PARK CITY, UTAH – When attendees at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology were asked if their institutions test to confirm alleged penicillin allergies, the only hands that went up were from clinicians at Duke University.

That’s a problem, according to Robert Heine, MD, a maternal-fetal medicine specialist at Duke, in Durham, N.C. “We, as a group, need to be doing [penicillin] allergy testing,” he said.

“Beta-lactam antibiotic prophylaxis reduced the risk of surgical site infections after cesareans by 60%,” said Benjamin Harris, MD, the lead investigator and an ob.gyn. resident at Duke, who presented the findings at the meeting.

[email protected]

PARK CITY, UTAH – When attendees at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology were asked if their institutions test to confirm alleged penicillin allergies, the only hands that went up were from clinicians at Duke University.

That’s a problem, according to Robert Heine, MD, a maternal-fetal medicine specialist at Duke, in Durham, N.C. “We, as a group, need to be doing [penicillin] allergy testing,” he said.

“Beta-lactam antibiotic prophylaxis reduced the risk of surgical site infections after cesareans by 60%,” said Benjamin Harris, MD, the lead investigator and an ob.gyn. resident at Duke, who presented the findings at the meeting.

[email protected]

PARK CITY, UTAH – When attendees at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology were asked if their institutions test to confirm alleged penicillin allergies, the only hands that went up were from clinicians at Duke University.

That’s a problem, according to Robert Heine, MD, a maternal-fetal medicine specialist at Duke, in Durham, N.C. “We, as a group, need to be doing [penicillin] allergy testing,” he said.

“Beta-lactam antibiotic prophylaxis reduced the risk of surgical site infections after cesareans by 60%,” said Benjamin Harris, MD, the lead investigator and an ob.gyn. resident at Duke, who presented the findings at the meeting.

[email protected]

How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”¹ a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies^2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

To perform the study,⁴ chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.⁵

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.⁴ “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”¹ a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies^2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

To perform the study,⁴ chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.⁵

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.⁴ “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

How hospitalists and other clinicians communicate with patients impacts a patient’s overall experience and satisfaction. But according to the authors of “Communication the Cleveland Way,”¹ a book about how the clinic created and applied communication skills training, “in a culture prioritizing clinical outcomes above all, there can be a tendency to lose sight of one of the most critical aspects of providing effective care: the communication skills that build and foster physician-patient relationships.”

“Studies^2,3 have shown that good communication between doctors and patients and among all caregivers who interface with patients directly results in better clinical outcomes, reduced costs, greater patient satisfaction, and lower rates of physician burnout,” the authors wrote.

How it works

Because a provider’s connection with a patient occurs when a relationship is established, the REDE course focuses on the beginning of the conversation. “It’s important for clinicians to exhibit value and respect through words and actions when welcoming patients,” Dr. Velez said. “Further, instead of guiding the medical interview with a series of close-ended questions like an interrogator would, we invite the use of open-ended questions and setting an agenda for the visit early on, by asking the patient what they wish to discuss.”

Another key component is empathy, which plays a huge role in patient satisfaction. “Learning how to express empathy is very important,” Dr. Velez said. “A patient may not remember all of the medical details discussed, but human interactions, rapport, expressions of care, support, validation, and acknowledgment of emotions tend to be more indelible.”

Dr. Velez notes that decades of literature regarding effective communication have demonstrated improved outcomes. “If trust in a therapeutic relationship is strong, a patient is more likely to follow instructions and have better engagement with their care plan,” he said. “If a clinician ensures that the patient understands the diagnosis and recommendations, then compliance will increase, especially if the plan is tailored to the patient’s goals and perspective.”

One surprising effect of the REDE course was how it improved relationships among professionals. “Many participants have shared that having a day out of one’s normal schedule, not only to learn, but also to share their own experiences, is quite therapeutic,” Dr. Velez said. “We can extend the same communication strategies to team building, interprofessional interactions, and challenging encounters.”
 

Study focuses on comportment and communication

In an effort to define optimal care in hospital medicine, a team from Johns Hopkins Health System set out to establish a metric that would comprehensively assess hospitalists’ comportment (which includes behavior as well as general demeanor) and communication to establish norms and expectations when they saw patients at the bedside.

To perform the study,⁴ chiefs of hospital medicine divisions at five independent hospitals located in Baltimore and Washington identified their most clinically excellent hospitalists. Then, an investigator observed each hospitalist during a routine clinical shift and recorded behaviors believed to be associated with excellent behavior and communication using the hospital medicine comportment and communication observation tool (HMCCOT), said Susrutha Kotwal, MD, assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, and lead author. The investigators collected basic demographic information while observing hospitalists for an average of 280 minutes; 26 physicians were observed for 181 separate clinical encounters. Each provider’s mean HMCCOT score was compared with patient satisfaction surveys such as Press Ganey (PG) scores.

Employing the tool

Hospitalists can choose whether to perform behaviors in the HMCCOT themselves, while others may wish to watch other hospitalists to give them feedback tied to specific behaviors. “These simple behaviors are intimately linked to excellent communication and comportment, which can serve as the foundation for delivering patient-centered care,” Dr. Kotwal said.

A positive correlation was found between spending more time with patients and higher HMCCOT scores. “Patients’ complaints about doctors often relate to feeling rushed, that their physicians did not listen to them, or that they did not convey information in a clear manner,” Dr. Kotwal said. “When successfully achieved, patient-centered communication has been associated with improved clinical outcomes, including adherence to recommended treatment and better self-management of chronic disease. Many of the components of the HMCCOT described in our study are at the heart of patient-centered care.”

Dr. Kotwal believes HMCCOT is a better strategy to improve patient satisfaction than patient satisfaction surveys because patients can’t always recall which specific provider saw them. In addition, patients’ recall about the provider may be poor because surveys are sent to patients days after they return home. In addition, patients’ recovery and health outcomes are likely to influence their assessment of the doctor. Finally, feedback is known to be most valuable and transformative when it is specific and given in real time. Therefore, a tool that is able to provide feedback at the encounter level should be more helpful than a tool that offers assessment at the level of the admission, particularly when it can be also delivered immediately after the data are collected.⁵

The study authors conclude that, “Future studies are necessary to determine whether hospitalists of all levels of experience and clinical skill can improve when given data and feedback using the HMCCOT. Larger studies are then needed to assess whether enhancing comportment and communication can truly improve patient satisfaction and clinical outcomes in the hospital. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication be established as a goal for every encounter.”
 

The effectiveness of care team rounds at the bedside

Investigators at the UMass Memorial Medical Center, in Worcester, Mass., studied the effectiveness of assembling the entire care team (i.e., physicians, including residents and attendings, nursing, and clinical pharmacy) to round at the patient’s bedside each morning – in lieu of its traditionally separate rounding strategies – on one unit of its academic hospitalist service for an internal quality program, said Patricia Seymour, MD, FAAFP, assistant professor and family medicine hospitalist education director.

Additionally, academic presentations and discussions were all done in front of patients and their families (with a few exceptions) rather than traditional hallway rounds or sit rounds. Over the course of the project, the hospital also offered residents training around physician behaviors that improve patient satisfaction; provided incentives for nurses and residents to work as a team; and created a welcome visit template for the nursing manager and instruments for patients to enhance engagement. Through all of these cycles, the collaborative rounding strategy continued.

Because Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores yielded low response rates for the singular test unit and service, the investigators used a validated patient satisfaction instrument and surveyed patients from the intervention group and patients on the same unit who did not experience this collaborative rounding on their day of discharge. The intervention group had higher satisfaction scores at most of the time points. The unit-based HCAHPS scores (not just study patients) improved during this time period.

“We think the strategy of collaborative rounding yielded positive results for obvious reasons – the entire team was on the same page and the information given to the patient was consistent,” said Dr. Seymour, who notes that the study’s findings weren’t published and the project was completed for an internal quality program. “Doctors had an increased understanding about nursing concerns and the nursing staff expressed improved understanding of patients’ care plans.”

Certainly, face time with the patient was extended because much of the academic discussion occurred at the bedside instead of at another physical location without patient awareness, Dr. Seymour said. She believes the strategy boosted patient satisfaction because it was patient centered. “While this rounding strategy is not the most convenient rounding strategy for nurses or doctors, it consolidates the discussion about the patient’s clinical condition and the plan for the day. The patient experiences a strong sense of being cared for by a unified team and receives consistent messaging,” she said.

Also noteworthy is that job satisfaction for residents and nurses improved on the unit over the study time period because of the expected collaboration that was built into the work flow.

Although the facility is no longer using this communication strategy to the same degree, teaching attendings have seen the value of true bedside rounding and continue to teach this skill to learners. “We have had some challenges with geographic cohorting at our institution, which is essential for this type of team-based strategy,” Dr. Seymour said. “Sustainability requires constant encouragement, oversight, and auditing from team leaders which is also challenging and fluctuates with competing demands.”

The results of this study, and others, show that employing tools to improve communication can also result in improved patient satisfaction and experience.

Karen Appold is a medical writer in Pennsylvania.

References

1. Boissy A, Gilligan T. “Communication the Cleveland Clinic Way: How to drive a relationship-centered strategy for superior patient experience.” New York: McGraw-Hill Education. 2016.

2. Weng HC, Hung CM, Liu YT, et al. Associations between emotional intelligence and doctor burnout, job satisfaction and patient satisfaction. Med Educ. 2011;45:835-42.

3. Boissy A, Windover AK, Bokar D, et al. Communication skills training for physicians improves patient satisfaction. J Gen Intern Med. 2016 Jul;31(7):755-761. doi: 10.1007/s11606-016-3597-2. Epub 2016 Feb 26.

4. Kotwal S, Khaliq W, Landis R, Wright S. Developing a comportment and communication tool for use in hospital medicine. J Hosp Med. 2016 Dec;11(12):853-858. doi: 10.1002/jhm.2647. Epub 2016 Aug 13.

5. Fong Ha J, Longnecker N. Doctor-patient communication: a review. Ochsner J. 2010 Spring; 10(1):38-43.

6. Bodenheimer T, Sinsky C. From Triple to Quadruple Aim: care of the patient requires care of the provider. Ann Fam Med. 2014 Nov;12(6): 573-6. doi: 10.1370/afm.1713.

Bonus Content

Clinicians wary of course's worthiness

Before clinicians took Cleveland Clinic’s Relationship Establishment, Development, and Engagement (REDE) course, only 20% strongly agreed that the course would be valuable, whereas afterward 58% strongly agreed that it was indeed valuable. Less than 1% said it wasn’t valuable.⁴ “Most likely clinicians had a preconceived notion about how communication courses go, but they were probably surprised at how much these sessions were equally about them as providers as they were about caring for patients,” said Vicente J. Velez, MD, FACP, FHM, a hospitalist who serves as the director of faculty enrichment for the leadership team of CEHC. “This is the power of relationship-centered care, and also why I think the model has been sustainable.”

Physicians also reported that before taking the course, they had moderate levels of burnout and low levels of empathy. After taking it, burnout metrics (i.e., emotional exhaustion, depersonalization, and personal achievement) and empathy improved significantly. “I observed that most are surprised to find out that empathy is a discreet set of skills that can be learned, practiced, observed, measured, and improved upon,” Dr. Velez said. “If taught in a safe and validating environment and if principles of adult learning are followed, improvement can be optimized and sustained.”

Since the REDE course rolled out in 2012, all attending physicians and medical staff members have been trained in it.
 

Why empathy is preferred over patient-centered care

The Cleveland Clinic intentionally puts a focus on relationship-centered care.

“When there’s an emphasis on patient-centered care, some physicians have a hard time figuring out what to do when the patient wants something that the physician doesn’t feel is appropriate,” said Katie Neuendorf, MD, director for the Center for Excellence in Healthcare Communication. “Patient-centered implies that the patient is always right and that their opinion should win out over the physician’s opinion. In that same scenario, relationship-centered care implies that the relationship should be prioritized, even when there’s disagreement in the plan of care. I can tell my patients that I hear what they are saying, that I empathize with their struggles, that I care about the way the illness is affecting their lives, and that I am here to support them. I can do all of that and still not prescribe a treatment that I feel is inappropriate just because it happens to be what the patient wants.”

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

Global mortality due to rheumatic heart disease fell by about 48% during a recent 25-year-period, but some of the poorest areas of the world were left behind, according to a report in the New England Journal of Medicine.

Those regions included Oceania, South Asia, and central sub-Saharan Africa, where rheumatic heart disease remains endemic, wrote David A. Watkins, MD, MPH, of the University of Washington, Seattle, and his coinvestigators. “We estimate that 10 persons per 1,000 population living in South Asia and central sub-Saharan Africa and 15 persons per 1,000 population in Oceania were living with rheumatic heart disease in the year 2015,” they wrote. “Improvements in the measurement of the burden of rheumatic heart disease will assist in planning for its control and will help identify countries where further investments are needed.”

NEW YORK – Dermatologists have an important role to play in caring for patients with chronic graft versus host disease (GVHD), a condition whose cutaneous manifestations are many, stubborn, and often disabling.

Although a wide range of systemic therapies are available, topical and intralesional treatment with such agents as potent steroids and calcineurin inhibitors can also help with cutaneous manifestations of GVHD in some instances, said Kathryn Martires, MD, at the American Academy of Dermatology summer meeting. However, she noted, “there are no studies or series examining the use of topical steroids alone in these patients, partly speaking to the complexity of these patients and required other care, but partly also due to the lack of dermatologists’ involvement in the care of these patients on a wide scale.”

“The types of GVHD that are particularly amenable to high dose steroids are predominantly the epidermal types,” she said. These include ichthyotic and eczematous as well as lichen planus–like cutaneous GVHD. “We also use topical steroids frequently in the papulosquamous type, though this is a rare variant,” she added.

Topical steroids can be used for dermal skin changes of GVHD as well, including lichen sclerosus–like and focal morphea–like plaques, according to Dr. Martires of the department of dermatology at Stanford (Calif.) University. These lesions are often first seen in the skin folds of the neck.

Even for patients with more diffuse dermal sclerosis, topical steroids have a role in quieting specific areas where active flares are occurring, she noted. These flares can look like erythematous, scaly patches and are “particularly amenable” to spot treatment with topical steroids.

“Just like in vitiligo that’s not associated with GVHD, certainly, topical steroids have their role in treating vitiligo that’s associated with chronic GVHD,” Dr. Martires said. This scenario stands in contrast to the situation where a patient has postinflammatory hyperpigmentation, for example, further along in the course of epidermal GVHD. Steroids should be avoided in situations where there’s hyperpigmentation.

Topical steroids are not usually useful for chronic poikilodermatous GVHD, or, generally, when patients have little epidermal change and the GVHD-associated changes are mostly dermal or subcutaneous, she said.

“Intralesional steroids have their role” in GVHD, although this is another instance where there are no studies to back up their efficacy, and recommendations are based on consensus, Dr. Martires pointed out. Nodular sclerotic GVHD is a rare manifestation, with firm, keloid-like lesions. These can flatten with intralesional injections, said Dr. Martires.

Intralesional injections have also been described in the literature as a treatment for ulcerative oral GVHD, she noted. Other therapy options for oral mucosal GVHD are fluocinonide gel 0.05% or clobetasol gel 0.05%, with spot application to the lesions. When there’s more diffuse lichenoid GVHD of the mouth, dexamethasone or prednisolone oral rinses can also be used, but should be combined with nystatin to prevent thrush, she advised. Triamcinolone 0.1% can be used with topical benzocaine dental paste (Orabase).

Calcineurin inhibitors are another option for oral lesions. Patients generally have a good comfort level with starting topical calcineurin inhibitors, said Dr. Martires, because they’ve likely had exposure to the systemic formulation. Case series have reported improvement “primarily in lichenoid GVHD” with the adjunctive use of topical calcineurin inhibitors, she said. In the mouth, tacrolimus 0.1% can be put in dental paste for focal lesions, and cyclosporine and azathioprine oral solutions can also be used.

Dry mouth is common in GVHD. “Remember, in patients who have other skin symptoms like pruritus, to ask about oral sicca symptoms in order to avoid things that might exacerbate it, like antihistamines and [tricyclic antidepressants],” she added.

Genital mucosal GVHD can respond to topical steroids, with ointment as the preferred vehicle, said Dr. Martires, noting that clobetasol 0.05% ointment and fluocinolone 0.025% ointment are good options, and tacrolimus 0.1% ointment is a logical nonsteroidal topical choice for the genital mucosa.

“Intralesionals are also first-line therapy here,” and “may prevent progression and permanent scarring if initiated early,” she pointed out. However, these injections are quite painful, so “patients have to be quite motivated” to be on board with this line of therapy, she said, adding that numbing prior to injections can help with pain.

Genital discomfort in women may not all be GVHD-related. “Remember, in patients who have undergone several cycles of chemotherapy prior to transplant, that they often have been experiencing menopausal symptoms, sometimes for years, so estrogen cream can sometimes go a long way,” said Dr. Martires, adding, “Certainly, a reminder about lubrication during intercourse is appropriate.”

Also, she said, dermatologists can help patients understand how important it is to be vigilant in preserving skin integrity by, for example, keeping skin well moisturized, avoiding aggressive nail care, and wearing gloves for wet work.

Dr. Martires reported no relevant financial relationships.

[email protected]

On Twitter @karioakes

NEW YORK – Dermatologists have an important role to play in caring for patients with chronic graft versus host disease (GVHD), a condition whose cutaneous manifestations are many, stubborn, and often disabling.

Although a wide range of systemic therapies are available, topical and intralesional treatment with such agents as potent steroids and calcineurin inhibitors can also help with cutaneous manifestations of GVHD in some instances, said Kathryn Martires, MD, at the American Academy of Dermatology summer meeting. However, she noted, “there are no studies or series examining the use of topical steroids alone in these patients, partly speaking to the complexity of these patients and required other care, but partly also due to the lack of dermatologists’ involvement in the care of these patients on a wide scale.”

“The types of GVHD that are particularly amenable to high dose steroids are predominantly the epidermal types,” she said. These include ichthyotic and eczematous as well as lichen planus–like cutaneous GVHD. “We also use topical steroids frequently in the papulosquamous type, though this is a rare variant,” she added.

Topical steroids can be used for dermal skin changes of GVHD as well, including lichen sclerosus–like and focal morphea–like plaques, according to Dr. Martires of the department of dermatology at Stanford (Calif.) University. These lesions are often first seen in the skin folds of the neck.

Even for patients with more diffuse dermal sclerosis, topical steroids have a role in quieting specific areas where active flares are occurring, she noted. These flares can look like erythematous, scaly patches and are “particularly amenable” to spot treatment with topical steroids.

“Just like in vitiligo that’s not associated with GVHD, certainly, topical steroids have their role in treating vitiligo that’s associated with chronic GVHD,” Dr. Martires said. This scenario stands in contrast to the situation where a patient has postinflammatory hyperpigmentation, for example, further along in the course of epidermal GVHD. Steroids should be avoided in situations where there’s hyperpigmentation.

Topical steroids are not usually useful for chronic poikilodermatous GVHD, or, generally, when patients have little epidermal change and the GVHD-associated changes are mostly dermal or subcutaneous, she said.

“Intralesional steroids have their role” in GVHD, although this is another instance where there are no studies to back up their efficacy, and recommendations are based on consensus, Dr. Martires pointed out. Nodular sclerotic GVHD is a rare manifestation, with firm, keloid-like lesions. These can flatten with intralesional injections, said Dr. Martires.

Intralesional injections have also been described in the literature as a treatment for ulcerative oral GVHD, she noted. Other therapy options for oral mucosal GVHD are fluocinonide gel 0.05% or clobetasol gel 0.05%, with spot application to the lesions. When there’s more diffuse lichenoid GVHD of the mouth, dexamethasone or prednisolone oral rinses can also be used, but should be combined with nystatin to prevent thrush, she advised. Triamcinolone 0.1% can be used with topical benzocaine dental paste (Orabase).

Calcineurin inhibitors are another option for oral lesions. Patients generally have a good comfort level with starting topical calcineurin inhibitors, said Dr. Martires, because they’ve likely had exposure to the systemic formulation. Case series have reported improvement “primarily in lichenoid GVHD” with the adjunctive use of topical calcineurin inhibitors, she said. In the mouth, tacrolimus 0.1% can be put in dental paste for focal lesions, and cyclosporine and azathioprine oral solutions can also be used.

Dry mouth is common in GVHD. “Remember, in patients who have other skin symptoms like pruritus, to ask about oral sicca symptoms in order to avoid things that might exacerbate it, like antihistamines and [tricyclic antidepressants],” she added.

Genital mucosal GVHD can respond to topical steroids, with ointment as the preferred vehicle, said Dr. Martires, noting that clobetasol 0.05% ointment and fluocinolone 0.025% ointment are good options, and tacrolimus 0.1% ointment is a logical nonsteroidal topical choice for the genital mucosa.

“Intralesionals are also first-line therapy here,” and “may prevent progression and permanent scarring if initiated early,” she pointed out. However, these injections are quite painful, so “patients have to be quite motivated” to be on board with this line of therapy, she said, adding that numbing prior to injections can help with pain.

Genital discomfort in women may not all be GVHD-related. “Remember, in patients who have undergone several cycles of chemotherapy prior to transplant, that they often have been experiencing menopausal symptoms, sometimes for years, so estrogen cream can sometimes go a long way,” said Dr. Martires, adding, “Certainly, a reminder about lubrication during intercourse is appropriate.”

Also, she said, dermatologists can help patients understand how important it is to be vigilant in preserving skin integrity by, for example, keeping skin well moisturized, avoiding aggressive nail care, and wearing gloves for wet work.

Dr. Martires reported no relevant financial relationships.

[email protected]

On Twitter @karioakes

NEW YORK – Dermatologists have an important role to play in caring for patients with chronic graft versus host disease (GVHD), a condition whose cutaneous manifestations are many, stubborn, and often disabling.

Although a wide range of systemic therapies are available, topical and intralesional treatment with such agents as potent steroids and calcineurin inhibitors can also help with cutaneous manifestations of GVHD in some instances, said Kathryn Martires, MD, at the American Academy of Dermatology summer meeting. However, she noted, “there are no studies or series examining the use of topical steroids alone in these patients, partly speaking to the complexity of these patients and required other care, but partly also due to the lack of dermatologists’ involvement in the care of these patients on a wide scale.”

“The types of GVHD that are particularly amenable to high dose steroids are predominantly the epidermal types,” she said. These include ichthyotic and eczematous as well as lichen planus–like cutaneous GVHD. “We also use topical steroids frequently in the papulosquamous type, though this is a rare variant,” she added.

Topical steroids can be used for dermal skin changes of GVHD as well, including lichen sclerosus–like and focal morphea–like plaques, according to Dr. Martires of the department of dermatology at Stanford (Calif.) University. These lesions are often first seen in the skin folds of the neck.

Even for patients with more diffuse dermal sclerosis, topical steroids have a role in quieting specific areas where active flares are occurring, she noted. These flares can look like erythematous, scaly patches and are “particularly amenable” to spot treatment with topical steroids.

“Just like in vitiligo that’s not associated with GVHD, certainly, topical steroids have their role in treating vitiligo that’s associated with chronic GVHD,” Dr. Martires said. This scenario stands in contrast to the situation where a patient has postinflammatory hyperpigmentation, for example, further along in the course of epidermal GVHD. Steroids should be avoided in situations where there’s hyperpigmentation.

Topical steroids are not usually useful for chronic poikilodermatous GVHD, or, generally, when patients have little epidermal change and the GVHD-associated changes are mostly dermal or subcutaneous, she said.

“Intralesional steroids have their role” in GVHD, although this is another instance where there are no studies to back up their efficacy, and recommendations are based on consensus, Dr. Martires pointed out. Nodular sclerotic GVHD is a rare manifestation, with firm, keloid-like lesions. These can flatten with intralesional injections, said Dr. Martires.

Intralesional injections have also been described in the literature as a treatment for ulcerative oral GVHD, she noted. Other therapy options for oral mucosal GVHD are fluocinonide gel 0.05% or clobetasol gel 0.05%, with spot application to the lesions. When there’s more diffuse lichenoid GVHD of the mouth, dexamethasone or prednisolone oral rinses can also be used, but should be combined with nystatin to prevent thrush, she advised. Triamcinolone 0.1% can be used with topical benzocaine dental paste (Orabase).

Calcineurin inhibitors are another option for oral lesions. Patients generally have a good comfort level with starting topical calcineurin inhibitors, said Dr. Martires, because they’ve likely had exposure to the systemic formulation. Case series have reported improvement “primarily in lichenoid GVHD” with the adjunctive use of topical calcineurin inhibitors, she said. In the mouth, tacrolimus 0.1% can be put in dental paste for focal lesions, and cyclosporine and azathioprine oral solutions can also be used.

Dry mouth is common in GVHD. “Remember, in patients who have other skin symptoms like pruritus, to ask about oral sicca symptoms in order to avoid things that might exacerbate it, like antihistamines and [tricyclic antidepressants],” she added.

Genital mucosal GVHD can respond to topical steroids, with ointment as the preferred vehicle, said Dr. Martires, noting that clobetasol 0.05% ointment and fluocinolone 0.025% ointment are good options, and tacrolimus 0.1% ointment is a logical nonsteroidal topical choice for the genital mucosa.

“Intralesionals are also first-line therapy here,” and “may prevent progression and permanent scarring if initiated early,” she pointed out. However, these injections are quite painful, so “patients have to be quite motivated” to be on board with this line of therapy, she said, adding that numbing prior to injections can help with pain.

Genital discomfort in women may not all be GVHD-related. “Remember, in patients who have undergone several cycles of chemotherapy prior to transplant, that they often have been experiencing menopausal symptoms, sometimes for years, so estrogen cream can sometimes go a long way,” said Dr. Martires, adding, “Certainly, a reminder about lubrication during intercourse is appropriate.”

Also, she said, dermatologists can help patients understand how important it is to be vigilant in preserving skin integrity by, for example, keeping skin well moisturized, avoiding aggressive nail care, and wearing gloves for wet work.

Dr. Martires reported no relevant financial relationships.

[email protected]

On Twitter @karioakes

BOSTON—Noninvasive vagal nerve stimulation (VNS) is well tolerated and effectively aborts episodic cluster headache attacks, according to a pooled analysis described at the 59th Annual Scientific Meeting of the American Headache Society. The treatment does not effectively abort attacks in chronic cluster headache, however.  

A Pooled Analysis of Two Trials

He and his colleagues studied ElectroCore's gammaCore noninvasive VNS device as an acute treatment of cluster headache in the double-blind, randomized, controlled ACT1 and ACT2 trials. Each trial included more than 100 patients with episodic or chronic cluster headache. The two studies took place at 20 centers in the United States and nine centers in the United Kingdom and Europe.  

Treatment was delivered on the patient's right side in ACT1, and on the side ipsilateral to the attack in ACT2. In ACT1, patients were allowed three stimulations, or a total of six minutes of treatment per attack. In ACT2, patients were permitted as many as six stimulations, representing 12 minutes of treatment per attack. In ACT1, the primary end point was response rate (ie, the proportion of patients who achieved pain relief at 15 minutes). The primary end point in ACT2 was pain freedom at 15 minutes, and a secondary end point was the 50% responder rate (ie, mild or no pain) at 15 minutes.  

Each study was underpowered for an analysis of results according to headache frequency, so the investigators performed a pooled analysis of the two studies. This examination included a fixed-effects meta-analysis and a first-order interaction test between the treatment group and the cluster headache subgroup to determine whether the magnitude of treatment effect varied significantly by cluster headache subtype.  

In all, 253 patients were included in the pooled analysis, 131 of whom had episodic cluster headache, and 122 of whom had chronic cluster headache. Patients' mean age was 46.6. Approximately 21% of patients were female, 2.4% were Asian, and 4.7% were black.   

Efficacy in Episodic, But Not Chronic Cluster Headache

Among patients with episodic cluster headache, the rate of pain freedom for all treated attacks at 15 minutes was significantly higher with VNS than with sham (15% vs 6% in ACT1, 35% vs 7% in ACT2, and 24% vs 7% in the pooled analysis). Among patients with chronic cluster headache, the researchers did not find significant differences in this end point between treatment groups (5% vs 14% in ACT1, 7% vs 9% in ACT2, and 7% vs 11% in the pooled analysis).   

For patients with episodic cluster headache, the 50% responder rate was 34% in ACT1, 64% in ACT2, and 42% in the pooled analysis. For patients with chronic cluster headache, the responder rates were 13.6% in ACT1, 29.4% in ACT2, and 23.2% in the pooled analysis. For the proportion of attacks that became pain free, the interaction test was significant for ACT1 and the pooled analysis, but it was not significant for ACT2. For the 50% responder end point, the interaction test was significant for ACT1, ACT2, and the pooled analysis.

In April 2017, the FDA cleared the gammaCore device for the acute treatment of pain associated with episodic cluster headache in adults. The device is now available in the US, said Mr. Liebler. 

“We are going to continue to examine the mechanism of action [of noninvasive VNS] and the reasons for possible [treatment] failure in chronic cluster headache,” said Mr. Liebler. These investigations could provide further clinical insight and clarify the pathogenesis of cluster headache, he added.

—Erik Greb

Suggested Reading

Silberstein SD, Mechtler LL, Kudrow DB, et al. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache. 2016;56(8):1317-1332.

BOSTON—Noninvasive vagal nerve stimulation (VNS) is well tolerated and effectively aborts episodic cluster headache attacks, according to a pooled analysis described at the 59th Annual Scientific Meeting of the American Headache Society. The treatment does not effectively abort attacks in chronic cluster headache, however.  

A Pooled Analysis of Two Trials

He and his colleagues studied ElectroCore's gammaCore noninvasive VNS device as an acute treatment of cluster headache in the double-blind, randomized, controlled ACT1 and ACT2 trials. Each trial included more than 100 patients with episodic or chronic cluster headache. The two studies took place at 20 centers in the United States and nine centers in the United Kingdom and Europe.  

Treatment was delivered on the patient's right side in ACT1, and on the side ipsilateral to the attack in ACT2. In ACT1, patients were allowed three stimulations, or a total of six minutes of treatment per attack. In ACT2, patients were permitted as many as six stimulations, representing 12 minutes of treatment per attack. In ACT1, the primary end point was response rate (ie, the proportion of patients who achieved pain relief at 15 minutes). The primary end point in ACT2 was pain freedom at 15 minutes, and a secondary end point was the 50% responder rate (ie, mild or no pain) at 15 minutes.  

Each study was underpowered for an analysis of results according to headache frequency, so the investigators performed a pooled analysis of the two studies. This examination included a fixed-effects meta-analysis and a first-order interaction test between the treatment group and the cluster headache subgroup to determine whether the magnitude of treatment effect varied significantly by cluster headache subtype.  

In all, 253 patients were included in the pooled analysis, 131 of whom had episodic cluster headache, and 122 of whom had chronic cluster headache. Patients' mean age was 46.6. Approximately 21% of patients were female, 2.4% were Asian, and 4.7% were black.   

Efficacy in Episodic, But Not Chronic Cluster Headache

Among patients with episodic cluster headache, the rate of pain freedom for all treated attacks at 15 minutes was significantly higher with VNS than with sham (15% vs 6% in ACT1, 35% vs 7% in ACT2, and 24% vs 7% in the pooled analysis). Among patients with chronic cluster headache, the researchers did not find significant differences in this end point between treatment groups (5% vs 14% in ACT1, 7% vs 9% in ACT2, and 7% vs 11% in the pooled analysis).   

For patients with episodic cluster headache, the 50% responder rate was 34% in ACT1, 64% in ACT2, and 42% in the pooled analysis. For patients with chronic cluster headache, the responder rates were 13.6% in ACT1, 29.4% in ACT2, and 23.2% in the pooled analysis. For the proportion of attacks that became pain free, the interaction test was significant for ACT1 and the pooled analysis, but it was not significant for ACT2. For the 50% responder end point, the interaction test was significant for ACT1, ACT2, and the pooled analysis.

In April 2017, the FDA cleared the gammaCore device for the acute treatment of pain associated with episodic cluster headache in adults. The device is now available in the US, said Mr. Liebler. 

“We are going to continue to examine the mechanism of action [of noninvasive VNS] and the reasons for possible [treatment] failure in chronic cluster headache,” said Mr. Liebler. These investigations could provide further clinical insight and clarify the pathogenesis of cluster headache, he added.

—Erik Greb

Suggested Reading

Silberstein SD, Mechtler LL, Kudrow DB, et al. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache. 2016;56(8):1317-1332.

BOSTON—Noninvasive vagal nerve stimulation (VNS) is well tolerated and effectively aborts episodic cluster headache attacks, according to a pooled analysis described at the 59th Annual Scientific Meeting of the American Headache Society. The treatment does not effectively abort attacks in chronic cluster headache, however.  

A Pooled Analysis of Two Trials

He and his colleagues studied ElectroCore's gammaCore noninvasive VNS device as an acute treatment of cluster headache in the double-blind, randomized, controlled ACT1 and ACT2 trials. Each trial included more than 100 patients with episodic or chronic cluster headache. The two studies took place at 20 centers in the United States and nine centers in the United Kingdom and Europe.  

Treatment was delivered on the patient's right side in ACT1, and on the side ipsilateral to the attack in ACT2. In ACT1, patients were allowed three stimulations, or a total of six minutes of treatment per attack. In ACT2, patients were permitted as many as six stimulations, representing 12 minutes of treatment per attack. In ACT1, the primary end point was response rate (ie, the proportion of patients who achieved pain relief at 15 minutes). The primary end point in ACT2 was pain freedom at 15 minutes, and a secondary end point was the 50% responder rate (ie, mild or no pain) at 15 minutes.  

Each study was underpowered for an analysis of results according to headache frequency, so the investigators performed a pooled analysis of the two studies. This examination included a fixed-effects meta-analysis and a first-order interaction test between the treatment group and the cluster headache subgroup to determine whether the magnitude of treatment effect varied significantly by cluster headache subtype.  

In all, 253 patients were included in the pooled analysis, 131 of whom had episodic cluster headache, and 122 of whom had chronic cluster headache. Patients' mean age was 46.6. Approximately 21% of patients were female, 2.4% were Asian, and 4.7% were black.   

Efficacy in Episodic, But Not Chronic Cluster Headache

Among patients with episodic cluster headache, the rate of pain freedom for all treated attacks at 15 minutes was significantly higher with VNS than with sham (15% vs 6% in ACT1, 35% vs 7% in ACT2, and 24% vs 7% in the pooled analysis). Among patients with chronic cluster headache, the researchers did not find significant differences in this end point between treatment groups (5% vs 14% in ACT1, 7% vs 9% in ACT2, and 7% vs 11% in the pooled analysis).   

For patients with episodic cluster headache, the 50% responder rate was 34% in ACT1, 64% in ACT2, and 42% in the pooled analysis. For patients with chronic cluster headache, the responder rates were 13.6% in ACT1, 29.4% in ACT2, and 23.2% in the pooled analysis. For the proportion of attacks that became pain free, the interaction test was significant for ACT1 and the pooled analysis, but it was not significant for ACT2. For the 50% responder end point, the interaction test was significant for ACT1, ACT2, and the pooled analysis.

In April 2017, the FDA cleared the gammaCore device for the acute treatment of pain associated with episodic cluster headache in adults. The device is now available in the US, said Mr. Liebler. 

“We are going to continue to examine the mechanism of action [of noninvasive VNS] and the reasons for possible [treatment] failure in chronic cluster headache,” said Mr. Liebler. These investigations could provide further clinical insight and clarify the pathogenesis of cluster headache, he added.

—Erik Greb

Suggested Reading

Silberstein SD, Mechtler LL, Kudrow DB, et al. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache. 2016;56(8):1317-1332.

The quality of studies and data relied upon to support Food and Drug Administration–accelerated drug approvals and high-risk device modifications is often lacking, two studies showed.

Between 2009 and 2013, the FDA granted accelerated approval for 22 drugs with 24 indications, which were supported by 30 preapproval studies with a median of 132 subjects. Only 12 of those studies (40%) were randomized, and only 6 (20%) were double blind. Eight (27%) included fewer than 100 subjects, and 20 (67%) included fewer than 200, reported Huseyin Naci, PhD, of the London School of Economics and Political Science, and his colleagues.

Further, at a minimum of 3 years after the approval, only half of the 38 confirmatory studies required by the FDA were completed, and, ultimately, only 25 of the 48 (66%) examined clinical efficacy, only 7 (18%) evaluated longer follow-up, and only 6 (16%) focused on safety, the investigators reported (JAMA. 2017 Aug 15;318[7]:626-36).

The proportion of studies that were randomized was slightly, but not significantly greater in the postapproval vs. preapproval period (56% vs. 40%), and only one was double blind. For 10 of 24 indications (42%), postapproval study requirements were completed and demonstrated efficacy based on surrogate measures, the investigators said.

Of the 14 remaining indications (58%) for which FDA study requirements had not yet been met, 2 (8%) had at least one confirmatory study that failed to demonstrate clinical benefit (without apparent action on the part of the FDA to rescind approval or impose additional requirements), 2 (8%) had a least one confirmatory study that was terminated, and 3 (13%) had at least one confirmatory study that was delayed by more than a year. The required studies for the remaining indications were progressing as planned, but for eight indications, clinical benefit had not yet been confirmed at 5 or more years after approval.

Similar concerns were seen in a review of clinical studies used to support high-risk medical device modification approvals. Such devices often undergo numerous modifications that receive FDA approval through one of six premarket approval (PMA) supplement pathways, and a total of 83 studies that supported 78 panel-track supplements (one of the 6 pathways and the only one that always required clinical data) approved between April 19, 2006, and Oct. 9, 2015, were identified. Nearly all (98%) of those 78 modifications were supported by just one study; only 45% of those studies were randomized clinical trials, and only 30% were blinded, reported Sarah Y. Zheng, MD, of the University of California, San Francisco, and her colleagues (JAMA. 2017 Aug 15;318[7]:619-25).

The median number of patients in the studies was 185, and the median follow-up was 180 days. Further, of 150 primary endpoints in the studies, 121 (81%) were surrogate endpoints, 57 (38%) were compared with controls, and 6 (11%) of those involved retrospective rather than active controls.

Age and sex were not reported for all enrolled patients in 40% and 30% of the studies, respectively, and in the case of one device modification study, 91% of enrolled patients were not included in the primary analysis.

“Given the extensive modification of many PMA supplement devices and the median preapproval follow-up of 6 months, obtaining additional data via [postapproval studies] is critical. However, the FDA required [postapproval studies] for the minority (37%) of the panel-track supplements,” the investigators noted, adding that only 13% of initiated postapproval studies were completed between 3 and 5 years after FDA approval, and that no warning letters, penalties, or fines were administered for noncompliance.

“These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved,” they concluded.

Dr. Zheng and her colleagues reported having no conflicts of interest. Dr. Naci reported having no conflicts of interest. One coauthor, Aaron S. Kesselheim, MD, reported receiving unrelated grants from the FDA Office of Generic Drugs and Division of Health Communication.

[email protected]

The quality of studies and data relied upon to support Food and Drug Administration–accelerated drug approvals and high-risk device modifications is often lacking, two studies showed.

Between 2009 and 2013, the FDA granted accelerated approval for 22 drugs with 24 indications, which were supported by 30 preapproval studies with a median of 132 subjects. Only 12 of those studies (40%) were randomized, and only 6 (20%) were double blind. Eight (27%) included fewer than 100 subjects, and 20 (67%) included fewer than 200, reported Huseyin Naci, PhD, of the London School of Economics and Political Science, and his colleagues.

Further, at a minimum of 3 years after the approval, only half of the 38 confirmatory studies required by the FDA were completed, and, ultimately, only 25 of the 48 (66%) examined clinical efficacy, only 7 (18%) evaluated longer follow-up, and only 6 (16%) focused on safety, the investigators reported (JAMA. 2017 Aug 15;318[7]:626-36).

The proportion of studies that were randomized was slightly, but not significantly greater in the postapproval vs. preapproval period (56% vs. 40%), and only one was double blind. For 10 of 24 indications (42%), postapproval study requirements were completed and demonstrated efficacy based on surrogate measures, the investigators said.

Of the 14 remaining indications (58%) for which FDA study requirements had not yet been met, 2 (8%) had at least one confirmatory study that failed to demonstrate clinical benefit (without apparent action on the part of the FDA to rescind approval or impose additional requirements), 2 (8%) had a least one confirmatory study that was terminated, and 3 (13%) had at least one confirmatory study that was delayed by more than a year. The required studies for the remaining indications were progressing as planned, but for eight indications, clinical benefit had not yet been confirmed at 5 or more years after approval.

Similar concerns were seen in a review of clinical studies used to support high-risk medical device modification approvals. Such devices often undergo numerous modifications that receive FDA approval through one of six premarket approval (PMA) supplement pathways, and a total of 83 studies that supported 78 panel-track supplements (one of the 6 pathways and the only one that always required clinical data) approved between April 19, 2006, and Oct. 9, 2015, were identified. Nearly all (98%) of those 78 modifications were supported by just one study; only 45% of those studies were randomized clinical trials, and only 30% were blinded, reported Sarah Y. Zheng, MD, of the University of California, San Francisco, and her colleagues (JAMA. 2017 Aug 15;318[7]:619-25).

The median number of patients in the studies was 185, and the median follow-up was 180 days. Further, of 150 primary endpoints in the studies, 121 (81%) were surrogate endpoints, 57 (38%) were compared with controls, and 6 (11%) of those involved retrospective rather than active controls.

Age and sex were not reported for all enrolled patients in 40% and 30% of the studies, respectively, and in the case of one device modification study, 91% of enrolled patients were not included in the primary analysis.

“Given the extensive modification of many PMA supplement devices and the median preapproval follow-up of 6 months, obtaining additional data via [postapproval studies] is critical. However, the FDA required [postapproval studies] for the minority (37%) of the panel-track supplements,” the investigators noted, adding that only 13% of initiated postapproval studies were completed between 3 and 5 years after FDA approval, and that no warning letters, penalties, or fines were administered for noncompliance.

“These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved,” they concluded.

Dr. Zheng and her colleagues reported having no conflicts of interest. Dr. Naci reported having no conflicts of interest. One coauthor, Aaron S. Kesselheim, MD, reported receiving unrelated grants from the FDA Office of Generic Drugs and Division of Health Communication.

[email protected]

The quality of studies and data relied upon to support Food and Drug Administration–accelerated drug approvals and high-risk device modifications is often lacking, two studies showed.

Between 2009 and 2013, the FDA granted accelerated approval for 22 drugs with 24 indications, which were supported by 30 preapproval studies with a median of 132 subjects. Only 12 of those studies (40%) were randomized, and only 6 (20%) were double blind. Eight (27%) included fewer than 100 subjects, and 20 (67%) included fewer than 200, reported Huseyin Naci, PhD, of the London School of Economics and Political Science, and his colleagues.

Further, at a minimum of 3 years after the approval, only half of the 38 confirmatory studies required by the FDA were completed, and, ultimately, only 25 of the 48 (66%) examined clinical efficacy, only 7 (18%) evaluated longer follow-up, and only 6 (16%) focused on safety, the investigators reported (JAMA. 2017 Aug 15;318[7]:626-36).

The proportion of studies that were randomized was slightly, but not significantly greater in the postapproval vs. preapproval period (56% vs. 40%), and only one was double blind. For 10 of 24 indications (42%), postapproval study requirements were completed and demonstrated efficacy based on surrogate measures, the investigators said.

Of the 14 remaining indications (58%) for which FDA study requirements had not yet been met, 2 (8%) had at least one confirmatory study that failed to demonstrate clinical benefit (without apparent action on the part of the FDA to rescind approval or impose additional requirements), 2 (8%) had a least one confirmatory study that was terminated, and 3 (13%) had at least one confirmatory study that was delayed by more than a year. The required studies for the remaining indications were progressing as planned, but for eight indications, clinical benefit had not yet been confirmed at 5 or more years after approval.

Similar concerns were seen in a review of clinical studies used to support high-risk medical device modification approvals. Such devices often undergo numerous modifications that receive FDA approval through one of six premarket approval (PMA) supplement pathways, and a total of 83 studies that supported 78 panel-track supplements (one of the 6 pathways and the only one that always required clinical data) approved between April 19, 2006, and Oct. 9, 2015, were identified. Nearly all (98%) of those 78 modifications were supported by just one study; only 45% of those studies were randomized clinical trials, and only 30% were blinded, reported Sarah Y. Zheng, MD, of the University of California, San Francisco, and her colleagues (JAMA. 2017 Aug 15;318[7]:619-25).

The median number of patients in the studies was 185, and the median follow-up was 180 days. Further, of 150 primary endpoints in the studies, 121 (81%) were surrogate endpoints, 57 (38%) were compared with controls, and 6 (11%) of those involved retrospective rather than active controls.

Age and sex were not reported for all enrolled patients in 40% and 30% of the studies, respectively, and in the case of one device modification study, 91% of enrolled patients were not included in the primary analysis.

“Given the extensive modification of many PMA supplement devices and the median preapproval follow-up of 6 months, obtaining additional data via [postapproval studies] is critical. However, the FDA required [postapproval studies] for the minority (37%) of the panel-track supplements,” the investigators noted, adding that only 13% of initiated postapproval studies were completed between 3 and 5 years after FDA approval, and that no warning letters, penalties, or fines were administered for noncompliance.

“These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved,” they concluded.

Dr. Zheng and her colleagues reported having no conflicts of interest. Dr. Naci reported having no conflicts of interest. One coauthor, Aaron S. Kesselheim, MD, reported receiving unrelated grants from the FDA Office of Generic Drugs and Division of Health Communication.

[email protected]

The pharmaceutical formulation of cannabidiol (CBD) is associated with significant changes in serum levels of clobazam, rufinamide, topiramate, zonisamide, and eslicarbazepine, according to research published online ahead of print August 6 in Epilepsia. Furthermore, patients taking CBD and valproate may have abnormal liver function test results.

“A perception exists that since CBD is plant-based, it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs [AEDs], has interactions with other seizure drugs that patients and providers need to be aware of,” said Tyler Gaston, MD, Assistant Professor of Neurology at the University of Alabama at Birmingham.

Patients in a Compassionate-Use Study

Few data about CBD’s interactions with AEDs are available. To gain more information, Dr. Gaston and colleagues examined 42 children and 39 adults in the University of Alabama’s open-label compassionate-use study of CBD as an add-on therapy for treatment-resistant epilepsy. At baseline, the investigators obtained participants’ serum AED levels. Participants initiated treatment with 5 mg/kg/day of CBD along with their other AEDs. Every two weeks, participants underwent a physical examination and laboratory testing. The investigators obtained serum AED levels and increased the dose of CBD by 5 mg/kg/day to a maximum of 50 mg/kg/day. AED doses were adjusted if a clinical symptom or laboratory result was related to a potential interaction.

Dr. Gaston and colleagues used a mixed linear model to determine whether the plasma levels of each AED changed significantly with increasing CBD dose.

Many Serum Levels Remained in Therapeutic Range

The mean age of pediatric participants was 10, and 20 of the children were female. The mean age of adults was 29, and 20 of the adult participants were female. The mean number of concomitant AEDs at enrollment for all participants was three.

The investigators noted increases in serum levels of topiramate, rufinamide, and N-desmethylclobazam (ie, the active metabolite of clobazam) and a decrease in serum levels of clobazam with increasing CBD dose. They also observed increases in serum levels of zonisamide and eslicarbazepine with increasing CBD dose in adults. All mean level changes were within the accepted therapeutic range, except for those in clobazam and N-desmethylclobazam. Sedation was more frequent with higher N-desmethylclobazam levels in adults. Levels of aspartate aminotransferase and alanine aminotransferase were significantly higher in participants taking concomitant valproate.

One of the study’s limitations was that the sample sizes of patients taking each AED were small, which may have masked potential interactions with CBD, according to the researchers. In addition, the naturalistic study design resulted in significant noise in the data for which the researchers could not completely account in their analyses. Nevertheless, “this study emphasizes the importance of monitoring serum AED levels and liver function tests during treatment with CBD,” said Dr. Gaston.

—Erik Greb

Suggested Reading

Gaston TE, Bebin EM, Cutter GR, et al. Interactions between cannabidiol and commonly used antiepileptic drugs. Epilepsia. 2017 Aug 6 [Epub ahead of print].

The pharmaceutical formulation of cannabidiol (CBD) is associated with significant changes in serum levels of clobazam, rufinamide, topiramate, zonisamide, and eslicarbazepine, according to research published online ahead of print August 6 in Epilepsia. Furthermore, patients taking CBD and valproate may have abnormal liver function test results.

“A perception exists that since CBD is plant-based, it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs [AEDs], has interactions with other seizure drugs that patients and providers need to be aware of,” said Tyler Gaston, MD, Assistant Professor of Neurology at the University of Alabama at Birmingham.

Patients in a Compassionate-Use Study

Few data about CBD’s interactions with AEDs are available. To gain more information, Dr. Gaston and colleagues examined 42 children and 39 adults in the University of Alabama’s open-label compassionate-use study of CBD as an add-on therapy for treatment-resistant epilepsy. At baseline, the investigators obtained participants’ serum AED levels. Participants initiated treatment with 5 mg/kg/day of CBD along with their other AEDs. Every two weeks, participants underwent a physical examination and laboratory testing. The investigators obtained serum AED levels and increased the dose of CBD by 5 mg/kg/day to a maximum of 50 mg/kg/day. AED doses were adjusted if a clinical symptom or laboratory result was related to a potential interaction.

Dr. Gaston and colleagues used a mixed linear model to determine whether the plasma levels of each AED changed significantly with increasing CBD dose.

Many Serum Levels Remained in Therapeutic Range

The mean age of pediatric participants was 10, and 20 of the children were female. The mean age of adults was 29, and 20 of the adult participants were female. The mean number of concomitant AEDs at enrollment for all participants was three.

The investigators noted increases in serum levels of topiramate, rufinamide, and N-desmethylclobazam (ie, the active metabolite of clobazam) and a decrease in serum levels of clobazam with increasing CBD dose. They also observed increases in serum levels of zonisamide and eslicarbazepine with increasing CBD dose in adults. All mean level changes were within the accepted therapeutic range, except for those in clobazam and N-desmethylclobazam. Sedation was more frequent with higher N-desmethylclobazam levels in adults. Levels of aspartate aminotransferase and alanine aminotransferase were significantly higher in participants taking concomitant valproate.

One of the study’s limitations was that the sample sizes of patients taking each AED were small, which may have masked potential interactions with CBD, according to the researchers. In addition, the naturalistic study design resulted in significant noise in the data for which the researchers could not completely account in their analyses. Nevertheless, “this study emphasizes the importance of monitoring serum AED levels and liver function tests during treatment with CBD,” said Dr. Gaston.

—Erik Greb

Suggested Reading

Gaston TE, Bebin EM, Cutter GR, et al. Interactions between cannabidiol and commonly used antiepileptic drugs. Epilepsia. 2017 Aug 6 [Epub ahead of print].

The pharmaceutical formulation of cannabidiol (CBD) is associated with significant changes in serum levels of clobazam, rufinamide, topiramate, zonisamide, and eslicarbazepine, according to research published online ahead of print August 6 in Epilepsia. Furthermore, patients taking CBD and valproate may have abnormal liver function test results.

“A perception exists that since CBD is plant-based, it is natural and safe; and while this may be mostly true, our study shows that CBD, just like other antiepileptic drugs [AEDs], has interactions with other seizure drugs that patients and providers need to be aware of,” said Tyler Gaston, MD, Assistant Professor of Neurology at the University of Alabama at Birmingham.

Patients in a Compassionate-Use Study

Few data about CBD’s interactions with AEDs are available. To gain more information, Dr. Gaston and colleagues examined 42 children and 39 adults in the University of Alabama’s open-label compassionate-use study of CBD as an add-on therapy for treatment-resistant epilepsy. At baseline, the investigators obtained participants’ serum AED levels. Participants initiated treatment with 5 mg/kg/day of CBD along with their other AEDs. Every two weeks, participants underwent a physical examination and laboratory testing. The investigators obtained serum AED levels and increased the dose of CBD by 5 mg/kg/day to a maximum of 50 mg/kg/day. AED doses were adjusted if a clinical symptom or laboratory result was related to a potential interaction.

Dr. Gaston and colleagues used a mixed linear model to determine whether the plasma levels of each AED changed significantly with increasing CBD dose.

Many Serum Levels Remained in Therapeutic Range

The mean age of pediatric participants was 10, and 20 of the children were female. The mean age of adults was 29, and 20 of the adult participants were female. The mean number of concomitant AEDs at enrollment for all participants was three.

The investigators noted increases in serum levels of topiramate, rufinamide, and N-desmethylclobazam (ie, the active metabolite of clobazam) and a decrease in serum levels of clobazam with increasing CBD dose. They also observed increases in serum levels of zonisamide and eslicarbazepine with increasing CBD dose in adults. All mean level changes were within the accepted therapeutic range, except for those in clobazam and N-desmethylclobazam. Sedation was more frequent with higher N-desmethylclobazam levels in adults. Levels of aspartate aminotransferase and alanine aminotransferase were significantly higher in participants taking concomitant valproate.

One of the study’s limitations was that the sample sizes of patients taking each AED were small, which may have masked potential interactions with CBD, according to the researchers. In addition, the naturalistic study design resulted in significant noise in the data for which the researchers could not completely account in their analyses. Nevertheless, “this study emphasizes the importance of monitoring serum AED levels and liver function tests during treatment with CBD,” said Dr. Gaston.

—Erik Greb

Suggested Reading

Gaston TE, Bebin EM, Cutter GR, et al. Interactions between cannabidiol and commonly used antiepileptic drugs. Epilepsia. 2017 Aug 6 [Epub ahead of print].

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

BOSTON—Over five years after traumatic brain injury (TBI), a relatively large (24% to 30%) group of individuals experience chronic headache pain and a significant functional impact of headache, according to a pattern analysis of headache pain and impact following moderate to severe TBI. These results were presented at the 59th Annual Scientific Meeting of the American Headache Society. “Identification of members within these groups may be important to assist with an appropriate intensity of treatment to improve satisfaction with life and employment opportunity after TBI,” said Sylvia Lucas, MD, PhD, Clinical Professor of Neurology and Neurological Surgery at the University of Washington in Seattle. “The identification of trajectory membership may also be useful in evaluation of appropriate subjects for inclusion in studies of headache treatment after TBI.”

Headache is the most common symptom following TBI of any severity. Dr. Lucas and her research colleagues have previously reported high rates of headache in a prospective cohort of patients who experienced moderate to severe TBI. These patients have been followed for five years. New or worse headache occurred at a rate of 37% at three months, 33% at six months, 34% at 12 months, and 35% at 60 months post injury. The present study examined whether certain patterns or trajectories of headache occur over five years after TBI and whether demographic or injury characteristics are related to these trajectories. Trajectory type was also examined in relation to satisfaction with life and employment status five years after injury.

Data on 316 individuals were evaluated at five years. These patients were initially enrolled during inpatient rehabilitation after moderate to severe TBI. Enrollment was performed in person in the hospital. Structured telephone interviews were conducted at three, six, 12, and 60 months after TBI. At each time point, individuals who reported headache in the previous three months were asked to rate their headache pain on a 0 to 10 scale (0 = no pain, 10 = worst pain) and to complete the Headache Impact Test (HIT-6). Discrete mixture modeling was used to estimate trajectory groups based on pain rating and on headache impact scores.

Four trajectories were found for headache pain over five years: minimal pain over time (25% of individuals), worsening pain over time (37%), improving pain over time (7%), and chronic pain over time (30%). A chronic pain trajectory was more common in females, those incurring TBI by violence, those who were unemployed prior to injury, those with a headache history prior to injury, and those with mental health problems. Those with a chronic pain trajectory had significantly lower satisfaction with life five years after injury, compared with other trajectory groups.  

A chronic impact trajectory was more common in females and in those who incurred TBI by violence, had a prior history of headache, or were unemployed prior to injury. At five years post TBI, the chronic impact group was significantly more likely to be unemployed and less satisfied with life, compared with individuals in the minimal or worsening impact trajectory groups. Those employed prior to injury were more frequently in the worsening group for pain and impact, compared with those not employed prior to injury. No relationship was found for other demographic and injury data, including age, posttraumatic amnesia, or substance abuse prior to injury.

An evidence-based model allows neurologists to predict individual patient outcomes following the withdrawal of antiepileptic drugs (AEDs), according to research published in the July issue of Epilepsia. The model indicates a patient’s risk of relapse and chance of long-term seizure freedom. The model therefore might help physicians and patients make individualized choices about treatment, said the authors.

Patients with epilepsy who have achieved seizure freedom may want to discontinue their AEDs to avoid their associated side effects. Discontinuation raises the risk of seizure recurrence, however. Previous prognostic meta-analyses have been unable to calculate individual outcome predictors’ effect sizes because of the heterogeneous methods and reporting in the literature.

Analyzing Individual Participant Data

To overcome this limitation, Herm J. Lamberink, MD, a doctoral student at University Medical Center Utrecht in the Netherlands, and colleagues conducted a meta-analysis using individual participant data from previous studies. They reviewed PubMed and Embase for articles that reported on patients with epilepsy who were seizure-free and had started withdrawal of AEDs. Eligible articles contained information regarding seizure recurrences during and after withdrawal. The investigators selected 25 candidate predictors based on a systematic review of the predictors of seizure recurrence after AED withdrawal.

Dr. Lamberink and colleagues identified 45 studies that included 7,082 patients in all. The meta-analysis included 10 studies with 1,769 patients. The populations included selected and nonselected children and adults. Median follow-up time was 5.3 years. In all, 812 patients (46%) had seizure relapse, which was a higher rate than the average reported in the literature. Approximately 9% of participants for whom data were available had seizures in their last year of follow-up, which suggests that they had not regained lasting seizure control.

Model Had Stable Performance

Epilepsy duration before remission, seizure-free interval before AED withdrawal, age at onset of epilepsy, history of febrile seizures, number of seizures before remission, absence of a self-limiting epilepsy syndrome, developmental delay, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizure recurrence. Epilepsy duration before remission, seizure-free interval before AED withdrawal, number of AEDs before withdrawal, female sex, family history of epilepsy, number of seizures before remission, focal seizures, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizures in the last year of follow-up.

The adjusted concordance statistics for the model were 0.65 for predicting seizure recurrence and 0.71 for predicting long-term seizure freedom. Internal–external cross validation indicated that the model had good and stable performance in all cohorts.

One limitation of the study is that the population included only participants who attempted to withdraw AEDs. In addition, too few cases of epileptic encephalopathy and juvenile myoclonic epilepsy were included in the population to determine whether these disorders predict outcomes after AED withdrawal.

—Erik Greb

Suggested Reading

Lamberink HJ, Otte WM, Geerts AT, et al. Individualised prediction model of seizure recurrence and long-term outcomes after withdrawal of antiepileptic drugs in seizure-free patients: a systematic review and individual participant data meta-analysis. Lancet Neurol. 2017;16(7):523-531.

An evidence-based model allows neurologists to predict individual patient outcomes following the withdrawal of antiepileptic drugs (AEDs), according to research published in the July issue of Epilepsia. The model indicates a patient’s risk of relapse and chance of long-term seizure freedom. The model therefore might help physicians and patients make individualized choices about treatment, said the authors.

Patients with epilepsy who have achieved seizure freedom may want to discontinue their AEDs to avoid their associated side effects. Discontinuation raises the risk of seizure recurrence, however. Previous prognostic meta-analyses have been unable to calculate individual outcome predictors’ effect sizes because of the heterogeneous methods and reporting in the literature.

Analyzing Individual Participant Data

To overcome this limitation, Herm J. Lamberink, MD, a doctoral student at University Medical Center Utrecht in the Netherlands, and colleagues conducted a meta-analysis using individual participant data from previous studies. They reviewed PubMed and Embase for articles that reported on patients with epilepsy who were seizure-free and had started withdrawal of AEDs. Eligible articles contained information regarding seizure recurrences during and after withdrawal. The investigators selected 25 candidate predictors based on a systematic review of the predictors of seizure recurrence after AED withdrawal.

Dr. Lamberink and colleagues identified 45 studies that included 7,082 patients in all. The meta-analysis included 10 studies with 1,769 patients. The populations included selected and nonselected children and adults. Median follow-up time was 5.3 years. In all, 812 patients (46%) had seizure relapse, which was a higher rate than the average reported in the literature. Approximately 9% of participants for whom data were available had seizures in their last year of follow-up, which suggests that they had not regained lasting seizure control.

Model Had Stable Performance

Epilepsy duration before remission, seizure-free interval before AED withdrawal, age at onset of epilepsy, history of febrile seizures, number of seizures before remission, absence of a self-limiting epilepsy syndrome, developmental delay, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizure recurrence. Epilepsy duration before remission, seizure-free interval before AED withdrawal, number of AEDs before withdrawal, female sex, family history of epilepsy, number of seizures before remission, focal seizures, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizures in the last year of follow-up.

The adjusted concordance statistics for the model were 0.65 for predicting seizure recurrence and 0.71 for predicting long-term seizure freedom. Internal–external cross validation indicated that the model had good and stable performance in all cohorts.

One limitation of the study is that the population included only participants who attempted to withdraw AEDs. In addition, too few cases of epileptic encephalopathy and juvenile myoclonic epilepsy were included in the population to determine whether these disorders predict outcomes after AED withdrawal.

—Erik Greb

Suggested Reading

Lamberink HJ, Otte WM, Geerts AT, et al. Individualised prediction model of seizure recurrence and long-term outcomes after withdrawal of antiepileptic drugs in seizure-free patients: a systematic review and individual participant data meta-analysis. Lancet Neurol. 2017;16(7):523-531.

An evidence-based model allows neurologists to predict individual patient outcomes following the withdrawal of antiepileptic drugs (AEDs), according to research published in the July issue of Epilepsia. The model indicates a patient’s risk of relapse and chance of long-term seizure freedom. The model therefore might help physicians and patients make individualized choices about treatment, said the authors.

Patients with epilepsy who have achieved seizure freedom may want to discontinue their AEDs to avoid their associated side effects. Discontinuation raises the risk of seizure recurrence, however. Previous prognostic meta-analyses have been unable to calculate individual outcome predictors’ effect sizes because of the heterogeneous methods and reporting in the literature.

Analyzing Individual Participant Data

To overcome this limitation, Herm J. Lamberink, MD, a doctoral student at University Medical Center Utrecht in the Netherlands, and colleagues conducted a meta-analysis using individual participant data from previous studies. They reviewed PubMed and Embase for articles that reported on patients with epilepsy who were seizure-free and had started withdrawal of AEDs. Eligible articles contained information regarding seizure recurrences during and after withdrawal. The investigators selected 25 candidate predictors based on a systematic review of the predictors of seizure recurrence after AED withdrawal.

Dr. Lamberink and colleagues identified 45 studies that included 7,082 patients in all. The meta-analysis included 10 studies with 1,769 patients. The populations included selected and nonselected children and adults. Median follow-up time was 5.3 years. In all, 812 patients (46%) had seizure relapse, which was a higher rate than the average reported in the literature. Approximately 9% of participants for whom data were available had seizures in their last year of follow-up, which suggests that they had not regained lasting seizure control.

Model Had Stable Performance

Epilepsy duration before remission, seizure-free interval before AED withdrawal, age at onset of epilepsy, history of febrile seizures, number of seizures before remission, absence of a self-limiting epilepsy syndrome, developmental delay, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizure recurrence. Epilepsy duration before remission, seizure-free interval before AED withdrawal, number of AEDs before withdrawal, female sex, family history of epilepsy, number of seizures before remission, focal seizures, and epileptiform abnormality on EEG before withdrawal were independent predictors of seizures in the last year of follow-up.

The adjusted concordance statistics for the model were 0.65 for predicting seizure recurrence and 0.71 for predicting long-term seizure freedom. Internal–external cross validation indicated that the model had good and stable performance in all cohorts.

One limitation of the study is that the population included only participants who attempted to withdraw AEDs. In addition, too few cases of epileptic encephalopathy and juvenile myoclonic epilepsy were included in the population to determine whether these disorders predict outcomes after AED withdrawal.

—Erik Greb

Suggested Reading

Lamberink HJ, Otte WM, Geerts AT, et al. Individualised prediction model of seizure recurrence and long-term outcomes after withdrawal of antiepileptic drugs in seizure-free patients: a systematic review and individual participant data meta-analysis. Lancet Neurol. 2017;16(7):523-531.

A 56-year-old woman has several lesions she is worried might be cancerous. Added to that, there have been changes to her facial skin over the past several years that are increasingly obvious to her friends and family and therefore concerning to the patient.

She has an extensive history of nonmelanoma skin cancers, including basal cell carcinomas and squamous cell carcinomas, which were removed from her trunk in the distant past. She has lived in the southwestern United States all her life and has been smoking cigarettes since age 14.

EXAMINATION
The patient’s skin is quite fair, with abundant evidence of sun damage. She looks considerably older than her stated age.

Fortunately, no skin cancers are found on examination, but many closed and open comedones can be seen on both of her cheeks, stippled on rough, weathered skin. Solar elastosis manifests in this area as diffuse white thickening—what some might call “chicken skin.”

What is the diagnosis?

Chronic overexposure to UV light is known to result in dermatologic changes such as solar elastosis and the aforementioned whitish plaques—which, on microscopic exam, are simply basophilic degeneration of the dermis. This degeneration can be seen all over the face, but it is particularly evident on the forehead and cheeks; the concentration of comedones on the cheeks is unique to FRS.

Treatment options include lasers and peels, which involve considerable expenditure of time and money. While the comedones can be extracted, they are likely to recur unless more invasive methods are used.

TAKE-HOME LEARNING POINTS

• Favre-Racouchot syndrome (FRS) is seen primarily in men with chronic overexposure to sunlight—particularly those who smoke.
• FRS is characterized by localized collections of open and closed comedones superimposed on thickened, white “chicken skin” (solar elastosis).
• These changes typically occur on the bilateral cheeks of patients in the later decades of life, though they have been seen on patients in their 20s.
• Treatment is possible by means of laser resurfacing and/or chemical peels.

A 56-year-old woman has several lesions she is worried might be cancerous. Added to that, there have been changes to her facial skin over the past several years that are increasingly obvious to her friends and family and therefore concerning to the patient.

She has an extensive history of nonmelanoma skin cancers, including basal cell carcinomas and squamous cell carcinomas, which were removed from her trunk in the distant past. She has lived in the southwestern United States all her life and has been smoking cigarettes since age 14.

EXAMINATION
The patient’s skin is quite fair, with abundant evidence of sun damage. She looks considerably older than her stated age.

Fortunately, no skin cancers are found on examination, but many closed and open comedones can be seen on both of her cheeks, stippled on rough, weathered skin. Solar elastosis manifests in this area as diffuse white thickening—what some might call “chicken skin.”

What is the diagnosis?

Chronic overexposure to UV light is known to result in dermatologic changes such as solar elastosis and the aforementioned whitish plaques—which, on microscopic exam, are simply basophilic degeneration of the dermis. This degeneration can be seen all over the face, but it is particularly evident on the forehead and cheeks; the concentration of comedones on the cheeks is unique to FRS.

Treatment options include lasers and peels, which involve considerable expenditure of time and money. While the comedones can be extracted, they are likely to recur unless more invasive methods are used.

TAKE-HOME LEARNING POINTS

• Favre-Racouchot syndrome (FRS) is seen primarily in men with chronic overexposure to sunlight—particularly those who smoke.
• FRS is characterized by localized collections of open and closed comedones superimposed on thickened, white “chicken skin” (solar elastosis).
• These changes typically occur on the bilateral cheeks of patients in the later decades of life, though they have been seen on patients in their 20s.
• Treatment is possible by means of laser resurfacing and/or chemical peels.

A 56-year-old woman has several lesions she is worried might be cancerous. Added to that, there have been changes to her facial skin over the past several years that are increasingly obvious to her friends and family and therefore concerning to the patient.

She has an extensive history of nonmelanoma skin cancers, including basal cell carcinomas and squamous cell carcinomas, which were removed from her trunk in the distant past. She has lived in the southwestern United States all her life and has been smoking cigarettes since age 14.

EXAMINATION
The patient’s skin is quite fair, with abundant evidence of sun damage. She looks considerably older than her stated age.

Fortunately, no skin cancers are found on examination, but many closed and open comedones can be seen on both of her cheeks, stippled on rough, weathered skin. Solar elastosis manifests in this area as diffuse white thickening—what some might call “chicken skin.”

What is the diagnosis?

Chronic overexposure to UV light is known to result in dermatologic changes such as solar elastosis and the aforementioned whitish plaques—which, on microscopic exam, are simply basophilic degeneration of the dermis. This degeneration can be seen all over the face, but it is particularly evident on the forehead and cheeks; the concentration of comedones on the cheeks is unique to FRS.

Treatment options include lasers and peels, which involve considerable expenditure of time and money. While the comedones can be extracted, they are likely to recur unless more invasive methods are used.

TAKE-HOME LEARNING POINTS

• Favre-Racouchot syndrome (FRS) is seen primarily in men with chronic overexposure to sunlight—particularly those who smoke.
• FRS is characterized by localized collections of open and closed comedones superimposed on thickened, white “chicken skin” (solar elastosis).
• These changes typically occur on the bilateral cheeks of patients in the later decades of life, though they have been seen on patients in their 20s.
• Treatment is possible by means of laser resurfacing and/or chemical peels.