WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Results from two large, multicenter comparisons of coronary stenting and coronary bypass surgery for treating patients with unprotected left main coronary disease may have superficially shown sharp differences, but the bottom line will likely be greater empowerment of percutaneous coronary intervention as an option for selected patients with less complex coronary disease.

Prior to the results from the EXCEL and NOBLE trials, reported at the Transcatheter Cardiovascular Therapeutics annual meeting, “guidelines put PCI [percutaneous coronary intervention] into a class 1, 2 or 3 status for treating left main coronary disease depending on disease complexity, but in the United States, PCI for patients eligible for CABG [coronary artery bypass grafting] has not been frequently done. I think these results, in a very circumscribed subset of patients and using a state-of-the-art stent, will affect the guidelines,” predicted Gregg W. Stone, MD, lead investigator for EXCEL and professor of medicine at Columbia University in New York.

“What the guidelines have not addressed are the patients with low- or intermediate-complexity disease who have an acceptable risk for undergoing either PCI or CABG. I think the trial results answer this question,” said David Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta and an EXCEL investigator.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

A 70-year-old man with hypertension and hypercholesterolemia presented to the emergency department after the acute onset of substernal, pressure-like chest pain while climbing a flight of stairs. His physical examination was normal, but he was noted to have bilateral diagonal earlobe creases (the Frank sign) (Figure 1), considered by some to indicate risk of coronary artery disease.^1–5

Electrocardiography showed atrial fibrillation with a ventricular rate of 149 beats per minute, ST-segment elevation in leads V₁ and aVR, and ST-segment depression in leads V₃ to V₆, II, III, and aVF.

Urgent coronary arteriography showed severe coronary artery disease (Figure 2). Left ventriculography showed an ejection fraction of 50% with mild anterior wall hypokinesis. A drug-eluting stent was placed in the mid-left anterior descending artery. The patient tolerated the procedure well, and his chest pain resolved afterward.

A STILL-UNCLEAR ASSOCIATION

Sanders T. Frank, in 1973, first described a diagonal wrinkle-like line on the earlobe as a sign of coronary artery disease.¹ Subsequently, autopsy studies suggested that deep bilateral earlobe creases could be an important sign of coronary atherosclerosis.² Diagonal earlobe creases have been shown to be independently associated with increased prevalence, extent, and severity of coronary artery disease.^3,4 They are also associated with major adverse cardiovascular events⁴ and ischemic stroke.⁵ The mechanism linking diagonal earlobe creases and atherosclerotic disease is not yet clear.

This patient’s presentation and evaluation remind us that bilateral earlobe creases may be useful to include in the clinical examination of patients with suspected coronary artery disease and may facilitate early recognition of disease in a patient at high risk.

A 70-year-old man with hypertension and hypercholesterolemia presented to the emergency department after the acute onset of substernal, pressure-like chest pain while climbing a flight of stairs. His physical examination was normal, but he was noted to have bilateral diagonal earlobe creases (the Frank sign) (Figure 1), considered by some to indicate risk of coronary artery disease.^1–5

Electrocardiography showed atrial fibrillation with a ventricular rate of 149 beats per minute, ST-segment elevation in leads V₁ and aVR, and ST-segment depression in leads V₃ to V₆, II, III, and aVF.

Urgent coronary arteriography showed severe coronary artery disease (Figure 2). Left ventriculography showed an ejection fraction of 50% with mild anterior wall hypokinesis. A drug-eluting stent was placed in the mid-left anterior descending artery. The patient tolerated the procedure well, and his chest pain resolved afterward.

A STILL-UNCLEAR ASSOCIATION

Sanders T. Frank, in 1973, first described a diagonal wrinkle-like line on the earlobe as a sign of coronary artery disease.¹ Subsequently, autopsy studies suggested that deep bilateral earlobe creases could be an important sign of coronary atherosclerosis.² Diagonal earlobe creases have been shown to be independently associated with increased prevalence, extent, and severity of coronary artery disease.^3,4 They are also associated with major adverse cardiovascular events⁴ and ischemic stroke.⁵ The mechanism linking diagonal earlobe creases and atherosclerotic disease is not yet clear.

This patient’s presentation and evaluation remind us that bilateral earlobe creases may be useful to include in the clinical examination of patients with suspected coronary artery disease and may facilitate early recognition of disease in a patient at high risk.

A 70-year-old man with hypertension and hypercholesterolemia presented to the emergency department after the acute onset of substernal, pressure-like chest pain while climbing a flight of stairs. His physical examination was normal, but he was noted to have bilateral diagonal earlobe creases (the Frank sign) (Figure 1), considered by some to indicate risk of coronary artery disease.^1–5

Electrocardiography showed atrial fibrillation with a ventricular rate of 149 beats per minute, ST-segment elevation in leads V₁ and aVR, and ST-segment depression in leads V₃ to V₆, II, III, and aVF.

Urgent coronary arteriography showed severe coronary artery disease (Figure 2). Left ventriculography showed an ejection fraction of 50% with mild anterior wall hypokinesis. A drug-eluting stent was placed in the mid-left anterior descending artery. The patient tolerated the procedure well, and his chest pain resolved afterward.

A STILL-UNCLEAR ASSOCIATION

Sanders T. Frank, in 1973, first described a diagonal wrinkle-like line on the earlobe as a sign of coronary artery disease.¹ Subsequently, autopsy studies suggested that deep bilateral earlobe creases could be an important sign of coronary atherosclerosis.² Diagonal earlobe creases have been shown to be independently associated with increased prevalence, extent, and severity of coronary artery disease.^3,4 They are also associated with major adverse cardiovascular events⁴ and ischemic stroke.⁵ The mechanism linking diagonal earlobe creases and atherosclerotic disease is not yet clear.

This patient’s presentation and evaluation remind us that bilateral earlobe creases may be useful to include in the clinical examination of patients with suspected coronary artery disease and may facilitate early recognition of disease in a patient at high risk.

On an otherwise pleasant evening during the first week of July 2016, a businessman who was a citizen of the United Arab Emirates visiting Cleveland for medical treatment was falsely accused of links to a terror organization. Officers stormed his hotel with assault rifles and handcuffed and arrested him—all this, apparently, because the man was dressed in traditional Emirati clothing.

See related article

This case highlights a level of complexity in providing medical care to foreigners far beyond language interpreting services and outside the borders of the institution where medical care is provided. In the current issue of the Journal, Cawcutt and Wilson¹ review their experiences in the care of international patients and the unique challenges associated with it.

FROM THE TEMPLE OF AESCULAPIUS TO CLEVELAND CLINIC

In 2015, patients from more than 100 countries traveled to Cleveland seeking care at Cleveland Clinic. But medical travel was part of the practice of medicine long before major US hospitals became destinations for international patients, and it has been refined over the years.

Ancient cultures had a thriving tradition of patients traveling long distances for the best and most advanced medical treatment.^2–4 In ancient Greece, people from all around the Mediterranean came to the city of Epidaurus to be cured in its famous temple of Aesculapius, built as a medical center.

Similarly, early Islamic cultures established a healthcare system that catered to foreigners. A noted example is the Mansuri hospital in Cairo, built in 1248 ce and considered the most advanced hospital of its time. Accommodating nearly 8,000 patients, the Mansuri hospital became a healthcare destination for foreigners regardless of race or religion.^2–4

Europe also had a great tradition of providing medical care to foreign patients. Between the 15th and 17th centuries, belief in the healing power of mineral water led to the establishment of spas and the rise of spa towns, particularly in the south of France near mineral springs. The poor sanitary conditions of Europe at the time may have prompted the interest in the healing effect of mineral spas, but wealthy individuals from all over the world traveled to these destinations, creating local prosperity due to medical tourism.^2–4

The city of Bath, in England, is a great example. In the 1720s, Bath was a popular destination for those traveling for healthcare. It became the first city in England to build a covered sewage system, ahead of London by several years. It also had paved roads, lights, hotels, and restaurants in much greater numbers than other cities in England, a likely result of prosperity associated with medical tourism.

ALL PATIENTS WANT TO BE TREATED WITH RESPECT AND KINDNESS

While medical knowledge and health delivery models have changed over the years, caring for foreign patients is perhaps as old as medicine itself. The central focus of restoring health is certainly not unique to international patients, but understanding their unique needs is important in order to achieve the best outcomes, something that Cawcutt and Wilson highlight well.¹

A number of studies have addressed the question of what patients really want. Responses were surprisingly consistent: they want to be treated with respect and kindness.^5,6 In other words, they want empathy, and this is true of all patients regardless of ethnicity or background. Empathy is a tremendous therapeutic force and can narrow what may look like an unbridgeable gap between patient and physician.^7,8

EMPATHY REQUIRES EFFECTIVE COMMUNICATION

Empathy, though sometimes innate, requires effective communication and shared experiences. Neither of these two requirements is easily achievable in the care of foreign patients.

Communication is hampered by language barriers, although it can be enhanced significantly by language translating services and the work of certified medical interpreters. These often-invisible heroes should be recognized as essential members of the medical team. Their work requires cultural sensitivity and formal training to avoid miscommunication and medical errors. Codes of ethics for medical interpreters include confidentiality, accuracy in conveying the content and spirit of the message, freedom from personal biases, cultural training, and professional boundaries.⁹

TOWARD CULTURAL COMPETENCY

Lack of shared experiences between the foreign patient and care provider is an even greater obstacle to overcome in eliminating any empathy deficit. Shared experiences, whether cultural, religious, or social, help us to see the world through the eyes of the patient.

International patients may differ from us in background, ethnicity, religion, dress, expectations, and other areas. Cultural and religious backgrounds often dictate certain behaviors in the event of critical illness or death. Even in routine and less acute medical care, the background of a foreign patient may lead to logistical quandaries such as the need for same-sex caregivers or a private room.

A paradox currently exists in our efforts to meet patients’ need and desire for empathy. While culturally empathic care is necessary to achieve the best medical outcomes, this topic is not yet part of the curriculum for physicians or other healthcare providers in training. A culturally sensitive institution has many business advantages.¹⁰ Thorough and focused cultural training of medical staff is essential. Shared experiences can potentially be fashioned through a well-designed cultural competency training program to enhance empathy for foreign patients.

A SERVICE-ORIENTED APPROACH

Besides cultural competency and language training, a service-oriented approach to accommodate the needs of medical travelers and their family members is of paramount importance. Many of the complaints and burdens of medical visitors concern services that are not medical in nature, such as daily living necessities. Transportation, religious services, banking, extended-stay facilities, cell phone service, legal services, shopping, dining, and entertainment are among many other living needs for those receiving medical care abroad. These services are inconsistently provided throughout medical institutions in the United States, which provide care to thousands of international patients annually.

Unique challenges of providing medical care to international patients have direct effects on medical outcomes. A population-based cohort study of US-born and foreign-born adults with lung or colorectal cancer suggested disparities in quality and type of care.¹¹ Foreign-born patients reported lower-quality care and were less likely to receive complex cancer treatments recommended by clinical guidelines. The authors proposed that quality of care and outcomes may be improved with greater emphasis on coordination of care and improving communication. Similar findings were reported in foreign-born patients with breast cancer.¹²

‘WHAT WOULD YOU THINK TO BE USED THUS?’

Four hundred years ago, in the play Sir Thomas More (a collaboration between several Elizabethan playwrights),¹³ the title character confronts a mob of anti-immigrant rioters, and in a speech believed to have been written by William Shakespeare (Act 2, Scene 4), asks them to imagine themselves banished to a foreign country and subjected to hostility such as they were meting out:

Empathy for foreigners seeking medical care is not merely an act of kindness; rather, it is a central piece of healing. Medical institutions interested in providing healthcare to this unique group of patients should take these principles into account and carefully examine their ability to deliver compassionate care collectively to local and foreign-born patients alike.

On an otherwise pleasant evening during the first week of July 2016, a businessman who was a citizen of the United Arab Emirates visiting Cleveland for medical treatment was falsely accused of links to a terror organization. Officers stormed his hotel with assault rifles and handcuffed and arrested him—all this, apparently, because the man was dressed in traditional Emirati clothing.

See related article

This case highlights a level of complexity in providing medical care to foreigners far beyond language interpreting services and outside the borders of the institution where medical care is provided. In the current issue of the Journal, Cawcutt and Wilson¹ review their experiences in the care of international patients and the unique challenges associated with it.

FROM THE TEMPLE OF AESCULAPIUS TO CLEVELAND CLINIC

In 2015, patients from more than 100 countries traveled to Cleveland seeking care at Cleveland Clinic. But medical travel was part of the practice of medicine long before major US hospitals became destinations for international patients, and it has been refined over the years.

Ancient cultures had a thriving tradition of patients traveling long distances for the best and most advanced medical treatment.^2–4 In ancient Greece, people from all around the Mediterranean came to the city of Epidaurus to be cured in its famous temple of Aesculapius, built as a medical center.

Similarly, early Islamic cultures established a healthcare system that catered to foreigners. A noted example is the Mansuri hospital in Cairo, built in 1248 ce and considered the most advanced hospital of its time. Accommodating nearly 8,000 patients, the Mansuri hospital became a healthcare destination for foreigners regardless of race or religion.^2–4

Europe also had a great tradition of providing medical care to foreign patients. Between the 15th and 17th centuries, belief in the healing power of mineral water led to the establishment of spas and the rise of spa towns, particularly in the south of France near mineral springs. The poor sanitary conditions of Europe at the time may have prompted the interest in the healing effect of mineral spas, but wealthy individuals from all over the world traveled to these destinations, creating local prosperity due to medical tourism.^2–4

The city of Bath, in England, is a great example. In the 1720s, Bath was a popular destination for those traveling for healthcare. It became the first city in England to build a covered sewage system, ahead of London by several years. It also had paved roads, lights, hotels, and restaurants in much greater numbers than other cities in England, a likely result of prosperity associated with medical tourism.

ALL PATIENTS WANT TO BE TREATED WITH RESPECT AND KINDNESS

While medical knowledge and health delivery models have changed over the years, caring for foreign patients is perhaps as old as medicine itself. The central focus of restoring health is certainly not unique to international patients, but understanding their unique needs is important in order to achieve the best outcomes, something that Cawcutt and Wilson highlight well.¹

A number of studies have addressed the question of what patients really want. Responses were surprisingly consistent: they want to be treated with respect and kindness.^5,6 In other words, they want empathy, and this is true of all patients regardless of ethnicity or background. Empathy is a tremendous therapeutic force and can narrow what may look like an unbridgeable gap between patient and physician.^7,8

EMPATHY REQUIRES EFFECTIVE COMMUNICATION

Empathy, though sometimes innate, requires effective communication and shared experiences. Neither of these two requirements is easily achievable in the care of foreign patients.

Communication is hampered by language barriers, although it can be enhanced significantly by language translating services and the work of certified medical interpreters. These often-invisible heroes should be recognized as essential members of the medical team. Their work requires cultural sensitivity and formal training to avoid miscommunication and medical errors. Codes of ethics for medical interpreters include confidentiality, accuracy in conveying the content and spirit of the message, freedom from personal biases, cultural training, and professional boundaries.⁹

TOWARD CULTURAL COMPETENCY

Lack of shared experiences between the foreign patient and care provider is an even greater obstacle to overcome in eliminating any empathy deficit. Shared experiences, whether cultural, religious, or social, help us to see the world through the eyes of the patient.

International patients may differ from us in background, ethnicity, religion, dress, expectations, and other areas. Cultural and religious backgrounds often dictate certain behaviors in the event of critical illness or death. Even in routine and less acute medical care, the background of a foreign patient may lead to logistical quandaries such as the need for same-sex caregivers or a private room.

A paradox currently exists in our efforts to meet patients’ need and desire for empathy. While culturally empathic care is necessary to achieve the best medical outcomes, this topic is not yet part of the curriculum for physicians or other healthcare providers in training. A culturally sensitive institution has many business advantages.¹⁰ Thorough and focused cultural training of medical staff is essential. Shared experiences can potentially be fashioned through a well-designed cultural competency training program to enhance empathy for foreign patients.

A SERVICE-ORIENTED APPROACH

Besides cultural competency and language training, a service-oriented approach to accommodate the needs of medical travelers and their family members is of paramount importance. Many of the complaints and burdens of medical visitors concern services that are not medical in nature, such as daily living necessities. Transportation, religious services, banking, extended-stay facilities, cell phone service, legal services, shopping, dining, and entertainment are among many other living needs for those receiving medical care abroad. These services are inconsistently provided throughout medical institutions in the United States, which provide care to thousands of international patients annually.

Unique challenges of providing medical care to international patients have direct effects on medical outcomes. A population-based cohort study of US-born and foreign-born adults with lung or colorectal cancer suggested disparities in quality and type of care.¹¹ Foreign-born patients reported lower-quality care and were less likely to receive complex cancer treatments recommended by clinical guidelines. The authors proposed that quality of care and outcomes may be improved with greater emphasis on coordination of care and improving communication. Similar findings were reported in foreign-born patients with breast cancer.¹²

‘WHAT WOULD YOU THINK TO BE USED THUS?’

Four hundred years ago, in the play Sir Thomas More (a collaboration between several Elizabethan playwrights),¹³ the title character confronts a mob of anti-immigrant rioters, and in a speech believed to have been written by William Shakespeare (Act 2, Scene 4), asks them to imagine themselves banished to a foreign country and subjected to hostility such as they were meting out:

Empathy for foreigners seeking medical care is not merely an act of kindness; rather, it is a central piece of healing. Medical institutions interested in providing healthcare to this unique group of patients should take these principles into account and carefully examine their ability to deliver compassionate care collectively to local and foreign-born patients alike.

On an otherwise pleasant evening during the first week of July 2016, a businessman who was a citizen of the United Arab Emirates visiting Cleveland for medical treatment was falsely accused of links to a terror organization. Officers stormed his hotel with assault rifles and handcuffed and arrested him—all this, apparently, because the man was dressed in traditional Emirati clothing.

See related article

This case highlights a level of complexity in providing medical care to foreigners far beyond language interpreting services and outside the borders of the institution where medical care is provided. In the current issue of the Journal, Cawcutt and Wilson¹ review their experiences in the care of international patients and the unique challenges associated with it.

FROM THE TEMPLE OF AESCULAPIUS TO CLEVELAND CLINIC

In 2015, patients from more than 100 countries traveled to Cleveland seeking care at Cleveland Clinic. But medical travel was part of the practice of medicine long before major US hospitals became destinations for international patients, and it has been refined over the years.

Ancient cultures had a thriving tradition of patients traveling long distances for the best and most advanced medical treatment.^2–4 In ancient Greece, people from all around the Mediterranean came to the city of Epidaurus to be cured in its famous temple of Aesculapius, built as a medical center.

Similarly, early Islamic cultures established a healthcare system that catered to foreigners. A noted example is the Mansuri hospital in Cairo, built in 1248 ce and considered the most advanced hospital of its time. Accommodating nearly 8,000 patients, the Mansuri hospital became a healthcare destination for foreigners regardless of race or religion.^2–4

Europe also had a great tradition of providing medical care to foreign patients. Between the 15th and 17th centuries, belief in the healing power of mineral water led to the establishment of spas and the rise of spa towns, particularly in the south of France near mineral springs. The poor sanitary conditions of Europe at the time may have prompted the interest in the healing effect of mineral spas, but wealthy individuals from all over the world traveled to these destinations, creating local prosperity due to medical tourism.^2–4

The city of Bath, in England, is a great example. In the 1720s, Bath was a popular destination for those traveling for healthcare. It became the first city in England to build a covered sewage system, ahead of London by several years. It also had paved roads, lights, hotels, and restaurants in much greater numbers than other cities in England, a likely result of prosperity associated with medical tourism.

ALL PATIENTS WANT TO BE TREATED WITH RESPECT AND KINDNESS

While medical knowledge and health delivery models have changed over the years, caring for foreign patients is perhaps as old as medicine itself. The central focus of restoring health is certainly not unique to international patients, but understanding their unique needs is important in order to achieve the best outcomes, something that Cawcutt and Wilson highlight well.¹

A number of studies have addressed the question of what patients really want. Responses were surprisingly consistent: they want to be treated with respect and kindness.^5,6 In other words, they want empathy, and this is true of all patients regardless of ethnicity or background. Empathy is a tremendous therapeutic force and can narrow what may look like an unbridgeable gap between patient and physician.^7,8

EMPATHY REQUIRES EFFECTIVE COMMUNICATION

Empathy, though sometimes innate, requires effective communication and shared experiences. Neither of these two requirements is easily achievable in the care of foreign patients.

Communication is hampered by language barriers, although it can be enhanced significantly by language translating services and the work of certified medical interpreters. These often-invisible heroes should be recognized as essential members of the medical team. Their work requires cultural sensitivity and formal training to avoid miscommunication and medical errors. Codes of ethics for medical interpreters include confidentiality, accuracy in conveying the content and spirit of the message, freedom from personal biases, cultural training, and professional boundaries.⁹

TOWARD CULTURAL COMPETENCY

Lack of shared experiences between the foreign patient and care provider is an even greater obstacle to overcome in eliminating any empathy deficit. Shared experiences, whether cultural, religious, or social, help us to see the world through the eyes of the patient.

International patients may differ from us in background, ethnicity, religion, dress, expectations, and other areas. Cultural and religious backgrounds often dictate certain behaviors in the event of critical illness or death. Even in routine and less acute medical care, the background of a foreign patient may lead to logistical quandaries such as the need for same-sex caregivers or a private room.

A paradox currently exists in our efforts to meet patients’ need and desire for empathy. While culturally empathic care is necessary to achieve the best medical outcomes, this topic is not yet part of the curriculum for physicians or other healthcare providers in training. A culturally sensitive institution has many business advantages.¹⁰ Thorough and focused cultural training of medical staff is essential. Shared experiences can potentially be fashioned through a well-designed cultural competency training program to enhance empathy for foreign patients.

A SERVICE-ORIENTED APPROACH

Besides cultural competency and language training, a service-oriented approach to accommodate the needs of medical travelers and their family members is of paramount importance. Many of the complaints and burdens of medical visitors concern services that are not medical in nature, such as daily living necessities. Transportation, religious services, banking, extended-stay facilities, cell phone service, legal services, shopping, dining, and entertainment are among many other living needs for those receiving medical care abroad. These services are inconsistently provided throughout medical institutions in the United States, which provide care to thousands of international patients annually.

Unique challenges of providing medical care to international patients have direct effects on medical outcomes. A population-based cohort study of US-born and foreign-born adults with lung or colorectal cancer suggested disparities in quality and type of care.¹¹ Foreign-born patients reported lower-quality care and were less likely to receive complex cancer treatments recommended by clinical guidelines. The authors proposed that quality of care and outcomes may be improved with greater emphasis on coordination of care and improving communication. Similar findings were reported in foreign-born patients with breast cancer.¹²

‘WHAT WOULD YOU THINK TO BE USED THUS?’

Four hundred years ago, in the play Sir Thomas More (a collaboration between several Elizabethan playwrights),¹³ the title character confronts a mob of anti-immigrant rioters, and in a speech believed to have been written by William Shakespeare (Act 2, Scene 4), asks them to imagine themselves banished to a foreign country and subjected to hostility such as they were meting out:

Empathy for foreigners seeking medical care is not merely an act of kindness; rather, it is a central piece of healing. Medical institutions interested in providing healthcare to this unique group of patients should take these principles into account and carefully examine their ability to deliver compassionate care collectively to local and foreign-born patients alike.

Of the seven deadly sins, the worst is said to be pride, often represented in allegorical form as a peacock. In this month’s Journal, Kelly A. Cawcutt, MD and John W. Wilson, MD, and Nizar N. Zein, MD, note the rewards and challenges of caring for international patients. Pride, it seems to me, can get in the way of a successful relationship with these patients.

In the United States, we encounter a wide range of international patients, but there are two distinct categories: medical tourists, who come here by choice and often have significant financial means, and immigrants, who come here by choice or necessity and run the gamut of economic status.

The former group generally seeks care at major academic medical centers such as Cleveland Clinic and Mayo Clinic, which have built infrastructures to accommodate them, including paying special attention to the social aspects of the visit. For the medical center, there are immediate financial gains as well as potential long-term benefits, including international networking and philanthropy.

On the other hand, new immigrants, including refugees, generally seek care as needed where they have settled, mostly hoping that medical issues will not arise in the midst of the challenges of resettlement. They deserve and should expect to be able to establish a comfortable therapeutic relationship with a physician in a local medical practice, although one likely dissimilar from what they previously encountered.

For all of these patients, the focal point of interaction is us, the physician next to the examination table. Dr. Zein emphasizes the power of empathy and how our demeanor and choice of words are critical in building the therapeutic relationship. But pride can slip in, and the peacock subtly fans his tail.

While medical practice in the United States is technologically advanced in terms of tests and procedures, we are not the world leaders in outcomes or cost-effective care. We most certainly do not have a monopoly on delivering compassionate and empathic care or forging one-on-one doctor-patient relationships. We must be careful not to express a demeaning or dismissive attitude about the care our patients’ physicians provided in their home countries. That the laboratory and imaging reports are written in a different language, and perhaps reported in different units, should not imply any lower standard. We should also recognize that many of our physical examination skills have atrophied as we have come to over-rely on imaging studies. The apparent omission of an echocardiogram may in fact be an act of commission—a careful and confident physical examination may have resulted in a thoughtful decision to save the patient money. Careless words or a casually chauvinistic attitude can be disruptive to building a comfortable ongoing doctor-patient relationship.

At the same time, international patients come to see us with significant expectations (they may even have read our hospital’s marketing materials). But they may not be accustomed to their physician openly expressing a lack of certainty about a diagnosis. They may never have heard their at-home doctor say, “I don’t know.” The concept of patient involvement in the treatment plan may be totally foreign and discomforting to some, while others will expect that the entire family entourage (filling the exam room) will have an active role in decision-making.

Cultural awareness is critical as we sort these issues out so they do not stand in the way of successfully caring for the patient in front of us. We should avoid being too self-confident in our entrenched approach to healthcare delivery in the exam room (as well as in the redesign of our healthcare system). The peacock can be an attractive impediment.

Of the seven deadly sins, the worst is said to be pride, often represented in allegorical form as a peacock. In this month’s Journal, Kelly A. Cawcutt, MD and John W. Wilson, MD, and Nizar N. Zein, MD, note the rewards and challenges of caring for international patients. Pride, it seems to me, can get in the way of a successful relationship with these patients.

In the United States, we encounter a wide range of international patients, but there are two distinct categories: medical tourists, who come here by choice and often have significant financial means, and immigrants, who come here by choice or necessity and run the gamut of economic status.

The former group generally seeks care at major academic medical centers such as Cleveland Clinic and Mayo Clinic, which have built infrastructures to accommodate them, including paying special attention to the social aspects of the visit. For the medical center, there are immediate financial gains as well as potential long-term benefits, including international networking and philanthropy.

On the other hand, new immigrants, including refugees, generally seek care as needed where they have settled, mostly hoping that medical issues will not arise in the midst of the challenges of resettlement. They deserve and should expect to be able to establish a comfortable therapeutic relationship with a physician in a local medical practice, although one likely dissimilar from what they previously encountered.

For all of these patients, the focal point of interaction is us, the physician next to the examination table. Dr. Zein emphasizes the power of empathy and how our demeanor and choice of words are critical in building the therapeutic relationship. But pride can slip in, and the peacock subtly fans his tail.

While medical practice in the United States is technologically advanced in terms of tests and procedures, we are not the world leaders in outcomes or cost-effective care. We most certainly do not have a monopoly on delivering compassionate and empathic care or forging one-on-one doctor-patient relationships. We must be careful not to express a demeaning or dismissive attitude about the care our patients’ physicians provided in their home countries. That the laboratory and imaging reports are written in a different language, and perhaps reported in different units, should not imply any lower standard. We should also recognize that many of our physical examination skills have atrophied as we have come to over-rely on imaging studies. The apparent omission of an echocardiogram may in fact be an act of commission—a careful and confident physical examination may have resulted in a thoughtful decision to save the patient money. Careless words or a casually chauvinistic attitude can be disruptive to building a comfortable ongoing doctor-patient relationship.

At the same time, international patients come to see us with significant expectations (they may even have read our hospital’s marketing materials). But they may not be accustomed to their physician openly expressing a lack of certainty about a diagnosis. They may never have heard their at-home doctor say, “I don’t know.” The concept of patient involvement in the treatment plan may be totally foreign and discomforting to some, while others will expect that the entire family entourage (filling the exam room) will have an active role in decision-making.

Cultural awareness is critical as we sort these issues out so they do not stand in the way of successfully caring for the patient in front of us. We should avoid being too self-confident in our entrenched approach to healthcare delivery in the exam room (as well as in the redesign of our healthcare system). The peacock can be an attractive impediment.

Of the seven deadly sins, the worst is said to be pride, often represented in allegorical form as a peacock. In this month’s Journal, Kelly A. Cawcutt, MD and John W. Wilson, MD, and Nizar N. Zein, MD, note the rewards and challenges of caring for international patients. Pride, it seems to me, can get in the way of a successful relationship with these patients.

In the United States, we encounter a wide range of international patients, but there are two distinct categories: medical tourists, who come here by choice and often have significant financial means, and immigrants, who come here by choice or necessity and run the gamut of economic status.

The former group generally seeks care at major academic medical centers such as Cleveland Clinic and Mayo Clinic, which have built infrastructures to accommodate them, including paying special attention to the social aspects of the visit. For the medical center, there are immediate financial gains as well as potential long-term benefits, including international networking and philanthropy.

On the other hand, new immigrants, including refugees, generally seek care as needed where they have settled, mostly hoping that medical issues will not arise in the midst of the challenges of resettlement. They deserve and should expect to be able to establish a comfortable therapeutic relationship with a physician in a local medical practice, although one likely dissimilar from what they previously encountered.

For all of these patients, the focal point of interaction is us, the physician next to the examination table. Dr. Zein emphasizes the power of empathy and how our demeanor and choice of words are critical in building the therapeutic relationship. But pride can slip in, and the peacock subtly fans his tail.

While medical practice in the United States is technologically advanced in terms of tests and procedures, we are not the world leaders in outcomes or cost-effective care. We most certainly do not have a monopoly on delivering compassionate and empathic care or forging one-on-one doctor-patient relationships. We must be careful not to express a demeaning or dismissive attitude about the care our patients’ physicians provided in their home countries. That the laboratory and imaging reports are written in a different language, and perhaps reported in different units, should not imply any lower standard. We should also recognize that many of our physical examination skills have atrophied as we have come to over-rely on imaging studies. The apparent omission of an echocardiogram may in fact be an act of commission—a careful and confident physical examination may have resulted in a thoughtful decision to save the patient money. Careless words or a casually chauvinistic attitude can be disruptive to building a comfortable ongoing doctor-patient relationship.

At the same time, international patients come to see us with significant expectations (they may even have read our hospital’s marketing materials). But they may not be accustomed to their physician openly expressing a lack of certainty about a diagnosis. They may never have heard their at-home doctor say, “I don’t know.” The concept of patient involvement in the treatment plan may be totally foreign and discomforting to some, while others will expect that the entire family entourage (filling the exam room) will have an active role in decision-making.

Cultural awareness is critical as we sort these issues out so they do not stand in the way of successfully caring for the patient in front of us. We should avoid being too self-confident in our entrenched approach to healthcare delivery in the exam room (as well as in the redesign of our healthcare system). The peacock can be an attractive impediment.

A 19-year-old woman presented with diffuse swelling on her neck and face that had been growing gradually over the past 12 years. There was no family history of similar swelling.

Examination revealed a diffuse, hyperpigmented, nodular swelling on the right side of her neck and extending upward to the lower part of the face and the scalp (Figure 1). The rest of the physical examination was normal. A diagnosis of plexiform neurofibroma was made based on the typical clinical presentation. The patient had come primarily because of cosmetic concerns but refused surgery. She was offered genetic counseling and was scheduled for regular follow-up.

Plexiform neurofibroma is mostly associated with autosomal dominant neurofibromatosis type 1, characterized by cutaneous findings such as café-au-lait spots, axillary freckling, skeletal dysplasias (usually of the tibia, fibula, ribs, and vertebrae), Lisch nodules in the eye (iris hamartomas), and neural tumors. Rarely, it may also be seen in germline p16 mutation-positive heritable melanoma and Cowden syndrome.

Diffuse plexiform neurofibroma of the face and neck rarely appears after the age of 1, and rarely develops on other parts of the body after adolescence. In contrast, deep nodular plexiform neurofibroma often originates from spinal nerve roots and usually becomes symptomatic in adulthood.

Plexiform neurofibroma has an 8% to 12% chance of changing into a malignant peripheral nerve-sheath tumor. Continuous pain in the tumor, rapid tumor growth, hardening of the tumor, or weakness or numbness in an arm or leg with a plexiform neurofibroma suggests malignant transformation.

The diagnosis is clinical, and the management involves a multidisciplinary team including a physician, geneticist, neurologist, surgeon, and ophthalmologist. Genetic counseling should be offered to patients for assessment of family risk, to look for other possible conditions such as Cowden syndrome, for marital and family planning, and whenever the diagnosis is unclear.

A 19-year-old woman presented with diffuse swelling on her neck and face that had been growing gradually over the past 12 years. There was no family history of similar swelling.

Examination revealed a diffuse, hyperpigmented, nodular swelling on the right side of her neck and extending upward to the lower part of the face and the scalp (Figure 1). The rest of the physical examination was normal. A diagnosis of plexiform neurofibroma was made based on the typical clinical presentation. The patient had come primarily because of cosmetic concerns but refused surgery. She was offered genetic counseling and was scheduled for regular follow-up.

Plexiform neurofibroma is mostly associated with autosomal dominant neurofibromatosis type 1, characterized by cutaneous findings such as café-au-lait spots, axillary freckling, skeletal dysplasias (usually of the tibia, fibula, ribs, and vertebrae), Lisch nodules in the eye (iris hamartomas), and neural tumors. Rarely, it may also be seen in germline p16 mutation-positive heritable melanoma and Cowden syndrome.

Diffuse plexiform neurofibroma of the face and neck rarely appears after the age of 1, and rarely develops on other parts of the body after adolescence. In contrast, deep nodular plexiform neurofibroma often originates from spinal nerve roots and usually becomes symptomatic in adulthood.

Plexiform neurofibroma has an 8% to 12% chance of changing into a malignant peripheral nerve-sheath tumor. Continuous pain in the tumor, rapid tumor growth, hardening of the tumor, or weakness or numbness in an arm or leg with a plexiform neurofibroma suggests malignant transformation.

The diagnosis is clinical, and the management involves a multidisciplinary team including a physician, geneticist, neurologist, surgeon, and ophthalmologist. Genetic counseling should be offered to patients for assessment of family risk, to look for other possible conditions such as Cowden syndrome, for marital and family planning, and whenever the diagnosis is unclear.

A 19-year-old woman presented with diffuse swelling on her neck and face that had been growing gradually over the past 12 years. There was no family history of similar swelling.

Examination revealed a diffuse, hyperpigmented, nodular swelling on the right side of her neck and extending upward to the lower part of the face and the scalp (Figure 1). The rest of the physical examination was normal. A diagnosis of plexiform neurofibroma was made based on the typical clinical presentation. The patient had come primarily because of cosmetic concerns but refused surgery. She was offered genetic counseling and was scheduled for regular follow-up.

Plexiform neurofibroma is mostly associated with autosomal dominant neurofibromatosis type 1, characterized by cutaneous findings such as café-au-lait spots, axillary freckling, skeletal dysplasias (usually of the tibia, fibula, ribs, and vertebrae), Lisch nodules in the eye (iris hamartomas), and neural tumors. Rarely, it may also be seen in germline p16 mutation-positive heritable melanoma and Cowden syndrome.

Diffuse plexiform neurofibroma of the face and neck rarely appears after the age of 1, and rarely develops on other parts of the body after adolescence. In contrast, deep nodular plexiform neurofibroma often originates from spinal nerve roots and usually becomes symptomatic in adulthood.

Plexiform neurofibroma has an 8% to 12% chance of changing into a malignant peripheral nerve-sheath tumor. Continuous pain in the tumor, rapid tumor growth, hardening of the tumor, or weakness or numbness in an arm or leg with a plexiform neurofibroma suggests malignant transformation.

The diagnosis is clinical, and the management involves a multidisciplinary team including a physician, geneticist, neurologist, surgeon, and ophthalmologist. Genetic counseling should be offered to patients for assessment of family risk, to look for other possible conditions such as Cowden syndrome, for marital and family planning, and whenever the diagnosis is unclear.

Older sexual minority veterans are less likely to report depression and/or posttraumatic stress disorder than their younger peers, a cross-sectional study of 3,157 U.S. veterans showed.

“These findings have important public health implications,” wrote Joan K. Monin, PhD, of Yale University, New Haven, Conn., and her associates. “For instance, it may be beneficial to engage older [lesbian, gay, or bisexual] adults as a social support resource … to help improve and/or protect the mental health of younger LGB veterans.”

Dr. Monin and her associates analyzed data from the National Health and Resilience in Veterans Study (Depress Anxiety. 2013 May;30[5]:432-43), which recruited participants originally by telephone and later by mail in late 2011. Subjects were asked how they characterized their sexual status. Overall, 2,993 people (97.2%) identified as heterosexual, 39 (1.1%) as gay, 12 (0.4%) as lesbian, and 51 (1.4%) as bisexual, the researchers reported (Am J Geriatr Psychiatry 2016 Sep 23. doi: 10.1016/j.jagp.2016.09.006).

The participants’ mental health status was evaluated using several screens, including the Mini-International Neuropsychiatric Interview, a lifetime version of the PTSD Checklist, and the Trauma History Screen.

The researchers found a significant interaction between age and LGB status predicting lifetime diagnosis of depression and/or PTSD (P = .027; adjusted odds ratio, 1.03; 95% confidence interval, 1.01-1.06). Specifically, younger LGB veterans were more likely to screen positive for lifetime depression and/or PTSD than were their older counterparts.

“I was surprised to find that older LGB veterans were reporting less mental health problems than younger LGB veterans,” Dr. Monin said in an interview. “I was expecting to find that older and younger LGB veterans would have similar mental health disparity.”

She and her associates also found that younger LGB veterans have stronger support networks, a factor that further suggests that older age is tied to resilience in this population.

The study can be found here.

Older sexual minority veterans are less likely to report depression and/or posttraumatic stress disorder than their younger peers, a cross-sectional study of 3,157 U.S. veterans showed.

“These findings have important public health implications,” wrote Joan K. Monin, PhD, of Yale University, New Haven, Conn., and her associates. “For instance, it may be beneficial to engage older [lesbian, gay, or bisexual] adults as a social support resource … to help improve and/or protect the mental health of younger LGB veterans.”

Dr. Monin and her associates analyzed data from the National Health and Resilience in Veterans Study (Depress Anxiety. 2013 May;30[5]:432-43), which recruited participants originally by telephone and later by mail in late 2011. Subjects were asked how they characterized their sexual status. Overall, 2,993 people (97.2%) identified as heterosexual, 39 (1.1%) as gay, 12 (0.4%) as lesbian, and 51 (1.4%) as bisexual, the researchers reported (Am J Geriatr Psychiatry 2016 Sep 23. doi: 10.1016/j.jagp.2016.09.006).

The participants’ mental health status was evaluated using several screens, including the Mini-International Neuropsychiatric Interview, a lifetime version of the PTSD Checklist, and the Trauma History Screen.

The researchers found a significant interaction between age and LGB status predicting lifetime diagnosis of depression and/or PTSD (P = .027; adjusted odds ratio, 1.03; 95% confidence interval, 1.01-1.06). Specifically, younger LGB veterans were more likely to screen positive for lifetime depression and/or PTSD than were their older counterparts.

“I was surprised to find that older LGB veterans were reporting less mental health problems than younger LGB veterans,” Dr. Monin said in an interview. “I was expecting to find that older and younger LGB veterans would have similar mental health disparity.”

She and her associates also found that younger LGB veterans have stronger support networks, a factor that further suggests that older age is tied to resilience in this population.

The study can be found here.

Older sexual minority veterans are less likely to report depression and/or posttraumatic stress disorder than their younger peers, a cross-sectional study of 3,157 U.S. veterans showed.

“These findings have important public health implications,” wrote Joan K. Monin, PhD, of Yale University, New Haven, Conn., and her associates. “For instance, it may be beneficial to engage older [lesbian, gay, or bisexual] adults as a social support resource … to help improve and/or protect the mental health of younger LGB veterans.”

Dr. Monin and her associates analyzed data from the National Health and Resilience in Veterans Study (Depress Anxiety. 2013 May;30[5]:432-43), which recruited participants originally by telephone and later by mail in late 2011. Subjects were asked how they characterized their sexual status. Overall, 2,993 people (97.2%) identified as heterosexual, 39 (1.1%) as gay, 12 (0.4%) as lesbian, and 51 (1.4%) as bisexual, the researchers reported (Am J Geriatr Psychiatry 2016 Sep 23. doi: 10.1016/j.jagp.2016.09.006).

The participants’ mental health status was evaluated using several screens, including the Mini-International Neuropsychiatric Interview, a lifetime version of the PTSD Checklist, and the Trauma History Screen.

The researchers found a significant interaction between age and LGB status predicting lifetime diagnosis of depression and/or PTSD (P = .027; adjusted odds ratio, 1.03; 95% confidence interval, 1.01-1.06). Specifically, younger LGB veterans were more likely to screen positive for lifetime depression and/or PTSD than were their older counterparts.

“I was surprised to find that older LGB veterans were reporting less mental health problems than younger LGB veterans,” Dr. Monin said in an interview. “I was expecting to find that older and younger LGB veterans would have similar mental health disparity.”

She and her associates also found that younger LGB veterans have stronger support networks, a factor that further suggests that older age is tied to resilience in this population.

The study can be found here.

Regulatory bodies and professional societies have encouraged or mandated written pain treatment agreements for over a decade as a way to establish informed consent, improve adherence, and mitigate risk. Unfortunately, the content of these agreements varies, their efficacy is uncertain, and some are stigmatizing or coercive and jeopardize trust. Additionally, many are written at reading levels beyond most patients’ understanding. However, we believe a well-written agreement is still an important tool in chronic pain management.

In this article, we explore common limitations of current pain treatment “contracts” and propose strategies to improve their usefulness and acceptance.

PAIN AND ITS TREATMENT HAVE COSTS

Chronic pain affects 100 million US adults and is estimated to cost $635 billion each year in treatment, lost wages, and reduced productivity.¹

Opioid therapy for chronic noncancer pain is being called into question,^2–5 and a 2016 guideline from the US Centers for Disease Control and Prevention has called for more limited and judicious use of opioids in primary care.⁶ Nevertheless, long-term opioid therapy is probably helpful in some circumstances and will likely continue to have a role in chronic pain management for the foreseeable future.⁷

Concerns about opioids include risks of overdose and death. Unintentional drug overdoses, typically with opioids, exceeded motor vehicle accidents in 2009 as the leading cause of accidental death in the United States⁸; by 2014, nearly one and a half times as many people were dying of a drug overdose than of a car accident.⁹ Even when used appropriately, opioids are associated with sedation, falls, motor vehicle accidents, addiction, and unintended overdose.¹⁰

The potential harm extends beyond the patient to the community at large. Diversion of prescription drugs for nonmedical use is common¹¹ and, after marijuana and alcohol abuse, is the most common form of drug abuse in the United States.¹² Misuse of prescription drugs costs health insurers an estimated $72.5 billion each year—a cost largely passed on to consumers through higher premiums.¹³ Most individuals who abuse prescription opioids get them from friends and family, sometimes by stealing them.¹⁴

THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN

Chronic pain is extremely prevalent in general internal medicine and primary care practice.^15,16 It has tremendous associated medical, social, and economic costs.¹

In light of the risks and complexity of opioid use and the increasing regulatory requirements for safe prescribing, some primary care physicians have stopped prescribing opioids altogether and refer patients elsewhere for pain management.

This does a disservice to patients. Primary care physicians cannot entirely avoid chronic pain management or absolutely refuse to prescribe opioids in all circumstances and still provide quality care. And although some primary care physicians may need more training in prescribing opioids, their comprehensive understanding of the patient’s other health issues enables them to address the psychosocial generators and consequences of the patient’s chronic pain more fully than a specialist can.

Furthermore, access to board-certified pain specialists is limited. There are only four such specialists for every 100,000 patients with chronic pain,¹⁷ and those who are available often restrict the types of insurance they accept, disproportionately excluding Medicaid patients.

We encourage primary care physicians to undertake continuing medical education and professional development as needed to prescribe opioids as safely and effectively as possible.

A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A ‘NARCOTIC CONTRACT’

To address the challenges of long-term opioid therapy, many state officials, medical licensing boards, professional societies, and other regulatory bodies recommend proactive monitoring and management of prescribing risks. Often promoted and sometimes mandated is the use of a written pain treatment agreement, sometimes called a “pain contract” or “narcotic contract,” in which the patient and the physician ostensibly agree to various conditions under which opioids will be prescribed or discontinued. Although well-intentioned, these documents can cause several problems.

Contracts were being advocated in treating opiate addiction as early as 1981.¹⁸ Since then, the term “narcotic contract” has become widely used, even as most professional guidelines have now moved away from using it. A Google search for the term on November 27, 2015, yielded 2,000 results, with numerous examples of the documents in clinical use.

But the phrase is misleading, and we believe physicians should avoid using it. Clinically, the word “narcotic” is imprecise and can refer to substances other than opioids. For example, the US Controlled Substances Act lists cocaine as a narcotic.¹⁹ The word also carries a stigma, as law enforcement agencies and drug abuse programs commonly use phrases such as “narcotic task force” or “narcotic treatment program.” On the other hand, the more accurate term “opioid” may be unfamiliar to patients. We recommend using the term “controlled substance” instead.

Similarly, the word “contract” can be perceived as coercive, can erode physician-patient trust, and implies that failure to agree to it will result in loss of access to pain medications.^20–23

For these reasons, we encourage physicians to adopt the phrase “controlled-substance agreement” or something similar. This label accurately reflects the specificity of the treatment and connotes a partnership between patient and physician. Furthermore, it allows the physician to use the agreement when prescribing other controlled substances such as benzodiazepines and stimulants that also carry a risk of addiction, misuse, and adverse effects.

STIGMATIZING THE PATIENT

Although no studies have systematically assessed the style and tone of available treatment agreements, many of the agreements seem to stigmatize the patient, using language that is mistrustful, accusatory, and even confrontational and that implies that the patient will misuse or abuse the medications.^21,24 For example, “Failure to comply with the terms of the contract will risk loss of medication or discharge from the medical practice” is inflammatory and coercive, but variations of this phrase appear in many of the results of the aforementioned Google search.

Such language defeats attempts to communicate openly and implies a deprecatory attitude towards patients. Stigmatization may result in undertreatment of pain, physician refusal to prescribe opioids, and patient refusal to submit to the terms of a one-sided agreement perceived as unfair. Therefore, poorly written opioid agreements impair the trust necessary for a therapeutic physician-patient relationship and can interfere with optimal pain management.^20–23

Some physicians stigmatize inadvertently. Believing that they can identify which patients will misuse their prescriptions, they use controlled-substance agreements only in this subgroup. But in fact, physicians are notoriously poor at predicting which patients will misuse prescription opioids or suffer adverse effects.²⁵ Therefore, it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.²⁶

Framing the controlled-substance agreement in terms of safety and using it universally can minimize miscommunication and unintentional stigmatization.

SHARED DECISION-MAKING AND CHRONIC OPIOID THERAPY

We recommend using controlled-substance agreements only in the context of personalized patient counseling and shared decision-making.

Shared decision-making promotes mutual respect between patients and physicians, is feasible to implement in primary care, and may improve health outcomes.^27,28 A study found that physicians who received 2 hours of training in shared decision-making for chronic opioid therapy were more likely to complete treatment agreements and set mutually agreed-upon functional goals with patients, and they felt more confident, competent, and comfortable treating chronic pain.²⁹ Additionally, after learning about the risks, some patients may choose to forgo opioid therapy.

To be consistent with shared decision-making, the controlled-substance agreement must:

• Engage the patient, emphasizing the shared, reciprocal obligations of physician and patient
• Address goals of treatment that are personalized and mutually agreed-upon and that incorporate the patient’s values and preferences
• Explain treatment options in a way that is understandable and informative for the patient.

Table 1 outlines other key elements in detail.^27,30,31

Shared decision-making is especially useful when the balance between the risks and benefits of a treatment plan is uncertain. It is not a substitute for medical expertise, and a patient’s preferences do not override the physician’s clinical judgment. A physician should not offer or implement chronic opioid therapy if he or she believes it is not indicated or is contraindicated, or that the risks for that patient clearly outweigh the benefits.³²

THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES

Stigmatizing language in the controlled-substance agreement may result from physician ambivalence regarding its intent and objectives. For example, some may perceive the agreement as a way to facilitate communication, while others may use it in a possibly unethical manner to control patient behavior with the threat of cutting off access to pain medication.³³

Controlled-substance agreements have four commonly identified objectives,³⁴ explored further below:

• To improve adherence with the safe use of controlled substances while reducing aberrant behaviors
• To obtain informed consent
• To outline the prescribing policies of the practice
• To mitigate the prescriber’s legal risk.

Improving adherence

Many authors say that the primary goal of the controlled-substance agreement is to promote the use of the medication as prescribed, without variance, and from one physician only.^35–38 This goal seems reasonable. However, many other classes of medications are also risky when used aberrantly, and we do not ask the patient to sign an agreement when we prescribe them. This double standard may reflect both the inherently higher risks associated with controlled substances and physician ambivalence regarding their use.

Regardless, the efficacy of controlled­substance agreements in improving safe-use adherence and reducing aberrant medication-taking behaviors is uncertain. A 2010 systematic review based on observational and largely poor-quality studies concluded that using treatment agreements along with urine drug testing modestly reduced opioid misuse,³⁹ while other reports have called their efficacy into question.⁴⁰ We remain optimistic that well-written controlled-substance agreements can advance this objective, and that absence of evidence is not evidence of absence—ie, lack of efficacy. However, the data are not yet clear.

Interestingly, a 2014 survey found that most primary care physicians thought that controlled-substance agreements do not meaningfully reduce opioid misuse but do give a sense of protection against liability.⁴¹ Additionally, these documents are associated with a greater sense of physician satisfaction and mastery,⁴² and for some physicians these reasons may be enough to justify their use.

Somewhat alarmingly though, one study suggests that many patients do not even know that they signed a treatment agreement.⁴³ Using a controlled-substance agreement without the full awareness and engagement of the patient cannot promote adherence and is likely counterproductive.

Obtaining informed consent

It is essential to discuss possible benefits and risks so that informed and shared decision-making can occur.

Controlled-substance agreements may advance this aim if carefully written, although medical practices often design them for use across a spectrum of patients with varying indications, contraindications, and risks, making these documents inherently inflexible. A one-size-fits-all document does not allow for meaningful personalization and is insufficient without patient-centered counseling.

We strongly recommend that treatment agreements complement but not replace personalized patient-centered counseling about individual risks and benefits. Well-written controlled-substance agreements may reduce the chance of overlooking key risks and launch further customized discussion. Additionally, they can be written in a manner that allows patients and physicians to agree on and document personalized goals (Table 2).

Furthermore, when crafted within a risk-benefit framework, a controlled-substance agreement can help to clarify an ethically important concept, ie, that the physician is judging the safety and appropriateness of the treatment, not the character of the patient.⁴⁴ The prescriber can focus on evaluating the risks and benefits of treatment choices, not being a police officer or a judge of how “deserving” of opioid therapy the patient is.

Importantly, for patients to provide meaningful informed consent, the agreement must be understandable. A study of 162 opioid treatment agreements found that on average, they were written at a 14th grade level, which is beyond the reading comprehension of most patients.⁴⁵ Another study evaluated patients’ ability to understand and follow instructions on labels for common prescriptions; even though 70% of the patients could read the labels, only 34.7% could demonstrate the instructions “take two tablets by mouth twice daily.”⁴⁶

We recommend analyzing all controlled- substance agreements for readability by assessing their Flesch-Kincaid grade level or a similar literacy assessment, using readily available computer apps. The average education level of the patients cared for in each practice will vary based on the demographic served, and the controlled-substance agreement can be modified accordingly, but typically writing the document at the 6th- to 7th-grade reading level is suggested.

Outlining practice policies

Opioids are federally controlled substances with prescribing restrictions that vary based on the drug’s Drug Enforcement Agency schedule. State laws and regulations also govern opioid prescribing and are constantly evolving.⁴⁷

Refilling opioid prescriptions should be a deliberate process during which the prescriber reviews the appropriateness of the medication and issues the prescription as safely as possible.

To promote practice consistency and to share expectations transparently with patients, we recommend spelling out in the agreement your policies on:

• Who can manage this patient’s opioid therapy
• How to handle refill requests after hours and on weekends
• When and how patients should request opioid refills
• Which pharmacies patients will use
• Whether the practice allows others to pick up refills for the patient.

This not only serves as a reference for patients, who keep a copy for their records, it also reduces the risk of inconsistent processes within the office, which will quickly lead to chaos and confusion among patients and physicians alike. Inconsistent prescription and refill practices can give the impression that a double standard exists and that some patients get more leeway than others, without apparent justification.

There is little evidence that this approach truly improves practice efficiency,^34,48 but we believe that it may avert future confusion and conflict.

Mitigating the prescriber’s risk

Most licensing boards and clinical guidelines recommend controlled-substance agreements as part of opioid risk mitigation. These documents are now the standard of care, with many bodies recommending or mandating them, including the Federation of State Medical Boards,⁴⁹ many states,⁵⁰ Physicians for Responsible Opioid Prescribing,⁵¹ the American Academy of Pain Management,⁵² and the American Pain Society along with the American Academy of Pain Medicine.⁵³

Historically, primary care physicians have used controlled-substance agreements inconsistently and primarily for patients believed to be at high risk of misuse.⁵⁴ However, because physicians cannot accurately predict who will misuse or divert medications,²⁵ controlled-substance agreements should be used universally, ie, for all patients prescribed controlled substances.

A controlled-substance agreement can serve as documentation. The patient can keep a copy for future reference, and a cosigned document is evidence that a discussion took place and may lower the risk of malpractice litigation.⁵⁵ Further, if a state requires physicians to check their prescription monitoring database before prescribing opioids, the controlled-substance agreement can serve to both inform patients about this obligation and to obtain their consent when required.

At a minimum, we recommend that prescribers learn about the regulatory framework in their state and use controlled-substance agreements as legislatively mandated.

A CHECKLIST FOR THE PHYSICIAN AND PATIENT

To facilitate the development and use of ethically appropriate controlled-substance agreements with a focus on shared decision-making, we offer a sample tool in the form of a checklist (Table 2). It can be modified and implemented instead of a traditional controlled-substance agreement or can be used alongside other more comprehensive documents to facilitate discussion.

The model presents critical information for the patient and physician to discuss and acknowledge (initial) in writing. It is divided into three sections: shared responsibilities, patient responsibilities, and physician responsibilities. Each contains an approximately equal number of items; this is deliberate and visually conveys the notion of equivalent and shared responsibilities for patient and physician. The patient, physician, or both should initial each item to indicate their agreement.

The document is customizable for the specific treatment prescribed. It is written at a Flesch-Kincaid grade level of 6.8, consistent with current health literacy recommendations, and avoids medical jargon and complex compound sentences as much as possible.

We indicate key elements of shared decision-making^27,30,31 in parentheses in Table 2 and cross-reference them with Table 1, which describes them more fully.

A BETTER TOOL

Both chronic pain and prescription drug abuse are highly prevalent and carry serious consequences. These overlapping epidemics put the prescriber in the difficult position of trying to prevent misuse, abuse, and diversion while simultaneously adequately treating pain.

Physicians and policy makers look to controlled-substance agreements as tools to help them balance the benefits and risks, but frequently at the expense of eroding trust between the patient and physician, stigmatizing the patient, using pejorative and coercive language, not adhering to health literacy guidelines, and failing to share decisions.

We believe a better tool is possible and suggest that controlled-substance agreements be universally applied, use deliberate and understandable language, be framed in terms of safety, and be implemented according to the principles of shared decision-making.

Regulatory bodies and professional societies have encouraged or mandated written pain treatment agreements for over a decade as a way to establish informed consent, improve adherence, and mitigate risk. Unfortunately, the content of these agreements varies, their efficacy is uncertain, and some are stigmatizing or coercive and jeopardize trust. Additionally, many are written at reading levels beyond most patients’ understanding. However, we believe a well-written agreement is still an important tool in chronic pain management.

In this article, we explore common limitations of current pain treatment “contracts” and propose strategies to improve their usefulness and acceptance.

PAIN AND ITS TREATMENT HAVE COSTS

Chronic pain affects 100 million US adults and is estimated to cost $635 billion each year in treatment, lost wages, and reduced productivity.¹

Opioid therapy for chronic noncancer pain is being called into question,^2–5 and a 2016 guideline from the US Centers for Disease Control and Prevention has called for more limited and judicious use of opioids in primary care.⁶ Nevertheless, long-term opioid therapy is probably helpful in some circumstances and will likely continue to have a role in chronic pain management for the foreseeable future.⁷

Concerns about opioids include risks of overdose and death. Unintentional drug overdoses, typically with opioids, exceeded motor vehicle accidents in 2009 as the leading cause of accidental death in the United States⁸; by 2014, nearly one and a half times as many people were dying of a drug overdose than of a car accident.⁹ Even when used appropriately, opioids are associated with sedation, falls, motor vehicle accidents, addiction, and unintended overdose.¹⁰

The potential harm extends beyond the patient to the community at large. Diversion of prescription drugs for nonmedical use is common¹¹ and, after marijuana and alcohol abuse, is the most common form of drug abuse in the United States.¹² Misuse of prescription drugs costs health insurers an estimated $72.5 billion each year—a cost largely passed on to consumers through higher premiums.¹³ Most individuals who abuse prescription opioids get them from friends and family, sometimes by stealing them.¹⁴

THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN

Chronic pain is extremely prevalent in general internal medicine and primary care practice.^15,16 It has tremendous associated medical, social, and economic costs.¹

In light of the risks and complexity of opioid use and the increasing regulatory requirements for safe prescribing, some primary care physicians have stopped prescribing opioids altogether and refer patients elsewhere for pain management.

This does a disservice to patients. Primary care physicians cannot entirely avoid chronic pain management or absolutely refuse to prescribe opioids in all circumstances and still provide quality care. And although some primary care physicians may need more training in prescribing opioids, their comprehensive understanding of the patient’s other health issues enables them to address the psychosocial generators and consequences of the patient’s chronic pain more fully than a specialist can.

Furthermore, access to board-certified pain specialists is limited. There are only four such specialists for every 100,000 patients with chronic pain,¹⁷ and those who are available often restrict the types of insurance they accept, disproportionately excluding Medicaid patients.

We encourage primary care physicians to undertake continuing medical education and professional development as needed to prescribe opioids as safely and effectively as possible.

A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A ‘NARCOTIC CONTRACT’

To address the challenges of long-term opioid therapy, many state officials, medical licensing boards, professional societies, and other regulatory bodies recommend proactive monitoring and management of prescribing risks. Often promoted and sometimes mandated is the use of a written pain treatment agreement, sometimes called a “pain contract” or “narcotic contract,” in which the patient and the physician ostensibly agree to various conditions under which opioids will be prescribed or discontinued. Although well-intentioned, these documents can cause several problems.

Contracts were being advocated in treating opiate addiction as early as 1981.¹⁸ Since then, the term “narcotic contract” has become widely used, even as most professional guidelines have now moved away from using it. A Google search for the term on November 27, 2015, yielded 2,000 results, with numerous examples of the documents in clinical use.

But the phrase is misleading, and we believe physicians should avoid using it. Clinically, the word “narcotic” is imprecise and can refer to substances other than opioids. For example, the US Controlled Substances Act lists cocaine as a narcotic.¹⁹ The word also carries a stigma, as law enforcement agencies and drug abuse programs commonly use phrases such as “narcotic task force” or “narcotic treatment program.” On the other hand, the more accurate term “opioid” may be unfamiliar to patients. We recommend using the term “controlled substance” instead.

Similarly, the word “contract” can be perceived as coercive, can erode physician-patient trust, and implies that failure to agree to it will result in loss of access to pain medications.^20–23

For these reasons, we encourage physicians to adopt the phrase “controlled-substance agreement” or something similar. This label accurately reflects the specificity of the treatment and connotes a partnership between patient and physician. Furthermore, it allows the physician to use the agreement when prescribing other controlled substances such as benzodiazepines and stimulants that also carry a risk of addiction, misuse, and adverse effects.

STIGMATIZING THE PATIENT

Although no studies have systematically assessed the style and tone of available treatment agreements, many of the agreements seem to stigmatize the patient, using language that is mistrustful, accusatory, and even confrontational and that implies that the patient will misuse or abuse the medications.^21,24 For example, “Failure to comply with the terms of the contract will risk loss of medication or discharge from the medical practice” is inflammatory and coercive, but variations of this phrase appear in many of the results of the aforementioned Google search.

Such language defeats attempts to communicate openly and implies a deprecatory attitude towards patients. Stigmatization may result in undertreatment of pain, physician refusal to prescribe opioids, and patient refusal to submit to the terms of a one-sided agreement perceived as unfair. Therefore, poorly written opioid agreements impair the trust necessary for a therapeutic physician-patient relationship and can interfere with optimal pain management.^20–23

Some physicians stigmatize inadvertently. Believing that they can identify which patients will misuse their prescriptions, they use controlled-substance agreements only in this subgroup. But in fact, physicians are notoriously poor at predicting which patients will misuse prescription opioids or suffer adverse effects.²⁵ Therefore, it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.²⁶

Framing the controlled-substance agreement in terms of safety and using it universally can minimize miscommunication and unintentional stigmatization.

SHARED DECISION-MAKING AND CHRONIC OPIOID THERAPY

We recommend using controlled-substance agreements only in the context of personalized patient counseling and shared decision-making.

Shared decision-making promotes mutual respect between patients and physicians, is feasible to implement in primary care, and may improve health outcomes.^27,28 A study found that physicians who received 2 hours of training in shared decision-making for chronic opioid therapy were more likely to complete treatment agreements and set mutually agreed-upon functional goals with patients, and they felt more confident, competent, and comfortable treating chronic pain.²⁹ Additionally, after learning about the risks, some patients may choose to forgo opioid therapy.

To be consistent with shared decision-making, the controlled-substance agreement must:

• Engage the patient, emphasizing the shared, reciprocal obligations of physician and patient
• Address goals of treatment that are personalized and mutually agreed-upon and that incorporate the patient’s values and preferences
• Explain treatment options in a way that is understandable and informative for the patient.

Table 1 outlines other key elements in detail.^27,30,31

Shared decision-making is especially useful when the balance between the risks and benefits of a treatment plan is uncertain. It is not a substitute for medical expertise, and a patient’s preferences do not override the physician’s clinical judgment. A physician should not offer or implement chronic opioid therapy if he or she believes it is not indicated or is contraindicated, or that the risks for that patient clearly outweigh the benefits.³²

THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES

Stigmatizing language in the controlled-substance agreement may result from physician ambivalence regarding its intent and objectives. For example, some may perceive the agreement as a way to facilitate communication, while others may use it in a possibly unethical manner to control patient behavior with the threat of cutting off access to pain medication.³³

Controlled-substance agreements have four commonly identified objectives,³⁴ explored further below:

• To improve adherence with the safe use of controlled substances while reducing aberrant behaviors
• To obtain informed consent
• To outline the prescribing policies of the practice
• To mitigate the prescriber’s legal risk.

Improving adherence

Many authors say that the primary goal of the controlled-substance agreement is to promote the use of the medication as prescribed, without variance, and from one physician only.^35–38 This goal seems reasonable. However, many other classes of medications are also risky when used aberrantly, and we do not ask the patient to sign an agreement when we prescribe them. This double standard may reflect both the inherently higher risks associated with controlled substances and physician ambivalence regarding their use.

Regardless, the efficacy of controlled­substance agreements in improving safe-use adherence and reducing aberrant medication-taking behaviors is uncertain. A 2010 systematic review based on observational and largely poor-quality studies concluded that using treatment agreements along with urine drug testing modestly reduced opioid misuse,³⁹ while other reports have called their efficacy into question.⁴⁰ We remain optimistic that well-written controlled-substance agreements can advance this objective, and that absence of evidence is not evidence of absence—ie, lack of efficacy. However, the data are not yet clear.

Interestingly, a 2014 survey found that most primary care physicians thought that controlled-substance agreements do not meaningfully reduce opioid misuse but do give a sense of protection against liability.⁴¹ Additionally, these documents are associated with a greater sense of physician satisfaction and mastery,⁴² and for some physicians these reasons may be enough to justify their use.

Somewhat alarmingly though, one study suggests that many patients do not even know that they signed a treatment agreement.⁴³ Using a controlled-substance agreement without the full awareness and engagement of the patient cannot promote adherence and is likely counterproductive.

Obtaining informed consent

It is essential to discuss possible benefits and risks so that informed and shared decision-making can occur.

Controlled-substance agreements may advance this aim if carefully written, although medical practices often design them for use across a spectrum of patients with varying indications, contraindications, and risks, making these documents inherently inflexible. A one-size-fits-all document does not allow for meaningful personalization and is insufficient without patient-centered counseling.

We strongly recommend that treatment agreements complement but not replace personalized patient-centered counseling about individual risks and benefits. Well-written controlled-substance agreements may reduce the chance of overlooking key risks and launch further customized discussion. Additionally, they can be written in a manner that allows patients and physicians to agree on and document personalized goals (Table 2).

Furthermore, when crafted within a risk-benefit framework, a controlled-substance agreement can help to clarify an ethically important concept, ie, that the physician is judging the safety and appropriateness of the treatment, not the character of the patient.⁴⁴ The prescriber can focus on evaluating the risks and benefits of treatment choices, not being a police officer or a judge of how “deserving” of opioid therapy the patient is.

Importantly, for patients to provide meaningful informed consent, the agreement must be understandable. A study of 162 opioid treatment agreements found that on average, they were written at a 14th grade level, which is beyond the reading comprehension of most patients.⁴⁵ Another study evaluated patients’ ability to understand and follow instructions on labels for common prescriptions; even though 70% of the patients could read the labels, only 34.7% could demonstrate the instructions “take two tablets by mouth twice daily.”⁴⁶

We recommend analyzing all controlled- substance agreements for readability by assessing their Flesch-Kincaid grade level or a similar literacy assessment, using readily available computer apps. The average education level of the patients cared for in each practice will vary based on the demographic served, and the controlled-substance agreement can be modified accordingly, but typically writing the document at the 6th- to 7th-grade reading level is suggested.

Outlining practice policies

Opioids are federally controlled substances with prescribing restrictions that vary based on the drug’s Drug Enforcement Agency schedule. State laws and regulations also govern opioid prescribing and are constantly evolving.⁴⁷

Refilling opioid prescriptions should be a deliberate process during which the prescriber reviews the appropriateness of the medication and issues the prescription as safely as possible.

To promote practice consistency and to share expectations transparently with patients, we recommend spelling out in the agreement your policies on:

• Who can manage this patient’s opioid therapy
• How to handle refill requests after hours and on weekends
• When and how patients should request opioid refills
• Which pharmacies patients will use
• Whether the practice allows others to pick up refills for the patient.

This not only serves as a reference for patients, who keep a copy for their records, it also reduces the risk of inconsistent processes within the office, which will quickly lead to chaos and confusion among patients and physicians alike. Inconsistent prescription and refill practices can give the impression that a double standard exists and that some patients get more leeway than others, without apparent justification.

There is little evidence that this approach truly improves practice efficiency,^34,48 but we believe that it may avert future confusion and conflict.

Mitigating the prescriber’s risk

Most licensing boards and clinical guidelines recommend controlled-substance agreements as part of opioid risk mitigation. These documents are now the standard of care, with many bodies recommending or mandating them, including the Federation of State Medical Boards,⁴⁹ many states,⁵⁰ Physicians for Responsible Opioid Prescribing,⁵¹ the American Academy of Pain Management,⁵² and the American Pain Society along with the American Academy of Pain Medicine.⁵³

Historically, primary care physicians have used controlled-substance agreements inconsistently and primarily for patients believed to be at high risk of misuse.⁵⁴ However, because physicians cannot accurately predict who will misuse or divert medications,²⁵ controlled-substance agreements should be used universally, ie, for all patients prescribed controlled substances.

A controlled-substance agreement can serve as documentation. The patient can keep a copy for future reference, and a cosigned document is evidence that a discussion took place and may lower the risk of malpractice litigation.⁵⁵ Further, if a state requires physicians to check their prescription monitoring database before prescribing opioids, the controlled-substance agreement can serve to both inform patients about this obligation and to obtain their consent when required.

At a minimum, we recommend that prescribers learn about the regulatory framework in their state and use controlled-substance agreements as legislatively mandated.

A CHECKLIST FOR THE PHYSICIAN AND PATIENT

To facilitate the development and use of ethically appropriate controlled-substance agreements with a focus on shared decision-making, we offer a sample tool in the form of a checklist (Table 2). It can be modified and implemented instead of a traditional controlled-substance agreement or can be used alongside other more comprehensive documents to facilitate discussion.

The model presents critical information for the patient and physician to discuss and acknowledge (initial) in writing. It is divided into three sections: shared responsibilities, patient responsibilities, and physician responsibilities. Each contains an approximately equal number of items; this is deliberate and visually conveys the notion of equivalent and shared responsibilities for patient and physician. The patient, physician, or both should initial each item to indicate their agreement.

The document is customizable for the specific treatment prescribed. It is written at a Flesch-Kincaid grade level of 6.8, consistent with current health literacy recommendations, and avoids medical jargon and complex compound sentences as much as possible.

We indicate key elements of shared decision-making^27,30,31 in parentheses in Table 2 and cross-reference them with Table 1, which describes them more fully.

A BETTER TOOL

Both chronic pain and prescription drug abuse are highly prevalent and carry serious consequences. These overlapping epidemics put the prescriber in the difficult position of trying to prevent misuse, abuse, and diversion while simultaneously adequately treating pain.

Physicians and policy makers look to controlled-substance agreements as tools to help them balance the benefits and risks, but frequently at the expense of eroding trust between the patient and physician, stigmatizing the patient, using pejorative and coercive language, not adhering to health literacy guidelines, and failing to share decisions.

We believe a better tool is possible and suggest that controlled-substance agreements be universally applied, use deliberate and understandable language, be framed in terms of safety, and be implemented according to the principles of shared decision-making.

Regulatory bodies and professional societies have encouraged or mandated written pain treatment agreements for over a decade as a way to establish informed consent, improve adherence, and mitigate risk. Unfortunately, the content of these agreements varies, their efficacy is uncertain, and some are stigmatizing or coercive and jeopardize trust. Additionally, many are written at reading levels beyond most patients’ understanding. However, we believe a well-written agreement is still an important tool in chronic pain management.

In this article, we explore common limitations of current pain treatment “contracts” and propose strategies to improve their usefulness and acceptance.

PAIN AND ITS TREATMENT HAVE COSTS

Chronic pain affects 100 million US adults and is estimated to cost $635 billion each year in treatment, lost wages, and reduced productivity.¹

Opioid therapy for chronic noncancer pain is being called into question,^2–5 and a 2016 guideline from the US Centers for Disease Control and Prevention has called for more limited and judicious use of opioids in primary care.⁶ Nevertheless, long-term opioid therapy is probably helpful in some circumstances and will likely continue to have a role in chronic pain management for the foreseeable future.⁷

Concerns about opioids include risks of overdose and death. Unintentional drug overdoses, typically with opioids, exceeded motor vehicle accidents in 2009 as the leading cause of accidental death in the United States⁸; by 2014, nearly one and a half times as many people were dying of a drug overdose than of a car accident.⁹ Even when used appropriately, opioids are associated with sedation, falls, motor vehicle accidents, addiction, and unintended overdose.¹⁰

The potential harm extends beyond the patient to the community at large. Diversion of prescription drugs for nonmedical use is common¹¹ and, after marijuana and alcohol abuse, is the most common form of drug abuse in the United States.¹² Misuse of prescription drugs costs health insurers an estimated $72.5 billion each year—a cost largely passed on to consumers through higher premiums.¹³ Most individuals who abuse prescription opioids get them from friends and family, sometimes by stealing them.¹⁴

THE SPECIAL ROLE OF THE PRIMARY CARE PHYSICIAN

Chronic pain is extremely prevalent in general internal medicine and primary care practice.^15,16 It has tremendous associated medical, social, and economic costs.¹

In light of the risks and complexity of opioid use and the increasing regulatory requirements for safe prescribing, some primary care physicians have stopped prescribing opioids altogether and refer patients elsewhere for pain management.

This does a disservice to patients. Primary care physicians cannot entirely avoid chronic pain management or absolutely refuse to prescribe opioids in all circumstances and still provide quality care. And although some primary care physicians may need more training in prescribing opioids, their comprehensive understanding of the patient’s other health issues enables them to address the psychosocial generators and consequences of the patient’s chronic pain more fully than a specialist can.

Furthermore, access to board-certified pain specialists is limited. There are only four such specialists for every 100,000 patients with chronic pain,¹⁷ and those who are available often restrict the types of insurance they accept, disproportionately excluding Medicaid patients.

We encourage primary care physicians to undertake continuing medical education and professional development as needed to prescribe opioids as safely and effectively as possible.

A CONTROLLED-SUBSTANCE AGREEMENT INSTEAD OF A ‘NARCOTIC CONTRACT’

To address the challenges of long-term opioid therapy, many state officials, medical licensing boards, professional societies, and other regulatory bodies recommend proactive monitoring and management of prescribing risks. Often promoted and sometimes mandated is the use of a written pain treatment agreement, sometimes called a “pain contract” or “narcotic contract,” in which the patient and the physician ostensibly agree to various conditions under which opioids will be prescribed or discontinued. Although well-intentioned, these documents can cause several problems.

Contracts were being advocated in treating opiate addiction as early as 1981.¹⁸ Since then, the term “narcotic contract” has become widely used, even as most professional guidelines have now moved away from using it. A Google search for the term on November 27, 2015, yielded 2,000 results, with numerous examples of the documents in clinical use.

But the phrase is misleading, and we believe physicians should avoid using it. Clinically, the word “narcotic” is imprecise and can refer to substances other than opioids. For example, the US Controlled Substances Act lists cocaine as a narcotic.¹⁹ The word also carries a stigma, as law enforcement agencies and drug abuse programs commonly use phrases such as “narcotic task force” or “narcotic treatment program.” On the other hand, the more accurate term “opioid” may be unfamiliar to patients. We recommend using the term “controlled substance” instead.

Similarly, the word “contract” can be perceived as coercive, can erode physician-patient trust, and implies that failure to agree to it will result in loss of access to pain medications.^20–23

For these reasons, we encourage physicians to adopt the phrase “controlled-substance agreement” or something similar. This label accurately reflects the specificity of the treatment and connotes a partnership between patient and physician. Furthermore, it allows the physician to use the agreement when prescribing other controlled substances such as benzodiazepines and stimulants that also carry a risk of addiction, misuse, and adverse effects.

STIGMATIZING THE PATIENT

Although no studies have systematically assessed the style and tone of available treatment agreements, many of the agreements seem to stigmatize the patient, using language that is mistrustful, accusatory, and even confrontational and that implies that the patient will misuse or abuse the medications.^21,24 For example, “Failure to comply with the terms of the contract will risk loss of medication or discharge from the medical practice” is inflammatory and coercive, but variations of this phrase appear in many of the results of the aforementioned Google search.

Such language defeats attempts to communicate openly and implies a deprecatory attitude towards patients. Stigmatization may result in undertreatment of pain, physician refusal to prescribe opioids, and patient refusal to submit to the terms of a one-sided agreement perceived as unfair. Therefore, poorly written opioid agreements impair the trust necessary for a therapeutic physician-patient relationship and can interfere with optimal pain management.^20–23

Some physicians stigmatize inadvertently. Believing that they can identify which patients will misuse their prescriptions, they use controlled-substance agreements only in this subgroup. But in fact, physicians are notoriously poor at predicting which patients will misuse prescription opioids or suffer adverse effects.²⁵ Therefore, it is important to be transparent and consistent with monitoring practices for all patients on chronic opioid therapy.²⁶

Framing the controlled-substance agreement in terms of safety and using it universally can minimize miscommunication and unintentional stigmatization.

SHARED DECISION-MAKING AND CHRONIC OPIOID THERAPY

We recommend using controlled-substance agreements only in the context of personalized patient counseling and shared decision-making.

Shared decision-making promotes mutual respect between patients and physicians, is feasible to implement in primary care, and may improve health outcomes.^27,28 A study found that physicians who received 2 hours of training in shared decision-making for chronic opioid therapy were more likely to complete treatment agreements and set mutually agreed-upon functional goals with patients, and they felt more confident, competent, and comfortable treating chronic pain.²⁹ Additionally, after learning about the risks, some patients may choose to forgo opioid therapy.

To be consistent with shared decision-making, the controlled-substance agreement must:

• Engage the patient, emphasizing the shared, reciprocal obligations of physician and patient
• Address goals of treatment that are personalized and mutually agreed-upon and that incorporate the patient’s values and preferences
• Explain treatment options in a way that is understandable and informative for the patient.

Table 1 outlines other key elements in detail.^27,30,31

Shared decision-making is especially useful when the balance between the risks and benefits of a treatment plan is uncertain. It is not a substitute for medical expertise, and a patient’s preferences do not override the physician’s clinical judgment. A physician should not offer or implement chronic opioid therapy if he or she believes it is not indicated or is contraindicated, or that the risks for that patient clearly outweigh the benefits.³²

THE CONTROLLED-SUBSTANCE AGREEMENT: FOUR OBJECTIVES

Stigmatizing language in the controlled-substance agreement may result from physician ambivalence regarding its intent and objectives. For example, some may perceive the agreement as a way to facilitate communication, while others may use it in a possibly unethical manner to control patient behavior with the threat of cutting off access to pain medication.³³

Controlled-substance agreements have four commonly identified objectives,³⁴ explored further below:

• To improve adherence with the safe use of controlled substances while reducing aberrant behaviors
• To obtain informed consent
• To outline the prescribing policies of the practice
• To mitigate the prescriber’s legal risk.

Improving adherence

Many authors say that the primary goal of the controlled-substance agreement is to promote the use of the medication as prescribed, without variance, and from one physician only.^35–38 This goal seems reasonable. However, many other classes of medications are also risky when used aberrantly, and we do not ask the patient to sign an agreement when we prescribe them. This double standard may reflect both the inherently higher risks associated with controlled substances and physician ambivalence regarding their use.

Regardless, the efficacy of controlled­substance agreements in improving safe-use adherence and reducing aberrant medication-taking behaviors is uncertain. A 2010 systematic review based on observational and largely poor-quality studies concluded that using treatment agreements along with urine drug testing modestly reduced opioid misuse,³⁹ while other reports have called their efficacy into question.⁴⁰ We remain optimistic that well-written controlled-substance agreements can advance this objective, and that absence of evidence is not evidence of absence—ie, lack of efficacy. However, the data are not yet clear.

Interestingly, a 2014 survey found that most primary care physicians thought that controlled-substance agreements do not meaningfully reduce opioid misuse but do give a sense of protection against liability.⁴¹ Additionally, these documents are associated with a greater sense of physician satisfaction and mastery,⁴² and for some physicians these reasons may be enough to justify their use.

Somewhat alarmingly though, one study suggests that many patients do not even know that they signed a treatment agreement.⁴³ Using a controlled-substance agreement without the full awareness and engagement of the patient cannot promote adherence and is likely counterproductive.

Obtaining informed consent

It is essential to discuss possible benefits and risks so that informed and shared decision-making can occur.

Controlled-substance agreements may advance this aim if carefully written, although medical practices often design them for use across a spectrum of patients with varying indications, contraindications, and risks, making these documents inherently inflexible. A one-size-fits-all document does not allow for meaningful personalization and is insufficient without patient-centered counseling.

We strongly recommend that treatment agreements complement but not replace personalized patient-centered counseling about individual risks and benefits. Well-written controlled-substance agreements may reduce the chance of overlooking key risks and launch further customized discussion. Additionally, they can be written in a manner that allows patients and physicians to agree on and document personalized goals (Table 2).

Furthermore, when crafted within a risk-benefit framework, a controlled-substance agreement can help to clarify an ethically important concept, ie, that the physician is judging the safety and appropriateness of the treatment, not the character of the patient.⁴⁴ The prescriber can focus on evaluating the risks and benefits of treatment choices, not being a police officer or a judge of how “deserving” of opioid therapy the patient is.

Importantly, for patients to provide meaningful informed consent, the agreement must be understandable. A study of 162 opioid treatment agreements found that on average, they were written at a 14th grade level, which is beyond the reading comprehension of most patients.⁴⁵ Another study evaluated patients’ ability to understand and follow instructions on labels for common prescriptions; even though 70% of the patients could read the labels, only 34.7% could demonstrate the instructions “take two tablets by mouth twice daily.”⁴⁶

We recommend analyzing all controlled- substance agreements for readability by assessing their Flesch-Kincaid grade level or a similar literacy assessment, using readily available computer apps. The average education level of the patients cared for in each practice will vary based on the demographic served, and the controlled-substance agreement can be modified accordingly, but typically writing the document at the 6th- to 7th-grade reading level is suggested.

Outlining practice policies

Opioids are federally controlled substances with prescribing restrictions that vary based on the drug’s Drug Enforcement Agency schedule. State laws and regulations also govern opioid prescribing and are constantly evolving.⁴⁷

Refilling opioid prescriptions should be a deliberate process during which the prescriber reviews the appropriateness of the medication and issues the prescription as safely as possible.

To promote practice consistency and to share expectations transparently with patients, we recommend spelling out in the agreement your policies on:

• Who can manage this patient’s opioid therapy
• How to handle refill requests after hours and on weekends
• When and how patients should request opioid refills
• Which pharmacies patients will use
• Whether the practice allows others to pick up refills for the patient.

This not only serves as a reference for patients, who keep a copy for their records, it also reduces the risk of inconsistent processes within the office, which will quickly lead to chaos and confusion among patients and physicians alike. Inconsistent prescription and refill practices can give the impression that a double standard exists and that some patients get more leeway than others, without apparent justification.

There is little evidence that this approach truly improves practice efficiency,^34,48 but we believe that it may avert future confusion and conflict.

Mitigating the prescriber’s risk

Most licensing boards and clinical guidelines recommend controlled-substance agreements as part of opioid risk mitigation. These documents are now the standard of care, with many bodies recommending or mandating them, including the Federation of State Medical Boards,⁴⁹ many states,⁵⁰ Physicians for Responsible Opioid Prescribing,⁵¹ the American Academy of Pain Management,⁵² and the American Pain Society along with the American Academy of Pain Medicine.⁵³

Historically, primary care physicians have used controlled-substance agreements inconsistently and primarily for patients believed to be at high risk of misuse.⁵⁴ However, because physicians cannot accurately predict who will misuse or divert medications,²⁵ controlled-substance agreements should be used universally, ie, for all patients prescribed controlled substances.

A controlled-substance agreement can serve as documentation. The patient can keep a copy for future reference, and a cosigned document is evidence that a discussion took place and may lower the risk of malpractice litigation.⁵⁵ Further, if a state requires physicians to check their prescription monitoring database before prescribing opioids, the controlled-substance agreement can serve to both inform patients about this obligation and to obtain their consent when required.

At a minimum, we recommend that prescribers learn about the regulatory framework in their state and use controlled-substance agreements as legislatively mandated.

A CHECKLIST FOR THE PHYSICIAN AND PATIENT

To facilitate the development and use of ethically appropriate controlled-substance agreements with a focus on shared decision-making, we offer a sample tool in the form of a checklist (Table 2). It can be modified and implemented instead of a traditional controlled-substance agreement or can be used alongside other more comprehensive documents to facilitate discussion.

The model presents critical information for the patient and physician to discuss and acknowledge (initial) in writing. It is divided into three sections: shared responsibilities, patient responsibilities, and physician responsibilities. Each contains an approximately equal number of items; this is deliberate and visually conveys the notion of equivalent and shared responsibilities for patient and physician. The patient, physician, or both should initial each item to indicate their agreement.

The document is customizable for the specific treatment prescribed. It is written at a Flesch-Kincaid grade level of 6.8, consistent with current health literacy recommendations, and avoids medical jargon and complex compound sentences as much as possible.

We indicate key elements of shared decision-making^27,30,31 in parentheses in Table 2 and cross-reference them with Table 1, which describes them more fully.

A BETTER TOOL

Both chronic pain and prescription drug abuse are highly prevalent and carry serious consequences. These overlapping epidemics put the prescriber in the difficult position of trying to prevent misuse, abuse, and diversion while simultaneously adequately treating pain.

Physicians and policy makers look to controlled-substance agreements as tools to help them balance the benefits and risks, but frequently at the expense of eroding trust between the patient and physician, stigmatizing the patient, using pejorative and coercive language, not adhering to health literacy guidelines, and failing to share decisions.

We believe a better tool is possible and suggest that controlled-substance agreements be universally applied, use deliberate and understandable language, be framed in terms of safety, and be implemented according to the principles of shared decision-making.

To the Editor: I much enjoyed the important article by Drs. Lipold, Batur, and Kagan on whether there is a time limit for systemic menopausal hormone therapy.¹ The simple answer is no. The authors did a good job of reviewing the factors to consider in terms of contraindications and precautions when prescribing menopausal hormone therapy.

An important part of the discussion regarding stopping hormone therapy is the recent evidence from Finland that has shown increased risks of myocardial infarction and stroke, especially in women under age 60, when taken off hormone therapy.² This fact is quite ironic, as many clinicians are trying to rush to get women off hormone therapy in order to protect the heart, when the evidence does not suggest this. Just as with other hormone-deficiency conditions, the status needs to be periodically reviewed, and doses may need to be adjusted. However, after age 60 or 65, women do not automatically start producing the sex hormone that they have been deficient in. While menopause is not a definite endocrinopathy, it is a potential endocrinopathy; and for some women, such as young women who are oophorectomized, it is an absolute endocrinopathy.

The International Menopause Society has published updated guidelines emphasizing that new data and reanalysis of older data show that for most women the benefits of menopausal hormone therapy are much greater than the risks, particularly when started within a few years of menopause.³

To the Editor: I much enjoyed the important article by Drs. Lipold, Batur, and Kagan on whether there is a time limit for systemic menopausal hormone therapy.¹ The simple answer is no. The authors did a good job of reviewing the factors to consider in terms of contraindications and precautions when prescribing menopausal hormone therapy.

An important part of the discussion regarding stopping hormone therapy is the recent evidence from Finland that has shown increased risks of myocardial infarction and stroke, especially in women under age 60, when taken off hormone therapy.² This fact is quite ironic, as many clinicians are trying to rush to get women off hormone therapy in order to protect the heart, when the evidence does not suggest this. Just as with other hormone-deficiency conditions, the status needs to be periodically reviewed, and doses may need to be adjusted. However, after age 60 or 65, women do not automatically start producing the sex hormone that they have been deficient in. While menopause is not a definite endocrinopathy, it is a potential endocrinopathy; and for some women, such as young women who are oophorectomized, it is an absolute endocrinopathy.

The International Menopause Society has published updated guidelines emphasizing that new data and reanalysis of older data show that for most women the benefits of menopausal hormone therapy are much greater than the risks, particularly when started within a few years of menopause.³

To the Editor: I much enjoyed the important article by Drs. Lipold, Batur, and Kagan on whether there is a time limit for systemic menopausal hormone therapy.¹ The simple answer is no. The authors did a good job of reviewing the factors to consider in terms of contraindications and precautions when prescribing menopausal hormone therapy.

An important part of the discussion regarding stopping hormone therapy is the recent evidence from Finland that has shown increased risks of myocardial infarction and stroke, especially in women under age 60, when taken off hormone therapy.² This fact is quite ironic, as many clinicians are trying to rush to get women off hormone therapy in order to protect the heart, when the evidence does not suggest this. Just as with other hormone-deficiency conditions, the status needs to be periodically reviewed, and doses may need to be adjusted. However, after age 60 or 65, women do not automatically start producing the sex hormone that they have been deficient in. While menopause is not a definite endocrinopathy, it is a potential endocrinopathy; and for some women, such as young women who are oophorectomized, it is an absolute endocrinopathy.

The International Menopause Society has published updated guidelines emphasizing that new data and reanalysis of older data show that for most women the benefits of menopausal hormone therapy are much greater than the risks, particularly when started within a few years of menopause.³

In Reply: We would like to thank Dr. Thacker for her interest in our article on the clinical considerations regarding optimal duration of hormone therapy.¹ We agree that the simple answer to whether there is there a time limit for systemic menopausal hormone therapy is no, emphasizing an individualized approach to each patient. After appropriate counseling and shared decision-making, some women may elect a short duration of therapy while others prefer longer-term use.

As Dr. Thacker mentioned, Mikkola et al² performed an observational study of more than 300,000 Finnish women who discontinued hormone therapy. Data on the number of deaths in this group were gathered from a national database and compared with the expected number of deaths in the background population; 30% of the listed causes of death were confirmed by autopsy. In women who had started hormone therapy before age 60, the risk of cardiac death was elevated within the first year after stopping it (standardized mortality ratio [SMR] 1.74; 95% confidence interval [CI] 1.37–2.19), as was the risk of stroke (SMR 2.59, 95% CI 2.08–3.19). This was not true in women who started hormone therapy at age 60 and older. These findings are consistent with our contemporary understanding that for many women younger than age 60 the benefits of hormone therapy outweigh the risks.

The study had several important limitations:

• A healthy-woman bias may have contributed to the reduction in cardiovascular risk.
• No dates for the myocardial infarctions or strokes were available, and the dates hormone therapy was discontined potentially had a 3-month error.
• No data were available on important confounding factors such as smoking, body mass index, blood pressure, lipid levels, and family history.
• Hormone therapy users were compared with an age-standardized background population, which also included hormone therapy users.
• Long-term follow-up data were also perplexing: although more women than expected died of stroke or coronary heart disease within the first year of stopping hormone therapy, after 1 year, significantly fewer women died of these conditions than expected, regardless of how long they had been on hormone therapy before stopping.

These observations highlight the need for long-term, randomized, prospective controlled studies that adequately assess all long-term outcomes (cardiovascular events, mortality, cancer, fracture) in women who initiate hormone therapy before age 60 and within 10 years of menopause, including long-term follow-up after discontinuation. Though future randomized controlled trials will be beneficial to help guide women to a more balanced understanding of long-term hormone therapy and the risks of discontinuation, the current evidence supports continuing hormone therapy in women who derive a net benefit.

In Reply: We would like to thank Dr. Thacker for her interest in our article on the clinical considerations regarding optimal duration of hormone therapy.¹ We agree that the simple answer to whether there is there a time limit for systemic menopausal hormone therapy is no, emphasizing an individualized approach to each patient. After appropriate counseling and shared decision-making, some women may elect a short duration of therapy while others prefer longer-term use.

As Dr. Thacker mentioned, Mikkola et al² performed an observational study of more than 300,000 Finnish women who discontinued hormone therapy. Data on the number of deaths in this group were gathered from a national database and compared with the expected number of deaths in the background population; 30% of the listed causes of death were confirmed by autopsy. In women who had started hormone therapy before age 60, the risk of cardiac death was elevated within the first year after stopping it (standardized mortality ratio [SMR] 1.74; 95% confidence interval [CI] 1.37–2.19), as was the risk of stroke (SMR 2.59, 95% CI 2.08–3.19). This was not true in women who started hormone therapy at age 60 and older. These findings are consistent with our contemporary understanding that for many women younger than age 60 the benefits of hormone therapy outweigh the risks.

The study had several important limitations:

• A healthy-woman bias may have contributed to the reduction in cardiovascular risk.
• No dates for the myocardial infarctions or strokes were available, and the dates hormone therapy was discontined potentially had a 3-month error.
• No data were available on important confounding factors such as smoking, body mass index, blood pressure, lipid levels, and family history.
• Hormone therapy users were compared with an age-standardized background population, which also included hormone therapy users.
• Long-term follow-up data were also perplexing: although more women than expected died of stroke or coronary heart disease within the first year of stopping hormone therapy, after 1 year, significantly fewer women died of these conditions than expected, regardless of how long they had been on hormone therapy before stopping.

These observations highlight the need for long-term, randomized, prospective controlled studies that adequately assess all long-term outcomes (cardiovascular events, mortality, cancer, fracture) in women who initiate hormone therapy before age 60 and within 10 years of menopause, including long-term follow-up after discontinuation. Though future randomized controlled trials will be beneficial to help guide women to a more balanced understanding of long-term hormone therapy and the risks of discontinuation, the current evidence supports continuing hormone therapy in women who derive a net benefit.

In Reply: We would like to thank Dr. Thacker for her interest in our article on the clinical considerations regarding optimal duration of hormone therapy.¹ We agree that the simple answer to whether there is there a time limit for systemic menopausal hormone therapy is no, emphasizing an individualized approach to each patient. After appropriate counseling and shared decision-making, some women may elect a short duration of therapy while others prefer longer-term use.

As Dr. Thacker mentioned, Mikkola et al² performed an observational study of more than 300,000 Finnish women who discontinued hormone therapy. Data on the number of deaths in this group were gathered from a national database and compared with the expected number of deaths in the background population; 30% of the listed causes of death were confirmed by autopsy. In women who had started hormone therapy before age 60, the risk of cardiac death was elevated within the first year after stopping it (standardized mortality ratio [SMR] 1.74; 95% confidence interval [CI] 1.37–2.19), as was the risk of stroke (SMR 2.59, 95% CI 2.08–3.19). This was not true in women who started hormone therapy at age 60 and older. These findings are consistent with our contemporary understanding that for many women younger than age 60 the benefits of hormone therapy outweigh the risks.

The study had several important limitations:

• A healthy-woman bias may have contributed to the reduction in cardiovascular risk.
• No dates for the myocardial infarctions or strokes were available, and the dates hormone therapy was discontined potentially had a 3-month error.
• No data were available on important confounding factors such as smoking, body mass index, blood pressure, lipid levels, and family history.
• Hormone therapy users were compared with an age-standardized background population, which also included hormone therapy users.
• Long-term follow-up data were also perplexing: although more women than expected died of stroke or coronary heart disease within the first year of stopping hormone therapy, after 1 year, significantly fewer women died of these conditions than expected, regardless of how long they had been on hormone therapy before stopping.

These observations highlight the need for long-term, randomized, prospective controlled studies that adequately assess all long-term outcomes (cardiovascular events, mortality, cancer, fracture) in women who initiate hormone therapy before age 60 and within 10 years of menopause, including long-term follow-up after discontinuation. Though future randomized controlled trials will be beneficial to help guide women to a more balanced understanding of long-term hormone therapy and the risks of discontinuation, the current evidence supports continuing hormone therapy in women who derive a net benefit.

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.
 

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.
 

Routine follow-up coronary angiography after percutaneous coronary intervention leads to increased rates of coronary revascularization but without any significant benefits for outcomes, according to a study presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously on Nov. 1 in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Hiroki Shiomi, MD, from Kyoto University, and his coauthors reported on ReACT, a prospective, open-label randomized controlled trial of routine follow-up coronary angiography in 700 patients who underwent successful percutaneous coronary intervention (PCI).

Among the 349 patients randomized to follow-up coronary angiography (FUCAG), 12.8% underwent any coronary revascularization within the first year after PCI, compared with 3.8% of the 351 patients randomized to standard clinical follow-up. The routine angiography group also had a higher incidence of target lesion revascularization in the first year after the index PCI (7.0% vs. 1.7%).

In both these cases, the cumulative 5-year incidence of coronary or target lesion revascularization was not significantly different between the routine angiography and control groups. However researchers saw no significant benefit from routine FUCAG in terms of the cumulative 5-year incidence of all-cause death, myocardial infarction, stroke, or emergency hospitalizations for acute coronary syndrome or heart failure, compared with clinical follow-up (22.4% vs. 24.7%; P = 0.70).

Nor were there any significant differences between the two groups in these individual components, or in the cumulative 5-year incidence of major bleeding (JACC Cardiovasc Interv. 2016 Nov 1.)

The authors commented that several previous studies have shown that routine FUCAG does not improve clinical outcomes, although it is still commonly performed in Japan after PCI.

“However, previous studies in the drug-eluting stents (DES) era were conducted in the context of pivotal randomized trials of DES and there have been no randomized clinical trials evaluating long-term clinical impact of routine FUCAG after PCI in the real world clinical practice including high-risk patients for cardiovascular events risk such as complex coronary artery disease and acute myocardial infarction (AMI) presentation,” the authors wrote.

Overall, 85.4% of patients in the routine angiography group and 12% of those in the clinical care group underwent coronary angiography in the first year, including for clinical reasons.

In the clinical follow-up group, coronary angiography was performed because of acute coronary syndrome (14%), recurrence of angina (60%), other clinical reasons (14%), or no clinical reason (12%). The control group also had more noninvasive physiological stress testing such as treadmill exercise test and stress nuclear study.

“Considering the invasive nature of coronary angiography and increased medical expenses, routine FUCAG after PCI would not be allowed as the usual clinical practice, unless patients have recurrent symptoms or objective evidence of ischemia,” the authors wrote.

“On the other hand, there was no excess of adverse clinical events with routine angiographic follow-up strategy except for the increased rate of 1-year repeat coronary revascularization.”

Given this, they suggested that scheduled angiographic follow-up might still be considered acceptable for early in vivo or significant coronary device trials.

While the authors said the trial ended up being underpowered because of a reduced final sample size and lower-than-anticipated event rate, it did warrant further larger-scale studies. In particular, they highlighted the question of what impact routine follow-up angiography might have in higher-risk patients, such as those with left main or multivessel coronary artery disease.

“Finally, because patient demographics, practice patterns including the indication of coronary revascularization, and clinical outcomes in Japan may be different from those outside Japan, generalizing the present study results to populations outside Japan should be done with caution.”

This study was supported by an educational grant from the Research Institute for Production Development (Kyoto). One author declared honoraria for education consulting from Boston Scientific Corporation.