User login
Differentiate Acute Bronchitis and Community Acquired Pneumonia
Treat sleep apnea with positive airway pressure, but don’t expect it to prevent heart attacks
Clinical question: In patients with sleep apnea, does using positive airway pressure (PAP) treatment prevent adverse cardiovascular events and death?
Background: Previous observational studies have suggested that untreated sleep apnea is a factor in cardiopulmonary morbidity as well as cerebrovascular events. Guidelines advise its use for prevention of cerebrovascular events. However, not enough is known from trials about its impact on prevention of cardiovascular events.
Synopsis: The authors analyzed 10 randomized-controlled trials encompassing 7,266 patients with sleep apnea. They examined instances of major adverse cardiovascular events (MACE; acute coronary syndrome, stroke, cardiovascular death) as well as hospitalization for unstable angina and all-cause deaths, among others. They found no association between treatment with positive airway pressure and MACEs (169 events vs. 187 events, with a relative risk of 0.77; 95% confidence interval, 0.53-1.13) or all-cause death (324 events vs. 289 events, RR 1.13; 95% CI,0.99-1.29).
Bottom line: Positive airway pressure treatment for patients with sleep apnea is not an intervention to prevent cardiovascular morbidity.
Citation: Yu J et al. Association of positive airway pressure with cardiovascular events and death in adults with sleep apnea. JAMA. 2017 Jul 11;318(2):156-66.
Dr. Sata is a medical instructor, Duke University Hospital.
Clinical question: In patients with sleep apnea, does using positive airway pressure (PAP) treatment prevent adverse cardiovascular events and death?
Background: Previous observational studies have suggested that untreated sleep apnea is a factor in cardiopulmonary morbidity as well as cerebrovascular events. Guidelines advise its use for prevention of cerebrovascular events. However, not enough is known from trials about its impact on prevention of cardiovascular events.
Synopsis: The authors analyzed 10 randomized-controlled trials encompassing 7,266 patients with sleep apnea. They examined instances of major adverse cardiovascular events (MACE; acute coronary syndrome, stroke, cardiovascular death) as well as hospitalization for unstable angina and all-cause deaths, among others. They found no association between treatment with positive airway pressure and MACEs (169 events vs. 187 events, with a relative risk of 0.77; 95% confidence interval, 0.53-1.13) or all-cause death (324 events vs. 289 events, RR 1.13; 95% CI,0.99-1.29).
Bottom line: Positive airway pressure treatment for patients with sleep apnea is not an intervention to prevent cardiovascular morbidity.
Citation: Yu J et al. Association of positive airway pressure with cardiovascular events and death in adults with sleep apnea. JAMA. 2017 Jul 11;318(2):156-66.
Dr. Sata is a medical instructor, Duke University Hospital.
Clinical question: In patients with sleep apnea, does using positive airway pressure (PAP) treatment prevent adverse cardiovascular events and death?
Background: Previous observational studies have suggested that untreated sleep apnea is a factor in cardiopulmonary morbidity as well as cerebrovascular events. Guidelines advise its use for prevention of cerebrovascular events. However, not enough is known from trials about its impact on prevention of cardiovascular events.
Synopsis: The authors analyzed 10 randomized-controlled trials encompassing 7,266 patients with sleep apnea. They examined instances of major adverse cardiovascular events (MACE; acute coronary syndrome, stroke, cardiovascular death) as well as hospitalization for unstable angina and all-cause deaths, among others. They found no association between treatment with positive airway pressure and MACEs (169 events vs. 187 events, with a relative risk of 0.77; 95% confidence interval, 0.53-1.13) or all-cause death (324 events vs. 289 events, RR 1.13; 95% CI,0.99-1.29).
Bottom line: Positive airway pressure treatment for patients with sleep apnea is not an intervention to prevent cardiovascular morbidity.
Citation: Yu J et al. Association of positive airway pressure with cardiovascular events and death in adults with sleep apnea. JAMA. 2017 Jul 11;318(2):156-66.
Dr. Sata is a medical instructor, Duke University Hospital.
The National Kidney Foundation Names Clinician Reviews® Recipient of the 2018 Nostradamus Award
Frontline Medical Communications today announced that its journal, Clinician Reviews (CR), dedicated to nurse practitioners and physician assistants, has been named recipient of the 2018 Nostradamus Award.
Annually, National Kidney Foundation’s Council of Advanced Practitioners (CAP) presents this award to an individual, group, or organization that, through forethought and vision, recognizes, supports, and promotes the contributions of Advance Practitioners in nephrology. Clinician Reviews is being recognized for its Q&A feature Renal Consult, which provides expert advice to help clinicians address the complexities of renal diseases.
“Clinician Reviews joins a list of outstanding winners, including nephrologists, a United States senator, and others who have recognized CAP’s worth and supported its advancement,” said Karen Clemments, Editorial Director of clinical publications and Editor of Clinician Reviews. She continued, “We are excited to be among an esteemed group of past recipients for our ongoing endeavors to educate advanced practitioners in support of their clinical, professional needs in preventing, diagnosing, and treating kidney diseases.”
In announcing the award, Ms. Clemments noted that Renal Consult aligns with CAP’s goal to improve patient outcomes by enhancing advanced practitioners’ knowledge base and skills that will have a direct impact on clinical practice in a variety of settings. Renal Consult appears quarterly in print and online in CR’s robust, interactive website, digital edition, and mobile app.
The National Kidney Foundation is the leading organization in the United States dedicated to the awareness, prevention, and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk. Clinician Reviews will be recognized during an awards luncheon at the NKF 2018 Spring Clinical Meeting in April.
Frontline Medical Communications today announced that its journal, Clinician Reviews (CR), dedicated to nurse practitioners and physician assistants, has been named recipient of the 2018 Nostradamus Award.
Annually, National Kidney Foundation’s Council of Advanced Practitioners (CAP) presents this award to an individual, group, or organization that, through forethought and vision, recognizes, supports, and promotes the contributions of Advance Practitioners in nephrology. Clinician Reviews is being recognized for its Q&A feature Renal Consult, which provides expert advice to help clinicians address the complexities of renal diseases.
“Clinician Reviews joins a list of outstanding winners, including nephrologists, a United States senator, and others who have recognized CAP’s worth and supported its advancement,” said Karen Clemments, Editorial Director of clinical publications and Editor of Clinician Reviews. She continued, “We are excited to be among an esteemed group of past recipients for our ongoing endeavors to educate advanced practitioners in support of their clinical, professional needs in preventing, diagnosing, and treating kidney diseases.”
In announcing the award, Ms. Clemments noted that Renal Consult aligns with CAP’s goal to improve patient outcomes by enhancing advanced practitioners’ knowledge base and skills that will have a direct impact on clinical practice in a variety of settings. Renal Consult appears quarterly in print and online in CR’s robust, interactive website, digital edition, and mobile app.
The National Kidney Foundation is the leading organization in the United States dedicated to the awareness, prevention, and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk. Clinician Reviews will be recognized during an awards luncheon at the NKF 2018 Spring Clinical Meeting in April.
Frontline Medical Communications today announced that its journal, Clinician Reviews (CR), dedicated to nurse practitioners and physician assistants, has been named recipient of the 2018 Nostradamus Award.
Annually, National Kidney Foundation’s Council of Advanced Practitioners (CAP) presents this award to an individual, group, or organization that, through forethought and vision, recognizes, supports, and promotes the contributions of Advance Practitioners in nephrology. Clinician Reviews is being recognized for its Q&A feature Renal Consult, which provides expert advice to help clinicians address the complexities of renal diseases.
“Clinician Reviews joins a list of outstanding winners, including nephrologists, a United States senator, and others who have recognized CAP’s worth and supported its advancement,” said Karen Clemments, Editorial Director of clinical publications and Editor of Clinician Reviews. She continued, “We are excited to be among an esteemed group of past recipients for our ongoing endeavors to educate advanced practitioners in support of their clinical, professional needs in preventing, diagnosing, and treating kidney diseases.”
In announcing the award, Ms. Clemments noted that Renal Consult aligns with CAP’s goal to improve patient outcomes by enhancing advanced practitioners’ knowledge base and skills that will have a direct impact on clinical practice in a variety of settings. Renal Consult appears quarterly in print and online in CR’s robust, interactive website, digital edition, and mobile app.
The National Kidney Foundation is the leading organization in the United States dedicated to the awareness, prevention, and treatment of kidney disease for hundreds of thousands of healthcare professionals, millions of patients and their families, and tens of millions of Americans at risk. Clinician Reviews will be recognized during an awards luncheon at the NKF 2018 Spring Clinical Meeting in April.
CHMP recommends generic drug for ET
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk ET patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
An at-risk ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation. 
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk ET patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
An at-risk ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk ET patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
An at-risk ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation.
Pembrolizumab sBLA receives priority review
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for the anti-PD-1 therapy pembrolizumab (KEYTRUDA).
With this sBLA, Merck is seeking approval for pembrolizumab to treat adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL) or patients with PMBCL who have relapsed after 2 or more prior lines of therapy.
The FDA expects to make a decision on the sBLA by April 3, 2018.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
Pembrolizumab is currently FDA-approved to treat classical Hodgkin lymphoma, melanoma, lung cancer, head and neck cancer, urothelial carcinoma, microsatellite instability-high cancer, and gastric cancer.
The sBLA for pembrolizumab as a treatment for PMBCL is supported by the phase 2 KEYNOTE-170 trial. Results from this trial were presented at the 2017 ASH Annual Meeting (abstract 2833).
KEYNOTE-170 is an ongoing study in which researchers are evaluating pembrolizumab (given at a 200 mg fixed dose every 3 weeks) in patients with relapsed/refractory PMBCL or relapsed/refractory Richter syndrome.
The PMBCL cohort enrolled patients who relapsed after autologous stem cell transplant (ASCT), were refractory to ASCT, or were ineligible for ASCT. Patients ineligible for ASCT had to have received 2 or more lines of prior therapy.
The median duration of follow-up was 10.5 months (range, 0.1-17.7).
In the efficacy population (n=29), the overall response rate was 41% (n=12), and the complete response rate was 24% (n=7).
The median time to response was 2.8 months (range, 2.4-5.5), and the median duration of response was not reached (range, 1.1+ to 13.6+ months).
Of the 53 patients evaluated for safety, 57% (n=30) experienced treatment-related adverse events (TRAEs), including 21% (n=11) who experienced grade 3-4 TRAEs.
The most common TRAEs (occurring in at least 5% of patients) were neutropenia (n=11), hypothyroidism (n=4), asthenia (n=3), and pyrexia (n=3).
Immune-mediated adverse events of all grades occurred in 11% (n=6) of patients. These include hypothyroidism (n=4), hyperthyroidism (n=2), pneumonitis (n=1), and thyroiditis (n=1). There were no treatment-related deaths.
*Data in the abstract differ from the presentation.
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for the anti-PD-1 therapy pembrolizumab (KEYTRUDA).
With this sBLA, Merck is seeking approval for pembrolizumab to treat adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL) or patients with PMBCL who have relapsed after 2 or more prior lines of therapy.
The FDA expects to make a decision on the sBLA by April 3, 2018.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
Pembrolizumab is currently FDA-approved to treat classical Hodgkin lymphoma, melanoma, lung cancer, head and neck cancer, urothelial carcinoma, microsatellite instability-high cancer, and gastric cancer.
The sBLA for pembrolizumab as a treatment for PMBCL is supported by the phase 2 KEYNOTE-170 trial. Results from this trial were presented at the 2017 ASH Annual Meeting (abstract 2833).
KEYNOTE-170 is an ongoing study in which researchers are evaluating pembrolizumab (given at a 200 mg fixed dose every 3 weeks) in patients with relapsed/refractory PMBCL or relapsed/refractory Richter syndrome.
The PMBCL cohort enrolled patients who relapsed after autologous stem cell transplant (ASCT), were refractory to ASCT, or were ineligible for ASCT. Patients ineligible for ASCT had to have received 2 or more lines of prior therapy.
The median duration of follow-up was 10.5 months (range, 0.1-17.7).
In the efficacy population (n=29), the overall response rate was 41% (n=12), and the complete response rate was 24% (n=7).
The median time to response was 2.8 months (range, 2.4-5.5), and the median duration of response was not reached (range, 1.1+ to 13.6+ months).
Of the 53 patients evaluated for safety, 57% (n=30) experienced treatment-related adverse events (TRAEs), including 21% (n=11) who experienced grade 3-4 TRAEs.
The most common TRAEs (occurring in at least 5% of patients) were neutropenia (n=11), hypothyroidism (n=4), asthenia (n=3), and pyrexia (n=3).
Immune-mediated adverse events of all grades occurred in 11% (n=6) of patients. These include hypothyroidism (n=4), hyperthyroidism (n=2), pneumonitis (n=1), and thyroiditis (n=1). There were no treatment-related deaths.
*Data in the abstract differ from the presentation.
The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for the anti-PD-1 therapy pembrolizumab (KEYTRUDA).
With this sBLA, Merck is seeking approval for pembrolizumab to treat adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL) or patients with PMBCL who have relapsed after 2 or more prior lines of therapy.
The FDA expects to make a decision on the sBLA by April 3, 2018.
The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.
Pembrolizumab is currently FDA-approved to treat classical Hodgkin lymphoma, melanoma, lung cancer, head and neck cancer, urothelial carcinoma, microsatellite instability-high cancer, and gastric cancer.
The sBLA for pembrolizumab as a treatment for PMBCL is supported by the phase 2 KEYNOTE-170 trial. Results from this trial were presented at the 2017 ASH Annual Meeting (abstract 2833).
KEYNOTE-170 is an ongoing study in which researchers are evaluating pembrolizumab (given at a 200 mg fixed dose every 3 weeks) in patients with relapsed/refractory PMBCL or relapsed/refractory Richter syndrome.
The PMBCL cohort enrolled patients who relapsed after autologous stem cell transplant (ASCT), were refractory to ASCT, or were ineligible for ASCT. Patients ineligible for ASCT had to have received 2 or more lines of prior therapy.
The median duration of follow-up was 10.5 months (range, 0.1-17.7).
In the efficacy population (n=29), the overall response rate was 41% (n=12), and the complete response rate was 24% (n=7).
The median time to response was 2.8 months (range, 2.4-5.5), and the median duration of response was not reached (range, 1.1+ to 13.6+ months).
Of the 53 patients evaluated for safety, 57% (n=30) experienced treatment-related adverse events (TRAEs), including 21% (n=11) who experienced grade 3-4 TRAEs.
The most common TRAEs (occurring in at least 5% of patients) were neutropenia (n=11), hypothyroidism (n=4), asthenia (n=3), and pyrexia (n=3).
Immune-mediated adverse events of all grades occurred in 11% (n=6) of patients. These include hypothyroidism (n=4), hyperthyroidism (n=2), pneumonitis (n=1), and thyroiditis (n=1). There were no treatment-related deaths.
*Data in the abstract differ from the presentation.
Different perspectives on the care delivery process
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 first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
Last month I was able to conduct five interviews with key stakeholders, generate the patient flow diagram, define the problems, and propose potential interventions. The project is on time for the allotted time frame.
Interviewees include physicians and managers from infectious disease, hospital medicine, psychiatry and care management. They represent the services which admitted IVDU patients have contacts with: inpatient primary team, inpatient ID consult time, BIT (behavior intervention team), and OPAT (Outpatient Parenteral Antibiotic Therapy) program. I asked each interviewee about the specific challenges of care delivery during the inpatient, discharge, and outpatient follow up process.
It is not surprising that most would agree that discharge was the most difficult part. The ID service showed me data that those with IVDU history may have a one-time longer length of stay compared to the average. The social-psychological issues, including medication compliance, insurance coverage, and mental health comorbidities, are the most commonly mentioned factor for delayed discharge.
When asked about a suggestion for a particular area for quality improvement, different services came up with different recommendations. ID suggested looking at availability of community resources and improving patients’ access to them. Psychiatry has been trying to screen all admitted patients for substance use disorders, with an intention of early intervention. Hospital medicine and care management were contemplating the potential means for a repatriation program, i.e., making the transferring acute care facility agree to receive patients back once tertiary care was complete. Given that Dartmouth-Hitchcock Medical Center has a few satellite community hospitals, it would make sense to establish some institutional protocol to optimize patient flow within the system.
My next step would be to pursue one or two areas for improvement from the above options. I will work with the relevant stakeholders to define the problems and come up with a plan. I am excited about moving forward to the next phase.
My research approach has changed slightly during the process. Initially I was narrowly focused on the desired outcomes of decreasing length of stay and readmission rate. Dr. Huntington challenged me to understand the whole process thoroughly as well as to spend time on defining the problems before diving into interventions. I enjoyed my role of being a learner, researcher, and consultant in this project. I gained a very in-depth perspective on how each service operates and coordinates. Also, it is both challenging and fun to coming up with an improvement plan. In my future residency and physician career, I am definitely going to pursue more care improvement initiatives.
Yun Li is an MD/MBA student attending Geisel School of Medicine and Tuck School of Business at Dartmouth. She obtained her Bachelor of Arts degree from Hanover College double-majoring in Economics and Biological Chemistry. Ms. Li participated in research in injury epidemiology and genetics, and has conducted studies on traditional Tibetan medicine, rural health, health NGOs, and digital health. Her career interest is practicing hospital medicine and geriatrics as a clinician/administrator, either in the US or China. Ms. Li is a student member of the Society of Hospital 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 first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
Last month I was able to conduct five interviews with key stakeholders, generate the patient flow diagram, define the problems, and propose potential interventions. The project is on time for the allotted time frame.
Interviewees include physicians and managers from infectious disease, hospital medicine, psychiatry and care management. They represent the services which admitted IVDU patients have contacts with: inpatient primary team, inpatient ID consult time, BIT (behavior intervention team), and OPAT (Outpatient Parenteral Antibiotic Therapy) program. I asked each interviewee about the specific challenges of care delivery during the inpatient, discharge, and outpatient follow up process.
It is not surprising that most would agree that discharge was the most difficult part. The ID service showed me data that those with IVDU history may have a one-time longer length of stay compared to the average. The social-psychological issues, including medication compliance, insurance coverage, and mental health comorbidities, are the most commonly mentioned factor for delayed discharge.
When asked about a suggestion for a particular area for quality improvement, different services came up with different recommendations. ID suggested looking at availability of community resources and improving patients’ access to them. Psychiatry has been trying to screen all admitted patients for substance use disorders, with an intention of early intervention. Hospital medicine and care management were contemplating the potential means for a repatriation program, i.e., making the transferring acute care facility agree to receive patients back once tertiary care was complete. Given that Dartmouth-Hitchcock Medical Center has a few satellite community hospitals, it would make sense to establish some institutional protocol to optimize patient flow within the system.
My next step would be to pursue one or two areas for improvement from the above options. I will work with the relevant stakeholders to define the problems and come up with a plan. I am excited about moving forward to the next phase.
My research approach has changed slightly during the process. Initially I was narrowly focused on the desired outcomes of decreasing length of stay and readmission rate. Dr. Huntington challenged me to understand the whole process thoroughly as well as to spend time on defining the problems before diving into interventions. I enjoyed my role of being a learner, researcher, and consultant in this project. I gained a very in-depth perspective on how each service operates and coordinates. Also, it is both challenging and fun to coming up with an improvement plan. In my future residency and physician career, I am definitely going to pursue more care improvement initiatives.
Yun Li is an MD/MBA student attending Geisel School of Medicine and Tuck School of Business at Dartmouth. She obtained her Bachelor of Arts degree from Hanover College double-majoring in Economics and Biological Chemistry. Ms. Li participated in research in injury epidemiology and genetics, and has conducted studies on traditional Tibetan medicine, rural health, health NGOs, and digital health. Her career interest is practicing hospital medicine and geriatrics as a clinician/administrator, either in the US or China. Ms. Li is a student member of the Society of Hospital 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 first, second and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
Last month I was able to conduct five interviews with key stakeholders, generate the patient flow diagram, define the problems, and propose potential interventions. The project is on time for the allotted time frame.
Interviewees include physicians and managers from infectious disease, hospital medicine, psychiatry and care management. They represent the services which admitted IVDU patients have contacts with: inpatient primary team, inpatient ID consult time, BIT (behavior intervention team), and OPAT (Outpatient Parenteral Antibiotic Therapy) program. I asked each interviewee about the specific challenges of care delivery during the inpatient, discharge, and outpatient follow up process.
It is not surprising that most would agree that discharge was the most difficult part. The ID service showed me data that those with IVDU history may have a one-time longer length of stay compared to the average. The social-psychological issues, including medication compliance, insurance coverage, and mental health comorbidities, are the most commonly mentioned factor for delayed discharge.
When asked about a suggestion for a particular area for quality improvement, different services came up with different recommendations. ID suggested looking at availability of community resources and improving patients’ access to them. Psychiatry has been trying to screen all admitted patients for substance use disorders, with an intention of early intervention. Hospital medicine and care management were contemplating the potential means for a repatriation program, i.e., making the transferring acute care facility agree to receive patients back once tertiary care was complete. Given that Dartmouth-Hitchcock Medical Center has a few satellite community hospitals, it would make sense to establish some institutional protocol to optimize patient flow within the system.
My next step would be to pursue one or two areas for improvement from the above options. I will work with the relevant stakeholders to define the problems and come up with a plan. I am excited about moving forward to the next phase.
My research approach has changed slightly during the process. Initially I was narrowly focused on the desired outcomes of decreasing length of stay and readmission rate. Dr. Huntington challenged me to understand the whole process thoroughly as well as to spend time on defining the problems before diving into interventions. I enjoyed my role of being a learner, researcher, and consultant in this project. I gained a very in-depth perspective on how each service operates and coordinates. Also, it is both challenging and fun to coming up with an improvement plan. In my future residency and physician career, I am definitely going to pursue more care improvement initiatives.
Yun Li is an MD/MBA student attending Geisel School of Medicine and Tuck School of Business at Dartmouth. She obtained her Bachelor of Arts degree from Hanover College double-majoring in Economics and Biological Chemistry. Ms. Li participated in research in injury epidemiology and genetics, and has conducted studies on traditional Tibetan medicine, rural health, health NGOs, and digital health. Her career interest is practicing hospital medicine and geriatrics as a clinician/administrator, either in the US or China. Ms. Li is a student member of the Society of Hospital Medicine.
Maternal mortality is set to be a top issue for 2018
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
[email protected]
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
[email protected]
Addressing issues around maternal mortality is going to be the top focus for the American Congress of Obstetricians and Gynecologists in 2018.
“It is will be the priority of my presidency here at ACOG,” President-elect Lisa Hollier, MD, said in an interview. Her term as president begins at the end of April 2018.
Rates of maternal mortality – defined as rates of death within 365 days of pregnancy – have become an increasingly prominent issue in the United States. Many states have created dedicated committees to examine the causes of increasing mortality and look for solutions. California, in particular, has had some success in reducing these rates.
To address the maternal mortality issue, ACOG is working on passing legislation through Congress that would give the federal government a role in funding these state-level committees.
“The main crux of the bill is to provide authorization for state maternal mortality, for funds to support state maternal mortality review committees,” said Rachel Tetlow, the director of federal affairs at ACOG. “We know that while a majority of states do have committees, there are still some who are struggling to stand them up and others that are struggling to fund them at full capacity. This legislation looks to support those state efforts to ensure that states really are able to move forward with reviewing maternal deaths and in some cases near misses in their states and recommend local state-based solutions.”
Another hot button issue that could affect maternal mortality is access to abortion.
“It is going to be interesting to see how those numbers shift as abortion providers are no longer available,” said Constance J. Bohon, MD, an ob.gyn. in Washington, D.C., and the ACOG state legislative chair from the District of Columbia. “For example, there is a concern that in states such as Texas, the maternal mortality rates may rise because of a lack of abortion providers.”
Attacks on abortion rights at both the state and federal level are expected in the coming year as well, Dr. Bohon said. She also expressed concerns over initiatives moving through some state houses that would hold doctors criminally liable for performing an abortion.
“What we have seen in the past is that these [abortion] bills come up really quickly without a whole lot of warning, so it’s difficult to say the specific legislation that we will see,” Ms. Tetlow said. “I am fairly confident that we will see at least one more vote in the House of Representatives and potentially one in the Senate ... before the 2018 elections.”
Maternal mortality could be symptomatic of another key issue in women’s health – an overall lack of access to adequate health care.
“One big issue is going to be how we get obstetrical care to women in communities where there is limited access,” she said. “We have got to figure out how to get all women, especially women in underserved areas who could be high risk into pregnancy care early on.”
Beyond that, ACOG is expecting that the women’s health services that have been in the cross hairs recently will continue to be so in 2018.
“2017 has been a year of just challenges and challenges and challenges for practicing ob.gyns. and patients, and we are expecting pretty much the same in 2018,” said Lucia DiVenere, a government and political affairs officer at ACOG.
Cuts to Medicaid, which House Speaker Paul Ryan (R-Wisc.) has identified as a key legislative priority for 2018, could create some significant issues for patients’ access to services.
“Roughly about 50% of deliveries are paid for by Medicaid,” Dr. Bohon said, noting that, for some states, that number can reach as high as 64%. “If those women don’t have access to care, it will be a disaster.”
The American Academy of Family Physicians will also be looking to maintain coverage of women’s health services in the Affordable Care Act.
“I think that our focus in 2018 is going to be around women’s continued access to comprehensive reproductive health care,” said AAFP President Michael Munger, MD. “Not only ensuring they have access to their breast, uterine, and cervical cancer screenings, prenatal maternity and postnatal care, but also preventive services.”
Dr. Munger singled out the Trump administration’s 2017 regulations allowing employers to opt out of providing contraception coverage for moral or religious reasons. “I think that is going to be a continued focus moving forward.”
“Three-quarters of women of childbearing age are in the workforce,” said Kandice Kapinos, PhD, of the Rand Corporation. “The studies on maternity leave show really positive effects of maternity leave on a wide range of child and maternal health outcomes.”
Not having an adequate amount of maternity leave can affect a woman’s ability to breastfeed her newborn, Dr. Kapinos added. “Breastfeeding can be difficult when you return to work,” she said. “Paid maternity leave would result in increases in breastfeeding. That has pretty big implications for health for women and children, which translates into pretty big cost savings.”
[email protected]
MMRV vaccine cut chickenpox hospitalizations in young Brazilian children
(VZV) in children aged 1-4 years, said Marcelo Comerlato Scotta and associates at Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
Of the 69,791 admissions caused by VZV in Brazilian patients younger than 20 years, the rate of such hospitalizations for children aged 1-4 years significantly decreased from 27 cases per 100,000 children per year to 14 cases per 100,000 children per year after the vaccine was introduced, a reduction of 48% (P < .001). Changes in other age groups were not significant. That decrease in the rate of VZV admissions remained statistically significant in the vaccinated group after adjusting for seasonality (P < .001).
Direct costs of VZV-related admissions dropped 38% after introducing the MMRV vaccine, the researchers said. “Further studies are needed to evaluate long-term direct and indirect impact on the epidemiology of VZV infections.”
Read more in Vaccine (2017 Dec 1. doi: 10.1016/j.vaccine.2017.11.057.)
(VZV) in children aged 1-4 years, said Marcelo Comerlato Scotta and associates at Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
Of the 69,791 admissions caused by VZV in Brazilian patients younger than 20 years, the rate of such hospitalizations for children aged 1-4 years significantly decreased from 27 cases per 100,000 children per year to 14 cases per 100,000 children per year after the vaccine was introduced, a reduction of 48% (P < .001). Changes in other age groups were not significant. That decrease in the rate of VZV admissions remained statistically significant in the vaccinated group after adjusting for seasonality (P < .001).
Direct costs of VZV-related admissions dropped 38% after introducing the MMRV vaccine, the researchers said. “Further studies are needed to evaluate long-term direct and indirect impact on the epidemiology of VZV infections.”
Read more in Vaccine (2017 Dec 1. doi: 10.1016/j.vaccine.2017.11.057.)
(VZV) in children aged 1-4 years, said Marcelo Comerlato Scotta and associates at Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
Of the 69,791 admissions caused by VZV in Brazilian patients younger than 20 years, the rate of such hospitalizations for children aged 1-4 years significantly decreased from 27 cases per 100,000 children per year to 14 cases per 100,000 children per year after the vaccine was introduced, a reduction of 48% (P < .001). Changes in other age groups were not significant. That decrease in the rate of VZV admissions remained statistically significant in the vaccinated group after adjusting for seasonality (P < .001).
Direct costs of VZV-related admissions dropped 38% after introducing the MMRV vaccine, the researchers said. “Further studies are needed to evaluate long-term direct and indirect impact on the epidemiology of VZV infections.”
Read more in Vaccine (2017 Dec 1. doi: 10.1016/j.vaccine.2017.11.057.)
FROM VACCINE
FDA approves Eskata for treatment of raised SKs
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.
Zika virus testing shows low incidence in donor blood outside of high-infection areas
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
SAN DIEGO – The Zika virus is primarily transmitted via the Aedes mosquitoes, most commonly by A. aegypti, but recent outbreaks have revealed that nonvector transmission routes may also spread the infection. Some data suggest that blood transfusion can be a source of transmission.
While the number of contaminated blood donations remains very small, three studies presented at the American Association of Blood Banks annual meeting confirmed the ability of new investigational assays to detect Zika virus in donated blood.
There have been no confirmed transfusion-transmission cases of Zika virus in the United States, but as cases have now been documented in Brazil, the Food and Drug Administration issued revised guidance in August 2016 recommending that blood centers in all states and U.S. territories screen individual units of donated whole blood and blood components.
In the first report (C7-A01C), Paula Saá, PhD, and her colleagues at the American Red Cross initially investigated the use of mini-pool (MP)- nucleic acid testing (NAT) using the Procleix Zika Virus Assay (TMA). Testing was initially implemented on blood collections from Florida, Georgia, South Carolina, Mississippi, and Alabama – five states that were presumed to be at high risk of Zika virus infection. After the FDA revised its guidance, the protocol changed and testing was extended to all blood donations. The use of the MP-NAT was also converted to individual donation (ID)-NAT, and questions concerning travel history was also eventually discontinued.
However, even with the use of ID-NAT, the rate of confirmed positive donations was quite small but the associated cost was quite high, the researchers pointed out. “In the first year of testing at the American Red Cross, we identified nine confirmed positive donations,” said Dr. Saá.
The rate of confirmed positive donations was 1:354, 602 during the study period, but if the period up until September 2017 is taken into account (no additional cases were identified), the rate increases to 1:514,266. “This is a very low rate,” Dr. Saá said. “If there are no changes to the current guidelines, we have estimated that the yearly cost for the American Red Cross of testing will exceed $48 million.”
These figures extrapolate to approximately $6 million per confirmed case, according to the results of this study sponsored by the American Red Cross.
Confirmatory testing included repeat TMA; in addition, RT-PCR, serology and red blood cell count (RBC) TMA were performed. Estimates of viral loads were performed by endpoint TMA on plasma and RBCs.
A total of 2,288,855 blood donations had been tested as of April 2017, including 393,713 (17%) in 24,611 MPs, which did not detect any reactive donations.
Of the confirmed positive blood donors, three lived in Florida and two of those were from local transmission. Six individuals had traveled to a region highly active for Zika virus, and returned to the United States between 2 and 73 days before donating blood. Clinical symptoms were reported in two individuals with a travel risk; the other donors with a confirmed positive test (75%) remained asymptomatic. The longest period for detection in RBCs was 91 days thus far, but in the same person, detection in plasma was only 17 days.
“The data that we are showing here recommends a testing strategy with mini pool testing in areas at low risk of Zika transmission,” said Dr. Saá.
A second related study (C9-A01C), described the detection of ZIKV RNA in blood donations collected in U.S. states between April 3, 2016, and September 23, 2017, using the cobas Zika test, to be used on the cobas 6800/8800 Systems.
Although the test was investigational during the study period, it has just been approved by the FDA, said study author Lisa Pate, MD, who is with Roche Molecular Systems, the manufacturer of the cobas Zika test and cobas 6800/8800 systems. “This is now the first licensed test for screening blood donations for Zika virus.”
Overall, testing showed that Zika contamination in the U.S. blood supply was quite low. Only 0.001% of screened blood donations in United States were confirmed as true positives.
The development of this test came about after the first cases of Zika virus in the United States were detected in Puerto Rico in December 2015, explained Dr. Pate. Shortly after that, the FDA issued guidance prohibiting the use of blood collected in Zika active areas, unless the donations were screened.
“The impact was significant in Puerto Rico, as blood donations were halted, which then forced Puerto Rico to rely on imported blood,” she said.
About that time the FDA reached out to Roche and competitors to see if a test could be developed to screen for Zika.
The cobas Zika test was approved under an investigational new drug application on March 30, 2016, and although initially used to test blood samples in Puerto Rico, testing was expanded to include donor blood from all over the country.
Screening was conducted by individual donation testing, with all initial reactive results repeated in duplicate. Supplemental testing was also done, and included an alternative NAT (AltNAT) assay which was considered to be less sensitive than cobas Zika and serology testing for anti-Zika IgM and IgG. A donor confirmed Zika confirmed positive if at least one replicate of the repeat testing by cobas Zika was reactive on index donation or follow-up, reactive by AltNAT on the index donation, or positive for anti-Zika IgM on index or follow-up.
Screening was conducted at 12 testing labs in the United States, and more than 4 million donations were screened and 27 positive donations were confirmed. Overall, that amounted to less than 1 in 100,000.
“For donors in the U.S. with confirmed positive results, and for whom follow-up information is available, 84% of them report recent travel to Zika active areas,” noted Dr. Pate.
For Puerto Rico, 111,842 blood donations were screened and there were 356 confirmed positive results. The incidence is much higher than in United States, and was 1.27% during peak incidence in July 2016.
A third paper (C12-A01C), also reported on testing the blood supply in Singapore, which had reported its first locally transmitted Zika case last August, using the investigational Procleix ZIKV nucleic acid technology (NAT) assay.
The presence of Zika virus in screened blood was also quite low, with an incidence of only 0.0032%. The Procleix ZIKV assay was found to suitable for screening for Zika infection in an asymptomatic population, as it showed good analytical sensitivity and clinical performance.
The Zika virus came to Singapore in May 2016, imported by an individual who had recently traveled to Brazil, said Sally Lam, laboratory director, Blood Services Group, Health Sciences Authority, Singapore.
“Then in August we had 41 confirmed local Zika virus cases,” she said.
In 2016, there were 458 clinical Zika cases reported, with 8 clusters identified. This year, 63 cases have been reported to date, she said.
Mandatory Zika virus screening in donor blood with ID-NAT began after the onset of local outbreaks, and was implemented in January 2017. A total of 126,906 blood donations were screened.
Researchers in Singapore assessed the performance of the Procleix ZIKV NAT assay for universal blood donation screening. They screened all blood that was donated, beginning Oct. 1, 2016, a confirmed case was defined as having Zika RNA by PCR and/or Zika antibodies. Analytical sensitivity was assessed by use of 300 blinded frozen samples containing Zika virus and 25 negative controls. The performance of the Procleix ZIKV assay was also evaluated by use of samples from the local patient population.
Of four confirmed positive cases, only one was available for follow-up. “In the index donation, the viral load was quite high in the plasma but at 10 days, it was reduced to about 400 copies/mL in the plasma,” said Ms. Lam. “The donor did not develop any symptoms.”
The analytical sensitivity for the Procleix ZIKV assay was determined to be 2.1 copies/mL at 50% LOD and 10.0 copies/mL at 95% LOD, and it detected RNA in six out of nine patient samples for an 85.7% agreement with reference material, according to the researchers.
AT AABB17