Recent wars have led to innovations in military trauma care that can be applied to civilians, say the authors of a JAMA Viewpoint published in June.¹

During the Afghanistan and Iraq wars, the percentage of wounded soldiers who died as a result of their injuries reached its lowest point in recorded history, writes lead author Donald M. Berwick, MD, MPP, of the Institute for Healthcare Improvement in Cambridge, Mass., along with colleagues from the National Academies of Sciences, Engineering, and Medicine in Washington, D.C.

“Effective bleeding-control measures, improved resuscitation techniques, and aggressive neurocritical care interventions are among many advances that saved lives on the battlefield that otherwise would have been lost,” they write.

The reduction in injury-related deaths is in part due to the Military Health System and its Joint Trauma System embracing a culture of continuous performance improvement and an agile approach, a model called “focused empiricism,” the authors say. A new report from the National Academies of Sciences, Engineering, and Medicine clarifies the components of such a learning health system, which can also be applied to civilian care:

• Leadership and a culture of learning: “A learning health system must be stewarded by leadership committed to nurturing a culture of continuous learning and improvement. ... Such a system should unite military and civilian trauma care leaders around a common, core aim established at the highest level in the nation; namely, to achieve zero preventable deaths after injury and minimize trauma-related disability.”
• Transparency and incentives for quality trauma care: “Trauma care practitioners at all levels, including trauma surgeons and other physicians, nurses, technicians, and prehospital care personnel, should have access to data on their performance relative to that of their peers.”
• Systems for ensuring an expert trauma care workforce: “A joint, integrated network of military and civilian trauma centers should be created as a training platform to prepare and sustain an expert workforce and to promote the translation of best practices between sectors.”

The progress made by the military’s trauma system could be lost, the writers conclude, without concerted efforts to disseminate and maintain the advances. The authors note that in the United States, there are nearly 150,000 deaths from trauma each year, and injury is the third-leading cause of death.

The “hundreds of thousands of civilians who have sustained trauma deserve the benefits of care improvements achieved in military medicine,” they conclude.

Reference

1. Berwick DM, Downey AS, Cornett EA. A national trauma care system to achieve zero preventable deaths after injury: recommendations from a National Academies of Sciences, Engineering, and Medicine report [published online ahead of print June 17, 2006]. JAMA. doi:10.1001/jama.2016.8524.

Quick Byte

Rating RTLS Options

The healthcare industry typically uses real-time location systems (RTLS) to help improve care quality, workflow efficiency, and bottom lines, according to a recent article in HealthcareITNews. The research firm KLAS rated 11 RTLS vendors and gave Centrak the highest overall performance score, beating competitors including AwarePoint, Cerner, GE Healthcare, and Intelligent Insights.

Reference

1. Siwicki B. KLAS ranks real-time location systems from AwarePoint, Cerner, CenTrak, Versus and others. HealthcareITNews website. Accessed July 13, 2016.

Recent wars have led to innovations in military trauma care that can be applied to civilians, say the authors of a JAMA Viewpoint published in June.¹

During the Afghanistan and Iraq wars, the percentage of wounded soldiers who died as a result of their injuries reached its lowest point in recorded history, writes lead author Donald M. Berwick, MD, MPP, of the Institute for Healthcare Improvement in Cambridge, Mass., along with colleagues from the National Academies of Sciences, Engineering, and Medicine in Washington, D.C.

“Effective bleeding-control measures, improved resuscitation techniques, and aggressive neurocritical care interventions are among many advances that saved lives on the battlefield that otherwise would have been lost,” they write.

The reduction in injury-related deaths is in part due to the Military Health System and its Joint Trauma System embracing a culture of continuous performance improvement and an agile approach, a model called “focused empiricism,” the authors say. A new report from the National Academies of Sciences, Engineering, and Medicine clarifies the components of such a learning health system, which can also be applied to civilian care:

• Leadership and a culture of learning: “A learning health system must be stewarded by leadership committed to nurturing a culture of continuous learning and improvement. ... Such a system should unite military and civilian trauma care leaders around a common, core aim established at the highest level in the nation; namely, to achieve zero preventable deaths after injury and minimize trauma-related disability.”
• Transparency and incentives for quality trauma care: “Trauma care practitioners at all levels, including trauma surgeons and other physicians, nurses, technicians, and prehospital care personnel, should have access to data on their performance relative to that of their peers.”
• Systems for ensuring an expert trauma care workforce: “A joint, integrated network of military and civilian trauma centers should be created as a training platform to prepare and sustain an expert workforce and to promote the translation of best practices between sectors.”

The progress made by the military’s trauma system could be lost, the writers conclude, without concerted efforts to disseminate and maintain the advances. The authors note that in the United States, there are nearly 150,000 deaths from trauma each year, and injury is the third-leading cause of death.

The “hundreds of thousands of civilians who have sustained trauma deserve the benefits of care improvements achieved in military medicine,” they conclude.

Reference

1. Berwick DM, Downey AS, Cornett EA. A national trauma care system to achieve zero preventable deaths after injury: recommendations from a National Academies of Sciences, Engineering, and Medicine report [published online ahead of print June 17, 2006]. JAMA. doi:10.1001/jama.2016.8524.

Quick Byte

Rating RTLS Options

The healthcare industry typically uses real-time location systems (RTLS) to help improve care quality, workflow efficiency, and bottom lines, according to a recent article in HealthcareITNews. The research firm KLAS rated 11 RTLS vendors and gave Centrak the highest overall performance score, beating competitors including AwarePoint, Cerner, GE Healthcare, and Intelligent Insights.

Reference

1. Siwicki B. KLAS ranks real-time location systems from AwarePoint, Cerner, CenTrak, Versus and others. HealthcareITNews website. Accessed July 13, 2016.

Recent wars have led to innovations in military trauma care that can be applied to civilians, say the authors of a JAMA Viewpoint published in June.¹

During the Afghanistan and Iraq wars, the percentage of wounded soldiers who died as a result of their injuries reached its lowest point in recorded history, writes lead author Donald M. Berwick, MD, MPP, of the Institute for Healthcare Improvement in Cambridge, Mass., along with colleagues from the National Academies of Sciences, Engineering, and Medicine in Washington, D.C.

“Effective bleeding-control measures, improved resuscitation techniques, and aggressive neurocritical care interventions are among many advances that saved lives on the battlefield that otherwise would have been lost,” they write.

The reduction in injury-related deaths is in part due to the Military Health System and its Joint Trauma System embracing a culture of continuous performance improvement and an agile approach, a model called “focused empiricism,” the authors say. A new report from the National Academies of Sciences, Engineering, and Medicine clarifies the components of such a learning health system, which can also be applied to civilian care:

• Leadership and a culture of learning: “A learning health system must be stewarded by leadership committed to nurturing a culture of continuous learning and improvement. ... Such a system should unite military and civilian trauma care leaders around a common, core aim established at the highest level in the nation; namely, to achieve zero preventable deaths after injury and minimize trauma-related disability.”
• Transparency and incentives for quality trauma care: “Trauma care practitioners at all levels, including trauma surgeons and other physicians, nurses, technicians, and prehospital care personnel, should have access to data on their performance relative to that of their peers.”
• Systems for ensuring an expert trauma care workforce: “A joint, integrated network of military and civilian trauma centers should be created as a training platform to prepare and sustain an expert workforce and to promote the translation of best practices between sectors.”

The progress made by the military’s trauma system could be lost, the writers conclude, without concerted efforts to disseminate and maintain the advances. The authors note that in the United States, there are nearly 150,000 deaths from trauma each year, and injury is the third-leading cause of death.

The “hundreds of thousands of civilians who have sustained trauma deserve the benefits of care improvements achieved in military medicine,” they conclude.

Reference

1. Berwick DM, Downey AS, Cornett EA. A national trauma care system to achieve zero preventable deaths after injury: recommendations from a National Academies of Sciences, Engineering, and Medicine report [published online ahead of print June 17, 2006]. JAMA. doi:10.1001/jama.2016.8524.

Quick Byte

Rating RTLS Options

The healthcare industry typically uses real-time location systems (RTLS) to help improve care quality, workflow efficiency, and bottom lines, according to a recent article in HealthcareITNews. The research firm KLAS rated 11 RTLS vendors and gave Centrak the highest overall performance score, beating competitors including AwarePoint, Cerner, GE Healthcare, and Intelligent Insights.

Reference

1. Siwicki B. KLAS ranks real-time location systems from AwarePoint, Cerner, CenTrak, Versus and others. HealthcareITNews website. Accessed July 13, 2016.

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Opioid-related lawsuits against physicians are on the rise. Common allegations include unnecessary prescribing, failing to heed contraindications, and missing warning signs of a likely overdose, said Ericka L. Adler, a Chicago-based health law attorney. To mitigate your risk of getting sued, legal and clinical experts offer the following advice.

1. Identify at-risk patients

Consider the full range of patient risk factors before prescribing or continuing opioids, said Ilene R. Robeck, MD, director of virtual pain education at Richmond VA Medical Center in St. Petersburg, Fla., and cochair of the National VA PACT Pain Champions Initiative.

“When we look at the overdose data, there used to be a perception that people who overdosed were not taking their medication as prescribed, and that’s not true all the time,” she said. “In fact, in some [studies], half the people who overdose take their medication exactly as prescribed. The problems are related to dose, mixing the opioids with other medications, [patient] age, and underlying medical problems.”

Ensure that therapy considerations related to opioids address the full patient picture, Dr. Robeck advised. For example, patients with liver disease, sleep apnea, chronic obstructive pulmonary disease (COPD), asthma, and kidney disease are more prone to overdose. In addition, while nonmedical use of prescription drugs is highest in patients aged 18-25 years, opioid overdose rates are highest among patients aged 25-54 years, according to the Centers for Disease Control and Prevention.

2. Monitor midlevel providers

Closely monitor and limit opioid prescribing by the midlevel providers you supervise, said pharmacologist and consultant James T. O’Donnell, PharmD. A fair share of medical malpractice lawsuits result from failing to supervise a physician assistant (PA) or nurse practitioner (NP) prescribing or treating pain patients.

“Excessive or inappropriate opiate prescribing will result in legal actions against the supervising physician,” Dr. O’Donnell said. “Close monitoring of midlevel providers requires establishing guidelines for opiate prescribing.”

Develop practice protocols that track and regulate midlevel prescribing and regularly discuss prescribing dangers with staff. Know your state law; the extent to which an NP or PA can prescribe varies widely.

3. Document

Keep detailed records of patient encounters that include specifics of what the patient tells you, said Ms. Adler.

Clear documentation about prior conditions, interactions with other health care providers, and past and current treatments help protect the doctor should liability later arise. In the case of a dishonest patient, clear record keeping could help show that a patient lied or omitted facts if the notes later become evidence in a lawsuit, she said.

“I also think [doctors] should document their policies, so there is clarity and understanding in the relationship,” Ms. Adler said. “Showing a policy where national standards/recommendations are followed will help protect the practice.”

4. Restrict refills

Require prescriber review before patients can obtain refills or new prescriptions for patients who run out of medicine before their next appointment, Dr. O’Donnell said.

“Excessive or early refills for opiate prescriptions are signs of abuse,” he said. “This creates risk to the patient and malpractice risk to the physician.”

It’s also helpful to limit the number of pharmacies used for opioid prescriptions, Ms. Adler said. This makes it easier track medications and narrows the pathway between prescription and drug obtainment.

5. Partner with pharmacists

Work closely with other health providers, such as psychiatrists, therapists, and pharmacists to ensure safe prescribing decisions. Pharmacists have a corresponding responsibility in dispensing opiates, Dr. O’Donnell said.

“Take the pharmacists’ calls regarding your opiates prescriptions,” he advised. “The pharmacist will know what other medicines the patient is taking and may advise of dangerous dosage or interactions.”

6. Require patient agreements

Opioid treatment agreements aid in patient accountability and promote education of drug risks, Dr. Robeck noted. In such contracts, patients agree to fully comply with all aspects of the treatment program and acknowledge that they will not use medication with harmful substances. Other terms can include that patients:

• Only obtain opioid prescriptions from one provider.

• Agree to keep all scheduled medical appointments.

• Promise to undergo urine drug screens as indicated.

• Agree not to share or sell medication.

• Agree not to drive or operate heavy machinery until medication-related drowsiness clears.

Contracts can help patients remain informed about the dangers and benefits of medications, while protecting the physician’s right to terminate treatment if the patient violates the agreement, Ms. Adler said. One sample agreement can be found here.

7. Involve family members

Family members and caregivers are critical to a patient’s opioid therapy plan, Dr. Robeck said. Discuss with patients ahead of time the potential for family member involvement. Family or the patient’s support system should be educated about the patient’s medications, the risks, and how to respond in an emergency.

“It may be life saving,” Dr. Robeck said. “It’s very important for the physician to communicate with the family. There may be times you want the family to come [to appointments].”

Such communication can ensure that family members’ concerns about a patient are conveyed to physicians. Family and caregivers can also have a role in improving home conditions to assist with pain management for the patient, she said. Family education in using a naloxone rescue kit in the event of a possible overdose is essential.

“Giving the patient naloxone to prevent an overdose is more than just handing them the nasal spray or the self-injector, it’s also about educating them and the family about the true risks of these medications,” Dr. Robeck said.

8. Watch for red flags

Be cognizant of warning signs that patients may be addicted, Ms. Adler advised. Patients who demand medications, act impatiently about waiting for refills, or refuse to answer questions about their history should raise alarm bells, she said. Patients who travel long distances for pain medication also should raise question marks, Dr. O’Donnell adds.

“If the patient is in too much of a hurry to wait for records or to get a urine test, that’s a red flag,” Ms. Adler said. “When doctors are not sure, the safest bet is to refer to a pain specialist.”

Consider the criteria for opioid use disorder, Dr. Robeck noted. The condition is defined as a problematic pattern of opioid use leading to clinically significant impairment or distress. Signs of opioid use disorder include recurrent use by patients resulting in a failure to fulfill major role obligations at work or home, continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by opioids, and spending a great deal of time in activities necessary to obtain the opioid, use the opioid, or recover from use, according to the American Psychiatric Association.

9. Develop an exit plan

Before starting a patient on opioid therapy, have a plan in place in case something goes awry, Dr. Robeck said. Create an exit strategy that includes both pharmacological and nonpharmacological resources from which to draw from should problems arise. Make sure you have a plan for tapering patients off opioids when necessary. This may include getting help from other clinicians in the community, she said.

“Those patients need very careful follow-up,” Dr. Robeck. “The rate of the taper needs to occur based on level of risk. Whenever possible, we try to taper patients slowly.”

10. Do your research

Always check your state’s prescription drug–monitoring program (PDMP) when prescribing an opiate to a new patient, Mr. O’Donnell advised.

Currently, 49 states and Guam have operational PDMP databases. The PDMP Training and Technical Assistance Center offers information about each PDMP, state pharmacy and practitioner data, drug schedules monitored, patient information data, and legislation dates and citations.

Perhaps most importantly, know best prescribing practices, Dr. Robeck said. Earlier this year, the CDC released guidelines for prescribing opioids for chronic pain.

“Thoroughly understand the CDC guidelines,” she said. “These are the keys to understanding where opioids fit into your plan of medications and nonpharmacological therapies for pain.”

[email protected]

On Twitter @legal_med

Opioid-related lawsuits against physicians are on the rise. Common allegations include unnecessary prescribing, failing to heed contraindications, and missing warning signs of a likely overdose, said Ericka L. Adler, a Chicago-based health law attorney. To mitigate your risk of getting sued, legal and clinical experts offer the following advice.

1. Identify at-risk patients

Consider the full range of patient risk factors before prescribing or continuing opioids, said Ilene R. Robeck, MD, director of virtual pain education at Richmond VA Medical Center in St. Petersburg, Fla., and cochair of the National VA PACT Pain Champions Initiative.

“When we look at the overdose data, there used to be a perception that people who overdosed were not taking their medication as prescribed, and that’s not true all the time,” she said. “In fact, in some [studies], half the people who overdose take their medication exactly as prescribed. The problems are related to dose, mixing the opioids with other medications, [patient] age, and underlying medical problems.”

Ensure that therapy considerations related to opioids address the full patient picture, Dr. Robeck advised. For example, patients with liver disease, sleep apnea, chronic obstructive pulmonary disease (COPD), asthma, and kidney disease are more prone to overdose. In addition, while nonmedical use of prescription drugs is highest in patients aged 18-25 years, opioid overdose rates are highest among patients aged 25-54 years, according to the Centers for Disease Control and Prevention.

2. Monitor midlevel providers

Closely monitor and limit opioid prescribing by the midlevel providers you supervise, said pharmacologist and consultant James T. O’Donnell, PharmD. A fair share of medical malpractice lawsuits result from failing to supervise a physician assistant (PA) or nurse practitioner (NP) prescribing or treating pain patients.

“Excessive or inappropriate opiate prescribing will result in legal actions against the supervising physician,” Dr. O’Donnell said. “Close monitoring of midlevel providers requires establishing guidelines for opiate prescribing.”

Develop practice protocols that track and regulate midlevel prescribing and regularly discuss prescribing dangers with staff. Know your state law; the extent to which an NP or PA can prescribe varies widely.

3. Document

Keep detailed records of patient encounters that include specifics of what the patient tells you, said Ms. Adler.

Clear documentation about prior conditions, interactions with other health care providers, and past and current treatments help protect the doctor should liability later arise. In the case of a dishonest patient, clear record keeping could help show that a patient lied or omitted facts if the notes later become evidence in a lawsuit, she said.

“I also think [doctors] should document their policies, so there is clarity and understanding in the relationship,” Ms. Adler said. “Showing a policy where national standards/recommendations are followed will help protect the practice.”

4. Restrict refills

Require prescriber review before patients can obtain refills or new prescriptions for patients who run out of medicine before their next appointment, Dr. O’Donnell said.

“Excessive or early refills for opiate prescriptions are signs of abuse,” he said. “This creates risk to the patient and malpractice risk to the physician.”

It’s also helpful to limit the number of pharmacies used for opioid prescriptions, Ms. Adler said. This makes it easier track medications and narrows the pathway between prescription and drug obtainment.

5. Partner with pharmacists

Work closely with other health providers, such as psychiatrists, therapists, and pharmacists to ensure safe prescribing decisions. Pharmacists have a corresponding responsibility in dispensing opiates, Dr. O’Donnell said.

“Take the pharmacists’ calls regarding your opiates prescriptions,” he advised. “The pharmacist will know what other medicines the patient is taking and may advise of dangerous dosage or interactions.”

6. Require patient agreements

Opioid treatment agreements aid in patient accountability and promote education of drug risks, Dr. Robeck noted. In such contracts, patients agree to fully comply with all aspects of the treatment program and acknowledge that they will not use medication with harmful substances. Other terms can include that patients:

• Only obtain opioid prescriptions from one provider.

• Agree to keep all scheduled medical appointments.

• Promise to undergo urine drug screens as indicated.

• Agree not to share or sell medication.

• Agree not to drive or operate heavy machinery until medication-related drowsiness clears.

Contracts can help patients remain informed about the dangers and benefits of medications, while protecting the physician’s right to terminate treatment if the patient violates the agreement, Ms. Adler said. One sample agreement can be found here.

7. Involve family members

Family members and caregivers are critical to a patient’s opioid therapy plan, Dr. Robeck said. Discuss with patients ahead of time the potential for family member involvement. Family or the patient’s support system should be educated about the patient’s medications, the risks, and how to respond in an emergency.

“It may be life saving,” Dr. Robeck said. “It’s very important for the physician to communicate with the family. There may be times you want the family to come [to appointments].”

Such communication can ensure that family members’ concerns about a patient are conveyed to physicians. Family and caregivers can also have a role in improving home conditions to assist with pain management for the patient, she said. Family education in using a naloxone rescue kit in the event of a possible overdose is essential.

“Giving the patient naloxone to prevent an overdose is more than just handing them the nasal spray or the self-injector, it’s also about educating them and the family about the true risks of these medications,” Dr. Robeck said.

8. Watch for red flags

Be cognizant of warning signs that patients may be addicted, Ms. Adler advised. Patients who demand medications, act impatiently about waiting for refills, or refuse to answer questions about their history should raise alarm bells, she said. Patients who travel long distances for pain medication also should raise question marks, Dr. O’Donnell adds.

“If the patient is in too much of a hurry to wait for records or to get a urine test, that’s a red flag,” Ms. Adler said. “When doctors are not sure, the safest bet is to refer to a pain specialist.”

Consider the criteria for opioid use disorder, Dr. Robeck noted. The condition is defined as a problematic pattern of opioid use leading to clinically significant impairment or distress. Signs of opioid use disorder include recurrent use by patients resulting in a failure to fulfill major role obligations at work or home, continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by opioids, and spending a great deal of time in activities necessary to obtain the opioid, use the opioid, or recover from use, according to the American Psychiatric Association.

9. Develop an exit plan

Before starting a patient on opioid therapy, have a plan in place in case something goes awry, Dr. Robeck said. Create an exit strategy that includes both pharmacological and nonpharmacological resources from which to draw from should problems arise. Make sure you have a plan for tapering patients off opioids when necessary. This may include getting help from other clinicians in the community, she said.

“Those patients need very careful follow-up,” Dr. Robeck. “The rate of the taper needs to occur based on level of risk. Whenever possible, we try to taper patients slowly.”

10. Do your research

Always check your state’s prescription drug–monitoring program (PDMP) when prescribing an opiate to a new patient, Mr. O’Donnell advised.

Currently, 49 states and Guam have operational PDMP databases. The PDMP Training and Technical Assistance Center offers information about each PDMP, state pharmacy and practitioner data, drug schedules monitored, patient information data, and legislation dates and citations.

Perhaps most importantly, know best prescribing practices, Dr. Robeck said. Earlier this year, the CDC released guidelines for prescribing opioids for chronic pain.

“Thoroughly understand the CDC guidelines,” she said. “These are the keys to understanding where opioids fit into your plan of medications and nonpharmacological therapies for pain.”

[email protected]

On Twitter @legal_med

Opioid-related lawsuits against physicians are on the rise. Common allegations include unnecessary prescribing, failing to heed contraindications, and missing warning signs of a likely overdose, said Ericka L. Adler, a Chicago-based health law attorney. To mitigate your risk of getting sued, legal and clinical experts offer the following advice.

1. Identify at-risk patients

Consider the full range of patient risk factors before prescribing or continuing opioids, said Ilene R. Robeck, MD, director of virtual pain education at Richmond VA Medical Center in St. Petersburg, Fla., and cochair of the National VA PACT Pain Champions Initiative.

“When we look at the overdose data, there used to be a perception that people who overdosed were not taking their medication as prescribed, and that’s not true all the time,” she said. “In fact, in some [studies], half the people who overdose take their medication exactly as prescribed. The problems are related to dose, mixing the opioids with other medications, [patient] age, and underlying medical problems.”

Ensure that therapy considerations related to opioids address the full patient picture, Dr. Robeck advised. For example, patients with liver disease, sleep apnea, chronic obstructive pulmonary disease (COPD), asthma, and kidney disease are more prone to overdose. In addition, while nonmedical use of prescription drugs is highest in patients aged 18-25 years, opioid overdose rates are highest among patients aged 25-54 years, according to the Centers for Disease Control and Prevention.

2. Monitor midlevel providers

Closely monitor and limit opioid prescribing by the midlevel providers you supervise, said pharmacologist and consultant James T. O’Donnell, PharmD. A fair share of medical malpractice lawsuits result from failing to supervise a physician assistant (PA) or nurse practitioner (NP) prescribing or treating pain patients.

“Excessive or inappropriate opiate prescribing will result in legal actions against the supervising physician,” Dr. O’Donnell said. “Close monitoring of midlevel providers requires establishing guidelines for opiate prescribing.”

Develop practice protocols that track and regulate midlevel prescribing and regularly discuss prescribing dangers with staff. Know your state law; the extent to which an NP or PA can prescribe varies widely.

3. Document

Keep detailed records of patient encounters that include specifics of what the patient tells you, said Ms. Adler.

Clear documentation about prior conditions, interactions with other health care providers, and past and current treatments help protect the doctor should liability later arise. In the case of a dishonest patient, clear record keeping could help show that a patient lied or omitted facts if the notes later become evidence in a lawsuit, she said.

“I also think [doctors] should document their policies, so there is clarity and understanding in the relationship,” Ms. Adler said. “Showing a policy where national standards/recommendations are followed will help protect the practice.”

4. Restrict refills

Require prescriber review before patients can obtain refills or new prescriptions for patients who run out of medicine before their next appointment, Dr. O’Donnell said.

“Excessive or early refills for opiate prescriptions are signs of abuse,” he said. “This creates risk to the patient and malpractice risk to the physician.”

It’s also helpful to limit the number of pharmacies used for opioid prescriptions, Ms. Adler said. This makes it easier track medications and narrows the pathway between prescription and drug obtainment.

5. Partner with pharmacists

Work closely with other health providers, such as psychiatrists, therapists, and pharmacists to ensure safe prescribing decisions. Pharmacists have a corresponding responsibility in dispensing opiates, Dr. O’Donnell said.

“Take the pharmacists’ calls regarding your opiates prescriptions,” he advised. “The pharmacist will know what other medicines the patient is taking and may advise of dangerous dosage or interactions.”

6. Require patient agreements

Opioid treatment agreements aid in patient accountability and promote education of drug risks, Dr. Robeck noted. In such contracts, patients agree to fully comply with all aspects of the treatment program and acknowledge that they will not use medication with harmful substances. Other terms can include that patients:

• Only obtain opioid prescriptions from one provider.

• Agree to keep all scheduled medical appointments.

• Promise to undergo urine drug screens as indicated.

• Agree not to share or sell medication.

• Agree not to drive or operate heavy machinery until medication-related drowsiness clears.

Contracts can help patients remain informed about the dangers and benefits of medications, while protecting the physician’s right to terminate treatment if the patient violates the agreement, Ms. Adler said. One sample agreement can be found here.

7. Involve family members

Family members and caregivers are critical to a patient’s opioid therapy plan, Dr. Robeck said. Discuss with patients ahead of time the potential for family member involvement. Family or the patient’s support system should be educated about the patient’s medications, the risks, and how to respond in an emergency.

“It may be life saving,” Dr. Robeck said. “It’s very important for the physician to communicate with the family. There may be times you want the family to come [to appointments].”

Such communication can ensure that family members’ concerns about a patient are conveyed to physicians. Family and caregivers can also have a role in improving home conditions to assist with pain management for the patient, she said. Family education in using a naloxone rescue kit in the event of a possible overdose is essential.

“Giving the patient naloxone to prevent an overdose is more than just handing them the nasal spray or the self-injector, it’s also about educating them and the family about the true risks of these medications,” Dr. Robeck said.

8. Watch for red flags

Be cognizant of warning signs that patients may be addicted, Ms. Adler advised. Patients who demand medications, act impatiently about waiting for refills, or refuse to answer questions about their history should raise alarm bells, she said. Patients who travel long distances for pain medication also should raise question marks, Dr. O’Donnell adds.

“If the patient is in too much of a hurry to wait for records or to get a urine test, that’s a red flag,” Ms. Adler said. “When doctors are not sure, the safest bet is to refer to a pain specialist.”

Consider the criteria for opioid use disorder, Dr. Robeck noted. The condition is defined as a problematic pattern of opioid use leading to clinically significant impairment or distress. Signs of opioid use disorder include recurrent use by patients resulting in a failure to fulfill major role obligations at work or home, continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by opioids, and spending a great deal of time in activities necessary to obtain the opioid, use the opioid, or recover from use, according to the American Psychiatric Association.

9. Develop an exit plan

Before starting a patient on opioid therapy, have a plan in place in case something goes awry, Dr. Robeck said. Create an exit strategy that includes both pharmacological and nonpharmacological resources from which to draw from should problems arise. Make sure you have a plan for tapering patients off opioids when necessary. This may include getting help from other clinicians in the community, she said.

“Those patients need very careful follow-up,” Dr. Robeck. “The rate of the taper needs to occur based on level of risk. Whenever possible, we try to taper patients slowly.”

10. Do your research

Always check your state’s prescription drug–monitoring program (PDMP) when prescribing an opiate to a new patient, Mr. O’Donnell advised.

Currently, 49 states and Guam have operational PDMP databases. The PDMP Training and Technical Assistance Center offers information about each PDMP, state pharmacy and practitioner data, drug schedules monitored, patient information data, and legislation dates and citations.

Perhaps most importantly, know best prescribing practices, Dr. Robeck said. Earlier this year, the CDC released guidelines for prescribing opioids for chronic pain.

“Thoroughly understand the CDC guidelines,” she said. “These are the keys to understanding where opioids fit into your plan of medications and nonpharmacological therapies for pain.”

[email protected]

On Twitter @legal_med

LONDON – Real-life experience shows that stopping treatment with a long-acting beta-agonist (LABA) does not worsen asthma control, nor does it lead to any immediate decline in lung function.

Spirometric parameters were similar before and 3 weeks after stopping LABA therapy in an observational study of 58 patients who had stable asthma and were being treated with an inhaled corticosteroid (ICS) and a LABA.

©tupungato/Thinkstock.com

The forced expiratory volume in 1 second (FEV₁) was 88.8% at baseline and 89.5% at the 3-week visit after stepping down their LABA therapy (P = .55). Patients’ average peak expiratory flow rate was 462 L/min both before and after LABA withdrawal.

In addition, no changes were seen in lung function based on impulse oscillometry, a noninvasive method for measuring airway resistance and reactance (Chest. 2014;146[3]:841-7). Similar levels of fractional exhaled nitric oxide (FeNO, 38 and 36 ppb) were recorded.

The findings were presented at the annual congress of the European Respiratory Society (ERS) and have been published in an early online edition of the Annals of Allergy, Asthma & Immunology (doi: 10.1016/j.anai.2016.07.022).

“About 45% of the UK adult asthma population are taking step 3 GINA [Global Initiative for Asthma] therapy, which is ICS/LABA,” explained Sunny Jabbal, MD, of the Scottish Centre for Respiratory Research at Ninewells Hospital in Dundee, Scotland, where the study was conducted. Patients should be on the lowest of the five steps in the 2016 GINA guidelines that achieve asthma control and should be regularly reviewed.

To test whether the LABA could be safely withdrawn, that is stepped down to ICS only [GINA step 2], Dr. Jabbal and colleagues studied 58 patients with a mean age of 39 years. All had well-controlled asthma, and had been receiving ICS/LABA for at least 3 months with no asthma exacerbations requiring treatment. None of the patients were current smokers.

At study entry, patients underwent spirometry, impulse oscillometry, and had FeNO measured. Their LABA was then stopped, and patients were reassessed 3 weeks later. “In accordance with GINA, their ICS dose was also reduced by approximately 25%,” Dr. Jabbal said.

Patients recorded their symptoms and short-term reliever (albuterol) use on simple diary cards. They were also given a 24-hour emergency mobile number, but no calls were received and no adverse events reported. The mean daily symptom score recorded during the step down process was 0.4 (out of a possible score of 3), and the mean albuterol usage was one puff per day.

One of the chairs of the session, Omar Usmani, MD, of Imperial College London noted that some clinicians are “very apprehensive” about stopping LABA and stepping down ICS therapy in their patients.

This was a short-term study, Dr. Jabbal acknowledged. Although a follow-up of 3 weeks may be enough to determine the effects of stopping a LABA, that time may not be sufficient to assess the effects of stepping down the ICS. Further real-life studies are needed to evaluate outcomes such as exacerbations and overall quality of life.

Improved adherence with ICS therapy after LABA withdrawal might explain the lack of deleterious effects, or perhaps some patients may not have initially needed an ICS/LABA combination, he speculated. Maybe even the steroid dose could be reduced further in this particular patient population.

The study received no commercial funding. Dr. Jabbal had no conflicts of interest related to his presentation.

LONDON – Real-life experience shows that stopping treatment with a long-acting beta-agonist (LABA) does not worsen asthma control, nor does it lead to any immediate decline in lung function.

Spirometric parameters were similar before and 3 weeks after stopping LABA therapy in an observational study of 58 patients who had stable asthma and were being treated with an inhaled corticosteroid (ICS) and a LABA.

©tupungato/Thinkstock.com

The forced expiratory volume in 1 second (FEV₁) was 88.8% at baseline and 89.5% at the 3-week visit after stepping down their LABA therapy (P = .55). Patients’ average peak expiratory flow rate was 462 L/min both before and after LABA withdrawal.

In addition, no changes were seen in lung function based on impulse oscillometry, a noninvasive method for measuring airway resistance and reactance (Chest. 2014;146[3]:841-7). Similar levels of fractional exhaled nitric oxide (FeNO, 38 and 36 ppb) were recorded.

The findings were presented at the annual congress of the European Respiratory Society (ERS) and have been published in an early online edition of the Annals of Allergy, Asthma & Immunology (doi: 10.1016/j.anai.2016.07.022).

“About 45% of the UK adult asthma population are taking step 3 GINA [Global Initiative for Asthma] therapy, which is ICS/LABA,” explained Sunny Jabbal, MD, of the Scottish Centre for Respiratory Research at Ninewells Hospital in Dundee, Scotland, where the study was conducted. Patients should be on the lowest of the five steps in the 2016 GINA guidelines that achieve asthma control and should be regularly reviewed.

To test whether the LABA could be safely withdrawn, that is stepped down to ICS only [GINA step 2], Dr. Jabbal and colleagues studied 58 patients with a mean age of 39 years. All had well-controlled asthma, and had been receiving ICS/LABA for at least 3 months with no asthma exacerbations requiring treatment. None of the patients were current smokers.

At study entry, patients underwent spirometry, impulse oscillometry, and had FeNO measured. Their LABA was then stopped, and patients were reassessed 3 weeks later. “In accordance with GINA, their ICS dose was also reduced by approximately 25%,” Dr. Jabbal said.

Patients recorded their symptoms and short-term reliever (albuterol) use on simple diary cards. They were also given a 24-hour emergency mobile number, but no calls were received and no adverse events reported. The mean daily symptom score recorded during the step down process was 0.4 (out of a possible score of 3), and the mean albuterol usage was one puff per day.

One of the chairs of the session, Omar Usmani, MD, of Imperial College London noted that some clinicians are “very apprehensive” about stopping LABA and stepping down ICS therapy in their patients.

This was a short-term study, Dr. Jabbal acknowledged. Although a follow-up of 3 weeks may be enough to determine the effects of stopping a LABA, that time may not be sufficient to assess the effects of stepping down the ICS. Further real-life studies are needed to evaluate outcomes such as exacerbations and overall quality of life.

Improved adherence with ICS therapy after LABA withdrawal might explain the lack of deleterious effects, or perhaps some patients may not have initially needed an ICS/LABA combination, he speculated. Maybe even the steroid dose could be reduced further in this particular patient population.

The study received no commercial funding. Dr. Jabbal had no conflicts of interest related to his presentation.

LONDON – Real-life experience shows that stopping treatment with a long-acting beta-agonist (LABA) does not worsen asthma control, nor does it lead to any immediate decline in lung function.

Spirometric parameters were similar before and 3 weeks after stopping LABA therapy in an observational study of 58 patients who had stable asthma and were being treated with an inhaled corticosteroid (ICS) and a LABA.

©tupungato/Thinkstock.com

The forced expiratory volume in 1 second (FEV₁) was 88.8% at baseline and 89.5% at the 3-week visit after stepping down their LABA therapy (P = .55). Patients’ average peak expiratory flow rate was 462 L/min both before and after LABA withdrawal.

In addition, no changes were seen in lung function based on impulse oscillometry, a noninvasive method for measuring airway resistance and reactance (Chest. 2014;146[3]:841-7). Similar levels of fractional exhaled nitric oxide (FeNO, 38 and 36 ppb) were recorded.

The findings were presented at the annual congress of the European Respiratory Society (ERS) and have been published in an early online edition of the Annals of Allergy, Asthma & Immunology (doi: 10.1016/j.anai.2016.07.022).

“About 45% of the UK adult asthma population are taking step 3 GINA [Global Initiative for Asthma] therapy, which is ICS/LABA,” explained Sunny Jabbal, MD, of the Scottish Centre for Respiratory Research at Ninewells Hospital in Dundee, Scotland, where the study was conducted. Patients should be on the lowest of the five steps in the 2016 GINA guidelines that achieve asthma control and should be regularly reviewed.

To test whether the LABA could be safely withdrawn, that is stepped down to ICS only [GINA step 2], Dr. Jabbal and colleagues studied 58 patients with a mean age of 39 years. All had well-controlled asthma, and had been receiving ICS/LABA for at least 3 months with no asthma exacerbations requiring treatment. None of the patients were current smokers.

At study entry, patients underwent spirometry, impulse oscillometry, and had FeNO measured. Their LABA was then stopped, and patients were reassessed 3 weeks later. “In accordance with GINA, their ICS dose was also reduced by approximately 25%,” Dr. Jabbal said.

Patients recorded their symptoms and short-term reliever (albuterol) use on simple diary cards. They were also given a 24-hour emergency mobile number, but no calls were received and no adverse events reported. The mean daily symptom score recorded during the step down process was 0.4 (out of a possible score of 3), and the mean albuterol usage was one puff per day.

One of the chairs of the session, Omar Usmani, MD, of Imperial College London noted that some clinicians are “very apprehensive” about stopping LABA and stepping down ICS therapy in their patients.

This was a short-term study, Dr. Jabbal acknowledged. Although a follow-up of 3 weeks may be enough to determine the effects of stopping a LABA, that time may not be sufficient to assess the effects of stepping down the ICS. Further real-life studies are needed to evaluate outcomes such as exacerbations and overall quality of life.

Improved adherence with ICS therapy after LABA withdrawal might explain the lack of deleterious effects, or perhaps some patients may not have initially needed an ICS/LABA combination, he speculated. Maybe even the steroid dose could be reduced further in this particular patient population.

The study received no commercial funding. Dr. Jabbal had no conflicts of interest related to his presentation.

NEWPORT BEACH, CALIF. – Over the past 20 years, the number of medical malpractice claims against dermatologists has remained steady, in the ballpark of 86-123 per year, according to Abel Torres, MD, JD.

In fact, a study that used claims data from the Physician Insurers Association of America between 1985 and 2008 revealed that dermatology ranked 19th among 28 medical specialties evaluated. “The bad news is we’re not ranked 28th, so we’re still getting sued,” said Dr. Torres, professor and chairman of dermatology at Loma Linda (Calif.) University and professor of dermatology at Case Western Reserve University, Cleveland. In the study, 2,704 of 239,756 (1.1%) closed claims in this time period involved dermatologists; only 29% of the claims that involved dermatologists resulted in a payment for the plaintiff, with a median and average indemnity of $35,000 and $137,538, respectively (J Am Acad Dermatol. 2012 Jan;66[1]:78-85).

Speaking at the annual meeting of the Pacific Dermatologic Association, Dr. Torres, who is also current president of the American Academy of Dermatology, said that communication breakdowns between health care providers and patients account for more than 80% of medical errors and adverse events. In addition, ineffective communication can lead to below-average scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS), and other surveys, impacting public scrutiny, reputation, referrals, patient retention, and loyalty, and pay for performance. “Physicians who are on the lower third of communication on surveys tend to have 110% more lawsuits than everybody else,” he said.

Dr. Torres underscored the importance of obtaining verbal or written consent with patients prior to performing dermatologic procedures. “You want to discuss material risk, that is, What’s the likely significant risk? What’s a viable alternative? Do you think it’s viable? And if not, be prepared with data to support that. And what’s your rationale of benefit?” he said.

In a study that evaluated informed consent in dermatologic surgery, 85 patients undergoing Mohs surgery were given verbal and written instructions, including information about the potential for 10 possible complications (Dermatol Surg. 2003;29[9]:952-5). The researchers asked the patients to recall the 10 complications at 20 minutes and at 1 week after the informed consent process. The overall group retention rates for both time periods were 27% and 24%, respectively.

“The reality is, people are nervous,” said Dr. Torres, who was not involved with the study. “They’re not focusing well and may not be listening very carefully to you. So when you give them informed consent you need to help them focus on the important issues. Be cautious about diluting the discussion with so much information that they’re not getting the message.”

Lawsuits involving the use of lasers in dermatology are on the rise, according to one study that examined trends in legal cases secondary to cutaneous laser surgery over a 28-year period that peaked in 2010 (JAMA Dermatol. 2013;149[2]:188-93). It found that laser hair removal was the most commonly litigated procedure (63%), followed by lack of informed consent (53%). Nearly half of the cases favored the defendant and the mean indemnity payment was $380,719.

This is in contrast with commonly reported litigation trends where a majority of the cases favor the defendant. The study also found that nearly 40% of cases involved a nonphysician operator. “So you need to be extra careful when you’re dealing with laser procedures, or you’re dealing with nonphysician operators or extenders,” Dr. Torres noted. “In that regard, know the rules in your state; make sure that you’re clear on them. Make sure that the people who are going to [perform the procedures] are appropriately trained. Provide an adequate degree of supervision to make sure that the proper procedure is being followed, especially as it relates to informed consent.”

Another liability risk for clinicians is failing to follow up with patients. “As a doctor, you may have the responsibility to make sure the patient actually saw the specialist and that their reports were acted upon,” Dr. Torres said. “The law requires that you interact with the specialist in the patients’ best interest. Also, if you refer a patient to another doctor and you have a reason to think that [doctor is] incompetent, you may be held accountable. Referring to the wrong specialist can be a pitfall.”

Dermatologists may at times also be liable for providing interpreter services for patients, no matter the size of their office or the number of employees on their payroll. He recommended that physicians explore whether the Canopy Medical Translator APP, a technology that enables clinicians to communicate with patients in 15 languages, can prove useful to them. Funded by the National Institutes of Health, the technology can be run on any device that runs on iOS or Android. “It can take phrases you have and translate them, or translate phrases that patients have to you,” Dr. Torres said.

In his clinical experience, dermatologists can protect themselves from a legal standpoint by maintaining honesty with the patient; showing kindness and concern at each encounter; validating the patient’s complaints about complications without conveying blame; avoiding isolating the patient after a complication; having a remedy planned for the complication, and seeing and communicating with the patient frequently.

When things go wrong, he offered the “AAA” mnemonic: Always acknowledge a complaint and express empathy; make sure someone you designate is easily accessible to the patient making a complaint, and avoid premature conclusions or comments. “Why? Because you want to maintain honesty with your patients, you want to show kindness and concern and validate patients’ emotions,” Dr. Torres said. “In other words, treat them as you would like to be treated.”

He reported having no financial disclosures.

[email protected]

NEWPORT BEACH, CALIF. – Over the past 20 years, the number of medical malpractice claims against dermatologists has remained steady, in the ballpark of 86-123 per year, according to Abel Torres, MD, JD.

In fact, a study that used claims data from the Physician Insurers Association of America between 1985 and 2008 revealed that dermatology ranked 19th among 28 medical specialties evaluated. “The bad news is we’re not ranked 28th, so we’re still getting sued,” said Dr. Torres, professor and chairman of dermatology at Loma Linda (Calif.) University and professor of dermatology at Case Western Reserve University, Cleveland. In the study, 2,704 of 239,756 (1.1%) closed claims in this time period involved dermatologists; only 29% of the claims that involved dermatologists resulted in a payment for the plaintiff, with a median and average indemnity of $35,000 and $137,538, respectively (J Am Acad Dermatol. 2012 Jan;66[1]:78-85).

Speaking at the annual meeting of the Pacific Dermatologic Association, Dr. Torres, who is also current president of the American Academy of Dermatology, said that communication breakdowns between health care providers and patients account for more than 80% of medical errors and adverse events. In addition, ineffective communication can lead to below-average scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS), and other surveys, impacting public scrutiny, reputation, referrals, patient retention, and loyalty, and pay for performance. “Physicians who are on the lower third of communication on surveys tend to have 110% more lawsuits than everybody else,” he said.

Dr. Torres underscored the importance of obtaining verbal or written consent with patients prior to performing dermatologic procedures. “You want to discuss material risk, that is, What’s the likely significant risk? What’s a viable alternative? Do you think it’s viable? And if not, be prepared with data to support that. And what’s your rationale of benefit?” he said.

In a study that evaluated informed consent in dermatologic surgery, 85 patients undergoing Mohs surgery were given verbal and written instructions, including information about the potential for 10 possible complications (Dermatol Surg. 2003;29[9]:952-5). The researchers asked the patients to recall the 10 complications at 20 minutes and at 1 week after the informed consent process. The overall group retention rates for both time periods were 27% and 24%, respectively.

“The reality is, people are nervous,” said Dr. Torres, who was not involved with the study. “They’re not focusing well and may not be listening very carefully to you. So when you give them informed consent you need to help them focus on the important issues. Be cautious about diluting the discussion with so much information that they’re not getting the message.”

Lawsuits involving the use of lasers in dermatology are on the rise, according to one study that examined trends in legal cases secondary to cutaneous laser surgery over a 28-year period that peaked in 2010 (JAMA Dermatol. 2013;149[2]:188-93). It found that laser hair removal was the most commonly litigated procedure (63%), followed by lack of informed consent (53%). Nearly half of the cases favored the defendant and the mean indemnity payment was $380,719.

This is in contrast with commonly reported litigation trends where a majority of the cases favor the defendant. The study also found that nearly 40% of cases involved a nonphysician operator. “So you need to be extra careful when you’re dealing with laser procedures, or you’re dealing with nonphysician operators or extenders,” Dr. Torres noted. “In that regard, know the rules in your state; make sure that you’re clear on them. Make sure that the people who are going to [perform the procedures] are appropriately trained. Provide an adequate degree of supervision to make sure that the proper procedure is being followed, especially as it relates to informed consent.”

Another liability risk for clinicians is failing to follow up with patients. “As a doctor, you may have the responsibility to make sure the patient actually saw the specialist and that their reports were acted upon,” Dr. Torres said. “The law requires that you interact with the specialist in the patients’ best interest. Also, if you refer a patient to another doctor and you have a reason to think that [doctor is] incompetent, you may be held accountable. Referring to the wrong specialist can be a pitfall.”

Dermatologists may at times also be liable for providing interpreter services for patients, no matter the size of their office or the number of employees on their payroll. He recommended that physicians explore whether the Canopy Medical Translator APP, a technology that enables clinicians to communicate with patients in 15 languages, can prove useful to them. Funded by the National Institutes of Health, the technology can be run on any device that runs on iOS or Android. “It can take phrases you have and translate them, or translate phrases that patients have to you,” Dr. Torres said.

In his clinical experience, dermatologists can protect themselves from a legal standpoint by maintaining honesty with the patient; showing kindness and concern at each encounter; validating the patient’s complaints about complications without conveying blame; avoiding isolating the patient after a complication; having a remedy planned for the complication, and seeing and communicating with the patient frequently.

When things go wrong, he offered the “AAA” mnemonic: Always acknowledge a complaint and express empathy; make sure someone you designate is easily accessible to the patient making a complaint, and avoid premature conclusions or comments. “Why? Because you want to maintain honesty with your patients, you want to show kindness and concern and validate patients’ emotions,” Dr. Torres said. “In other words, treat them as you would like to be treated.”

He reported having no financial disclosures.

[email protected]

NEWPORT BEACH, CALIF. – Over the past 20 years, the number of medical malpractice claims against dermatologists has remained steady, in the ballpark of 86-123 per year, according to Abel Torres, MD, JD.

In fact, a study that used claims data from the Physician Insurers Association of America between 1985 and 2008 revealed that dermatology ranked 19th among 28 medical specialties evaluated. “The bad news is we’re not ranked 28th, so we’re still getting sued,” said Dr. Torres, professor and chairman of dermatology at Loma Linda (Calif.) University and professor of dermatology at Case Western Reserve University, Cleveland. In the study, 2,704 of 239,756 (1.1%) closed claims in this time period involved dermatologists; only 29% of the claims that involved dermatologists resulted in a payment for the plaintiff, with a median and average indemnity of $35,000 and $137,538, respectively (J Am Acad Dermatol. 2012 Jan;66[1]:78-85).

Speaking at the annual meeting of the Pacific Dermatologic Association, Dr. Torres, who is also current president of the American Academy of Dermatology, said that communication breakdowns between health care providers and patients account for more than 80% of medical errors and adverse events. In addition, ineffective communication can lead to below-average scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS), and other surveys, impacting public scrutiny, reputation, referrals, patient retention, and loyalty, and pay for performance. “Physicians who are on the lower third of communication on surveys tend to have 110% more lawsuits than everybody else,” he said.

Dr. Torres underscored the importance of obtaining verbal or written consent with patients prior to performing dermatologic procedures. “You want to discuss material risk, that is, What’s the likely significant risk? What’s a viable alternative? Do you think it’s viable? And if not, be prepared with data to support that. And what’s your rationale of benefit?” he said.

In a study that evaluated informed consent in dermatologic surgery, 85 patients undergoing Mohs surgery were given verbal and written instructions, including information about the potential for 10 possible complications (Dermatol Surg. 2003;29[9]:952-5). The researchers asked the patients to recall the 10 complications at 20 minutes and at 1 week after the informed consent process. The overall group retention rates for both time periods were 27% and 24%, respectively.

“The reality is, people are nervous,” said Dr. Torres, who was not involved with the study. “They’re not focusing well and may not be listening very carefully to you. So when you give them informed consent you need to help them focus on the important issues. Be cautious about diluting the discussion with so much information that they’re not getting the message.”

Lawsuits involving the use of lasers in dermatology are on the rise, according to one study that examined trends in legal cases secondary to cutaneous laser surgery over a 28-year period that peaked in 2010 (JAMA Dermatol. 2013;149[2]:188-93). It found that laser hair removal was the most commonly litigated procedure (63%), followed by lack of informed consent (53%). Nearly half of the cases favored the defendant and the mean indemnity payment was $380,719.

This is in contrast with commonly reported litigation trends where a majority of the cases favor the defendant. The study also found that nearly 40% of cases involved a nonphysician operator. “So you need to be extra careful when you’re dealing with laser procedures, or you’re dealing with nonphysician operators or extenders,” Dr. Torres noted. “In that regard, know the rules in your state; make sure that you’re clear on them. Make sure that the people who are going to [perform the procedures] are appropriately trained. Provide an adequate degree of supervision to make sure that the proper procedure is being followed, especially as it relates to informed consent.”

Another liability risk for clinicians is failing to follow up with patients. “As a doctor, you may have the responsibility to make sure the patient actually saw the specialist and that their reports were acted upon,” Dr. Torres said. “The law requires that you interact with the specialist in the patients’ best interest. Also, if you refer a patient to another doctor and you have a reason to think that [doctor is] incompetent, you may be held accountable. Referring to the wrong specialist can be a pitfall.”

Dermatologists may at times also be liable for providing interpreter services for patients, no matter the size of their office or the number of employees on their payroll. He recommended that physicians explore whether the Canopy Medical Translator APP, a technology that enables clinicians to communicate with patients in 15 languages, can prove useful to them. Funded by the National Institutes of Health, the technology can be run on any device that runs on iOS or Android. “It can take phrases you have and translate them, or translate phrases that patients have to you,” Dr. Torres said.

In his clinical experience, dermatologists can protect themselves from a legal standpoint by maintaining honesty with the patient; showing kindness and concern at each encounter; validating the patient’s complaints about complications without conveying blame; avoiding isolating the patient after a complication; having a remedy planned for the complication, and seeing and communicating with the patient frequently.

When things go wrong, he offered the “AAA” mnemonic: Always acknowledge a complaint and express empathy; make sure someone you designate is easily accessible to the patient making a complaint, and avoid premature conclusions or comments. “Why? Because you want to maintain honesty with your patients, you want to show kindness and concern and validate patients’ emotions,” Dr. Torres said. “In other words, treat them as you would like to be treated.”

He reported having no financial disclosures.

[email protected]

The Baylor Research Institute and SHM joined forces to provide a new resource to help accelerate adoption of a specific set of patient safety practices (collectively termed the ABCDEF bundle) to mitigate delirium in the ICU. This guide will allow you to impact care at both the individual patient and the institutional levels. It is intended for the broad, multidisciplinary spectrum of personnel involved in hospital-based quality improvement and patient safety efforts, ranging from frontline care providers to executive leaders. View the toolkit and download the guide at www.hospitalmedicine.org/delirium.

The Baylor Research Institute and SHM joined forces to provide a new resource to help accelerate adoption of a specific set of patient safety practices (collectively termed the ABCDEF bundle) to mitigate delirium in the ICU. This guide will allow you to impact care at both the individual patient and the institutional levels. It is intended for the broad, multidisciplinary spectrum of personnel involved in hospital-based quality improvement and patient safety efforts, ranging from frontline care providers to executive leaders. View the toolkit and download the guide at www.hospitalmedicine.org/delirium.

The Baylor Research Institute and SHM joined forces to provide a new resource to help accelerate adoption of a specific set of patient safety practices (collectively termed the ABCDEF bundle) to mitigate delirium in the ICU. This guide will allow you to impact care at both the individual patient and the institutional levels. It is intended for the broad, multidisciplinary spectrum of personnel involved in hospital-based quality improvement and patient safety efforts, ranging from frontline care providers to executive leaders. View the toolkit and download the guide at www.hospitalmedicine.org/delirium.

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

• A $35 credit toward 2017–2018 dues when recruiting 1 new member.
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members.
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members.
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members.

For each member recruited, referrers will receive one entry into a grand-prize drawing to receive complimentary registration to Hospital Medicine 2017 in Las Vegas.

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

ROME – Adding ticagrelor at 60 mg twice daily in patients on low-dose aspirin due to a prior MI reduced their risk of a first stroke by 25% in a secondary analysis of the landmark PEGASUS-TIMI 54 trial, Marc P. Bonaca, MD, reported at the annual congress of the European Society of Cardiology.

PEGASUS-TIMI 54 was a randomized, double-blind, placebo-controlled clinical trial conducted in more than 21,000 stable patients on low-dose aspirin with a history of an acute MI 1-3 years earlier. The significant reduction in secondary cardiovascular events seen in this study during a median 33 months of follow-up (N Engl J Med. 2015 May 7;372[19]:1791-800) led to approval of ticagrelor (Brilinta) at 60 mg twice daily for long-term secondary prevention.

Bruce Jancin/Frontline Medical News

But while PEGASUS-TIMI 54 was a secondary prevention study in terms of cardiovascular events, it was actually a primary prevention study in terms of stroke, since patients with a history of stroke weren’t eligible for enrollment. And in this trial, recipients of ticagrelor at 50 mg twice daily experienced a 25% reduction in the risk of stroke relative to placebo, from 1.94% at 3 years to 1.47%. This benefit was driven by fewer ischemic strokes, with no increase in hemorrhagic strokes seen with ticagrelor. And therein lies a clinical take home point: “When evaluating the overall benefits and risks of long-term ticagrelor in patients with prior MI, stroke reduction should also be considered,” according to Dr. Bonaca of Brigham and Women’s Hospital, Boston.

All strokes were adjudicated and subclassified by a blinded central committee. A total of 213 stroke events occurred during follow-up: 81% ischemic, 7% hemorrhagic, 4% ischemic with hemorrhagic conversion, and 8% unknown; 18% of the strokes were fatal. Another 15% resulted in moderate or severe disability at 30 days. All PEGASUS-TIMI 54 participants were on aspirin and more than 90% were on statin therapy.

The strokes that occurred in patients on ticagrelor were generally less severe than in controls. The risk of having a modified Rankin score of 3-6, which encompasses outcomes ranging from moderate disability to death, was reduced by 43% in stroke patients on ticagrelor relative to those on placebo, the cardiologist continued.

To ensure that the stroke benefit with ticagrelor seen in PEGASUS-TIMI 54 wasn’t a fluke, Dr. Bonaca and his coinvestigators performed a meta-analysis of four placebo-controlled randomized trials of more intensive versus less intensive antiplatelet therapy in nearly 45,000 participants with coronary disease in the CHARISMA, DAPT, PEGASUS-TIMI 54, and TRA 2*P-TIMI 50 trials. A total of 532 strokes occurred in this enlarged analysis. More intensive antiplatelet therapy – typically adding a second drug to low-dose aspirin – resulted in a 34% reduction in ischemic stroke, compared with low-dose aspirin and placebo.

Excluding from the meta-analysis the large subgroup of patients in TRA 2*P-TIMI 50 who were on triple-drug antiplatelet therapy, investigators were left with 32,348 participants in the four trials who were randomized to dual-antiplatelet therapy or monotherapy with aspirin. In this population, there was no increase in the risk of hemorrhagic stroke associated with more intensive antiplatelet therapy, according to Dr. Bonaca.

Session co-chair Keith A.A. Fox, MD, of the University of Edinburgh, noted that various studies have shown monotherapy with aspirin or another antiplatelet agent reduces stroke risk by about 15%, and now PEGASUS-TIMI 54 shows that ticagrelor plus aspirin decreases stroke risk by 25%. He posed a direct question: “How much is too much?”

“More and more antiplatelet therapy begets more bleeding, so I think that more than two agents may be approaching too much, although it really depends on what agents you’re using and in what dosages,” Dr. Bonaca replied.

He reported serving as a consultant to AstraZeneca, Merck, and Bayer.

Simultaneous with Dr. Bonaca’s presentation at ESC 2016 in Rome, the new report from PEGASUS-TIMI 54 including the four-trial meta-analysis was published online (Circulation. 2016 Aug 30. doi: circulationaha.116.024637).

[email protected]

ROME – Adding ticagrelor at 60 mg twice daily in patients on low-dose aspirin due to a prior MI reduced their risk of a first stroke by 25% in a secondary analysis of the landmark PEGASUS-TIMI 54 trial, Marc P. Bonaca, MD, reported at the annual congress of the European Society of Cardiology.

PEGASUS-TIMI 54 was a randomized, double-blind, placebo-controlled clinical trial conducted in more than 21,000 stable patients on low-dose aspirin with a history of an acute MI 1-3 years earlier. The significant reduction in secondary cardiovascular events seen in this study during a median 33 months of follow-up (N Engl J Med. 2015 May 7;372[19]:1791-800) led to approval of ticagrelor (Brilinta) at 60 mg twice daily for long-term secondary prevention.

Bruce Jancin/Frontline Medical News

But while PEGASUS-TIMI 54 was a secondary prevention study in terms of cardiovascular events, it was actually a primary prevention study in terms of stroke, since patients with a history of stroke weren’t eligible for enrollment. And in this trial, recipients of ticagrelor at 50 mg twice daily experienced a 25% reduction in the risk of stroke relative to placebo, from 1.94% at 3 years to 1.47%. This benefit was driven by fewer ischemic strokes, with no increase in hemorrhagic strokes seen with ticagrelor. And therein lies a clinical take home point: “When evaluating the overall benefits and risks of long-term ticagrelor in patients with prior MI, stroke reduction should also be considered,” according to Dr. Bonaca of Brigham and Women’s Hospital, Boston.

All strokes were adjudicated and subclassified by a blinded central committee. A total of 213 stroke events occurred during follow-up: 81% ischemic, 7% hemorrhagic, 4% ischemic with hemorrhagic conversion, and 8% unknown; 18% of the strokes were fatal. Another 15% resulted in moderate or severe disability at 30 days. All PEGASUS-TIMI 54 participants were on aspirin and more than 90% were on statin therapy.

The strokes that occurred in patients on ticagrelor were generally less severe than in controls. The risk of having a modified Rankin score of 3-6, which encompasses outcomes ranging from moderate disability to death, was reduced by 43% in stroke patients on ticagrelor relative to those on placebo, the cardiologist continued.

To ensure that the stroke benefit with ticagrelor seen in PEGASUS-TIMI 54 wasn’t a fluke, Dr. Bonaca and his coinvestigators performed a meta-analysis of four placebo-controlled randomized trials of more intensive versus less intensive antiplatelet therapy in nearly 45,000 participants with coronary disease in the CHARISMA, DAPT, PEGASUS-TIMI 54, and TRA 2*P-TIMI 50 trials. A total of 532 strokes occurred in this enlarged analysis. More intensive antiplatelet therapy – typically adding a second drug to low-dose aspirin – resulted in a 34% reduction in ischemic stroke, compared with low-dose aspirin and placebo.

Excluding from the meta-analysis the large subgroup of patients in TRA 2*P-TIMI 50 who were on triple-drug antiplatelet therapy, investigators were left with 32,348 participants in the four trials who were randomized to dual-antiplatelet therapy or monotherapy with aspirin. In this population, there was no increase in the risk of hemorrhagic stroke associated with more intensive antiplatelet therapy, according to Dr. Bonaca.

Session co-chair Keith A.A. Fox, MD, of the University of Edinburgh, noted that various studies have shown monotherapy with aspirin or another antiplatelet agent reduces stroke risk by about 15%, and now PEGASUS-TIMI 54 shows that ticagrelor plus aspirin decreases stroke risk by 25%. He posed a direct question: “How much is too much?”

“More and more antiplatelet therapy begets more bleeding, so I think that more than two agents may be approaching too much, although it really depends on what agents you’re using and in what dosages,” Dr. Bonaca replied.

He reported serving as a consultant to AstraZeneca, Merck, and Bayer.

Simultaneous with Dr. Bonaca’s presentation at ESC 2016 in Rome, the new report from PEGASUS-TIMI 54 including the four-trial meta-analysis was published online (Circulation. 2016 Aug 30. doi: circulationaha.116.024637).

[email protected]

ROME – Adding ticagrelor at 60 mg twice daily in patients on low-dose aspirin due to a prior MI reduced their risk of a first stroke by 25% in a secondary analysis of the landmark PEGASUS-TIMI 54 trial, Marc P. Bonaca, MD, reported at the annual congress of the European Society of Cardiology.

PEGASUS-TIMI 54 was a randomized, double-blind, placebo-controlled clinical trial conducted in more than 21,000 stable patients on low-dose aspirin with a history of an acute MI 1-3 years earlier. The significant reduction in secondary cardiovascular events seen in this study during a median 33 months of follow-up (N Engl J Med. 2015 May 7;372[19]:1791-800) led to approval of ticagrelor (Brilinta) at 60 mg twice daily for long-term secondary prevention.

Bruce Jancin/Frontline Medical News

But while PEGASUS-TIMI 54 was a secondary prevention study in terms of cardiovascular events, it was actually a primary prevention study in terms of stroke, since patients with a history of stroke weren’t eligible for enrollment. And in this trial, recipients of ticagrelor at 50 mg twice daily experienced a 25% reduction in the risk of stroke relative to placebo, from 1.94% at 3 years to 1.47%. This benefit was driven by fewer ischemic strokes, with no increase in hemorrhagic strokes seen with ticagrelor. And therein lies a clinical take home point: “When evaluating the overall benefits and risks of long-term ticagrelor in patients with prior MI, stroke reduction should also be considered,” according to Dr. Bonaca of Brigham and Women’s Hospital, Boston.

All strokes were adjudicated and subclassified by a blinded central committee. A total of 213 stroke events occurred during follow-up: 81% ischemic, 7% hemorrhagic, 4% ischemic with hemorrhagic conversion, and 8% unknown; 18% of the strokes were fatal. Another 15% resulted in moderate or severe disability at 30 days. All PEGASUS-TIMI 54 participants were on aspirin and more than 90% were on statin therapy.

The strokes that occurred in patients on ticagrelor were generally less severe than in controls. The risk of having a modified Rankin score of 3-6, which encompasses outcomes ranging from moderate disability to death, was reduced by 43% in stroke patients on ticagrelor relative to those on placebo, the cardiologist continued.

To ensure that the stroke benefit with ticagrelor seen in PEGASUS-TIMI 54 wasn’t a fluke, Dr. Bonaca and his coinvestigators performed a meta-analysis of four placebo-controlled randomized trials of more intensive versus less intensive antiplatelet therapy in nearly 45,000 participants with coronary disease in the CHARISMA, DAPT, PEGASUS-TIMI 54, and TRA 2*P-TIMI 50 trials. A total of 532 strokes occurred in this enlarged analysis. More intensive antiplatelet therapy – typically adding a second drug to low-dose aspirin – resulted in a 34% reduction in ischemic stroke, compared with low-dose aspirin and placebo.

Excluding from the meta-analysis the large subgroup of patients in TRA 2*P-TIMI 50 who were on triple-drug antiplatelet therapy, investigators were left with 32,348 participants in the four trials who were randomized to dual-antiplatelet therapy or monotherapy with aspirin. In this population, there was no increase in the risk of hemorrhagic stroke associated with more intensive antiplatelet therapy, according to Dr. Bonaca.

Session co-chair Keith A.A. Fox, MD, of the University of Edinburgh, noted that various studies have shown monotherapy with aspirin or another antiplatelet agent reduces stroke risk by about 15%, and now PEGASUS-TIMI 54 shows that ticagrelor plus aspirin decreases stroke risk by 25%. He posed a direct question: “How much is too much?”

“More and more antiplatelet therapy begets more bleeding, so I think that more than two agents may be approaching too much, although it really depends on what agents you’re using and in what dosages,” Dr. Bonaca replied.

He reported serving as a consultant to AstraZeneca, Merck, and Bayer.

Simultaneous with Dr. Bonaca’s presentation at ESC 2016 in Rome, the new report from PEGASUS-TIMI 54 including the four-trial meta-analysis was published online (Circulation. 2016 Aug 30. doi: circulationaha.116.024637).

[email protected]

Conventional wisdom holds that for randomized, controlled trials, it’s all about the primary endpoint. If it’s negative or neutral, then none of the other results means much beyond “hypothesis generating.”

This strict-constructionist thinking has now been called into question. A recent article in the New England Journal of Medicine declared “an unreasonable yet widespread practice is the labeling of all randomized trials as either positive or negative on the basis of whether the P value for the primary outcome is less than .05. This view is overly simplistic.” (2016 Sept 1;375[9]:861-70).

Mitchel L. Zoler/Frontline Medical News

The article, by the highly experienced and respected trialists Stuart J. Pocock, PhD, and Gregg W. Stone, MD, adds this: “If the primary outcome is negative, positive findings for secondary outcomes are usually considered to be hypothesis generating. Certainly, regulatory approval of a new drug is unlikely to follow. However, in some instances, secondary findings are compelling enough to affect guidelines and practice.”

This unconventional take from a pair of high-level trialists was especially timely given the buzz around the results from two studies reported at the European Society of Cardiology annual congress in late August, DANISH and NORSTENT.

The DANISH trial compared the impact of implantable cardioverter-defibrillators (ICDs) plus optimal care against optimal care without ICDs in 1,116 patients with nonischemic systolic heart failure. The primary outcome, all-cause death during more than 5 years of follow-up, was a relative 13% less with ICD use, a difference that was not statistically significant, and one secondary outcome, cardiovascular death, was cut by a relative 25% with ICD use, also not statistically significant.

Mitchel L. Zoler/Frontline Medical News

But for the study’s second prespecified secondary endpoint of sudden cardiac death, treatment with ICDs cut the rate in half, compared with nonischemic heart failure patients who did not receive an ICD, a 4-percentage-point difference that was statistically significant.

And in a prespecified secondary analysis of the primary endpoint that broke down the study group by age, the two-thirds of patients younger than 68 years had a significant reduction in all-cause mortality with ICD use, a benefit not seen in patients aged 68 or older.

Discussion of the results at the meeting mainly focused on what meaning, if any, could be drawn from these strongly positive secondary outcomes in a trial neutral for its primary outcome.

“The ICDs did what they were supposed to, prevent sudden cardiac death,” said the lead investigator of the study, Lars Køber, MD. “As a principle I say don’t believe in a subgroup, but guidelines are often based on subgroup analyses.”

“The primary outcome was neutral, but the reduction in sudden cardiac death, the primary objective of an ICD, was significant, so an ICD should be taken into consideration,” commented Michel Komajda, MD, a discussant for the report.

Frontline Medical News

After I wrote a news article about the DANISH report at ESC, I received an email from a reader who objected to spinning the results this way and insisted that no valid lessons can be drawn from the DANISH results because the study’s primary endpoint failed to show a statistical significance. This purist view misses the important, relevant lessons from the DANISH results. The DANISH trial was not designed to provide pivotal data for regulatory approval of ICDs in these patients. Rather, Dr. Køber and his associates designed DANISH to see whether ICD use in these patients could cut all-cause death over a fairly long follow-up. It was a very high bar and ICDs failed, but the deck was stacked against an ICD win. Enrolled patients averaged 64 years old at entry into the study, and they all had New York Heart Association class II or III heart failure. “The overall survival curves start to diverge, but then converge after 5 years because of the comorbidities and patients dying for other reasons,” Dr. Køber noted.

“The message is, in younger patients with less morbidity and more life expectancy, sudden cardiac death is a bigger problem, and they had a substantial drop in mortality” with ICD use, commented heart failure specialist Javed Butler, MD. “It’s very consistent with the way we think about providing ICD treatment to patients.”

Mitchel L. Zoler/Frontline Medical News

In other words, the DANISH results showed that all patients with nonischemic systolic heart failure can’t expect to live substantially longer during extended follow-up if they get an ICD, because the cut in sudden cardiac death the devices provide eventually gets washed out by the many other risks for death these patients face. But younger, relatively healthier patients might very well see their reduced rate of sudden cardiac death translate into an overall mortality benefit even when they are followed for at least 5 years. That’s important information to help an individual patient decide whether to have an ICD placed, and an important message from the DANISH trial despite the neutral primary endpoint.

NORSTENT involved a similar scenario in a trial that addressed a totally different issue: Should patients with either stable or unstable coronary artery disease who are undergoing coronary stenting receive a drug-eluting stent (DES) or a bare metal stent (BMS)? The trial randomized 9,013 patients to receive either of the two stent types plus optimal medical therapy. The primary endpoint was the rate of all-cause death or nonfatal MI during 5 years of follow-up, and the results showed no statistically significant difference between the patients who received a DES and those who got a BMS (N Engl J Med. 2016 Aug 30. doi: 10.1056/NEJMoa1607991).

But for the secondary endpoint of repeat revascularizations performed during follow-up, the use of a DES cut the procedure rate by 3.3 percentage points, a 17% relative risk reduction that was statistically significant. The use of a DES also cut the stent thrombosis rate by 0.4 percentage points, a one-third relative drop in these events that was also statistically significant.

Mitchel L. Zoler/Frontline Medical News

In short, despite the neutral primary endpoint for the trial, the results showed that drug-eluting stents did what they were designed to do relative to bare metal stents: cut the rate of target lesion restenosis and the need for repeat revascularization. Several interventional cardiologists who heard the results at the meeting said that the findings would not change their practice and that they would continue to use the DES as their default device for percutaneous coronary interventions. Although “the long-term benefit of contemporary DES over BMS was less than expected,” said Kaare H. Bønaa, MD, lead investigator for the NORSTENT trial, the secondary benefit of significantly reduced repeat revascularization and the very modest price difference that now exists between drug-eluting stents and bare metal stents means that many interventionalists will continue to use a DES for most patients.

The message from Dr. Pocock and Dr. Stone, underscored by the DANISH and NORSTENT results, is that large and well-run randomized trials can yield important evidence to inform practice that transcends a simple black or white statistical assessment of the primary endpoint.

[email protected]

On Twitter @mitchelzoler

Conventional wisdom holds that for randomized, controlled trials, it’s all about the primary endpoint. If it’s negative or neutral, then none of the other results means much beyond “hypothesis generating.”

This strict-constructionist thinking has now been called into question. A recent article in the New England Journal of Medicine declared “an unreasonable yet widespread practice is the labeling of all randomized trials as either positive or negative on the basis of whether the P value for the primary outcome is less than .05. This view is overly simplistic.” (2016 Sept 1;375[9]:861-70).

Mitchel L. Zoler/Frontline Medical News

The article, by the highly experienced and respected trialists Stuart J. Pocock, PhD, and Gregg W. Stone, MD, adds this: “If the primary outcome is negative, positive findings for secondary outcomes are usually considered to be hypothesis generating. Certainly, regulatory approval of a new drug is unlikely to follow. However, in some instances, secondary findings are compelling enough to affect guidelines and practice.”

This unconventional take from a pair of high-level trialists was especially timely given the buzz around the results from two studies reported at the European Society of Cardiology annual congress in late August, DANISH and NORSTENT.

The DANISH trial compared the impact of implantable cardioverter-defibrillators (ICDs) plus optimal care against optimal care without ICDs in 1,116 patients with nonischemic systolic heart failure. The primary outcome, all-cause death during more than 5 years of follow-up, was a relative 13% less with ICD use, a difference that was not statistically significant, and one secondary outcome, cardiovascular death, was cut by a relative 25% with ICD use, also not statistically significant.

Mitchel L. Zoler/Frontline Medical News

But for the study’s second prespecified secondary endpoint of sudden cardiac death, treatment with ICDs cut the rate in half, compared with nonischemic heart failure patients who did not receive an ICD, a 4-percentage-point difference that was statistically significant.

And in a prespecified secondary analysis of the primary endpoint that broke down the study group by age, the two-thirds of patients younger than 68 years had a significant reduction in all-cause mortality with ICD use, a benefit not seen in patients aged 68 or older.

Discussion of the results at the meeting mainly focused on what meaning, if any, could be drawn from these strongly positive secondary outcomes in a trial neutral for its primary outcome.

“The ICDs did what they were supposed to, prevent sudden cardiac death,” said the lead investigator of the study, Lars Køber, MD. “As a principle I say don’t believe in a subgroup, but guidelines are often based on subgroup analyses.”

“The primary outcome was neutral, but the reduction in sudden cardiac death, the primary objective of an ICD, was significant, so an ICD should be taken into consideration,” commented Michel Komajda, MD, a discussant for the report.

Frontline Medical News

After I wrote a news article about the DANISH report at ESC, I received an email from a reader who objected to spinning the results this way and insisted that no valid lessons can be drawn from the DANISH results because the study’s primary endpoint failed to show a statistical significance. This purist view misses the important, relevant lessons from the DANISH results. The DANISH trial was not designed to provide pivotal data for regulatory approval of ICDs in these patients. Rather, Dr. Køber and his associates designed DANISH to see whether ICD use in these patients could cut all-cause death over a fairly long follow-up. It was a very high bar and ICDs failed, but the deck was stacked against an ICD win. Enrolled patients averaged 64 years old at entry into the study, and they all had New York Heart Association class II or III heart failure. “The overall survival curves start to diverge, but then converge after 5 years because of the comorbidities and patients dying for other reasons,” Dr. Køber noted.

“The message is, in younger patients with less morbidity and more life expectancy, sudden cardiac death is a bigger problem, and they had a substantial drop in mortality” with ICD use, commented heart failure specialist Javed Butler, MD. “It’s very consistent with the way we think about providing ICD treatment to patients.”

Mitchel L. Zoler/Frontline Medical News

In other words, the DANISH results showed that all patients with nonischemic systolic heart failure can’t expect to live substantially longer during extended follow-up if they get an ICD, because the cut in sudden cardiac death the devices provide eventually gets washed out by the many other risks for death these patients face. But younger, relatively healthier patients might very well see their reduced rate of sudden cardiac death translate into an overall mortality benefit even when they are followed for at least 5 years. That’s important information to help an individual patient decide whether to have an ICD placed, and an important message from the DANISH trial despite the neutral primary endpoint.

NORSTENT involved a similar scenario in a trial that addressed a totally different issue: Should patients with either stable or unstable coronary artery disease who are undergoing coronary stenting receive a drug-eluting stent (DES) or a bare metal stent (BMS)? The trial randomized 9,013 patients to receive either of the two stent types plus optimal medical therapy. The primary endpoint was the rate of all-cause death or nonfatal MI during 5 years of follow-up, and the results showed no statistically significant difference between the patients who received a DES and those who got a BMS (N Engl J Med. 2016 Aug 30. doi: 10.1056/NEJMoa1607991).

But for the secondary endpoint of repeat revascularizations performed during follow-up, the use of a DES cut the procedure rate by 3.3 percentage points, a 17% relative risk reduction that was statistically significant. The use of a DES also cut the stent thrombosis rate by 0.4 percentage points, a one-third relative drop in these events that was also statistically significant.

Mitchel L. Zoler/Frontline Medical News

In short, despite the neutral primary endpoint for the trial, the results showed that drug-eluting stents did what they were designed to do relative to bare metal stents: cut the rate of target lesion restenosis and the need for repeat revascularization. Several interventional cardiologists who heard the results at the meeting said that the findings would not change their practice and that they would continue to use the DES as their default device for percutaneous coronary interventions. Although “the long-term benefit of contemporary DES over BMS was less than expected,” said Kaare H. Bønaa, MD, lead investigator for the NORSTENT trial, the secondary benefit of significantly reduced repeat revascularization and the very modest price difference that now exists between drug-eluting stents and bare metal stents means that many interventionalists will continue to use a DES for most patients.

The message from Dr. Pocock and Dr. Stone, underscored by the DANISH and NORSTENT results, is that large and well-run randomized trials can yield important evidence to inform practice that transcends a simple black or white statistical assessment of the primary endpoint.

[email protected]

On Twitter @mitchelzoler

Conventional wisdom holds that for randomized, controlled trials, it’s all about the primary endpoint. If it’s negative or neutral, then none of the other results means much beyond “hypothesis generating.”

This strict-constructionist thinking has now been called into question. A recent article in the New England Journal of Medicine declared “an unreasonable yet widespread practice is the labeling of all randomized trials as either positive or negative on the basis of whether the P value for the primary outcome is less than .05. This view is overly simplistic.” (2016 Sept 1;375[9]:861-70).

Mitchel L. Zoler/Frontline Medical News

The article, by the highly experienced and respected trialists Stuart J. Pocock, PhD, and Gregg W. Stone, MD, adds this: “If the primary outcome is negative, positive findings for secondary outcomes are usually considered to be hypothesis generating. Certainly, regulatory approval of a new drug is unlikely to follow. However, in some instances, secondary findings are compelling enough to affect guidelines and practice.”

This unconventional take from a pair of high-level trialists was especially timely given the buzz around the results from two studies reported at the European Society of Cardiology annual congress in late August, DANISH and NORSTENT.

The DANISH trial compared the impact of implantable cardioverter-defibrillators (ICDs) plus optimal care against optimal care without ICDs in 1,116 patients with nonischemic systolic heart failure. The primary outcome, all-cause death during more than 5 years of follow-up, was a relative 13% less with ICD use, a difference that was not statistically significant, and one secondary outcome, cardiovascular death, was cut by a relative 25% with ICD use, also not statistically significant.

Mitchel L. Zoler/Frontline Medical News

But for the study’s second prespecified secondary endpoint of sudden cardiac death, treatment with ICDs cut the rate in half, compared with nonischemic heart failure patients who did not receive an ICD, a 4-percentage-point difference that was statistically significant.

And in a prespecified secondary analysis of the primary endpoint that broke down the study group by age, the two-thirds of patients younger than 68 years had a significant reduction in all-cause mortality with ICD use, a benefit not seen in patients aged 68 or older.

Discussion of the results at the meeting mainly focused on what meaning, if any, could be drawn from these strongly positive secondary outcomes in a trial neutral for its primary outcome.

“The ICDs did what they were supposed to, prevent sudden cardiac death,” said the lead investigator of the study, Lars Køber, MD. “As a principle I say don’t believe in a subgroup, but guidelines are often based on subgroup analyses.”

“The primary outcome was neutral, but the reduction in sudden cardiac death, the primary objective of an ICD, was significant, so an ICD should be taken into consideration,” commented Michel Komajda, MD, a discussant for the report.

Frontline Medical News

After I wrote a news article about the DANISH report at ESC, I received an email from a reader who objected to spinning the results this way and insisted that no valid lessons can be drawn from the DANISH results because the study’s primary endpoint failed to show a statistical significance. This purist view misses the important, relevant lessons from the DANISH results. The DANISH trial was not designed to provide pivotal data for regulatory approval of ICDs in these patients. Rather, Dr. Køber and his associates designed DANISH to see whether ICD use in these patients could cut all-cause death over a fairly long follow-up. It was a very high bar and ICDs failed, but the deck was stacked against an ICD win. Enrolled patients averaged 64 years old at entry into the study, and they all had New York Heart Association class II or III heart failure. “The overall survival curves start to diverge, but then converge after 5 years because of the comorbidities and patients dying for other reasons,” Dr. Køber noted.

“The message is, in younger patients with less morbidity and more life expectancy, sudden cardiac death is a bigger problem, and they had a substantial drop in mortality” with ICD use, commented heart failure specialist Javed Butler, MD. “It’s very consistent with the way we think about providing ICD treatment to patients.”

Mitchel L. Zoler/Frontline Medical News

In other words, the DANISH results showed that all patients with nonischemic systolic heart failure can’t expect to live substantially longer during extended follow-up if they get an ICD, because the cut in sudden cardiac death the devices provide eventually gets washed out by the many other risks for death these patients face. But younger, relatively healthier patients might very well see their reduced rate of sudden cardiac death translate into an overall mortality benefit even when they are followed for at least 5 years. That’s important information to help an individual patient decide whether to have an ICD placed, and an important message from the DANISH trial despite the neutral primary endpoint.

NORSTENT involved a similar scenario in a trial that addressed a totally different issue: Should patients with either stable or unstable coronary artery disease who are undergoing coronary stenting receive a drug-eluting stent (DES) or a bare metal stent (BMS)? The trial randomized 9,013 patients to receive either of the two stent types plus optimal medical therapy. The primary endpoint was the rate of all-cause death or nonfatal MI during 5 years of follow-up, and the results showed no statistically significant difference between the patients who received a DES and those who got a BMS (N Engl J Med. 2016 Aug 30. doi: 10.1056/NEJMoa1607991).

But for the secondary endpoint of repeat revascularizations performed during follow-up, the use of a DES cut the procedure rate by 3.3 percentage points, a 17% relative risk reduction that was statistically significant. The use of a DES also cut the stent thrombosis rate by 0.4 percentage points, a one-third relative drop in these events that was also statistically significant.

Mitchel L. Zoler/Frontline Medical News

In short, despite the neutral primary endpoint for the trial, the results showed that drug-eluting stents did what they were designed to do relative to bare metal stents: cut the rate of target lesion restenosis and the need for repeat revascularization. Several interventional cardiologists who heard the results at the meeting said that the findings would not change their practice and that they would continue to use the DES as their default device for percutaneous coronary interventions. Although “the long-term benefit of contemporary DES over BMS was less than expected,” said Kaare H. Bønaa, MD, lead investigator for the NORSTENT trial, the secondary benefit of significantly reduced repeat revascularization and the very modest price difference that now exists between drug-eluting stents and bare metal stents means that many interventionalists will continue to use a DES for most patients.

The message from Dr. Pocock and Dr. Stone, underscored by the DANISH and NORSTENT results, is that large and well-run randomized trials can yield important evidence to inform practice that transcends a simple black or white statistical assessment of the primary endpoint.

[email protected]

On Twitter @mitchelzoler