An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common allegationsby patients¹:

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD,a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco (see “Frequent sources of malpractice claims” below).

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims¹:  

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”¹ See “Tips for reducing malpractice claims in obstetrics” below.

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.¹

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common allegationsby patients¹:

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD,a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco (see “Frequent sources of malpractice claims” below).

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims¹:  

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”¹ See “Tips for reducing malpractice claims in obstetrics” below.

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.¹

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common allegationsby patients¹:

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD,a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco (see “Frequent sources of malpractice claims” below).

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims¹:  

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”¹ See “Tips for reducing malpractice claims in obstetrics” below.

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.¹

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Critique

Patients with mild pancreatitis can be treated with hydration alone. Initial feeding with a low-fat diet is safe and may reduce the duration of hospitalization, compared with a clear liquid diet in patients with mild pancreatitis. Multiple studies have demonstrated that enteral feeding is safe and tolerated in acute pancreatitis. Additionally, enteral feeding may preserve gut barrier function and prevent translocation of bacteria, which are implicated in pancreatic infections. A meta-analysis of the existing literature has demonstrated improved outcome with enteral feeding, compared with parenteral feeding, with less infectious complications, reduced cost, and better glycemic control.

References

1. McClave, S.A., Change, W.K., Dhaliwal, R., et al. Nutritional support in acute pancreatitis; a systemic review of the literature. J. Parenteral Enteral Nutr. 2006;30:143–56.

2. Vu M.K., van der Veek P.P., Frolich M., et al. Does jejunal feeding activate exocrine pancreatic secretions? Eur. J. Clin. Invest. 1999;29:1053–9.

3. Petrov M.S., van Santvoort H.C., Besselink M.S., et al. Enteral nutrition and the risk of mortality and infectious complications in patients with severe acute pancreatitis: a meta-analysis of randomized trials. Arch. Surg. 2008;143:1111–7.

Critique

Patients with mild pancreatitis can be treated with hydration alone. Initial feeding with a low-fat diet is safe and may reduce the duration of hospitalization, compared with a clear liquid diet in patients with mild pancreatitis. Multiple studies have demonstrated that enteral feeding is safe and tolerated in acute pancreatitis. Additionally, enteral feeding may preserve gut barrier function and prevent translocation of bacteria, which are implicated in pancreatic infections. A meta-analysis of the existing literature has demonstrated improved outcome with enteral feeding, compared with parenteral feeding, with less infectious complications, reduced cost, and better glycemic control.

References

1. McClave, S.A., Change, W.K., Dhaliwal, R., et al. Nutritional support in acute pancreatitis; a systemic review of the literature. J. Parenteral Enteral Nutr. 2006;30:143–56.

2. Vu M.K., van der Veek P.P., Frolich M., et al. Does jejunal feeding activate exocrine pancreatic secretions? Eur. J. Clin. Invest. 1999;29:1053–9.

3. Petrov M.S., van Santvoort H.C., Besselink M.S., et al. Enteral nutrition and the risk of mortality and infectious complications in patients with severe acute pancreatitis: a meta-analysis of randomized trials. Arch. Surg. 2008;143:1111–7.

Critique

Patients with mild pancreatitis can be treated with hydration alone. Initial feeding with a low-fat diet is safe and may reduce the duration of hospitalization, compared with a clear liquid diet in patients with mild pancreatitis. Multiple studies have demonstrated that enteral feeding is safe and tolerated in acute pancreatitis. Additionally, enteral feeding may preserve gut barrier function and prevent translocation of bacteria, which are implicated in pancreatic infections. A meta-analysis of the existing literature has demonstrated improved outcome with enteral feeding, compared with parenteral feeding, with less infectious complications, reduced cost, and better glycemic control.

References

1. McClave, S.A., Change, W.K., Dhaliwal, R., et al. Nutritional support in acute pancreatitis; a systemic review of the literature. J. Parenteral Enteral Nutr. 2006;30:143–56.

2. Vu M.K., van der Veek P.P., Frolich M., et al. Does jejunal feeding activate exocrine pancreatic secretions? Eur. J. Clin. Invest. 1999;29:1053–9.

3. Petrov M.S., van Santvoort H.C., Besselink M.S., et al. Enteral nutrition and the risk of mortality and infectious complications in patients with severe acute pancreatitis: a meta-analysis of randomized trials. Arch. Surg. 2008;143:1111–7.

Q1: ANSWER: B

Critique

This patient has developed an ulcer because of chronic NSAID use. She is older than 60 years old and is also on antiplatelet therapy. Therefore, her risk of peptic ulcer rebleeding is high and warrants lifelong secondary prophylaxis with a proton pump inhibitor (Choice B). Therefore, stopping all prophylactic measures would be inappropriate (Choice A). Repeat endoscopy to assess for gastric ulcer healing may be warranted, especially in the setting of risk factors for malignancy, but duodenal ulcers do not require endoscopic follow-up (Choice C). There is no role to empirically treat H. pylori in the context of having negative test results (Choice E).

References

1. Bhatt, D.L., et al. ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. Am. J. Gastroenterol. 2008;103:2890-907.

2. Abraham, N., et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. J. Am. Coll. Cardiol. 2010;56:2051-66.

Q1: ANSWER: B

Critique

This patient has developed an ulcer because of chronic NSAID use. She is older than 60 years old and is also on antiplatelet therapy. Therefore, her risk of peptic ulcer rebleeding is high and warrants lifelong secondary prophylaxis with a proton pump inhibitor (Choice B). Therefore, stopping all prophylactic measures would be inappropriate (Choice A). Repeat endoscopy to assess for gastric ulcer healing may be warranted, especially in the setting of risk factors for malignancy, but duodenal ulcers do not require endoscopic follow-up (Choice C). There is no role to empirically treat H. pylori in the context of having negative test results (Choice E).

References

1. Bhatt, D.L., et al. ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. Am. J. Gastroenterol. 2008;103:2890-907.

2. Abraham, N., et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. J. Am. Coll. Cardiol. 2010;56:2051-66.

Q1: ANSWER: B

Critique

This patient has developed an ulcer because of chronic NSAID use. She is older than 60 years old and is also on antiplatelet therapy. Therefore, her risk of peptic ulcer rebleeding is high and warrants lifelong secondary prophylaxis with a proton pump inhibitor (Choice B). Therefore, stopping all prophylactic measures would be inappropriate (Choice A). Repeat endoscopy to assess for gastric ulcer healing may be warranted, especially in the setting of risk factors for malignancy, but duodenal ulcers do not require endoscopic follow-up (Choice C). There is no role to empirically treat H. pylori in the context of having negative test results (Choice E).

References

1. Bhatt, D.L., et al. ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. Am. J. Gastroenterol. 2008;103:2890-907.

2. Abraham, N., et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. J. Am. Coll. Cardiol. 2010;56:2051-66.

Summary:

One of PHM15's first sessions was a workshop led by Dr. Rachna May focusing on the role of pediatric hospitalists in end-of-life conversations.

Medically complex pediatric patients are more likely to have end-of-life care in the hospital, placing the pediatric hospitalist in a unique position to address end-of-life issues. Medically complex patients may have waxing and waning courses, with frequent admissions for acute illness. Following these admissions, they may not fully return to their pre-illness baseline, leading to an overall gradual decline in health. An opportunity for discussing quality of life is available with each acute illness and hospitalization.

These conversations, however, can be difficult to initiate and present several barriers to overcome. These barriers include:

• Unknown parental expectations regarding outcome,
• Lack of an established relationship with the patient and family, and
• Lack of readiness of the patient and family to discuss end-of-life decisions.

To overcome these barriers, providers must develop tools for delivery. They must find the right setting for the conversation, limit distractions, and avoid medical jargon. Begin with asking the patient and family's perceptions of the clinical prognosis and be honest when discussing the predicted medical outcomes for the patient. Open discussion of the prognosis allows autonomy in decision making, helps families feel supported, and can help them manage distress surrounding end-of-life care.

Such terminology as "do not resuscitate" can be interpreted as “doing nothing,” and result in feelings of guilt for a family desiring care for their child. Using a phrase such as "allowing a natural death" can alleviate feelings of guilt over end-of-life decisions and help the family actively provide care while optimizing quality of life. TH

Dr. Player is a hospitalist and assistant professor in the Department of Pediatrics at Medical College of Wisconsin, Children’s Hospital of Wisconsin in Milwaukee.

Summary:

One of PHM15's first sessions was a workshop led by Dr. Rachna May focusing on the role of pediatric hospitalists in end-of-life conversations.

Medically complex pediatric patients are more likely to have end-of-life care in the hospital, placing the pediatric hospitalist in a unique position to address end-of-life issues. Medically complex patients may have waxing and waning courses, with frequent admissions for acute illness. Following these admissions, they may not fully return to their pre-illness baseline, leading to an overall gradual decline in health. An opportunity for discussing quality of life is available with each acute illness and hospitalization.

These conversations, however, can be difficult to initiate and present several barriers to overcome. These barriers include:

• Unknown parental expectations regarding outcome,
• Lack of an established relationship with the patient and family, and
• Lack of readiness of the patient and family to discuss end-of-life decisions.

To overcome these barriers, providers must develop tools for delivery. They must find the right setting for the conversation, limit distractions, and avoid medical jargon. Begin with asking the patient and family's perceptions of the clinical prognosis and be honest when discussing the predicted medical outcomes for the patient. Open discussion of the prognosis allows autonomy in decision making, helps families feel supported, and can help them manage distress surrounding end-of-life care.

Such terminology as "do not resuscitate" can be interpreted as “doing nothing,” and result in feelings of guilt for a family desiring care for their child. Using a phrase such as "allowing a natural death" can alleviate feelings of guilt over end-of-life decisions and help the family actively provide care while optimizing quality of life. TH

Dr. Player is a hospitalist and assistant professor in the Department of Pediatrics at Medical College of Wisconsin, Children’s Hospital of Wisconsin in Milwaukee.

Summary:

One of PHM15's first sessions was a workshop led by Dr. Rachna May focusing on the role of pediatric hospitalists in end-of-life conversations.

Medically complex pediatric patients are more likely to have end-of-life care in the hospital, placing the pediatric hospitalist in a unique position to address end-of-life issues. Medically complex patients may have waxing and waning courses, with frequent admissions for acute illness. Following these admissions, they may not fully return to their pre-illness baseline, leading to an overall gradual decline in health. An opportunity for discussing quality of life is available with each acute illness and hospitalization.

These conversations, however, can be difficult to initiate and present several barriers to overcome. These barriers include:

• Unknown parental expectations regarding outcome,
• Lack of an established relationship with the patient and family, and
• Lack of readiness of the patient and family to discuss end-of-life decisions.

To overcome these barriers, providers must develop tools for delivery. They must find the right setting for the conversation, limit distractions, and avoid medical jargon. Begin with asking the patient and family's perceptions of the clinical prognosis and be honest when discussing the predicted medical outcomes for the patient. Open discussion of the prognosis allows autonomy in decision making, helps families feel supported, and can help them manage distress surrounding end-of-life care.

Such terminology as "do not resuscitate" can be interpreted as “doing nothing,” and result in feelings of guilt for a family desiring care for their child. Using a phrase such as "allowing a natural death" can alleviate feelings of guilt over end-of-life decisions and help the family actively provide care while optimizing quality of life. TH

Dr. Player is a hospitalist and assistant professor in the Department of Pediatrics at Medical College of Wisconsin, Children’s Hospital of Wisconsin in Milwaukee.

Summary:

In an era where a majority of the pediatric hospital workforce is just starting to recognize fish bone diagrams, five why questions, root cause analysis, IHI, Lean, six sigma and pareto charts, hospitalists can be daunted as they try to serve as the home for quality improvement and patient safety in hospitals. Hospitalists are expected to know, understand, and practice these models for improvement with limited training and expertise. Beyond being looked at as experts, they are expected to teach residents and other learners when they are unsure of it ourselves. Governing education bodies (i.e., ACGME and CLER) have made it a requirement that residents have these concepts integrated into their curriculums and tracked.

Presented by an inter-professional team from Floating Hospital for Children at Tufts Medical Center in Boston, this PHM15 workshop focused on how to work in multidisciplinary teams to identify, analyze, and create patient-safety solutions, and, therefore, set the stage for systems- or department-based QI projects.

“It is OK to make mistakes, but it is not OK to not learn from them,” stated the presenters.

Starting with a near-miss event that led to a department/resident-led root cause analysis, the importance of system improvement became apparent. Presenters discussed the 12-week curriculum they created for pediatric residents and nursing students, which includes:

• Didactics,
• Online, self-directed learning, and
• An inter-professional, small-group project.

Trainees present their analysis and action items to their departments and, at times, even administration. This helps align hospital goals with resident teaching, while simultaneously providing an environment where discussing errors safely in order to prevent further harms.

Attendees of the workshop walked away with a generalizable, step-by-step toolkit to take home to their home institution.

Key Takeaways:

1. Convene a leadership team of nurses and physicians to develop the inter-professional program
2. Consider scheduling demands of nurses, physicians and residents.
3. Implement administrative support to assist with scheduling of meetings, maintenance of documents and email distribution.
4. Program participation must bring value to the staff such as CME credits
5. Make the educational experience program flexible in a blended learning environment.
6. Recognize staff’s completion of the program with a certificate.
7. Provide the opportunity, mentorship and support for staff willing to continue the project as a quality improvement initiative. TH

Dr. Hopkins is a pediatric hospitalist at All Children's Hospital Johns Hopkins Medicine, and an instructor at Johns Hopkins Medicine in St. Petersburg, Fla.

Summary:

In an era where a majority of the pediatric hospital workforce is just starting to recognize fish bone diagrams, five why questions, root cause analysis, IHI, Lean, six sigma and pareto charts, hospitalists can be daunted as they try to serve as the home for quality improvement and patient safety in hospitals. Hospitalists are expected to know, understand, and practice these models for improvement with limited training and expertise. Beyond being looked at as experts, they are expected to teach residents and other learners when they are unsure of it ourselves. Governing education bodies (i.e., ACGME and CLER) have made it a requirement that residents have these concepts integrated into their curriculums and tracked.

Presented by an inter-professional team from Floating Hospital for Children at Tufts Medical Center in Boston, this PHM15 workshop focused on how to work in multidisciplinary teams to identify, analyze, and create patient-safety solutions, and, therefore, set the stage for systems- or department-based QI projects.

“It is OK to make mistakes, but it is not OK to not learn from them,” stated the presenters.

Starting with a near-miss event that led to a department/resident-led root cause analysis, the importance of system improvement became apparent. Presenters discussed the 12-week curriculum they created for pediatric residents and nursing students, which includes:

• Didactics,
• Online, self-directed learning, and
• An inter-professional, small-group project.

Trainees present their analysis and action items to their departments and, at times, even administration. This helps align hospital goals with resident teaching, while simultaneously providing an environment where discussing errors safely in order to prevent further harms.

Attendees of the workshop walked away with a generalizable, step-by-step toolkit to take home to their home institution.

Key Takeaways:

1. Convene a leadership team of nurses and physicians to develop the inter-professional program
2. Consider scheduling demands of nurses, physicians and residents.
3. Implement administrative support to assist with scheduling of meetings, maintenance of documents and email distribution.
4. Program participation must bring value to the staff such as CME credits
5. Make the educational experience program flexible in a blended learning environment.
6. Recognize staff’s completion of the program with a certificate.
7. Provide the opportunity, mentorship and support for staff willing to continue the project as a quality improvement initiative. TH

Dr. Hopkins is a pediatric hospitalist at All Children's Hospital Johns Hopkins Medicine, and an instructor at Johns Hopkins Medicine in St. Petersburg, Fla.

Summary:

In an era where a majority of the pediatric hospital workforce is just starting to recognize fish bone diagrams, five why questions, root cause analysis, IHI, Lean, six sigma and pareto charts, hospitalists can be daunted as they try to serve as the home for quality improvement and patient safety in hospitals. Hospitalists are expected to know, understand, and practice these models for improvement with limited training and expertise. Beyond being looked at as experts, they are expected to teach residents and other learners when they are unsure of it ourselves. Governing education bodies (i.e., ACGME and CLER) have made it a requirement that residents have these concepts integrated into their curriculums and tracked.

Presented by an inter-professional team from Floating Hospital for Children at Tufts Medical Center in Boston, this PHM15 workshop focused on how to work in multidisciplinary teams to identify, analyze, and create patient-safety solutions, and, therefore, set the stage for systems- or department-based QI projects.

“It is OK to make mistakes, but it is not OK to not learn from them,” stated the presenters.

Starting with a near-miss event that led to a department/resident-led root cause analysis, the importance of system improvement became apparent. Presenters discussed the 12-week curriculum they created for pediatric residents and nursing students, which includes:

• Didactics,
• Online, self-directed learning, and
• An inter-professional, small-group project.

Trainees present their analysis and action items to their departments and, at times, even administration. This helps align hospital goals with resident teaching, while simultaneously providing an environment where discussing errors safely in order to prevent further harms.

Attendees of the workshop walked away with a generalizable, step-by-step toolkit to take home to their home institution.

Key Takeaways:

1. Convene a leadership team of nurses and physicians to develop the inter-professional program
2. Consider scheduling demands of nurses, physicians and residents.
3. Implement administrative support to assist with scheduling of meetings, maintenance of documents and email distribution.
4. Program participation must bring value to the staff such as CME credits
5. Make the educational experience program flexible in a blended learning environment.
6. Recognize staff’s completion of the program with a certificate.
7. Provide the opportunity, mentorship and support for staff willing to continue the project as a quality improvement initiative. TH

Dr. Hopkins is a pediatric hospitalist at All Children's Hospital Johns Hopkins Medicine, and an instructor at Johns Hopkins Medicine in St. Petersburg, Fla.

Presenters: Kelly Basaldua, MD; Daniel Sedillo, MD, MBA, and Jason Reynolds, MD

Summary:

In an environment where medicine is becoming ever more specialized and the scope of practice for many is ever narrowing into corridors of expertise, the hospitalist remains a bastion of generalism with an ever-diversifying skill set. One of the skills acquired by many hospitalists to aid in the overall efficiency of the hospital is intranasal (IN) sedation.

Intranasal sedation is becoming more popular given the rapid onset and offset and the relative safety of the sedation of patients without the need for intravenous catheters. This phenomenon is accomplished by avoiding the gut and thus avoiding first-pass metabolism. This allows for greatly increased bioavailability compared with oral administration. In addition, the nasal mucosa is in near direct contact with the CSF via the cribriform plate, allowing for rapid and effective action.

To maximize the effectiveness of intranasal sedation, low volumes with high concentrations, atomization, and minimal nasal occlusion are vital. The ideal volume per nostril is approximately 0.5 ml as using any greater volume results in oversaturation and minimal additional absorption. Thus, concentrating the medications into minimal volumes provides for more efficacious usage. Atomization aids in ensuring thorough surface area coverage and higher absorption. This is a far more efficacious method of delivery than liquid/drop administration.

Because intranasally administered agents have a delayed and widened serum peak compared to IV, IN sedation carries less of a chance to reach serum levels high enough to cause respiratory depression, though monitoring is still necessary. When compared to IV sedation, IN does have a delay in onset, but also provides for a more gentle recovery process, often resulting in a less disorienting recovery for the patient, while also providing for a wider safety profile.

The presenters covered three primary agents:

• midazolam,
• dexmedetomidine, and
• fentanyl

Midazolam is useful for non-painful, minimally invasive procedures. Fentanyl is more useful for painful or more invasive procedures. Dexmedetomidine is off-label use for intranasal sedation at this time, but has promising initial research given its safety profile and longer duration of action compared to most intranasal agents. Also, dexmedetomidine works extremely effectively in combination with other agents, particularly midazolam, to prolong sedations, making it very useful for longer procedures like combination MRIs.

The presenters then provided a practical workshop to practice the delivery of intranasal medication effectively. One of the pearls provided involved proper positioning of the patient in a reclined position as sitting to erect will cause the medication to drip out and having the patient lying flat will result in the medication dripping down the posterior pharynx. This position should be held for 30 seconds after delivery of the medication. Practicing with atomizers to achieve effective aerosolization was discussed. The target of medication should avoid the nasal septum given its poor absorption.

Key Takeaway:

With hospitalists being called to assist in ever-expanding roles within the hospital system while improving efficiency and throughput, intranasal sedation may provide reduced imaging wait times, bedside and ED procedure times in a safe and effective manner. TH

Dr. Crook is a hospitalist in the division of hospitalist medicine, assistant professor of pediatrics, and assistant pediatric clerkship director in the Department of Pediatrics at Vanderbilt University School of Medicine and Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville.

Presenters: Kelly Basaldua, MD; Daniel Sedillo, MD, MBA, and Jason Reynolds, MD

Summary:

In an environment where medicine is becoming ever more specialized and the scope of practice for many is ever narrowing into corridors of expertise, the hospitalist remains a bastion of generalism with an ever-diversifying skill set. One of the skills acquired by many hospitalists to aid in the overall efficiency of the hospital is intranasal (IN) sedation.

Intranasal sedation is becoming more popular given the rapid onset and offset and the relative safety of the sedation of patients without the need for intravenous catheters. This phenomenon is accomplished by avoiding the gut and thus avoiding first-pass metabolism. This allows for greatly increased bioavailability compared with oral administration. In addition, the nasal mucosa is in near direct contact with the CSF via the cribriform plate, allowing for rapid and effective action.

To maximize the effectiveness of intranasal sedation, low volumes with high concentrations, atomization, and minimal nasal occlusion are vital. The ideal volume per nostril is approximately 0.5 ml as using any greater volume results in oversaturation and minimal additional absorption. Thus, concentrating the medications into minimal volumes provides for more efficacious usage. Atomization aids in ensuring thorough surface area coverage and higher absorption. This is a far more efficacious method of delivery than liquid/drop administration.

Because intranasally administered agents have a delayed and widened serum peak compared to IV, IN sedation carries less of a chance to reach serum levels high enough to cause respiratory depression, though monitoring is still necessary. When compared to IV sedation, IN does have a delay in onset, but also provides for a more gentle recovery process, often resulting in a less disorienting recovery for the patient, while also providing for a wider safety profile.

The presenters covered three primary agents:

• midazolam,
• dexmedetomidine, and
• fentanyl

Midazolam is useful for non-painful, minimally invasive procedures. Fentanyl is more useful for painful or more invasive procedures. Dexmedetomidine is off-label use for intranasal sedation at this time, but has promising initial research given its safety profile and longer duration of action compared to most intranasal agents. Also, dexmedetomidine works extremely effectively in combination with other agents, particularly midazolam, to prolong sedations, making it very useful for longer procedures like combination MRIs.

The presenters then provided a practical workshop to practice the delivery of intranasal medication effectively. One of the pearls provided involved proper positioning of the patient in a reclined position as sitting to erect will cause the medication to drip out and having the patient lying flat will result in the medication dripping down the posterior pharynx. This position should be held for 30 seconds after delivery of the medication. Practicing with atomizers to achieve effective aerosolization was discussed. The target of medication should avoid the nasal septum given its poor absorption.

Key Takeaway:

With hospitalists being called to assist in ever-expanding roles within the hospital system while improving efficiency and throughput, intranasal sedation may provide reduced imaging wait times, bedside and ED procedure times in a safe and effective manner. TH

Dr. Crook is a hospitalist in the division of hospitalist medicine, assistant professor of pediatrics, and assistant pediatric clerkship director in the Department of Pediatrics at Vanderbilt University School of Medicine and Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville.

Presenters: Kelly Basaldua, MD; Daniel Sedillo, MD, MBA, and Jason Reynolds, MD

Summary:

In an environment where medicine is becoming ever more specialized and the scope of practice for many is ever narrowing into corridors of expertise, the hospitalist remains a bastion of generalism with an ever-diversifying skill set. One of the skills acquired by many hospitalists to aid in the overall efficiency of the hospital is intranasal (IN) sedation.

Intranasal sedation is becoming more popular given the rapid onset and offset and the relative safety of the sedation of patients without the need for intravenous catheters. This phenomenon is accomplished by avoiding the gut and thus avoiding first-pass metabolism. This allows for greatly increased bioavailability compared with oral administration. In addition, the nasal mucosa is in near direct contact with the CSF via the cribriform plate, allowing for rapid and effective action.

To maximize the effectiveness of intranasal sedation, low volumes with high concentrations, atomization, and minimal nasal occlusion are vital. The ideal volume per nostril is approximately 0.5 ml as using any greater volume results in oversaturation and minimal additional absorption. Thus, concentrating the medications into minimal volumes provides for more efficacious usage. Atomization aids in ensuring thorough surface area coverage and higher absorption. This is a far more efficacious method of delivery than liquid/drop administration.

Because intranasally administered agents have a delayed and widened serum peak compared to IV, IN sedation carries less of a chance to reach serum levels high enough to cause respiratory depression, though monitoring is still necessary. When compared to IV sedation, IN does have a delay in onset, but also provides for a more gentle recovery process, often resulting in a less disorienting recovery for the patient, while also providing for a wider safety profile.

The presenters covered three primary agents:

• midazolam,
• dexmedetomidine, and
• fentanyl

Midazolam is useful for non-painful, minimally invasive procedures. Fentanyl is more useful for painful or more invasive procedures. Dexmedetomidine is off-label use for intranasal sedation at this time, but has promising initial research given its safety profile and longer duration of action compared to most intranasal agents. Also, dexmedetomidine works extremely effectively in combination with other agents, particularly midazolam, to prolong sedations, making it very useful for longer procedures like combination MRIs.

The presenters then provided a practical workshop to practice the delivery of intranasal medication effectively. One of the pearls provided involved proper positioning of the patient in a reclined position as sitting to erect will cause the medication to drip out and having the patient lying flat will result in the medication dripping down the posterior pharynx. This position should be held for 30 seconds after delivery of the medication. Practicing with atomizers to achieve effective aerosolization was discussed. The target of medication should avoid the nasal septum given its poor absorption.

Key Takeaway:

With hospitalists being called to assist in ever-expanding roles within the hospital system while improving efficiency and throughput, intranasal sedation may provide reduced imaging wait times, bedside and ED procedure times in a safe and effective manner. TH

Dr. Crook is a hospitalist in the division of hospitalist medicine, assistant professor of pediatrics, and assistant pediatric clerkship director in the Department of Pediatrics at Vanderbilt University School of Medicine and Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville.

Presenters: Gitanjli Arora, Phuc Le, and Christiana Russ

Summary:

Overseas medical missions can be rewarding experiences for both trainees as part of a supervised program and attending physicians. There is substantial inequity in the global distribution of disease versus health care providers with most providers being located in developed countries and higher disease burdens in underdeveloped countries.  The goal of global healthcare training is mutual benefit, where the provider gains clinical experience and the host country gains enhanced medical care. Both provider and hosts gain increased cultural awareness.

The American Academy of Pediatrics guidelines for a meaningful international experience recommend 4 components:

• Pre-trip Training.  Don’t go without some idea of what to expect
• Pre-travel preparations.  Get your vaccines, travel plans, licensure, scope of practice taken care of.
• Preceptorship by host and US faculty
• Post-travel evaluation and feedback

Key Takeaways:

Providers in overseas medical missions will encounter challenging situations—culturally, ethically and medically. Get as much information beforehand. Be respectful of different cultural norms. Get a cultural ambassador. Keep in mind the Serenity Prayer. TH

Presenters: Gitanjli Arora, Phuc Le, and Christiana Russ

Summary:

Overseas medical missions can be rewarding experiences for both trainees as part of a supervised program and attending physicians. There is substantial inequity in the global distribution of disease versus health care providers with most providers being located in developed countries and higher disease burdens in underdeveloped countries.  The goal of global healthcare training is mutual benefit, where the provider gains clinical experience and the host country gains enhanced medical care. Both provider and hosts gain increased cultural awareness.

The American Academy of Pediatrics guidelines for a meaningful international experience recommend 4 components:

• Pre-trip Training.  Don’t go without some idea of what to expect
• Pre-travel preparations.  Get your vaccines, travel plans, licensure, scope of practice taken care of.
• Preceptorship by host and US faculty
• Post-travel evaluation and feedback

Key Takeaways:

Providers in overseas medical missions will encounter challenging situations—culturally, ethically and medically. Get as much information beforehand. Be respectful of different cultural norms. Get a cultural ambassador. Keep in mind the Serenity Prayer. TH

Presenters: Gitanjli Arora, Phuc Le, and Christiana Russ

Summary:

Overseas medical missions can be rewarding experiences for both trainees as part of a supervised program and attending physicians. There is substantial inequity in the global distribution of disease versus health care providers with most providers being located in developed countries and higher disease burdens in underdeveloped countries.  The goal of global healthcare training is mutual benefit, where the provider gains clinical experience and the host country gains enhanced medical care. Both provider and hosts gain increased cultural awareness.

The American Academy of Pediatrics guidelines for a meaningful international experience recommend 4 components:

• Pre-trip Training.  Don’t go without some idea of what to expect
• Pre-travel preparations.  Get your vaccines, travel plans, licensure, scope of practice taken care of.
• Preceptorship by host and US faculty
• Post-travel evaluation and feedback

Key Takeaways:

Providers in overseas medical missions will encounter challenging situations—culturally, ethically and medically. Get as much information beforehand. Be respectful of different cultural norms. Get a cultural ambassador. Keep in mind the Serenity Prayer. TH

Presenters: Sarah White MD, Mark Corden, MD, and Parminder Suchdev, MD, MPH

Summary:

This PHM15 workshop kicked off the Global Health pathway. The speakers explained that they had become interested in nutrition through the international experiences they had in the past with malnourished children around the world.

The learning objectives included reviewing:

• Criteria for admission of malnourished children to feeding centers or inpatient care for severe acute malnutrition (SAM);
• Micronutrient deficiencies in SAM;
• Specific things to look for when treating SAM using rehydration and refeeding protocols;
• Definitions and classification of malnutrition states; and
• The burden disease malnutrition represents in global children’s health, as well as its association with increased mortality.

The presenters used case studies to give specific examples of how malnutrition complicates children’s health. Mid-upper arm circumference (MUAC) was reviewed as a proxy measure to quickly identify children at risk for malnutrition as well as the need for length and weight to fully describe the nutritional/growth state of a child. “Appetite test” was introduced as a way to assess if children have capability to try to increase feeding at home (if access to food is assured) or if they are experiencing a malnutrition state that would benefit from inpatient management. Comorbidities, such as edema, shock, and infections, were considered as reasons to admit the patient for malnutrition rated illness. WHO guidelines for use of specific refeeding formulas [PDF] and therapeutic ready-to-use food (RUTF) to manage stabilization versus transition phases were also reviewed.

In caring for acutely malnourished children, providers also need to be prepared to manage refeeding syndrome. It can be confused with sepsis due to both conditions presenting with acute decompensation of the patient, so it is important to keep in mind. Dehydrated malnourished children have very specialized needs, are sodium sensitive and are at risk of heart failure and pulmonary edema with typical rehydration methods. ReSoMal rehydration solution was described as an oral rehydration solution and lactated ringers IV for use in the management of a dehydrated, malnourished child.

Other topics covered in the workshop included the implications of the presence of edema in a malnourished patient, the use of antibiotics in improving mortality, and need for replenishing micronutrient stores. Overall, the workshop had an effective use of cases to show specific complications that a health care provider may encounter when treating children with SAM. TH

Dr. Hodge is a pediatric hospitalist at Kosair Children’s Hospital in Louisville, Ky., an assistant professor in the department of pediatrics, and director of distinction in global health track at the University of Louisville School of Medicine.

Presenters: Sarah White MD, Mark Corden, MD, and Parminder Suchdev, MD, MPH

Summary:

This PHM15 workshop kicked off the Global Health pathway. The speakers explained that they had become interested in nutrition through the international experiences they had in the past with malnourished children around the world.

The learning objectives included reviewing:

• Criteria for admission of malnourished children to feeding centers or inpatient care for severe acute malnutrition (SAM);
• Micronutrient deficiencies in SAM;
• Specific things to look for when treating SAM using rehydration and refeeding protocols;
• Definitions and classification of malnutrition states; and
• The burden disease malnutrition represents in global children’s health, as well as its association with increased mortality.

The presenters used case studies to give specific examples of how malnutrition complicates children’s health. Mid-upper arm circumference (MUAC) was reviewed as a proxy measure to quickly identify children at risk for malnutrition as well as the need for length and weight to fully describe the nutritional/growth state of a child. “Appetite test” was introduced as a way to assess if children have capability to try to increase feeding at home (if access to food is assured) or if they are experiencing a malnutrition state that would benefit from inpatient management. Comorbidities, such as edema, shock, and infections, were considered as reasons to admit the patient for malnutrition rated illness. WHO guidelines for use of specific refeeding formulas [PDF] and therapeutic ready-to-use food (RUTF) to manage stabilization versus transition phases were also reviewed.

In caring for acutely malnourished children, providers also need to be prepared to manage refeeding syndrome. It can be confused with sepsis due to both conditions presenting with acute decompensation of the patient, so it is important to keep in mind. Dehydrated malnourished children have very specialized needs, are sodium sensitive and are at risk of heart failure and pulmonary edema with typical rehydration methods. ReSoMal rehydration solution was described as an oral rehydration solution and lactated ringers IV for use in the management of a dehydrated, malnourished child.

Other topics covered in the workshop included the implications of the presence of edema in a malnourished patient, the use of antibiotics in improving mortality, and need for replenishing micronutrient stores. Overall, the workshop had an effective use of cases to show specific complications that a health care provider may encounter when treating children with SAM. TH

Dr. Hodge is a pediatric hospitalist at Kosair Children’s Hospital in Louisville, Ky., an assistant professor in the department of pediatrics, and director of distinction in global health track at the University of Louisville School of Medicine.

Presenters: Sarah White MD, Mark Corden, MD, and Parminder Suchdev, MD, MPH

Summary:

This PHM15 workshop kicked off the Global Health pathway. The speakers explained that they had become interested in nutrition through the international experiences they had in the past with malnourished children around the world.

The learning objectives included reviewing:

• Criteria for admission of malnourished children to feeding centers or inpatient care for severe acute malnutrition (SAM);
• Micronutrient deficiencies in SAM;
• Specific things to look for when treating SAM using rehydration and refeeding protocols;
• Definitions and classification of malnutrition states; and
• The burden disease malnutrition represents in global children’s health, as well as its association with increased mortality.

The presenters used case studies to give specific examples of how malnutrition complicates children’s health. Mid-upper arm circumference (MUAC) was reviewed as a proxy measure to quickly identify children at risk for malnutrition as well as the need for length and weight to fully describe the nutritional/growth state of a child. “Appetite test” was introduced as a way to assess if children have capability to try to increase feeding at home (if access to food is assured) or if they are experiencing a malnutrition state that would benefit from inpatient management. Comorbidities, such as edema, shock, and infections, were considered as reasons to admit the patient for malnutrition rated illness. WHO guidelines for use of specific refeeding formulas [PDF] and therapeutic ready-to-use food (RUTF) to manage stabilization versus transition phases were also reviewed.

In caring for acutely malnourished children, providers also need to be prepared to manage refeeding syndrome. It can be confused with sepsis due to both conditions presenting with acute decompensation of the patient, so it is important to keep in mind. Dehydrated malnourished children have very specialized needs, are sodium sensitive and are at risk of heart failure and pulmonary edema with typical rehydration methods. ReSoMal rehydration solution was described as an oral rehydration solution and lactated ringers IV for use in the management of a dehydrated, malnourished child.

Other topics covered in the workshop included the implications of the presence of edema in a malnourished patient, the use of antibiotics in improving mortality, and need for replenishing micronutrient stores. Overall, the workshop had an effective use of cases to show specific complications that a health care provider may encounter when treating children with SAM. TH

Dr. Hodge is a pediatric hospitalist at Kosair Children’s Hospital in Louisville, Ky., an assistant professor in the department of pediatrics, and director of distinction in global health track at the University of Louisville School of Medicine.

Doctor and patient in hospital

Photo courtesy of the CDC

New research indicates that a higher institutional case volume is associated with lower in-hospital mortality in patients with lower extremity deep vein thrombosis (LE-DVT) who undergo catheter-directed thrombolysis (CDT).

However, a hospital’s CDT case volume did not have a significant impact on other outcomes, such as bleeding events, the incidence of pulmonary embolism, or the need for blood transfusion.

Researchers reported these findings in Circulation.

The team noted that patients who have LE-DVT are increasingly undergoing CDT rather than receiving anticoagulation alone. Recent studies have shown reductions in lifestyle-limiting complications, such as post-thrombotic syndrome, in patients who undergo CDT. However, data have also shown CDT to be associated with an increased risk of bleeding complications.

So Riyaz Bashir, MD, of Temple University Health System in Philadelphia, Pennsylvania, led a study aimed at determining whether the increase in bleeding complications was correlated with the volume of CDT procedures performed at a particular institution.

Dr Bashir and his colleagues used the Nationwide Inpatient Sample database to identify 90,618 patients admitted to US hospitals with an LE-DVT diagnosis from 2005 to 2010.

The researchers further narrowed that group down to 3649 patients treated with CDT. The team then divided the hospitals into 2 groups: high-volume centers, which performed 6 or more CDT procedures per year, and low-volume centers, which performed less than 6 CDT procedures per year.

In-hospital mortality in patients treated with CDT was significantly lower at high-volume centers than low-volume centers—0.6% and 1.5%, respectively (P=0.04).

The rate of intracranial hemorrhage for high-volume centers was less than half that of low-volume centers, but this difference was not statistically significant—0.4% and 1.0%, respectively (P=0.07).

Likewise, there was no significant difference between high-volume centers and low-volume centers with regard to the rate of blood transfusion (10.4% vs 10.8%, P=0.70), gastrointestinal bleeding (1.4% vs 1.8%, P=0.35), or pulmonary embolism (18.4% vs 17.9% P=0.72).

The median length of hospital stay was 6 days in both groups. But hospital charges were higher at high-volume centers than low-volume centers—$75,870 and $65,500, respectively.

“These findings have potentially major future implications for the treatment of deep vein thrombosis,” Dr Bashir said. “For the first time, we have shown a significant inverse relationship between the institutional CDT volumes and adverse outcomes like death . . . .”

“This does not mean that low-volume centers should not perform CDT for patients with LE-DVT. It means that we should focus on standardizing CDT protocols that include careful patient selection as well as peri-procedural patient monitoring. In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized.”

Dr Bashir added that patients with LE-DVT, especially young patients, should feel comfortable considering CDT, particularly at a high-volume center, as a viable option to prevent post-thrombotic syndrome.

“Our overall goal is to treat these DVT patients early on and prevent post-thrombotic syndrome and its adverse consequences on the quality of life,” he said. “We feel this research provides more clarity and direction in identifying the best strategies for how to achieve that goal.”

Doctor and patient in hospital

Photo courtesy of the CDC

New research indicates that a higher institutional case volume is associated with lower in-hospital mortality in patients with lower extremity deep vein thrombosis (LE-DVT) who undergo catheter-directed thrombolysis (CDT).

However, a hospital’s CDT case volume did not have a significant impact on other outcomes, such as bleeding events, the incidence of pulmonary embolism, or the need for blood transfusion.

Researchers reported these findings in Circulation.

The team noted that patients who have LE-DVT are increasingly undergoing CDT rather than receiving anticoagulation alone. Recent studies have shown reductions in lifestyle-limiting complications, such as post-thrombotic syndrome, in patients who undergo CDT. However, data have also shown CDT to be associated with an increased risk of bleeding complications.

So Riyaz Bashir, MD, of Temple University Health System in Philadelphia, Pennsylvania, led a study aimed at determining whether the increase in bleeding complications was correlated with the volume of CDT procedures performed at a particular institution.

Dr Bashir and his colleagues used the Nationwide Inpatient Sample database to identify 90,618 patients admitted to US hospitals with an LE-DVT diagnosis from 2005 to 2010.

The researchers further narrowed that group down to 3649 patients treated with CDT. The team then divided the hospitals into 2 groups: high-volume centers, which performed 6 or more CDT procedures per year, and low-volume centers, which performed less than 6 CDT procedures per year.

In-hospital mortality in patients treated with CDT was significantly lower at high-volume centers than low-volume centers—0.6% and 1.5%, respectively (P=0.04).

The rate of intracranial hemorrhage for high-volume centers was less than half that of low-volume centers, but this difference was not statistically significant—0.4% and 1.0%, respectively (P=0.07).

Likewise, there was no significant difference between high-volume centers and low-volume centers with regard to the rate of blood transfusion (10.4% vs 10.8%, P=0.70), gastrointestinal bleeding (1.4% vs 1.8%, P=0.35), or pulmonary embolism (18.4% vs 17.9% P=0.72).

The median length of hospital stay was 6 days in both groups. But hospital charges were higher at high-volume centers than low-volume centers—$75,870 and $65,500, respectively.

“These findings have potentially major future implications for the treatment of deep vein thrombosis,” Dr Bashir said. “For the first time, we have shown a significant inverse relationship between the institutional CDT volumes and adverse outcomes like death . . . .”

“This does not mean that low-volume centers should not perform CDT for patients with LE-DVT. It means that we should focus on standardizing CDT protocols that include careful patient selection as well as peri-procedural patient monitoring. In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized.”

Dr Bashir added that patients with LE-DVT, especially young patients, should feel comfortable considering CDT, particularly at a high-volume center, as a viable option to prevent post-thrombotic syndrome.

“Our overall goal is to treat these DVT patients early on and prevent post-thrombotic syndrome and its adverse consequences on the quality of life,” he said. “We feel this research provides more clarity and direction in identifying the best strategies for how to achieve that goal.”

Doctor and patient in hospital

Photo courtesy of the CDC

New research indicates that a higher institutional case volume is associated with lower in-hospital mortality in patients with lower extremity deep vein thrombosis (LE-DVT) who undergo catheter-directed thrombolysis (CDT).

However, a hospital’s CDT case volume did not have a significant impact on other outcomes, such as bleeding events, the incidence of pulmonary embolism, or the need for blood transfusion.

Researchers reported these findings in Circulation.

The team noted that patients who have LE-DVT are increasingly undergoing CDT rather than receiving anticoagulation alone. Recent studies have shown reductions in lifestyle-limiting complications, such as post-thrombotic syndrome, in patients who undergo CDT. However, data have also shown CDT to be associated with an increased risk of bleeding complications.

So Riyaz Bashir, MD, of Temple University Health System in Philadelphia, Pennsylvania, led a study aimed at determining whether the increase in bleeding complications was correlated with the volume of CDT procedures performed at a particular institution.

Dr Bashir and his colleagues used the Nationwide Inpatient Sample database to identify 90,618 patients admitted to US hospitals with an LE-DVT diagnosis from 2005 to 2010.

The researchers further narrowed that group down to 3649 patients treated with CDT. The team then divided the hospitals into 2 groups: high-volume centers, which performed 6 or more CDT procedures per year, and low-volume centers, which performed less than 6 CDT procedures per year.

In-hospital mortality in patients treated with CDT was significantly lower at high-volume centers than low-volume centers—0.6% and 1.5%, respectively (P=0.04).

The rate of intracranial hemorrhage for high-volume centers was less than half that of low-volume centers, but this difference was not statistically significant—0.4% and 1.0%, respectively (P=0.07).

Likewise, there was no significant difference between high-volume centers and low-volume centers with regard to the rate of blood transfusion (10.4% vs 10.8%, P=0.70), gastrointestinal bleeding (1.4% vs 1.8%, P=0.35), or pulmonary embolism (18.4% vs 17.9% P=0.72).

The median length of hospital stay was 6 days in both groups. But hospital charges were higher at high-volume centers than low-volume centers—$75,870 and $65,500, respectively.

“These findings have potentially major future implications for the treatment of deep vein thrombosis,” Dr Bashir said. “For the first time, we have shown a significant inverse relationship between the institutional CDT volumes and adverse outcomes like death . . . .”

“This does not mean that low-volume centers should not perform CDT for patients with LE-DVT. It means that we should focus on standardizing CDT protocols that include careful patient selection as well as peri-procedural patient monitoring. In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized.”

Dr Bashir added that patients with LE-DVT, especially young patients, should feel comfortable considering CDT, particularly at a high-volume center, as a viable option to prevent post-thrombotic syndrome.

“Our overall goal is to treat these DVT patients early on and prevent post-thrombotic syndrome and its adverse consequences on the quality of life,” he said. “We feel this research provides more clarity and direction in identifying the best strategies for how to achieve that goal.”

Child receiving RTS,S

Photo by Caitlin Kleiboer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) for use in children ages 6 weeks to 17 months.

RTS,S is the first candidate vaccine for malaria to reach this milestone. The vaccine was designed to prevent malaria caused by the Plasmodium falciparum parasite.

The CHMP’s opinion on RTS,S is a final stage in the European Medicines Agency’s Article 58 procedure. This allows the CHMP, in cooperation with the World Health Organization (WHO), to give a scientific opinion on a medicinal product intended for markets outside the European Union. This assessment requires products to meet the same standards as those intended for use in the European Union.

Because the CHMP has issued a positive opinion of RTS,S, the WHO is now formulating a policy recommendation on use of the vaccine in national immunization programs.

The vaccine must also pass the WHO pre-qualification process and be approved by national regulatory authorities before it can be used in countries in sub-Saharan Africa, where P falciparum malaria is most prevalent.

About RTS,S

RTS,S aims to trigger the body’s immune system to defend against P falciparum when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.

The vaccine is designed to prevent the parasite from infecting, maturing, and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

The safety and efficacy of RTS,S has been evaluated in a large-scale, phase 3 trial. The CHMP’s recommendation was based mainly on the results of this study. Updated results were published in The Lancet last April.

According to that account, the trial included 15,459 young infants (aged 6 weeks to 12 weeks at first vaccination) and children (5 months to 17 months at first vaccination) from 11 sites across 7 sub-Saharan African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and United Republic of Tanzania) with varying levels of malaria transmission.

The subjects received RTS,S in 3 doses, 1 month apart. Some subjects received an additional booster dose 18 months later. Researchers compared subjects receiving RTS,S to those receiving a control vaccine.

Children who received 3 doses of RTS,S plus a booster had a 36% reduction in the number of clinical episodes of malaria at 4 years. Infants who received 3 doses of RTS,S plus a booster had a 26% reduction in the number of clinical malaria episodes over 3 years.

Children had a significantly lower incidence of severe malaria only if they received the booster dose of RTS,S. The vaccine (with or without a booster dose) did not confer the same benefit in infants.

Subjects who received RTS,S had more adverse events than subjects in the control group. This included meningitis and convulsions.

The road to approval

Two of the WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), are reviewing the evidence base for RTS,S and will make a joint policy recommendation for how it might be used with other tools to prevent malaria if RTS,S is approved by national regulatory authorities in sub-Saharan Africa.

The WHO has indicated that such a policy recommendation may be possible by end of this year.

Once the WHO policy recommendation is complete, GSK (the company developing RTS,S in partnership with the PATH Malaria Vaccine Initiative) will submit an application to the WHO for pre-qualification of RTS,S.

WHO pre-qualification involves a scientific assessment of the quality, safety, and efficacy of any new vaccine proposed for introduction in the WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large-scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorization in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin using RTS,S through their universal immunization program.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunization programs supported by UNICEF.

GSK has committed to a not-for-profit price for RTS,S. If the vaccine is approved, the price would cover the cost of

manufacturing RTS,S and a return of around 5% to be reinvested in

research and development for second-generation malaria vaccines or

vaccines against other neglected tropical diseases.

Child receiving RTS,S

Photo by Caitlin Kleiboer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) for use in children ages 6 weeks to 17 months.

RTS,S is the first candidate vaccine for malaria to reach this milestone. The vaccine was designed to prevent malaria caused by the Plasmodium falciparum parasite.

The CHMP’s opinion on RTS,S is a final stage in the European Medicines Agency’s Article 58 procedure. This allows the CHMP, in cooperation with the World Health Organization (WHO), to give a scientific opinion on a medicinal product intended for markets outside the European Union. This assessment requires products to meet the same standards as those intended for use in the European Union.

Because the CHMP has issued a positive opinion of RTS,S, the WHO is now formulating a policy recommendation on use of the vaccine in national immunization programs.

The vaccine must also pass the WHO pre-qualification process and be approved by national regulatory authorities before it can be used in countries in sub-Saharan Africa, where P falciparum malaria is most prevalent.

About RTS,S

RTS,S aims to trigger the body’s immune system to defend against P falciparum when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.

The vaccine is designed to prevent the parasite from infecting, maturing, and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

The safety and efficacy of RTS,S has been evaluated in a large-scale, phase 3 trial. The CHMP’s recommendation was based mainly on the results of this study. Updated results were published in The Lancet last April.

According to that account, the trial included 15,459 young infants (aged 6 weeks to 12 weeks at first vaccination) and children (5 months to 17 months at first vaccination) from 11 sites across 7 sub-Saharan African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and United Republic of Tanzania) with varying levels of malaria transmission.

The subjects received RTS,S in 3 doses, 1 month apart. Some subjects received an additional booster dose 18 months later. Researchers compared subjects receiving RTS,S to those receiving a control vaccine.

Children who received 3 doses of RTS,S plus a booster had a 36% reduction in the number of clinical episodes of malaria at 4 years. Infants who received 3 doses of RTS,S plus a booster had a 26% reduction in the number of clinical malaria episodes over 3 years.

Children had a significantly lower incidence of severe malaria only if they received the booster dose of RTS,S. The vaccine (with or without a booster dose) did not confer the same benefit in infants.

Subjects who received RTS,S had more adverse events than subjects in the control group. This included meningitis and convulsions.

The road to approval

Two of the WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), are reviewing the evidence base for RTS,S and will make a joint policy recommendation for how it might be used with other tools to prevent malaria if RTS,S is approved by national regulatory authorities in sub-Saharan Africa.

The WHO has indicated that such a policy recommendation may be possible by end of this year.

Once the WHO policy recommendation is complete, GSK (the company developing RTS,S in partnership with the PATH Malaria Vaccine Initiative) will submit an application to the WHO for pre-qualification of RTS,S.

WHO pre-qualification involves a scientific assessment of the quality, safety, and efficacy of any new vaccine proposed for introduction in the WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large-scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorization in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin using RTS,S through their universal immunization program.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunization programs supported by UNICEF.

GSK has committed to a not-for-profit price for RTS,S. If the vaccine is approved, the price would cover the cost of

manufacturing RTS,S and a return of around 5% to be reinvested in

research and development for second-generation malaria vaccines or

vaccines against other neglected tropical diseases.

Child receiving RTS,S

Photo by Caitlin Kleiboer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of the malaria vaccine RTS,S (also known as RTS,S/AS01 or Mosquirix) for use in children ages 6 weeks to 17 months.

RTS,S is the first candidate vaccine for malaria to reach this milestone. The vaccine was designed to prevent malaria caused by the Plasmodium falciparum parasite.

The CHMP’s opinion on RTS,S is a final stage in the European Medicines Agency’s Article 58 procedure. This allows the CHMP, in cooperation with the World Health Organization (WHO), to give a scientific opinion on a medicinal product intended for markets outside the European Union. This assessment requires products to meet the same standards as those intended for use in the European Union.

Because the CHMP has issued a positive opinion of RTS,S, the WHO is now formulating a policy recommendation on use of the vaccine in national immunization programs.

The vaccine must also pass the WHO pre-qualification process and be approved by national regulatory authorities before it can be used in countries in sub-Saharan Africa, where P falciparum malaria is most prevalent.

About RTS,S

RTS,S aims to trigger the body’s immune system to defend against P falciparum when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.

The vaccine is designed to prevent the parasite from infecting, maturing, and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

The safety and efficacy of RTS,S has been evaluated in a large-scale, phase 3 trial. The CHMP’s recommendation was based mainly on the results of this study. Updated results were published in The Lancet last April.

According to that account, the trial included 15,459 young infants (aged 6 weeks to 12 weeks at first vaccination) and children (5 months to 17 months at first vaccination) from 11 sites across 7 sub-Saharan African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and United Republic of Tanzania) with varying levels of malaria transmission.

The subjects received RTS,S in 3 doses, 1 month apart. Some subjects received an additional booster dose 18 months later. Researchers compared subjects receiving RTS,S to those receiving a control vaccine.

Children who received 3 doses of RTS,S plus a booster had a 36% reduction in the number of clinical episodes of malaria at 4 years. Infants who received 3 doses of RTS,S plus a booster had a 26% reduction in the number of clinical malaria episodes over 3 years.

Children had a significantly lower incidence of severe malaria only if they received the booster dose of RTS,S. The vaccine (with or without a booster dose) did not confer the same benefit in infants.

Subjects who received RTS,S had more adverse events than subjects in the control group. This included meningitis and convulsions.

The road to approval

Two of the WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), are reviewing the evidence base for RTS,S and will make a joint policy recommendation for how it might be used with other tools to prevent malaria if RTS,S is approved by national regulatory authorities in sub-Saharan Africa.

The WHO has indicated that such a policy recommendation may be possible by end of this year.

Once the WHO policy recommendation is complete, GSK (the company developing RTS,S in partnership with the PATH Malaria Vaccine Initiative) will submit an application to the WHO for pre-qualification of RTS,S.

WHO pre-qualification involves a scientific assessment of the quality, safety, and efficacy of any new vaccine proposed for introduction in the WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large-scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorization in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin using RTS,S through their universal immunization program.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunization programs supported by UNICEF.

GSK has committed to a not-for-profit price for RTS,S. If the vaccine is approved, the price would cover the cost of

manufacturing RTS,S and a return of around 5% to be reinvested in

research and development for second-generation malaria vaccines or

vaccines against other neglected tropical diseases.