By working on my current research project I’ve learned some valuable clinical pearls that I can utilize when I head back to the wards. For instance, working on this project has required me to read published guidelines on osteomyelitis and has helped me grow my understanding of the diagnosis and management of the disease. I also feel more confident in deciding which patients would benefit most from image-guided bone biopsies, and I also have a better understanding of the expected diagnostic yield from that procedure.

In terms of my current project, I am pleased to say that I am on track to complete it within the dedicated ten week time period. I am now in writing mode, typing away furiously to complete an abstract to showcase my work, and eventually a manuscript to publish in an academic journal. I believe careful planning and prioritization has helped me stay on track with such a short deadline.

The one problem I have faced in the last couple of weeks has been figuring out how to display my data graphically. Unfortunately, the nature of the data lends itself to tables rather than figurers. Although a figure by itself won’t change the results, I personally enjoy reading papers with interesting figures more than those without them. However, I also don’t want to create meaningless figures just for the sake of having them, so it’s been a challenge figuring out how to display data in a way that will assist readers in interpreting the data.

Overall, this experience has encouraged me to participate in future research projects. I now know the importance of mentors in guiding a successful research project, and the impact preparation and planning can have on the outcome of the project. I am enthusiastic about incorporating clinical research into my medical career.

Cole Hirschfeld is originally from Phoenix. He received undergraduate degrees in finance and entrepreneurship from the University of Arizona and went on to work in the finance industry for 2 years before deciding to change careers and attend medical school. He is now a 4th year medical student at Cornell University, New York, and plans to apply for residency in internal medicine.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

The Maintenance of Certification wars come to your state

Article Type
Changed
Thu, 03/28/2019 - 14:45

 

The struggle against mandatory maintenance of certification (MOC) is working its way across the country. Personally, I have always been opposed to mandatory MOC, and based on my experience with the Board of Directors of the American Academy of Dermatology, most of them also are opposed. . Practically, I have not wanted dermatologists to be the first specialty group to break ranks, refuse to participate and be branded as anti-quality and anti-improvement, although there is no good evidence MOC improves quality of care.

Dr. Brett M. Coldiron
Dr. Brett M. Coldiron
When a proposal to prohibit the requirement to participate in MOC was introduced in the Ohio House of Representatives by Rep. Theresa Gavarone (R-Dist. 3), I recognized it as a blessing for Ohio physicians, most of whom are not grandfathered in for life. (Some doctors have a lifetime certification and are grandfathered into the old system, thereby not subject to MOC.) As written, House Bill 273 would prohibit a physician from being required to participate in MOC for licensure, reimbursement, employment, or for admitting or operating privileges. This would allow a way out of the tightening MOC noose. If enacted, it effectively would eliminate most of the negative consequences of not participating in MOC. The bill does not prohibit a specialty board from revoking certification, or from listing a doctor as noncompliant, nor does it prevent a physician from continuing to participate in MOC on a voluntary basis.

While several states have passed anti-MOC legislation, not all are as comprehensive as the proposal in Ohio. Notably, anti-MOC legislation failed in Florida, and is considered dead in Michigan and Mississippi. If you are planning to practice in those states in the near future, you had better stay on the MOC treadmill.

The following was excerpted from my testimony at the Ohio statehouse on Oct. 11 in favor of House Bill 273:

I have nothing personal to gain from passage of this legislation since I am old enough to be “grandfathered” in as lifetime board certified in internal medicine and dermatology. However, since I was serving as president of the American College of Mohs Surgeons and the American Academy of Dermatology, I did retake the certification exam and participate in MOC, just to walk the walk, so to speak ...

My personal experience with MOC has demonstrated how useless much of it is ... most of what I must study and retest on are diseases I will never see. The “quizzes” I pay for and self-score are silly, and the 10-year exam is terrifying since it has little relevance to my practice.

Please note that I am not saying that initial board certification is not of value ... I think the requirement for several years of certified residency training, and years of study do set a high quality bar for physicians, and believe it is a useful exercise for the physician and useful for public safety and quality assurance. I do not believe a practicing physician loses all of this [knowledge] every 10 years, in fact, they learn much more as they go. The MOC process assumes that we are all rusty scuba tanks that need to be pressure tested at 10-year intervals. I must also point out that Ohio physicians are required to complete 100 continuing medical education hours every 2 years for their medical licensure, which I have no complaint about. So even if there is some leakage, there is already some topping off.

I think one board certification gauntlet is enough. I note that physicians are the only professional group masochistic enough to self-flagellate with recertification in such a fashion. ... Lawyers pass their bar once. ...

Physician burnout has been identified as a major issue for Ohio physicians and relieving them of these onerous mandates can only help. These recertification requirements cost a lot of money, and take a lot of time. ... Ohio still has a shortage of physicians relative to other Midwestern states, and anything to make the environment more hospitable is welcome. Some physicians may argue that only physicians should regulate physicians, a position I agree with until it results in unreasonable tyranny by the few [physicians] who may materially profit from the rest [of us]. Then a legislative remedy such as this is called for.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Publications
Topics
Sections

 

The struggle against mandatory maintenance of certification (MOC) is working its way across the country. Personally, I have always been opposed to mandatory MOC, and based on my experience with the Board of Directors of the American Academy of Dermatology, most of them also are opposed. . Practically, I have not wanted dermatologists to be the first specialty group to break ranks, refuse to participate and be branded as anti-quality and anti-improvement, although there is no good evidence MOC improves quality of care.

Dr. Brett M. Coldiron
Dr. Brett M. Coldiron
When a proposal to prohibit the requirement to participate in MOC was introduced in the Ohio House of Representatives by Rep. Theresa Gavarone (R-Dist. 3), I recognized it as a blessing for Ohio physicians, most of whom are not grandfathered in for life. (Some doctors have a lifetime certification and are grandfathered into the old system, thereby not subject to MOC.) As written, House Bill 273 would prohibit a physician from being required to participate in MOC for licensure, reimbursement, employment, or for admitting or operating privileges. This would allow a way out of the tightening MOC noose. If enacted, it effectively would eliminate most of the negative consequences of not participating in MOC. The bill does not prohibit a specialty board from revoking certification, or from listing a doctor as noncompliant, nor does it prevent a physician from continuing to participate in MOC on a voluntary basis.

While several states have passed anti-MOC legislation, not all are as comprehensive as the proposal in Ohio. Notably, anti-MOC legislation failed in Florida, and is considered dead in Michigan and Mississippi. If you are planning to practice in those states in the near future, you had better stay on the MOC treadmill.

The following was excerpted from my testimony at the Ohio statehouse on Oct. 11 in favor of House Bill 273:

I have nothing personal to gain from passage of this legislation since I am old enough to be “grandfathered” in as lifetime board certified in internal medicine and dermatology. However, since I was serving as president of the American College of Mohs Surgeons and the American Academy of Dermatology, I did retake the certification exam and participate in MOC, just to walk the walk, so to speak ...

My personal experience with MOC has demonstrated how useless much of it is ... most of what I must study and retest on are diseases I will never see. The “quizzes” I pay for and self-score are silly, and the 10-year exam is terrifying since it has little relevance to my practice.

Please note that I am not saying that initial board certification is not of value ... I think the requirement for several years of certified residency training, and years of study do set a high quality bar for physicians, and believe it is a useful exercise for the physician and useful for public safety and quality assurance. I do not believe a practicing physician loses all of this [knowledge] every 10 years, in fact, they learn much more as they go. The MOC process assumes that we are all rusty scuba tanks that need to be pressure tested at 10-year intervals. I must also point out that Ohio physicians are required to complete 100 continuing medical education hours every 2 years for their medical licensure, which I have no complaint about. So even if there is some leakage, there is already some topping off.

I think one board certification gauntlet is enough. I note that physicians are the only professional group masochistic enough to self-flagellate with recertification in such a fashion. ... Lawyers pass their bar once. ...

Physician burnout has been identified as a major issue for Ohio physicians and relieving them of these onerous mandates can only help. These recertification requirements cost a lot of money, and take a lot of time. ... Ohio still has a shortage of physicians relative to other Midwestern states, and anything to make the environment more hospitable is welcome. Some physicians may argue that only physicians should regulate physicians, a position I agree with until it results in unreasonable tyranny by the few [physicians] who may materially profit from the rest [of us]. Then a legislative remedy such as this is called for.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

 

The struggle against mandatory maintenance of certification (MOC) is working its way across the country. Personally, I have always been opposed to mandatory MOC, and based on my experience with the Board of Directors of the American Academy of Dermatology, most of them also are opposed. . Practically, I have not wanted dermatologists to be the first specialty group to break ranks, refuse to participate and be branded as anti-quality and anti-improvement, although there is no good evidence MOC improves quality of care.

Dr. Brett M. Coldiron
Dr. Brett M. Coldiron
When a proposal to prohibit the requirement to participate in MOC was introduced in the Ohio House of Representatives by Rep. Theresa Gavarone (R-Dist. 3), I recognized it as a blessing for Ohio physicians, most of whom are not grandfathered in for life. (Some doctors have a lifetime certification and are grandfathered into the old system, thereby not subject to MOC.) As written, House Bill 273 would prohibit a physician from being required to participate in MOC for licensure, reimbursement, employment, or for admitting or operating privileges. This would allow a way out of the tightening MOC noose. If enacted, it effectively would eliminate most of the negative consequences of not participating in MOC. The bill does not prohibit a specialty board from revoking certification, or from listing a doctor as noncompliant, nor does it prevent a physician from continuing to participate in MOC on a voluntary basis.

While several states have passed anti-MOC legislation, not all are as comprehensive as the proposal in Ohio. Notably, anti-MOC legislation failed in Florida, and is considered dead in Michigan and Mississippi. If you are planning to practice in those states in the near future, you had better stay on the MOC treadmill.

The following was excerpted from my testimony at the Ohio statehouse on Oct. 11 in favor of House Bill 273:

I have nothing personal to gain from passage of this legislation since I am old enough to be “grandfathered” in as lifetime board certified in internal medicine and dermatology. However, since I was serving as president of the American College of Mohs Surgeons and the American Academy of Dermatology, I did retake the certification exam and participate in MOC, just to walk the walk, so to speak ...

My personal experience with MOC has demonstrated how useless much of it is ... most of what I must study and retest on are diseases I will never see. The “quizzes” I pay for and self-score are silly, and the 10-year exam is terrifying since it has little relevance to my practice.

Please note that I am not saying that initial board certification is not of value ... I think the requirement for several years of certified residency training, and years of study do set a high quality bar for physicians, and believe it is a useful exercise for the physician and useful for public safety and quality assurance. I do not believe a practicing physician loses all of this [knowledge] every 10 years, in fact, they learn much more as they go. The MOC process assumes that we are all rusty scuba tanks that need to be pressure tested at 10-year intervals. I must also point out that Ohio physicians are required to complete 100 continuing medical education hours every 2 years for their medical licensure, which I have no complaint about. So even if there is some leakage, there is already some topping off.

I think one board certification gauntlet is enough. I note that physicians are the only professional group masochistic enough to self-flagellate with recertification in such a fashion. ... Lawyers pass their bar once. ...

Physician burnout has been identified as a major issue for Ohio physicians and relieving them of these onerous mandates can only help. These recertification requirements cost a lot of money, and take a lot of time. ... Ohio still has a shortage of physicians relative to other Midwestern states, and anything to make the environment more hospitable is welcome. Some physicians may argue that only physicians should regulate physicians, a position I agree with until it results in unreasonable tyranny by the few [physicians] who may materially profit from the rest [of us]. Then a legislative remedy such as this is called for.

 

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Fetal fibronectin may be underused in preterm birth detection

Article Type
Changed
Tue, 08/28/2018 - 10:21

 

Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

Publications
Topics
Sections

 

Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

 

Only a small percentage of pregnant women with symptoms of preterm labor who are admitted to emergency departments or labor and delivery units receive fetal fibronectin testing, suggesting the test may not be fully utilized, according to results from a retrospective study.

Using data collected from the Medical Outcomes Research for Effectiveness and Economics Registry, 23,062 patients were included in the study, of whom just 12% received fetal fibronectin (fFN) testing, according to Sean C. Blackwell, MD, of the department of obstetrics, gynecology and reproductive sciences at the University of Texas, Houston, and his associates (Clinicoecon Outcomes Res. 2017 Oct 3;9:585-94. doi: 10.2147/CEOR.S141061).

The rate of fFN testing was even lower – 4.2% – among women who were discharged home but gave birth within 3 days, compared with the testing rate of 16.7% in women who were discharged and did not give birth within 3 days, which suggests “that there may be opportunities to improve the care management of these patients with the use of such screening tools as fFN testing,” the researchers wrote.



Patients who resided in the Northeast were less likely to receive fFN testing, while patients in the West were slightly more likely to receive testing. Patients with more all-cause physician visits and who had received transvaginal ultrasound also were more likely to receive fFN testing, they reported.

“Additional research is needed to determine how to use quantitative fFN testing tools currently under development as part of screening for risk of [preterm labor] allowing physicians the opportunity to better understand patient risk factors and tailor interventions to optimize pre- and perinatal care for the woman and her neonate,” Dr. Blackwell and his associates wrote.

Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CLINICOECONOMICS AND OUTCOMES RESEARCH

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: The rate of fetal fibronectin (fFN) testing is low, especially in women who give birth within 3 days of emergency department discharge.

Major finding: Pregnant women with symptoms of preterm labor received fFN testing at an overall rate of 12%.

Data source: A total of 23,062 patients from the Medical Outcomes Research for Effectiveness and Economics Registry.

Disclosures: Three of the study authors are employees of Avalere Health, which received funding from Hologic Inc., to support the study. Another author is an employee of Hologic, which produces fFN tests. The authors had no other disclosures.

Disqus Comments
Default

Biosimilars poised to save $54 billion over the next decade

Article Type
Changed
Tue, 02/07/2023 - 16:56


Biosimilars could reduce overall spending on biologic products by $54 billion from 2017 to 2026, according to new research from the Rand Corp.

 

Given the level of uncertainty surrounding the biosimilars market, however, the range of savings could be as low at $24 billion or as high as $150 billion.

“Because of limited U.S. experience with biosimilars, the key assumptions on market share and biosimilar prices are ‘best guesses’ based on anecdotes or professional opinion,” Andrew Mulcahy, PhD, a health policy researcher at Rand, and his colleagues, wrote in a perspective report.

Mathier/Thinkstock
There are currently three biosimilars on the market, including one product that is a biosimilar to filgrastim and two that are biosimilar to infliximab. Two other biosimilar products, one for adalimumab and one for etanercept, have received approval from the Food and Drug Administration, but neither has been made available for sale yet.

“Whether actual cost savings end up above or below our baseline estimate hinges in large part on whether manufacturers continue to have a business case to invest in developing and marketing biosimilars,” the authors noted, citing a number of areas, including intellectual property litigation, payment, price competition, nonprice competition from reference biologic manufacturers, naming convention, and interchangeability.

Getting over these hurdles could require legislative or regulatory solutions.

“The pervasive uncertainty in the U.S. biosimilar market – including questions as to whether the market will be sustainable and lead to cost savings, as intended – presents two choices for policymakers,” Dr. Mulcahy and his colleagues wrote. “One strategy is to let the market continue to develop under current policies,” with stability coming from experience.

The alternative could be policy levers to “help steer the U.S. biosimilar market more quickly to a sustainable, competitive state,” they continued. “For example, regulators at the FDA could experiment with new approaches to provide stronger, earlier signals through guidance documents or other mechanisms on expectations surrounding interchangeability and other topics.”

The FDA appears to be moving on the latter. In an Oct. 23 blog post, FDA Commissioner Scott Gottlieb, MD, and Leah Christl, PhD, associate director for therapeutic biologics in the office of new drugs at the FDA’s Center for Drug Evaluation and Research, outlined a number of recent tools to help biosimilar adoption. The resources provide basics such as the basic definition associated with biosimilars (i.e., what is a biosimilar and a reference product, and what it means to be interchangeable), the standards of approval that biosimilars must go through, and easily accessible information on what the FDA is using to review biosimilarity.

“Next, FDA plans to embark on additional research with health care professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars,” Commissioner Gottlieb and Dr. Christl wrote. “An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our health care system.”

The Centers for Medicare & Medicaid Services also plays a role in developing policy to spur biosimilar adoption, Dr. Mulcahy and his colleagues wrote. They note work being done by the Medicare Payment Advisory Commission on recommendations that could address payment for physician-administered biosimilars under Part B, as well as incentives in the Part D prescription drug program to steer patients and providers toward lower cost biosimilars when appropriate. CMS changed current payment policy for biosimilars for 2018, which may have an effect.

“Beyond FDA regulation, payment, and coverage, both government and industry could play a role in educating patients and providers about the potential cost savings from biosimilars, much like both groups have done for generic drugs,” they stated. “While our study does not address whether policy action is needed now, it is likely that the answer will become clearer over the next 1 to 3 years as the market continues to develop.”

Publications
Topics
Sections


Biosimilars could reduce overall spending on biologic products by $54 billion from 2017 to 2026, according to new research from the Rand Corp.

 

Given the level of uncertainty surrounding the biosimilars market, however, the range of savings could be as low at $24 billion or as high as $150 billion.

“Because of limited U.S. experience with biosimilars, the key assumptions on market share and biosimilar prices are ‘best guesses’ based on anecdotes or professional opinion,” Andrew Mulcahy, PhD, a health policy researcher at Rand, and his colleagues, wrote in a perspective report.

Mathier/Thinkstock
There are currently three biosimilars on the market, including one product that is a biosimilar to filgrastim and two that are biosimilar to infliximab. Two other biosimilar products, one for adalimumab and one for etanercept, have received approval from the Food and Drug Administration, but neither has been made available for sale yet.

“Whether actual cost savings end up above or below our baseline estimate hinges in large part on whether manufacturers continue to have a business case to invest in developing and marketing biosimilars,” the authors noted, citing a number of areas, including intellectual property litigation, payment, price competition, nonprice competition from reference biologic manufacturers, naming convention, and interchangeability.

Getting over these hurdles could require legislative or regulatory solutions.

“The pervasive uncertainty in the U.S. biosimilar market – including questions as to whether the market will be sustainable and lead to cost savings, as intended – presents two choices for policymakers,” Dr. Mulcahy and his colleagues wrote. “One strategy is to let the market continue to develop under current policies,” with stability coming from experience.

The alternative could be policy levers to “help steer the U.S. biosimilar market more quickly to a sustainable, competitive state,” they continued. “For example, regulators at the FDA could experiment with new approaches to provide stronger, earlier signals through guidance documents or other mechanisms on expectations surrounding interchangeability and other topics.”

The FDA appears to be moving on the latter. In an Oct. 23 blog post, FDA Commissioner Scott Gottlieb, MD, and Leah Christl, PhD, associate director for therapeutic biologics in the office of new drugs at the FDA’s Center for Drug Evaluation and Research, outlined a number of recent tools to help biosimilar adoption. The resources provide basics such as the basic definition associated with biosimilars (i.e., what is a biosimilar and a reference product, and what it means to be interchangeable), the standards of approval that biosimilars must go through, and easily accessible information on what the FDA is using to review biosimilarity.

“Next, FDA plans to embark on additional research with health care professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars,” Commissioner Gottlieb and Dr. Christl wrote. “An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our health care system.”

The Centers for Medicare & Medicaid Services also plays a role in developing policy to spur biosimilar adoption, Dr. Mulcahy and his colleagues wrote. They note work being done by the Medicare Payment Advisory Commission on recommendations that could address payment for physician-administered biosimilars under Part B, as well as incentives in the Part D prescription drug program to steer patients and providers toward lower cost biosimilars when appropriate. CMS changed current payment policy for biosimilars for 2018, which may have an effect.

“Beyond FDA regulation, payment, and coverage, both government and industry could play a role in educating patients and providers about the potential cost savings from biosimilars, much like both groups have done for generic drugs,” they stated. “While our study does not address whether policy action is needed now, it is likely that the answer will become clearer over the next 1 to 3 years as the market continues to develop.”


Biosimilars could reduce overall spending on biologic products by $54 billion from 2017 to 2026, according to new research from the Rand Corp.

 

Given the level of uncertainty surrounding the biosimilars market, however, the range of savings could be as low at $24 billion or as high as $150 billion.

“Because of limited U.S. experience with biosimilars, the key assumptions on market share and biosimilar prices are ‘best guesses’ based on anecdotes or professional opinion,” Andrew Mulcahy, PhD, a health policy researcher at Rand, and his colleagues, wrote in a perspective report.

Mathier/Thinkstock
There are currently three biosimilars on the market, including one product that is a biosimilar to filgrastim and two that are biosimilar to infliximab. Two other biosimilar products, one for adalimumab and one for etanercept, have received approval from the Food and Drug Administration, but neither has been made available for sale yet.

“Whether actual cost savings end up above or below our baseline estimate hinges in large part on whether manufacturers continue to have a business case to invest in developing and marketing biosimilars,” the authors noted, citing a number of areas, including intellectual property litigation, payment, price competition, nonprice competition from reference biologic manufacturers, naming convention, and interchangeability.

Getting over these hurdles could require legislative or regulatory solutions.

“The pervasive uncertainty in the U.S. biosimilar market – including questions as to whether the market will be sustainable and lead to cost savings, as intended – presents two choices for policymakers,” Dr. Mulcahy and his colleagues wrote. “One strategy is to let the market continue to develop under current policies,” with stability coming from experience.

The alternative could be policy levers to “help steer the U.S. biosimilar market more quickly to a sustainable, competitive state,” they continued. “For example, regulators at the FDA could experiment with new approaches to provide stronger, earlier signals through guidance documents or other mechanisms on expectations surrounding interchangeability and other topics.”

The FDA appears to be moving on the latter. In an Oct. 23 blog post, FDA Commissioner Scott Gottlieb, MD, and Leah Christl, PhD, associate director for therapeutic biologics in the office of new drugs at the FDA’s Center for Drug Evaluation and Research, outlined a number of recent tools to help biosimilar adoption. The resources provide basics such as the basic definition associated with biosimilars (i.e., what is a biosimilar and a reference product, and what it means to be interchangeable), the standards of approval that biosimilars must go through, and easily accessible information on what the FDA is using to review biosimilarity.

“Next, FDA plans to embark on additional research with health care professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars,” Commissioner Gottlieb and Dr. Christl wrote. “An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our health care system.”

The Centers for Medicare & Medicaid Services also plays a role in developing policy to spur biosimilar adoption, Dr. Mulcahy and his colleagues wrote. They note work being done by the Medicare Payment Advisory Commission on recommendations that could address payment for physician-administered biosimilars under Part B, as well as incentives in the Part D prescription drug program to steer patients and providers toward lower cost biosimilars when appropriate. CMS changed current payment policy for biosimilars for 2018, which may have an effect.

“Beyond FDA regulation, payment, and coverage, both government and industry could play a role in educating patients and providers about the potential cost savings from biosimilars, much like both groups have done for generic drugs,” they stated. “While our study does not address whether policy action is needed now, it is likely that the answer will become clearer over the next 1 to 3 years as the market continues to develop.”

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Force Protection in the Spotlight at AMSUS Meeting

Article Type
Changed
Thu, 01/25/2018 - 11:29
Annual meeting will focus on force protection and health care transitions as the new executive director prepares to take over.

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

 

Publications
Sections
Related Articles
Annual meeting will focus on force protection and health care transitions as the new executive director prepares to take over.
Annual meeting will focus on force protection and health care transitions as the new executive director prepares to take over.

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

 

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

 

Publications
Publications
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

VIDEO: How to manage surgical pain in opioid addiction treatment

Article Type
Changed
Fri, 06/21/2019 - 07:32

– How do you manage surgical pain when someone is in treatment for opioid addiction? And how do you manage chronic pain?

It is possible to give patients opioids for post-op pain without increasing the risk of relapse, according to Margaret Chaplin, MD, a staff psychiatrist at Community Mental Health Affiliates in New Britain, Conn.

Dr. Chaplin generally uses buprenorphine and naloxone (Suboxone) for opioid use disorder, and she likes to keep her patients on it for surgery. That often means, however, talking with skeptical surgeons and anesthesiologists beforehand, and reminding them that buprenorphine itself has analgesic effects. Meanwhile, when her patients have chronic pain, sometimes they need help understanding that aspirin and acetaminophen help, even if they don’t give patients a warm, fuzzy feeling.

Dr. Chaplin shared those tips and more about pain management in opioid addiction in an interview at the American Psychiatric Association’s Institute on Psychiatric Services.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

– How do you manage surgical pain when someone is in treatment for opioid addiction? And how do you manage chronic pain?

It is possible to give patients opioids for post-op pain without increasing the risk of relapse, according to Margaret Chaplin, MD, a staff psychiatrist at Community Mental Health Affiliates in New Britain, Conn.

Dr. Chaplin generally uses buprenorphine and naloxone (Suboxone) for opioid use disorder, and she likes to keep her patients on it for surgery. That often means, however, talking with skeptical surgeons and anesthesiologists beforehand, and reminding them that buprenorphine itself has analgesic effects. Meanwhile, when her patients have chronic pain, sometimes they need help understanding that aspirin and acetaminophen help, even if they don’t give patients a warm, fuzzy feeling.

Dr. Chaplin shared those tips and more about pain management in opioid addiction in an interview at the American Psychiatric Association’s Institute on Psychiatric Services.

– How do you manage surgical pain when someone is in treatment for opioid addiction? And how do you manage chronic pain?

It is possible to give patients opioids for post-op pain without increasing the risk of relapse, according to Margaret Chaplin, MD, a staff psychiatrist at Community Mental Health Affiliates in New Britain, Conn.

Dr. Chaplin generally uses buprenorphine and naloxone (Suboxone) for opioid use disorder, and she likes to keep her patients on it for surgery. That often means, however, talking with skeptical surgeons and anesthesiologists beforehand, and reminding them that buprenorphine itself has analgesic effects. Meanwhile, when her patients have chronic pain, sometimes they need help understanding that aspirin and acetaminophen help, even if they don’t give patients a warm, fuzzy feeling.

Dr. Chaplin shared those tips and more about pain management in opioid addiction in an interview at the American Psychiatric Association’s Institute on Psychiatric Services.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT IPS 2017

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Multiple Comorbidities: Does Age Matter?

Article Type
Changed
Tue, 08/21/2018 - 14:36
New research creates a younger image of patients with multiple comorbid conditions.

The stereotype of someone with multiple comorbid conditions (MCCs) is an older, often overweight person. But according to an analysis of data from > 200,000 respondents in the 2015 Behavioral Risk Factor Surveillance System (BRFSS), people aged < 65 years are more likely to report MCCs, such as asthma, cognitive impairment, depression, smoking, obesity, disability, and lower quality of life (QOL). In fact, research indicates that most people with MCCs are of working age.

The study compared 2 groups of adults with MCCs: those aged > 65 years with those aged < 65 years. The researchers found significant differences by age group in 18 measures, suggesting that adults aged < 65 years were “worse off” compared with those aged > 65 years. Results were similar regardless of whether diabetes, depression, hypertension, and high cholesterol were included.

Other results from BRFSS data have shown that people with ≥ 3 chronic conditions are more likely to report poor QOL than those with fewer conditions. But that analysis did not compare age groups, the researchers say. In this study, most uninsured adults were aged < 65 years, and the younger adults with MCCs were more likely to report a cost barrier to health care. They also were less likely to report a recent routine check-up. According to the study. these are important findings because managing and treating existing chronic conditions and diagnosing incident ones are key to preventing worse health in the future. The younger cohort had lower levels of well-recognized risk factors—diabetes, hypertension, high cholesterol—than the older, but their levels were still high enough to be concerning.

A “somewhat unexpected” finding was that the younger group had a high rate of cognitive impairment. That could be the result of lack of sleep, side effects of medication, or use of illicit drugs, the researcher notes, and may not be associated with future risk of dementia. Whatever the cause, though, the researcher adds that being cognitively impaired can affect someone’s ability to manage other chronic conditions.

Publications
Topics
Sections
Related Articles
New research creates a younger image of patients with multiple comorbid conditions.
New research creates a younger image of patients with multiple comorbid conditions.

The stereotype of someone with multiple comorbid conditions (MCCs) is an older, often overweight person. But according to an analysis of data from > 200,000 respondents in the 2015 Behavioral Risk Factor Surveillance System (BRFSS), people aged < 65 years are more likely to report MCCs, such as asthma, cognitive impairment, depression, smoking, obesity, disability, and lower quality of life (QOL). In fact, research indicates that most people with MCCs are of working age.

The study compared 2 groups of adults with MCCs: those aged > 65 years with those aged < 65 years. The researchers found significant differences by age group in 18 measures, suggesting that adults aged < 65 years were “worse off” compared with those aged > 65 years. Results were similar regardless of whether diabetes, depression, hypertension, and high cholesterol were included.

Other results from BRFSS data have shown that people with ≥ 3 chronic conditions are more likely to report poor QOL than those with fewer conditions. But that analysis did not compare age groups, the researchers say. In this study, most uninsured adults were aged < 65 years, and the younger adults with MCCs were more likely to report a cost barrier to health care. They also were less likely to report a recent routine check-up. According to the study. these are important findings because managing and treating existing chronic conditions and diagnosing incident ones are key to preventing worse health in the future. The younger cohort had lower levels of well-recognized risk factors—diabetes, hypertension, high cholesterol—than the older, but their levels were still high enough to be concerning.

A “somewhat unexpected” finding was that the younger group had a high rate of cognitive impairment. That could be the result of lack of sleep, side effects of medication, or use of illicit drugs, the researcher notes, and may not be associated with future risk of dementia. Whatever the cause, though, the researcher adds that being cognitively impaired can affect someone’s ability to manage other chronic conditions.

The stereotype of someone with multiple comorbid conditions (MCCs) is an older, often overweight person. But according to an analysis of data from > 200,000 respondents in the 2015 Behavioral Risk Factor Surveillance System (BRFSS), people aged < 65 years are more likely to report MCCs, such as asthma, cognitive impairment, depression, smoking, obesity, disability, and lower quality of life (QOL). In fact, research indicates that most people with MCCs are of working age.

The study compared 2 groups of adults with MCCs: those aged > 65 years with those aged < 65 years. The researchers found significant differences by age group in 18 measures, suggesting that adults aged < 65 years were “worse off” compared with those aged > 65 years. Results were similar regardless of whether diabetes, depression, hypertension, and high cholesterol were included.

Other results from BRFSS data have shown that people with ≥ 3 chronic conditions are more likely to report poor QOL than those with fewer conditions. But that analysis did not compare age groups, the researchers say. In this study, most uninsured adults were aged < 65 years, and the younger adults with MCCs were more likely to report a cost barrier to health care. They also were less likely to report a recent routine check-up. According to the study. these are important findings because managing and treating existing chronic conditions and diagnosing incident ones are key to preventing worse health in the future. The younger cohort had lower levels of well-recognized risk factors—diabetes, hypertension, high cholesterol—than the older, but their levels were still high enough to be concerning.

A “somewhat unexpected” finding was that the younger group had a high rate of cognitive impairment. That could be the result of lack of sleep, side effects of medication, or use of illicit drugs, the researcher notes, and may not be associated with future risk of dementia. Whatever the cause, though, the researcher adds that being cognitively impaired can affect someone’s ability to manage other chronic conditions.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica

Results support early blood transfusion

Article Type
Changed
Wed, 10/25/2017 - 00:04
Display Headline
Results support early blood transfusion

Photo from UAB Hospital
Blood for transfusion

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

  • A traumatic limb amputation at or above the knee or elbow
  • Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Publications
Topics

Photo from UAB Hospital
Blood for transfusion

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

  • A traumatic limb amputation at or above the knee or elbow
  • Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Photo from UAB Hospital
Blood for transfusion

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

  • A traumatic limb amputation at or above the knee or elbow
  • Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Publications
Publications
Topics
Article Type
Display Headline
Results support early blood transfusion
Display Headline
Results support early blood transfusion
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica