Prehospital spinal immobilization has long been the standard of care (SOC) to prevent spinal cord injury in trauma patients, but utilizing the best data currently available, some professional societies recently released new recommendations that question this practice. Guidelines released in 2014 from the National Association of EMS Physicians (NAEMSP) and the American College of Surgeons Committee on Trauma (ACS-COT) support limited application of spinal immobilization.¹ These guidelines note, “Given the rarity of unstable spinal injuries in EMS trauma patients, the number that might benefit from immobilization to prevent secondary injury is likely extremely small. For each patient who has potential benefit, hundreds to thousands of patients must undergo immobilization with no potential benefit.” Further, they advise “utilization of backboards for spinal immobilization during transport should be judicious, so that potential benefits outweigh risks.”¹ Spinal immobilization should not be used at all in patients with penetrating trauma who do not present with obvious neurological injury and should be selective, based on objective findings of injury or the high potential for same.¹

Questioning a Long-standing Practice

Fear of the consequences of spinal cord injury from significant vertebral fractures has dictated prehospital spinal immobilization to manage injured trauma patients for decades. For almost 50 years, it has been the SOC. However, increasing evidence that spinal immobilization is not only unnecessary, but may even cause harm has resulted in questioning this paradigm, which has lead to promoting a change in the SOC.

Spinal immobilization dates back to the mid-1960s, when Geisler et al² reported on a cohort of patients who suffered long-term paralysis from what was believed to be improper handling and failure to discover spinal injuries. Soon after, Farrington^3,4 developed and published a systematic approach to spinal immobilization during extrication following blunt force trauma, supporting the widespread acceptance of backboards and cervical collars to immobilize the spine in injured trauma patients. Logic dictated that an unstable spine fracture could be worsened, or a cord injury could result, by unnecessary movement during extrication, transport, and initial evaluation in the ED, resulting in avoidable injury. This fear of potential secondary injury grew as more papers were published examining the link between prehospital handling of blunt force trauma patients and delayed paralysis. This resulted in the use of spinal immobilization on the majority of trauma patients, regardless of mechanism of injury or presenting symptoms.^5,6

One review estimated that over 50% of trauma patients with no complaint of neck or back pain were transported with full spinal immobilization.⁷ This immobilization on uncomfortable long backboards typically continued in the ED for prolonged periods, until the spine could be cleared by physical examination and/or imaging studies. Yet a 2001 Cochrane review found that despite increasing use of spinal immobilization, no prospective, randomized controlled trial of the appropriate use of spinal immobilization or patient outcomes had ever been conducted.⁸

What the Evidence Says

How much evidence exists that supports the benefits of spinal immobilization? Not much. Studies on healthy volunteers and cadavers evaluating spinal motion with immobilization have been contradictory.⁹ One study found there was less motion with a cervical collar in place than without,¹⁰ whereas others found that the use of a cervical collar did not effectively reduce motion in an unstable spine.^11,12 Perry et al¹³ studied the effectiveness of different head immobilization techniques and found that none could eliminate head and neck motion during emergency medical services (EMS) transport. Still other reports, including two biomechanical studies, demonstrated increased neck motion when using conventional extrication techniques (cervical collar with backboard) versus controlled self-extrication with cervical collar only.^14,15

An Abundance of Literature on the Risks

Whereas data regarding the actual benefits of spinal immobilization is lacking, an abundance of literature details the risks. One of the most frequently cited studies is also one of the most controversial. Hauswald et al¹⁶ compared the outcomes of two groups of patients with blunt force trauma who were either immobilized during transport (in New Mexico) or non-immobilized (in Malaysia) and found that the risk of disability was higher in the immobilized group (odds ratio, 2.03). Although these environments are very different, the authors noted that mechanism of injury, resources, and the size of the hospitals were similar.¹⁶

Studies of spinal immobilization in patients with penetrating trauma report even worse outcomes. In separate studies, Haut et al¹⁷ and Vanderlan et al¹⁸ demonstrated increased mortality when immobilization led to increased transport times and interference with other resuscitative measures. These and other studies have led the American College of Emergency Physicians, NAEMSP, ACS-COT, the Prehospital Trauma Life Support Executive Committee, and other national organizations to recommend no spinal immobilization in patients with penetrating neck trauma.^1,19,20

Many trauma patients arrive with complaints of pain at one or more sites. Some of these complaints, particularly back pain, may be secondary to the use of the backboard itself, especially in cases of prolonged transport.^21,22 In a study of healthy volunteers who were immobilized on a backboard for 30 minutes, all of them reported pain, along with headaches, most often involving the occipital and sacral regions.²³ A 1996 study compared spinal immobilization utilizing a backboard versus a vacuum mattress in 37 healthy volunteers with no history of back pain or spinal disease.²⁴ Compared to those immobilized with the vacuum mattress, patients immobilized with a backboard for 30 minutes were 3.1 times more likely to have symptoms, 7.9 times more likely to complain of occipital pain, and 4.3 times more likely to have lumbosacral pain.²⁴

Increased pain complaints in the setting of trauma can result in increased imaging, leading to increased costs and unnecessary radiation exposure.²⁵ Prolonged backboard times can also result in sacral pressure ulcers.²⁶ A recent study has shown that patients who undergo computed tomography (CT) scans with automatic tube current modulation (as most modern multidetector row CT systems utilize) while on a backboard  may be exposed to a significant increase in radiation dose.²⁷

Spinal immobilization has also been linked to respiratory compromise, particularly with the use of straps across the chest, even when not applied tightly. One study found worse lung function test results in healthy immobilized volunteers.²⁸ Other studies have shown that older patients (even when healthy) and those with lung or chest injury have an even larger degree of restriction and respiratory compromise.^29,30

Risks from immobilization are not isolated to backboards. The use of cervical collars alone also carries potential risks. (See “What About Cervical Collars?”^8,31-39)

Risk of Secondary Neurological Deterioration Is Low

Many EMS systems have already adopted the new standards calling for less use of spinal immobilization. Though the evidence is compelling, not all EMS systems have adopted these standards due to strongly rooted beliefs and fears of long-term patient disability and subsequent litigation. However, these fears do not appear justified.

A recent review by Oto et al⁴⁰ found only 42 cases of early secondary neurological deterioration after blunt trauma in all of the indexed medical literature. They noted, “In twelve cases the authors did attribute deterioration to temporally associated precipitants, seven of which were possibly iatrogenic; these included removal of a cervical collar, placement of a halo device, patient agitation, performance of flexion/extension films, ‘unintentional manipulation,’ falling in or near the ED, and forced collar application in patients with ankylosing spondylitis.” Thirteen of these cases occurred during prehospital care, none of them sudden and movement-provoked, and all reported by a single study.” This review highlights the rarity of secondary deterioration.

When Should Immobilization Be Used?

So what’s the next step for spinal immobilization in the field? How do we appropriately protect trauma patients during transport? As always seems to be the case in medicine, more evidence is needed. Oteir et al⁴¹ recently published a review of new literature on the epidemiology and current practice of prehospital spine management. They reported that early (8-24 hours) transfer of patients with spinal injury to spinal care units, along with effective resuscitation, was the most important determinant of better neurological outcomes.⁴¹ This review reaffirms the need for more data evaluating the relationship between spinal immobilization and neurological outcomes.

Currently, recommendations call for selective spinal immobilization to decrease unnecessary application and potential harm. Use of backboards for spinal immobilization should be limited to the following types of patients:^1,20

• Blunt trauma and altered level of consciousness;
• Spinal pain or tenderness;
• Neurological complaint (eg, numbness or motor weakness);
• Anatomic deformity of the spine;
• High-energy mechanism of injury and:
  
  • Drug or alcohol intoxication;
  • Inability to communicate; and/or
  • Distracting injury.

Patients for whom immobilization on a backboard is not necessary include those with all of the following:

• Normal level of consciousness (GCS 15);
• No spine tenderness or anatomic abnormality;
• No neurological findings or complaints;
• No distracting injury;
• No intoxication.

Cervical collars alone are still recommended for use in patients who do not meet validated clinical rules, such as the NEXUS or Canadian C spine rules.^1,20,42,43 As these rules are well validated, they can be safely used to determine who should have a cervical collar placed, with or without a backboard. In a retrospective review, selective spinal immobilization was found to be 99% sensitive in identifying patients with cervical injuries.⁴⁴

Clearly, there is still work to be done. Due to the relative rarity of actual spinal cord injury with the conse­quences of neurological injury, prospective trials in this area are rare and very difficult to safely design. However, there is growing confidence that selective spinal protocols, together with the inclusion of validated clinical rules, can effectively limit exposure to unnecessary spinal immobilization. As the current evidence continues to mount for the potential harm in indiscriminate backboard and cervical collar use, it seems clear we should strive to decrease the overuse of prehospital and early spinal immobilization consistent with current position statements and validated clinical rules.

Prehospital spinal immobilization has long been the standard of care (SOC) to prevent spinal cord injury in trauma patients, but utilizing the best data currently available, some professional societies recently released new recommendations that question this practice. Guidelines released in 2014 from the National Association of EMS Physicians (NAEMSP) and the American College of Surgeons Committee on Trauma (ACS-COT) support limited application of spinal immobilization.¹ These guidelines note, “Given the rarity of unstable spinal injuries in EMS trauma patients, the number that might benefit from immobilization to prevent secondary injury is likely extremely small. For each patient who has potential benefit, hundreds to thousands of patients must undergo immobilization with no potential benefit.” Further, they advise “utilization of backboards for spinal immobilization during transport should be judicious, so that potential benefits outweigh risks.”¹ Spinal immobilization should not be used at all in patients with penetrating trauma who do not present with obvious neurological injury and should be selective, based on objective findings of injury or the high potential for same.¹

Questioning a Long-standing Practice

Fear of the consequences of spinal cord injury from significant vertebral fractures has dictated prehospital spinal immobilization to manage injured trauma patients for decades. For almost 50 years, it has been the SOC. However, increasing evidence that spinal immobilization is not only unnecessary, but may even cause harm has resulted in questioning this paradigm, which has lead to promoting a change in the SOC.

Spinal immobilization dates back to the mid-1960s, when Geisler et al² reported on a cohort of patients who suffered long-term paralysis from what was believed to be improper handling and failure to discover spinal injuries. Soon after, Farrington^3,4 developed and published a systematic approach to spinal immobilization during extrication following blunt force trauma, supporting the widespread acceptance of backboards and cervical collars to immobilize the spine in injured trauma patients. Logic dictated that an unstable spine fracture could be worsened, or a cord injury could result, by unnecessary movement during extrication, transport, and initial evaluation in the ED, resulting in avoidable injury. This fear of potential secondary injury grew as more papers were published examining the link between prehospital handling of blunt force trauma patients and delayed paralysis. This resulted in the use of spinal immobilization on the majority of trauma patients, regardless of mechanism of injury or presenting symptoms.^5,6

One review estimated that over 50% of trauma patients with no complaint of neck or back pain were transported with full spinal immobilization.⁷ This immobilization on uncomfortable long backboards typically continued in the ED for prolonged periods, until the spine could be cleared by physical examination and/or imaging studies. Yet a 2001 Cochrane review found that despite increasing use of spinal immobilization, no prospective, randomized controlled trial of the appropriate use of spinal immobilization or patient outcomes had ever been conducted.⁸

What the Evidence Says

How much evidence exists that supports the benefits of spinal immobilization? Not much. Studies on healthy volunteers and cadavers evaluating spinal motion with immobilization have been contradictory.⁹ One study found there was less motion with a cervical collar in place than without,¹⁰ whereas others found that the use of a cervical collar did not effectively reduce motion in an unstable spine.^11,12 Perry et al¹³ studied the effectiveness of different head immobilization techniques and found that none could eliminate head and neck motion during emergency medical services (EMS) transport. Still other reports, including two biomechanical studies, demonstrated increased neck motion when using conventional extrication techniques (cervical collar with backboard) versus controlled self-extrication with cervical collar only.^14,15

An Abundance of Literature on the Risks

Whereas data regarding the actual benefits of spinal immobilization is lacking, an abundance of literature details the risks. One of the most frequently cited studies is also one of the most controversial. Hauswald et al¹⁶ compared the outcomes of two groups of patients with blunt force trauma who were either immobilized during transport (in New Mexico) or non-immobilized (in Malaysia) and found that the risk of disability was higher in the immobilized group (odds ratio, 2.03). Although these environments are very different, the authors noted that mechanism of injury, resources, and the size of the hospitals were similar.¹⁶

Studies of spinal immobilization in patients with penetrating trauma report even worse outcomes. In separate studies, Haut et al¹⁷ and Vanderlan et al¹⁸ demonstrated increased mortality when immobilization led to increased transport times and interference with other resuscitative measures. These and other studies have led the American College of Emergency Physicians, NAEMSP, ACS-COT, the Prehospital Trauma Life Support Executive Committee, and other national organizations to recommend no spinal immobilization in patients with penetrating neck trauma.^1,19,20

Many trauma patients arrive with complaints of pain at one or more sites. Some of these complaints, particularly back pain, may be secondary to the use of the backboard itself, especially in cases of prolonged transport.^21,22 In a study of healthy volunteers who were immobilized on a backboard for 30 minutes, all of them reported pain, along with headaches, most often involving the occipital and sacral regions.²³ A 1996 study compared spinal immobilization utilizing a backboard versus a vacuum mattress in 37 healthy volunteers with no history of back pain or spinal disease.²⁴ Compared to those immobilized with the vacuum mattress, patients immobilized with a backboard for 30 minutes were 3.1 times more likely to have symptoms, 7.9 times more likely to complain of occipital pain, and 4.3 times more likely to have lumbosacral pain.²⁴

Increased pain complaints in the setting of trauma can result in increased imaging, leading to increased costs and unnecessary radiation exposure.²⁵ Prolonged backboard times can also result in sacral pressure ulcers.²⁶ A recent study has shown that patients who undergo computed tomography (CT) scans with automatic tube current modulation (as most modern multidetector row CT systems utilize) while on a backboard  may be exposed to a significant increase in radiation dose.²⁷

Spinal immobilization has also been linked to respiratory compromise, particularly with the use of straps across the chest, even when not applied tightly. One study found worse lung function test results in healthy immobilized volunteers.²⁸ Other studies have shown that older patients (even when healthy) and those with lung or chest injury have an even larger degree of restriction and respiratory compromise.^29,30

Risks from immobilization are not isolated to backboards. The use of cervical collars alone also carries potential risks. (See “What About Cervical Collars?”^8,31-39)

Risk of Secondary Neurological Deterioration Is Low

Many EMS systems have already adopted the new standards calling for less use of spinal immobilization. Though the evidence is compelling, not all EMS systems have adopted these standards due to strongly rooted beliefs and fears of long-term patient disability and subsequent litigation. However, these fears do not appear justified.

A recent review by Oto et al⁴⁰ found only 42 cases of early secondary neurological deterioration after blunt trauma in all of the indexed medical literature. They noted, “In twelve cases the authors did attribute deterioration to temporally associated precipitants, seven of which were possibly iatrogenic; these included removal of a cervical collar, placement of a halo device, patient agitation, performance of flexion/extension films, ‘unintentional manipulation,’ falling in or near the ED, and forced collar application in patients with ankylosing spondylitis.” Thirteen of these cases occurred during prehospital care, none of them sudden and movement-provoked, and all reported by a single study.” This review highlights the rarity of secondary deterioration.

When Should Immobilization Be Used?

So what’s the next step for spinal immobilization in the field? How do we appropriately protect trauma patients during transport? As always seems to be the case in medicine, more evidence is needed. Oteir et al⁴¹ recently published a review of new literature on the epidemiology and current practice of prehospital spine management. They reported that early (8-24 hours) transfer of patients with spinal injury to spinal care units, along with effective resuscitation, was the most important determinant of better neurological outcomes.⁴¹ This review reaffirms the need for more data evaluating the relationship between spinal immobilization and neurological outcomes.

Currently, recommendations call for selective spinal immobilization to decrease unnecessary application and potential harm. Use of backboards for spinal immobilization should be limited to the following types of patients:^1,20

• Blunt trauma and altered level of consciousness;
• Spinal pain or tenderness;
• Neurological complaint (eg, numbness or motor weakness);
• Anatomic deformity of the spine;
• High-energy mechanism of injury and:
  
  • Drug or alcohol intoxication;
  • Inability to communicate; and/or
  • Distracting injury.

Patients for whom immobilization on a backboard is not necessary include those with all of the following:

• Normal level of consciousness (GCS 15);
• No spine tenderness or anatomic abnormality;
• No neurological findings or complaints;
• No distracting injury;
• No intoxication.

Cervical collars alone are still recommended for use in patients who do not meet validated clinical rules, such as the NEXUS or Canadian C spine rules.^1,20,42,43 As these rules are well validated, they can be safely used to determine who should have a cervical collar placed, with or without a backboard. In a retrospective review, selective spinal immobilization was found to be 99% sensitive in identifying patients with cervical injuries.⁴⁴

Clearly, there is still work to be done. Due to the relative rarity of actual spinal cord injury with the conse­quences of neurological injury, prospective trials in this area are rare and very difficult to safely design. However, there is growing confidence that selective spinal protocols, together with the inclusion of validated clinical rules, can effectively limit exposure to unnecessary spinal immobilization. As the current evidence continues to mount for the potential harm in indiscriminate backboard and cervical collar use, it seems clear we should strive to decrease the overuse of prehospital and early spinal immobilization consistent with current position statements and validated clinical rules.

Prehospital spinal immobilization has long been the standard of care (SOC) to prevent spinal cord injury in trauma patients, but utilizing the best data currently available, some professional societies recently released new recommendations that question this practice. Guidelines released in 2014 from the National Association of EMS Physicians (NAEMSP) and the American College of Surgeons Committee on Trauma (ACS-COT) support limited application of spinal immobilization.¹ These guidelines note, “Given the rarity of unstable spinal injuries in EMS trauma patients, the number that might benefit from immobilization to prevent secondary injury is likely extremely small. For each patient who has potential benefit, hundreds to thousands of patients must undergo immobilization with no potential benefit.” Further, they advise “utilization of backboards for spinal immobilization during transport should be judicious, so that potential benefits outweigh risks.”¹ Spinal immobilization should not be used at all in patients with penetrating trauma who do not present with obvious neurological injury and should be selective, based on objective findings of injury or the high potential for same.¹

Questioning a Long-standing Practice

Fear of the consequences of spinal cord injury from significant vertebral fractures has dictated prehospital spinal immobilization to manage injured trauma patients for decades. For almost 50 years, it has been the SOC. However, increasing evidence that spinal immobilization is not only unnecessary, but may even cause harm has resulted in questioning this paradigm, which has lead to promoting a change in the SOC.

Spinal immobilization dates back to the mid-1960s, when Geisler et al² reported on a cohort of patients who suffered long-term paralysis from what was believed to be improper handling and failure to discover spinal injuries. Soon after, Farrington^3,4 developed and published a systematic approach to spinal immobilization during extrication following blunt force trauma, supporting the widespread acceptance of backboards and cervical collars to immobilize the spine in injured trauma patients. Logic dictated that an unstable spine fracture could be worsened, or a cord injury could result, by unnecessary movement during extrication, transport, and initial evaluation in the ED, resulting in avoidable injury. This fear of potential secondary injury grew as more papers were published examining the link between prehospital handling of blunt force trauma patients and delayed paralysis. This resulted in the use of spinal immobilization on the majority of trauma patients, regardless of mechanism of injury or presenting symptoms.^5,6

One review estimated that over 50% of trauma patients with no complaint of neck or back pain were transported with full spinal immobilization.⁷ This immobilization on uncomfortable long backboards typically continued in the ED for prolonged periods, until the spine could be cleared by physical examination and/or imaging studies. Yet a 2001 Cochrane review found that despite increasing use of spinal immobilization, no prospective, randomized controlled trial of the appropriate use of spinal immobilization or patient outcomes had ever been conducted.⁸

What the Evidence Says

How much evidence exists that supports the benefits of spinal immobilization? Not much. Studies on healthy volunteers and cadavers evaluating spinal motion with immobilization have been contradictory.⁹ One study found there was less motion with a cervical collar in place than without,¹⁰ whereas others found that the use of a cervical collar did not effectively reduce motion in an unstable spine.^11,12 Perry et al¹³ studied the effectiveness of different head immobilization techniques and found that none could eliminate head and neck motion during emergency medical services (EMS) transport. Still other reports, including two biomechanical studies, demonstrated increased neck motion when using conventional extrication techniques (cervical collar with backboard) versus controlled self-extrication with cervical collar only.^14,15

An Abundance of Literature on the Risks

Whereas data regarding the actual benefits of spinal immobilization is lacking, an abundance of literature details the risks. One of the most frequently cited studies is also one of the most controversial. Hauswald et al¹⁶ compared the outcomes of two groups of patients with blunt force trauma who were either immobilized during transport (in New Mexico) or non-immobilized (in Malaysia) and found that the risk of disability was higher in the immobilized group (odds ratio, 2.03). Although these environments are very different, the authors noted that mechanism of injury, resources, and the size of the hospitals were similar.¹⁶

Studies of spinal immobilization in patients with penetrating trauma report even worse outcomes. In separate studies, Haut et al¹⁷ and Vanderlan et al¹⁸ demonstrated increased mortality when immobilization led to increased transport times and interference with other resuscitative measures. These and other studies have led the American College of Emergency Physicians, NAEMSP, ACS-COT, the Prehospital Trauma Life Support Executive Committee, and other national organizations to recommend no spinal immobilization in patients with penetrating neck trauma.^1,19,20

Many trauma patients arrive with complaints of pain at one or more sites. Some of these complaints, particularly back pain, may be secondary to the use of the backboard itself, especially in cases of prolonged transport.^21,22 In a study of healthy volunteers who were immobilized on a backboard for 30 minutes, all of them reported pain, along with headaches, most often involving the occipital and sacral regions.²³ A 1996 study compared spinal immobilization utilizing a backboard versus a vacuum mattress in 37 healthy volunteers with no history of back pain or spinal disease.²⁴ Compared to those immobilized with the vacuum mattress, patients immobilized with a backboard for 30 minutes were 3.1 times more likely to have symptoms, 7.9 times more likely to complain of occipital pain, and 4.3 times more likely to have lumbosacral pain.²⁴

Increased pain complaints in the setting of trauma can result in increased imaging, leading to increased costs and unnecessary radiation exposure.²⁵ Prolonged backboard times can also result in sacral pressure ulcers.²⁶ A recent study has shown that patients who undergo computed tomography (CT) scans with automatic tube current modulation (as most modern multidetector row CT systems utilize) while on a backboard  may be exposed to a significant increase in radiation dose.²⁷

Spinal immobilization has also been linked to respiratory compromise, particularly with the use of straps across the chest, even when not applied tightly. One study found worse lung function test results in healthy immobilized volunteers.²⁸ Other studies have shown that older patients (even when healthy) and those with lung or chest injury have an even larger degree of restriction and respiratory compromise.^29,30

Risks from immobilization are not isolated to backboards. The use of cervical collars alone also carries potential risks. (See “What About Cervical Collars?”^8,31-39)

Risk of Secondary Neurological Deterioration Is Low

Many EMS systems have already adopted the new standards calling for less use of spinal immobilization. Though the evidence is compelling, not all EMS systems have adopted these standards due to strongly rooted beliefs and fears of long-term patient disability and subsequent litigation. However, these fears do not appear justified.

A recent review by Oto et al⁴⁰ found only 42 cases of early secondary neurological deterioration after blunt trauma in all of the indexed medical literature. They noted, “In twelve cases the authors did attribute deterioration to temporally associated precipitants, seven of which were possibly iatrogenic; these included removal of a cervical collar, placement of a halo device, patient agitation, performance of flexion/extension films, ‘unintentional manipulation,’ falling in or near the ED, and forced collar application in patients with ankylosing spondylitis.” Thirteen of these cases occurred during prehospital care, none of them sudden and movement-provoked, and all reported by a single study.” This review highlights the rarity of secondary deterioration.

When Should Immobilization Be Used?

So what’s the next step for spinal immobilization in the field? How do we appropriately protect trauma patients during transport? As always seems to be the case in medicine, more evidence is needed. Oteir et al⁴¹ recently published a review of new literature on the epidemiology and current practice of prehospital spine management. They reported that early (8-24 hours) transfer of patients with spinal injury to spinal care units, along with effective resuscitation, was the most important determinant of better neurological outcomes.⁴¹ This review reaffirms the need for more data evaluating the relationship between spinal immobilization and neurological outcomes.

Currently, recommendations call for selective spinal immobilization to decrease unnecessary application and potential harm. Use of backboards for spinal immobilization should be limited to the following types of patients:^1,20

• Blunt trauma and altered level of consciousness;
• Spinal pain or tenderness;
• Neurological complaint (eg, numbness or motor weakness);
• Anatomic deformity of the spine;
• High-energy mechanism of injury and:
  
  • Drug or alcohol intoxication;
  • Inability to communicate; and/or
  • Distracting injury.

Patients for whom immobilization on a backboard is not necessary include those with all of the following:

• Normal level of consciousness (GCS 15);
• No spine tenderness or anatomic abnormality;
• No neurological findings or complaints;
• No distracting injury;
• No intoxication.

Cervical collars alone are still recommended for use in patients who do not meet validated clinical rules, such as the NEXUS or Canadian C spine rules.^1,20,42,43 As these rules are well validated, they can be safely used to determine who should have a cervical collar placed, with or without a backboard. In a retrospective review, selective spinal immobilization was found to be 99% sensitive in identifying patients with cervical injuries.⁴⁴

Clearly, there is still work to be done. Due to the relative rarity of actual spinal cord injury with the conse­quences of neurological injury, prospective trials in this area are rare and very difficult to safely design. However, there is growing confidence that selective spinal protocols, together with the inclusion of validated clinical rules, can effectively limit exposure to unnecessary spinal immobilization. As the current evidence continues to mount for the potential harm in indiscriminate backboard and cervical collar use, it seems clear we should strive to decrease the overuse of prehospital and early spinal immobilization consistent with current position statements and validated clinical rules.

AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.

“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”

The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.

She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.

The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.

The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.

After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.

Mitchel L. Zoler/Frontline Medical News

“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”

In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”

One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.

Dr. Mooney and Dr. Mansel reported having no financial disclosures.

[email protected]

On Twitter @mitchelzoler

AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.

“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”

The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.

She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.

The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.

The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.

After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.

Mitchel L. Zoler/Frontline Medical News

“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”

In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”

One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.

Dr. Mooney and Dr. Mansel reported having no financial disclosures.

[email protected]

On Twitter @mitchelzoler

AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.

“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”

The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.

She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.

The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.

The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.

After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.

Mitchel L. Zoler/Frontline Medical News

“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”

In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”

One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.

Dr. Mooney and Dr. Mansel reported having no financial disclosures.

[email protected]

On Twitter @mitchelzoler

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.

“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.

Bruce Jancin/Frontline Medical News

Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.

Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.

“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.

It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.

Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.

Diphenoxylate/atropine (Lomotil) is another effective prescription option.

Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.

The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.

Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”

Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.

Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.

“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.

He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.

[email protected]

Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).

Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.

Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.

Learn More

Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).

Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.

Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.

Learn More

Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).

Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.

Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.

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AATS Week 2016 includes Two Terrific Events

AATS Week 2016 Registration & Housing Open!

Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)

96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)

Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.

Registration/Housing 

AATS Aortic Symposium
May 12–13, 2016
New York, NY

Course Directors
Joseph S. Coselli
Steven L. Lansman

The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.

Be sure to register for a Friday Morning Breakfast Breakout session.

View Aortic Symposium Program 

Learn More 

AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts  

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.

Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.

Check out the AATS Week Video 

AATS Week 2016 includes Two Terrific Events

AATS Week 2016 Registration & Housing Open!

Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)

96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)

Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.

Registration/Housing 

AATS Aortic Symposium
May 12–13, 2016
New York, NY

Course Directors
Joseph S. Coselli
Steven L. Lansman

The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.

Be sure to register for a Friday Morning Breakfast Breakout session.

View Aortic Symposium Program 

Learn More 

AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts  

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.

Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.

Check out the AATS Week Video 

AATS Week 2016 includes Two Terrific Events

AATS Week 2016 Registration & Housing Open!

Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)

96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)

Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.

Registration/Housing 

AATS Aortic Symposium
May 12–13, 2016
New York, NY

Course Directors
Joseph S. Coselli
Steven L. Lansman

The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.

Be sure to register for a Friday Morning Breakfast Breakout session.

View Aortic Symposium Program 

Learn More 

AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD

President & Annual Meeting Chair
Joseph S. Coselli

Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones

View Preliminary Program, Speakers, Presentations and Full Abstracts  

Don’t miss this year’s exciting program including:

Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions

Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner

New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)

Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine

Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.

Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic

VAD/ECMO SessionMasters of Surgery Video Sessions

AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.

Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.

Check out the AATS Week Video 

Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.

F. Griffith Pearson Fellowship

Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology

Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery

Marc R. de Leval Fellowship

Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA

Program Information

Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.

F. Griffith Pearson Fellowship

Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology

Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery

Marc R. de Leval Fellowship

Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA

Program Information

Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.

F. Griffith Pearson Fellowship

Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology

Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery

Marc R. de Leval Fellowship

Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA

Program Information

The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.

Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.

The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.

New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.

Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.

Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.

For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.

Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.

The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.

New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.

Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.

Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.

For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.

Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.

The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.

New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.

Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.

Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.

For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.

In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.

Related: Promising Method to Evaluate Response to Treatment

Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.

According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.

Related: FDA Approves Rescue Drug for Chemotherapy Overdose

The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.

Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.

Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.

In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.

Related: Promising Method to Evaluate Response to Treatment

Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.

According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.

Related: FDA Approves Rescue Drug for Chemotherapy Overdose

The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.

Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.

Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.

In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.

Related: Promising Method to Evaluate Response to Treatment

Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.

According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.

Related: FDA Approves Rescue Drug for Chemotherapy Overdose

The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.

Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.

Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.

In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.

©Ingram Publishing/Thinkstock

The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].

Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.

A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).

Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).

Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.

Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.

In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.

“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.

The authors reported that they had no relevant disclosures.

[email protected]

Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.

In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.

©Ingram Publishing/Thinkstock

The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].

Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.

A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).

Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).

Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.

Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.

In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.

“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.

The authors reported that they had no relevant disclosures.

[email protected]

Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.

In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.

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The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].

Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.

A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).

Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).

Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.

Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.

In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.

“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.

The authors reported that they had no relevant disclosures.

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