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A risk score based on EEG variables and seizure history may quickly and accurately aid clinical judgment of seizure risk in patients who are critically ill, according to research published online ahead of print October 9 in JAMA Neurology.

Studies have detected a high incidence of subclinical seizures in patients with sepsis, traumatic brain injury, and other conditions, but no simple, validated method exists to assess a patient’s seizure risk using a combination of factors. Aaron F. Struck, MD, Assistant Professor of Neurology at the University of Wisconsin in Madison, and colleagues sought to create a simple scoring system associated with the probability of seizures in patients with acute illness.

Data From Three Centers

The investigators created the scoring system using data from a multicenter prospective database. The database included clinical and electrographic variables from patients who had more than six hours of uninterrupted EEG recordings for clinical indications other than epilepsy monitoring unit admissions. The continuous EEG sessions were recorded at Emory University Hospital in Atlanta, Brigham and Women’s Hospital in Boston, and Yale New Haven Hospital in Connecticut. In all, 5,427 continuous EEGs were performed on 4,772 patients (49.9% men; median age, 61).

To build their scoring model, the investigators used a machine-learning method, Risk-Calibrated Supersparse Linear Integer Model (RiskSLIM), that considered 24 candidate variables. The researchers used cross-validation to validate the model’s accuracy and risk calibration.

The final model, which the researchers called 2HELPS2B, had an area under the curve of 0.819 and an average calibration error of 2.7%. A patient’s score ranges from 0–7 and is based on the following six variables:

• brief (ictal) rhythmic discharges (B[I]RDS) (2 points)
• presence of lateralized periodic discharges, lateralized rhythmic delta activity, or bilateral independent periodic discharges (1 point)
• prior seizure (1 point)
• sporadic epileptiform discharges (1 point)
• frequency greater than 2.0 Hz for any periodic or rhythmic pattern (1 point)
• presence of “plus” features (ie, superimposed, rhythmic, sharp, or fast activity) (1 point).

The seizure risk associated with each score from 0–5 was 5%, 12%, 27%, 50%, 73%, and 88%, respectively. For a score of 6 or 7, the probable seizure risk was greater than 95%.

The large sample size and use of data from multiple centers are among the study’s strengths. Limitations of the study include that duration of EEG was not included in the database, and that no sessions of less than six hours were included in the study.

“The 2HELPS2B score is an easy-to-use tool to augment clinical judgment of the risk for seizures in individual patients,” Dr. Struck and colleagues said. “The simplicity of the system allows for easy integration into clinical workflow. With increasing familiarity, 2HELPS2B will improve communication between EEG interpreters and clinicians through the use of a quickly comprehensible single number to describe seizure risk for patients on continuous EEG.”

Questions Remain

The investigators designed “a simple scale with good accuracy, which can be easily used by clinicians to estimate seizure risk in their patients,” said Barry M. Czeisler, MD, Assistant Professor of Neurology and Neurosurgery at New York University School of Medicine, and Jan Claassen, MD, PhD, Associate Professor of Neurology at Columbia University College of Physicians and Surgeons in New York, in an accompanying editorial. Still, the score is unvalidated for prediction based on less than six hours of EEG recordings and should be validated in prospective studies, they said.

A seizure risk scale has the potential to inform clinical practice. “Certain patients may not need to stay on continuous EEG for a long time if their seizure risk is low,” but an acceptable level of risk remains unclear, said Drs. Czeisler and Claassen. In addition, the score potentially could guide which patterns of features warrant more aggressive treatment, such as with additional antiepileptic medication. “Appropriate risk stratification using 2HELPS2B may allow us to answer these questions adequately in the near future,” they said. “The development of adequate measurement tools is often necessary to appropriately study a condition, which in turn may allow for future optimization of treatment algorithms.”

—Jake Remaly

Suggested Reading

Czeisler BM, Claassen J. A novel clinical score to assess seizure risk. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

Struck AF, Ustun B, Rodriguez Ruiz A, et al. Association of an electroencephalography-based risk score with seizure probability in hospitalized patients. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

A risk score based on EEG variables and seizure history may quickly and accurately aid clinical judgment of seizure risk in patients who are critically ill, according to research published online ahead of print October 9 in JAMA Neurology.

Studies have detected a high incidence of subclinical seizures in patients with sepsis, traumatic brain injury, and other conditions, but no simple, validated method exists to assess a patient’s seizure risk using a combination of factors. Aaron F. Struck, MD, Assistant Professor of Neurology at the University of Wisconsin in Madison, and colleagues sought to create a simple scoring system associated with the probability of seizures in patients with acute illness.

Data From Three Centers

The investigators created the scoring system using data from a multicenter prospective database. The database included clinical and electrographic variables from patients who had more than six hours of uninterrupted EEG recordings for clinical indications other than epilepsy monitoring unit admissions. The continuous EEG sessions were recorded at Emory University Hospital in Atlanta, Brigham and Women’s Hospital in Boston, and Yale New Haven Hospital in Connecticut. In all, 5,427 continuous EEGs were performed on 4,772 patients (49.9% men; median age, 61).

To build their scoring model, the investigators used a machine-learning method, Risk-Calibrated Supersparse Linear Integer Model (RiskSLIM), that considered 24 candidate variables. The researchers used cross-validation to validate the model’s accuracy and risk calibration.

The final model, which the researchers called 2HELPS2B, had an area under the curve of 0.819 and an average calibration error of 2.7%. A patient’s score ranges from 0–7 and is based on the following six variables:

• brief (ictal) rhythmic discharges (B[I]RDS) (2 points)
• presence of lateralized periodic discharges, lateralized rhythmic delta activity, or bilateral independent periodic discharges (1 point)
• prior seizure (1 point)
• sporadic epileptiform discharges (1 point)
• frequency greater than 2.0 Hz for any periodic or rhythmic pattern (1 point)
• presence of “plus” features (ie, superimposed, rhythmic, sharp, or fast activity) (1 point).

The seizure risk associated with each score from 0–5 was 5%, 12%, 27%, 50%, 73%, and 88%, respectively. For a score of 6 or 7, the probable seizure risk was greater than 95%.

The large sample size and use of data from multiple centers are among the study’s strengths. Limitations of the study include that duration of EEG was not included in the database, and that no sessions of less than six hours were included in the study.

“The 2HELPS2B score is an easy-to-use tool to augment clinical judgment of the risk for seizures in individual patients,” Dr. Struck and colleagues said. “The simplicity of the system allows for easy integration into clinical workflow. With increasing familiarity, 2HELPS2B will improve communication between EEG interpreters and clinicians through the use of a quickly comprehensible single number to describe seizure risk for patients on continuous EEG.”

Questions Remain

The investigators designed “a simple scale with good accuracy, which can be easily used by clinicians to estimate seizure risk in their patients,” said Barry M. Czeisler, MD, Assistant Professor of Neurology and Neurosurgery at New York University School of Medicine, and Jan Claassen, MD, PhD, Associate Professor of Neurology at Columbia University College of Physicians and Surgeons in New York, in an accompanying editorial. Still, the score is unvalidated for prediction based on less than six hours of EEG recordings and should be validated in prospective studies, they said.

A seizure risk scale has the potential to inform clinical practice. “Certain patients may not need to stay on continuous EEG for a long time if their seizure risk is low,” but an acceptable level of risk remains unclear, said Drs. Czeisler and Claassen. In addition, the score potentially could guide which patterns of features warrant more aggressive treatment, such as with additional antiepileptic medication. “Appropriate risk stratification using 2HELPS2B may allow us to answer these questions adequately in the near future,” they said. “The development of adequate measurement tools is often necessary to appropriately study a condition, which in turn may allow for future optimization of treatment algorithms.”

—Jake Remaly

Suggested Reading

Czeisler BM, Claassen J. A novel clinical score to assess seizure risk. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

Struck AF, Ustun B, Rodriguez Ruiz A, et al. Association of an electroencephalography-based risk score with seizure probability in hospitalized patients. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

A risk score based on EEG variables and seizure history may quickly and accurately aid clinical judgment of seizure risk in patients who are critically ill, according to research published online ahead of print October 9 in JAMA Neurology.

Studies have detected a high incidence of subclinical seizures in patients with sepsis, traumatic brain injury, and other conditions, but no simple, validated method exists to assess a patient’s seizure risk using a combination of factors. Aaron F. Struck, MD, Assistant Professor of Neurology at the University of Wisconsin in Madison, and colleagues sought to create a simple scoring system associated with the probability of seizures in patients with acute illness.

Data From Three Centers

The investigators created the scoring system using data from a multicenter prospective database. The database included clinical and electrographic variables from patients who had more than six hours of uninterrupted EEG recordings for clinical indications other than epilepsy monitoring unit admissions. The continuous EEG sessions were recorded at Emory University Hospital in Atlanta, Brigham and Women’s Hospital in Boston, and Yale New Haven Hospital in Connecticut. In all, 5,427 continuous EEGs were performed on 4,772 patients (49.9% men; median age, 61).

To build their scoring model, the investigators used a machine-learning method, Risk-Calibrated Supersparse Linear Integer Model (RiskSLIM), that considered 24 candidate variables. The researchers used cross-validation to validate the model’s accuracy and risk calibration.

The final model, which the researchers called 2HELPS2B, had an area under the curve of 0.819 and an average calibration error of 2.7%. A patient’s score ranges from 0–7 and is based on the following six variables:

• brief (ictal) rhythmic discharges (B[I]RDS) (2 points)
• presence of lateralized periodic discharges, lateralized rhythmic delta activity, or bilateral independent periodic discharges (1 point)
• prior seizure (1 point)
• sporadic epileptiform discharges (1 point)
• frequency greater than 2.0 Hz for any periodic or rhythmic pattern (1 point)
• presence of “plus” features (ie, superimposed, rhythmic, sharp, or fast activity) (1 point).

The seizure risk associated with each score from 0–5 was 5%, 12%, 27%, 50%, 73%, and 88%, respectively. For a score of 6 or 7, the probable seizure risk was greater than 95%.

The large sample size and use of data from multiple centers are among the study’s strengths. Limitations of the study include that duration of EEG was not included in the database, and that no sessions of less than six hours were included in the study.

“The 2HELPS2B score is an easy-to-use tool to augment clinical judgment of the risk for seizures in individual patients,” Dr. Struck and colleagues said. “The simplicity of the system allows for easy integration into clinical workflow. With increasing familiarity, 2HELPS2B will improve communication between EEG interpreters and clinicians through the use of a quickly comprehensible single number to describe seizure risk for patients on continuous EEG.”

Questions Remain

The investigators designed “a simple scale with good accuracy, which can be easily used by clinicians to estimate seizure risk in their patients,” said Barry M. Czeisler, MD, Assistant Professor of Neurology and Neurosurgery at New York University School of Medicine, and Jan Claassen, MD, PhD, Associate Professor of Neurology at Columbia University College of Physicians and Surgeons in New York, in an accompanying editorial. Still, the score is unvalidated for prediction based on less than six hours of EEG recordings and should be validated in prospective studies, they said.

A seizure risk scale has the potential to inform clinical practice. “Certain patients may not need to stay on continuous EEG for a long time if their seizure risk is low,” but an acceptable level of risk remains unclear, said Drs. Czeisler and Claassen. In addition, the score potentially could guide which patterns of features warrant more aggressive treatment, such as with additional antiepileptic medication. “Appropriate risk stratification using 2HELPS2B may allow us to answer these questions adequately in the near future,” they said. “The development of adequate measurement tools is often necessary to appropriately study a condition, which in turn may allow for future optimization of treatment algorithms.”

—Jake Remaly

Suggested Reading

Czeisler BM, Claassen J. A novel clinical score to assess seizure risk. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

Struck AF, Ustun B, Rodriguez Ruiz A, et al. Association of an electroencephalography-based risk score with seizure probability in hospitalized patients. JAMA Neurology. 2017 Oct 9 [Epub ahead of print].

ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.

Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.

Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.

The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.

Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.

A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.

The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.

Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.

A recent study conducted by the AGA Institute Education and Training Committee and reported in AGA Perspectives supports these findings. Read more here and join the discussion on the AGA Community.

[email protected]

On Twitter @mitchelzoler

ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.

Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.

Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.

The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.

Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.

A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.

The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.

Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.

A recent study conducted by the AGA Institute Education and Training Committee and reported in AGA Perspectives supports these findings. Read more here and join the discussion on the AGA Community.

[email protected]

On Twitter @mitchelzoler

ORLANDO – Nearly half of U.S. gastroenterologists who responded to a recent survey had symptoms of burnout that seemed largely driven by work-life balance issues.

Burnout appeared to disproportionately affect younger gastroenterologists, those who spend more time on chores at home including caring for young children, physicians who were neutral toward or dissatisfied with a spouse or partner, and clinicians planning to soon leave their practice, Carol A. Burke, MD, said at the World Congress of Gastroenterology at ACG 2017.

Factors not linked with burnout included their type of practice, whether the gastroenterologists worked full or part time, their location, and their compensation, said Dr. Burke, director of the Center for Colon Polyp and Cancer Prevention at the Cleveland Clinic.

The life issues that appeared most strongly linked to burnout “speak to a problem for physicians to balance” their professional and personal lives, Dr. Burke said in a video interview. Several interventions exist that can potentially mitigate burnout, and the American College of Gastroenterology, which ran the survey, is taking steps to make information on these interventions available to members, noted Dr. Burke, the organization’s president.

Dr. Burke and her associates sent a 60-item survey to all 11,080 College members during 2014 and 2015 and received 1,021 replies including 754 fully completed responses. Their prespecified definition of burnout was a high score for emotional exhaustion or for depersonalization, or both, on the Maslach Burnout Inventory. The results showed that 45% of respondents had a high score for emotional exhaustion, 21% scored high on depersonalization, and overall 49% met the burnout criteria set by the investigators. The Inventory answers also showed that 18% had a low sense of personal accomplishment.

A multivariate analysis showed that significant links with burnout were younger age, more time spent on domestic chores, having a neutral or dissatisfying relationship with a spouse or partner, and plans for imminent retirement from gastroenterology practice, Dr. Burke reported.

The main reasons for planning imminent retirement were reimbursement, cited by 32% of this subgroup, regulations, cited by 21%, recertification, cited by 16%, and electronic medical records, cited by 10% as the main reason for leaving practice.

Strategies and resources aimed at better dealing with burnout were requested by 60% of all survey respondents, and the College is in the process of making these tools available, Dr. Burke said.

A recent study conducted by the AGA Institute Education and Training Committee and reported in AGA Perspectives supports these findings. Read more here and join the discussion on the AGA Community.

[email protected]

On Twitter @mitchelzoler

Detainee operations is a dark topic and one that often is avoided in the welcome home of veterans participating in detainee operations. Many veterans who have been involved have hidden these missions, fearing that they would be tarnished by past scandals. However, the burden of these detainee missions may contribute to depression, moral injury, and suicidal behaviors.

The recent conflicts in Afghanistan and Iraq have produced many opportunities for lessons on detainee operations. Unfortunately, often the lessons learned from one conflict have not been carried forward to the next. The scandals at the Abu Ghraib prison in Iraq and the continuing controversy over practices at Guantanamo Bay (GTMO) in Cuba illustrate these lapses. This column will not dwell on these issues but on what has been the psychological effects on U.S. service members of guarding and caring for detainees.

Background

Since 9/11, military service members have been involved in detainee operations in many roles, including at the point of capture (when the detainee is taken into custody), guarding the detainee; interrogating the detainee, and providing medical and psychological care.

Our service members have been woefully underprepared for these missions, and as a result may have faced adverse psychological consequences. The work is often dangerous and tedious. The following dangerous or frustrating examples are from my experiences:

• Correctional staff at GTMO had feces thrown at them;
• U.S. staff were targeted by rocket propelled grenades at Abu Ghraib and moved into jail cells for protection;
• Medical personnel at Camp Bucca in Iraq were attacked by the detainees who used hand sanitizer and latex gloves to make miniature fire balls;
• Insufficient medical equipment at Abu Ghraib and other facilities to care for detainees;
• An overall lack of perceived support from the medical and correctional chain of commands; and
• Numerous different chains of commands with different priorities, leading to a sense of chaos.

Corrections Overlap

There is overlap with traditional correctional medical care, including the care of prisoners in traditional jails and prisons. Likewise, there are similar issues with migrants from Central America and other regions who enter the country illegally and often are put into makeshift camps or overcrowded jails. However, there are key differences when treating detainees in facilities outside the U.S.

These differences include the cultural aspects in caring for detainees from the Middle East and elsewhere, large holding areas with 200 to 300 detainees, such as Camp Bucca and Abhu Ghraib, indefinite terms of confinement, such as at GTMO, and high-visibility political implications especially suicide attempts and interrogations.

There are many challenges to providing medical support in detainee operations that may have adverse psychological consequences. These include the following:

• Care for detainees when first captured;
• Fear of infectious diseases in detainees;
• Care for detainees in the correctional facilities in Abu Ghraib, GTMO, the Theater Internment Facility at Bagram Air Base Afghanistan; and other facilities;
• Involvement in force-feeding and during hunger strikes;
• Avoiding abuse of detainees by military staff;
• Providing psychological support to interrogation efforts often known as Behavioral Science Consultation Teams; and
• Challenges in treatment of complex medical and psychiatric conditions among detainees, which may include a limited formulary, lack of full medical equipment, and austere conditions.

Psychological Reactions

These challenges contribute to the development of negative psychological reactions, including posttramatic stress syndrome (PTSD) and moral injury, in medical and corrections staff. The negative view of the American public toward these correctional issues contributes to a sense of shame among those who have guarded or treated detainees.

One veteran who worked at GTMO and the jail in Bagram reported that 10 of his colleagues killed themselves. Although there is robust literature on suicides in army and other military personnel, I do not know of any studies that examine suicides specifically in detainee’s operational staff.^1,2 There have been analyses of the relationship between suicide and military occupational specialty (MOS).¹ However, personnel in detainee operations may come from many different disciplines, including medical, correctional, and others.

Again, data here are anecdotal, since there is no public information available. However, I was sent to Abu Ghraib and Camp Bucca in 2004 to evaluate these issues. I have been to GTMO 5 times. Thus, I have personal experience that in forms this column.

Although there are many books and manuals about treating PTSD and some literature about providing mental health care to detainees, there is little published about providing care to staff involved with detainee’s operations. I postulate that many staff will have shame, guilt, or moral injury, which leads to suicidal thoughts. Treatment thus needs to be supportive, whether with medications or psychotherapy.

Conclusion

All these issues should be considered by clinical staff who are caring for service members who have been involved in detainee operations. Veterans may not volunteer that they have been involved in these operations; it is important to ask.

Guilt and shame may be large components of the presenting psychological presentation. This may lead to moral injury. Careful exploration of depressive and suicidal thoughts with these patients is needed. An understanding of these challenges will help with clinical care.

Detainee operations is a dark topic and one that often is avoided in the welcome home of veterans participating in detainee operations. Many veterans who have been involved have hidden these missions, fearing that they would be tarnished by past scandals. However, the burden of these detainee missions may contribute to depression, moral injury, and suicidal behaviors.

The recent conflicts in Afghanistan and Iraq have produced many opportunities for lessons on detainee operations. Unfortunately, often the lessons learned from one conflict have not been carried forward to the next. The scandals at the Abu Ghraib prison in Iraq and the continuing controversy over practices at Guantanamo Bay (GTMO) in Cuba illustrate these lapses. This column will not dwell on these issues but on what has been the psychological effects on U.S. service members of guarding and caring for detainees.

Background

Since 9/11, military service members have been involved in detainee operations in many roles, including at the point of capture (when the detainee is taken into custody), guarding the detainee; interrogating the detainee, and providing medical and psychological care.

Our service members have been woefully underprepared for these missions, and as a result may have faced adverse psychological consequences. The work is often dangerous and tedious. The following dangerous or frustrating examples are from my experiences:

• Correctional staff at GTMO had feces thrown at them;
• U.S. staff were targeted by rocket propelled grenades at Abu Ghraib and moved into jail cells for protection;
• Medical personnel at Camp Bucca in Iraq were attacked by the detainees who used hand sanitizer and latex gloves to make miniature fire balls;
• Insufficient medical equipment at Abu Ghraib and other facilities to care for detainees;
• An overall lack of perceived support from the medical and correctional chain of commands; and
• Numerous different chains of commands with different priorities, leading to a sense of chaos.

Corrections Overlap

There is overlap with traditional correctional medical care, including the care of prisoners in traditional jails and prisons. Likewise, there are similar issues with migrants from Central America and other regions who enter the country illegally and often are put into makeshift camps or overcrowded jails. However, there are key differences when treating detainees in facilities outside the U.S.

These differences include the cultural aspects in caring for detainees from the Middle East and elsewhere, large holding areas with 200 to 300 detainees, such as Camp Bucca and Abhu Ghraib, indefinite terms of confinement, such as at GTMO, and high-visibility political implications especially suicide attempts and interrogations.

There are many challenges to providing medical support in detainee operations that may have adverse psychological consequences. These include the following:

• Care for detainees when first captured;
• Fear of infectious diseases in detainees;
• Care for detainees in the correctional facilities in Abu Ghraib, GTMO, the Theater Internment Facility at Bagram Air Base Afghanistan; and other facilities;
• Involvement in force-feeding and during hunger strikes;
• Avoiding abuse of detainees by military staff;
• Providing psychological support to interrogation efforts often known as Behavioral Science Consultation Teams; and
• Challenges in treatment of complex medical and psychiatric conditions among detainees, which may include a limited formulary, lack of full medical equipment, and austere conditions.

Psychological Reactions

These challenges contribute to the development of negative psychological reactions, including posttramatic stress syndrome (PTSD) and moral injury, in medical and corrections staff. The negative view of the American public toward these correctional issues contributes to a sense of shame among those who have guarded or treated detainees.

One veteran who worked at GTMO and the jail in Bagram reported that 10 of his colleagues killed themselves. Although there is robust literature on suicides in army and other military personnel, I do not know of any studies that examine suicides specifically in detainee’s operational staff.^1,2 There have been analyses of the relationship between suicide and military occupational specialty (MOS).¹ However, personnel in detainee operations may come from many different disciplines, including medical, correctional, and others.

Again, data here are anecdotal, since there is no public information available. However, I was sent to Abu Ghraib and Camp Bucca in 2004 to evaluate these issues. I have been to GTMO 5 times. Thus, I have personal experience that in forms this column.

Although there are many books and manuals about treating PTSD and some literature about providing mental health care to detainees, there is little published about providing care to staff involved with detainee’s operations. I postulate that many staff will have shame, guilt, or moral injury, which leads to suicidal thoughts. Treatment thus needs to be supportive, whether with medications or psychotherapy.

Conclusion

All these issues should be considered by clinical staff who are caring for service members who have been involved in detainee operations. Veterans may not volunteer that they have been involved in these operations; it is important to ask.

Guilt and shame may be large components of the presenting psychological presentation. This may lead to moral injury. Careful exploration of depressive and suicidal thoughts with these patients is needed. An understanding of these challenges will help with clinical care.

Detainee operations is a dark topic and one that often is avoided in the welcome home of veterans participating in detainee operations. Many veterans who have been involved have hidden these missions, fearing that they would be tarnished by past scandals. However, the burden of these detainee missions may contribute to depression, moral injury, and suicidal behaviors.

The recent conflicts in Afghanistan and Iraq have produced many opportunities for lessons on detainee operations. Unfortunately, often the lessons learned from one conflict have not been carried forward to the next. The scandals at the Abu Ghraib prison in Iraq and the continuing controversy over practices at Guantanamo Bay (GTMO) in Cuba illustrate these lapses. This column will not dwell on these issues but on what has been the psychological effects on U.S. service members of guarding and caring for detainees.

Background

Since 9/11, military service members have been involved in detainee operations in many roles, including at the point of capture (when the detainee is taken into custody), guarding the detainee; interrogating the detainee, and providing medical and psychological care.

Our service members have been woefully underprepared for these missions, and as a result may have faced adverse psychological consequences. The work is often dangerous and tedious. The following dangerous or frustrating examples are from my experiences:

• Correctional staff at GTMO had feces thrown at them;
• U.S. staff were targeted by rocket propelled grenades at Abu Ghraib and moved into jail cells for protection;
• Medical personnel at Camp Bucca in Iraq were attacked by the detainees who used hand sanitizer and latex gloves to make miniature fire balls;
• Insufficient medical equipment at Abu Ghraib and other facilities to care for detainees;
• An overall lack of perceived support from the medical and correctional chain of commands; and
• Numerous different chains of commands with different priorities, leading to a sense of chaos.

Corrections Overlap

There is overlap with traditional correctional medical care, including the care of prisoners in traditional jails and prisons. Likewise, there are similar issues with migrants from Central America and other regions who enter the country illegally and often are put into makeshift camps or overcrowded jails. However, there are key differences when treating detainees in facilities outside the U.S.

These differences include the cultural aspects in caring for detainees from the Middle East and elsewhere, large holding areas with 200 to 300 detainees, such as Camp Bucca and Abhu Ghraib, indefinite terms of confinement, such as at GTMO, and high-visibility political implications especially suicide attempts and interrogations.

There are many challenges to providing medical support in detainee operations that may have adverse psychological consequences. These include the following:

• Care for detainees when first captured;
• Fear of infectious diseases in detainees;
• Care for detainees in the correctional facilities in Abu Ghraib, GTMO, the Theater Internment Facility at Bagram Air Base Afghanistan; and other facilities;
• Involvement in force-feeding and during hunger strikes;
• Avoiding abuse of detainees by military staff;
• Providing psychological support to interrogation efforts often known as Behavioral Science Consultation Teams; and
• Challenges in treatment of complex medical and psychiatric conditions among detainees, which may include a limited formulary, lack of full medical equipment, and austere conditions.

Psychological Reactions

These challenges contribute to the development of negative psychological reactions, including posttramatic stress syndrome (PTSD) and moral injury, in medical and corrections staff. The negative view of the American public toward these correctional issues contributes to a sense of shame among those who have guarded or treated detainees.

One veteran who worked at GTMO and the jail in Bagram reported that 10 of his colleagues killed themselves. Although there is robust literature on suicides in army and other military personnel, I do not know of any studies that examine suicides specifically in detainee’s operational staff.^1,2 There have been analyses of the relationship between suicide and military occupational specialty (MOS).¹ However, personnel in detainee operations may come from many different disciplines, including medical, correctional, and others.

Again, data here are anecdotal, since there is no public information available. However, I was sent to Abu Ghraib and Camp Bucca in 2004 to evaluate these issues. I have been to GTMO 5 times. Thus, I have personal experience that in forms this column.

Although there are many books and manuals about treating PTSD and some literature about providing mental health care to detainees, there is little published about providing care to staff involved with detainee’s operations. I postulate that many staff will have shame, guilt, or moral injury, which leads to suicidal thoughts. Treatment thus needs to be supportive, whether with medications or psychotherapy.

Conclusion

All these issues should be considered by clinical staff who are caring for service members who have been involved in detainee operations. Veterans may not volunteer that they have been involved in these operations; it is important to ask.

Guilt and shame may be large components of the presenting psychological presentation. This may lead to moral injury. Careful exploration of depressive and suicidal thoughts with these patients is needed. An understanding of these challenges will help with clinical care.

Poor cognitive function is associated with an increased risk of incident parkinsonism, including probable Parkinson’s disease, according to research published online ahead of print September 25 in JAMA Neurology. The association is strong beyond eight years of follow-up and holds for patients with incident parkinsonism without dementia.

Cognitive loss is not among the Movement Disorder Society’s criteria for prodromal Parkinson’s disease because prospective evidence about this variable was lacking when the criteria were developed. “Our results, as well as those of other published studies, suggest that cognitive dysfunction now warrants inclusion as a prodromal marker,” said Sirwan K. L. Darweesh, MD, of the Department of Epidemiology at Erasmus MC University Medical Center in Rotterdam, the Netherlands.

Prospective Data From the Rotterdam Study

Dr. Darweesh and colleagues conducted research to test their hypothesis that poor cognitive function is associated with an increased risk of parkinsonism. They examined participants in the prospective, population-based Rotterdam Study, which began in 1990. The study instituted a comprehensive battery of cognitive tests between 2002 and 2008, and Dr. Darweesh and colleagues used this period as the baseline of their investigation. During this time, researchers assessed cognitive function in 7,386 participants who were free of parkinsonism and dementia. The assessments included the Stroop color word test, letter-digit substitution, verbal fluency, and word learning.

During follow-up, participants presented for serial in-person examinations, and investigators had full access to participants’ medical records. Follow-up ended on January 1, 2015. The main outcome was the hazard ratio for incident parkinsonism per standard deviation decrease in global cognition. The researchers adjusted the data for age and sex.

Education Did Not Affect the Association

The population’s mean age was 65, and 57.4% of the population was female. During a median follow-up of 8.3 years, 79 participants (1.1%) received a diagnosis of incident parkinsonism. Of these patients, 57 (72.2%) received a diagnosis of probable Parkinson’s disease. Among participants with incident parkinsonism, 24 (30.4%) received a diagnosis of incident dementia. In addition, 446 people (6.1%) who remained free of incident parkinsonism received a diagnosis of incident dementia.

Each standard-deviation decrease in global cognition was associated with a 79% increase in the risk of incident parkinsonism. After the researchers censored people with incident dementia and restricted the analysis to patients with incident parkinsonism who were examined by a neurologist or geriatrician, the association remained strong beyond the first eight years of follow-up. Adjustment for education did not affect the association, but adjustment for subtle motor signs weakened it slightly. Poor cognitive functioning also was associated with probable Parkinson’s disease (hazard ratio [HR], 1.52) and with a joint end point of probable Parkinson’s disease or dementia with Lewy bodies (HR, 1.59).

Incident parkinsonism was associated with lower scores on letter-digit substitution (HR, 1.59), verbal fluency (HR, 1.61), and inverted interference task Stroop color word test (HR, 1.56). The association with word learning delayed-task scores was weaker (HR, 1.18).

A possible explanation for the association is that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic Parkinson’s disease.” Another possible explanation is that people who probably will develop parkinsonism in mid- or late life never attain a high level of cognitive functioning in early life, said the researchers.

Results May Prompt Screening and Interventions

The study results are broadly applicable because they come from a large, community-based cohort with low attrition, said Ethan G. Brown, MD, a clinical fellow, and Caroline M. Tanner, MD, PhD, Professor of Neurology, both at the University of California, San Francisco, in an accompanying editorial. The researchers may have overlooked some participants’ cognitive impairment, however, because the neuropsychologic assessment was not as thorough as recommended. Also, the study design made specialist adjudication of all diagnoses of Parkinson’s disease impossible, and the primary outcome was incident parkinsonism, rather than incident Parkinson’s disease.

The findings nevertheless reiterate the presence of cognitive impairment early in Parkinson’s disease, thus emphasizing the need for therapeutic trials to target this symptom, said Drs. Brown and Tanner. The study also provides guidance for identifying people most at risk for Parkinson’s disease.

In addition, Dr. Darweesh’s group has found evidence that supports the Braak hypothesis about Parkinson’s disease progression, said Drs. Brown and Tanner. The data challenge the idea that synuclein pathology always spreads through the vagus and substantia nigra.

“Now we … know that people with early mild cognitive impairment, especially in the setting of subtle motor findings, may have prodromal Parkinson’s disease,” said Drs. Brown and Tanner. “This recognition can allow physicians to screen for falls or other nonmotor aspects of Parkinson’s disease in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in Parkinson’s disease.”

—Erik Greb

Suggested Reading

Brown EG, Tanner CM. Impaired cognition and the risk of Parkinson disease: Trouble in mind. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

Darweesh SKL, Wolters FJ, Postuma RB, et al. Association between poor cognitive functioning and risk of incident parkinsonism: The Rotterdam Study. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

Poor cognitive function is associated with an increased risk of incident parkinsonism, including probable Parkinson’s disease, according to research published online ahead of print September 25 in JAMA Neurology. The association is strong beyond eight years of follow-up and holds for patients with incident parkinsonism without dementia.

Cognitive loss is not among the Movement Disorder Society’s criteria for prodromal Parkinson’s disease because prospective evidence about this variable was lacking when the criteria were developed. “Our results, as well as those of other published studies, suggest that cognitive dysfunction now warrants inclusion as a prodromal marker,” said Sirwan K. L. Darweesh, MD, of the Department of Epidemiology at Erasmus MC University Medical Center in Rotterdam, the Netherlands.

Prospective Data From the Rotterdam Study

Dr. Darweesh and colleagues conducted research to test their hypothesis that poor cognitive function is associated with an increased risk of parkinsonism. They examined participants in the prospective, population-based Rotterdam Study, which began in 1990. The study instituted a comprehensive battery of cognitive tests between 2002 and 2008, and Dr. Darweesh and colleagues used this period as the baseline of their investigation. During this time, researchers assessed cognitive function in 7,386 participants who were free of parkinsonism and dementia. The assessments included the Stroop color word test, letter-digit substitution, verbal fluency, and word learning.

During follow-up, participants presented for serial in-person examinations, and investigators had full access to participants’ medical records. Follow-up ended on January 1, 2015. The main outcome was the hazard ratio for incident parkinsonism per standard deviation decrease in global cognition. The researchers adjusted the data for age and sex.

Education Did Not Affect the Association

The population’s mean age was 65, and 57.4% of the population was female. During a median follow-up of 8.3 years, 79 participants (1.1%) received a diagnosis of incident parkinsonism. Of these patients, 57 (72.2%) received a diagnosis of probable Parkinson’s disease. Among participants with incident parkinsonism, 24 (30.4%) received a diagnosis of incident dementia. In addition, 446 people (6.1%) who remained free of incident parkinsonism received a diagnosis of incident dementia.

Each standard-deviation decrease in global cognition was associated with a 79% increase in the risk of incident parkinsonism. After the researchers censored people with incident dementia and restricted the analysis to patients with incident parkinsonism who were examined by a neurologist or geriatrician, the association remained strong beyond the first eight years of follow-up. Adjustment for education did not affect the association, but adjustment for subtle motor signs weakened it slightly. Poor cognitive functioning also was associated with probable Parkinson’s disease (hazard ratio [HR], 1.52) and with a joint end point of probable Parkinson’s disease or dementia with Lewy bodies (HR, 1.59).

Incident parkinsonism was associated with lower scores on letter-digit substitution (HR, 1.59), verbal fluency (HR, 1.61), and inverted interference task Stroop color word test (HR, 1.56). The association with word learning delayed-task scores was weaker (HR, 1.18).

A possible explanation for the association is that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic Parkinson’s disease.” Another possible explanation is that people who probably will develop parkinsonism in mid- or late life never attain a high level of cognitive functioning in early life, said the researchers.

Results May Prompt Screening and Interventions

The study results are broadly applicable because they come from a large, community-based cohort with low attrition, said Ethan G. Brown, MD, a clinical fellow, and Caroline M. Tanner, MD, PhD, Professor of Neurology, both at the University of California, San Francisco, in an accompanying editorial. The researchers may have overlooked some participants’ cognitive impairment, however, because the neuropsychologic assessment was not as thorough as recommended. Also, the study design made specialist adjudication of all diagnoses of Parkinson’s disease impossible, and the primary outcome was incident parkinsonism, rather than incident Parkinson’s disease.

The findings nevertheless reiterate the presence of cognitive impairment early in Parkinson’s disease, thus emphasizing the need for therapeutic trials to target this symptom, said Drs. Brown and Tanner. The study also provides guidance for identifying people most at risk for Parkinson’s disease.

In addition, Dr. Darweesh’s group has found evidence that supports the Braak hypothesis about Parkinson’s disease progression, said Drs. Brown and Tanner. The data challenge the idea that synuclein pathology always spreads through the vagus and substantia nigra.

“Now we … know that people with early mild cognitive impairment, especially in the setting of subtle motor findings, may have prodromal Parkinson’s disease,” said Drs. Brown and Tanner. “This recognition can allow physicians to screen for falls or other nonmotor aspects of Parkinson’s disease in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in Parkinson’s disease.”

—Erik Greb

Suggested Reading

Brown EG, Tanner CM. Impaired cognition and the risk of Parkinson disease: Trouble in mind. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

Darweesh SKL, Wolters FJ, Postuma RB, et al. Association between poor cognitive functioning and risk of incident parkinsonism: The Rotterdam Study. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

Poor cognitive function is associated with an increased risk of incident parkinsonism, including probable Parkinson’s disease, according to research published online ahead of print September 25 in JAMA Neurology. The association is strong beyond eight years of follow-up and holds for patients with incident parkinsonism without dementia.

Cognitive loss is not among the Movement Disorder Society’s criteria for prodromal Parkinson’s disease because prospective evidence about this variable was lacking when the criteria were developed. “Our results, as well as those of other published studies, suggest that cognitive dysfunction now warrants inclusion as a prodromal marker,” said Sirwan K. L. Darweesh, MD, of the Department of Epidemiology at Erasmus MC University Medical Center in Rotterdam, the Netherlands.

Prospective Data From the Rotterdam Study

Dr. Darweesh and colleagues conducted research to test their hypothesis that poor cognitive function is associated with an increased risk of parkinsonism. They examined participants in the prospective, population-based Rotterdam Study, which began in 1990. The study instituted a comprehensive battery of cognitive tests between 2002 and 2008, and Dr. Darweesh and colleagues used this period as the baseline of their investigation. During this time, researchers assessed cognitive function in 7,386 participants who were free of parkinsonism and dementia. The assessments included the Stroop color word test, letter-digit substitution, verbal fluency, and word learning.

During follow-up, participants presented for serial in-person examinations, and investigators had full access to participants’ medical records. Follow-up ended on January 1, 2015. The main outcome was the hazard ratio for incident parkinsonism per standard deviation decrease in global cognition. The researchers adjusted the data for age and sex.

Education Did Not Affect the Association

The population’s mean age was 65, and 57.4% of the population was female. During a median follow-up of 8.3 years, 79 participants (1.1%) received a diagnosis of incident parkinsonism. Of these patients, 57 (72.2%) received a diagnosis of probable Parkinson’s disease. Among participants with incident parkinsonism, 24 (30.4%) received a diagnosis of incident dementia. In addition, 446 people (6.1%) who remained free of incident parkinsonism received a diagnosis of incident dementia.

Each standard-deviation decrease in global cognition was associated with a 79% increase in the risk of incident parkinsonism. After the researchers censored people with incident dementia and restricted the analysis to patients with incident parkinsonism who were examined by a neurologist or geriatrician, the association remained strong beyond the first eight years of follow-up. Adjustment for education did not affect the association, but adjustment for subtle motor signs weakened it slightly. Poor cognitive functioning also was associated with probable Parkinson’s disease (hazard ratio [HR], 1.52) and with a joint end point of probable Parkinson’s disease or dementia with Lewy bodies (HR, 1.59).

Incident parkinsonism was associated with lower scores on letter-digit substitution (HR, 1.59), verbal fluency (HR, 1.61), and inverted interference task Stroop color word test (HR, 1.56). The association with word learning delayed-task scores was weaker (HR, 1.18).

A possible explanation for the association is that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic Parkinson’s disease.” Another possible explanation is that people who probably will develop parkinsonism in mid- or late life never attain a high level of cognitive functioning in early life, said the researchers.

Results May Prompt Screening and Interventions

The study results are broadly applicable because they come from a large, community-based cohort with low attrition, said Ethan G. Brown, MD, a clinical fellow, and Caroline M. Tanner, MD, PhD, Professor of Neurology, both at the University of California, San Francisco, in an accompanying editorial. The researchers may have overlooked some participants’ cognitive impairment, however, because the neuropsychologic assessment was not as thorough as recommended. Also, the study design made specialist adjudication of all diagnoses of Parkinson’s disease impossible, and the primary outcome was incident parkinsonism, rather than incident Parkinson’s disease.

The findings nevertheless reiterate the presence of cognitive impairment early in Parkinson’s disease, thus emphasizing the need for therapeutic trials to target this symptom, said Drs. Brown and Tanner. The study also provides guidance for identifying people most at risk for Parkinson’s disease.

In addition, Dr. Darweesh’s group has found evidence that supports the Braak hypothesis about Parkinson’s disease progression, said Drs. Brown and Tanner. The data challenge the idea that synuclein pathology always spreads through the vagus and substantia nigra.

“Now we … know that people with early mild cognitive impairment, especially in the setting of subtle motor findings, may have prodromal Parkinson’s disease,” said Drs. Brown and Tanner. “This recognition can allow physicians to screen for falls or other nonmotor aspects of Parkinson’s disease in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in Parkinson’s disease.”

—Erik Greb

Suggested Reading

Brown EG, Tanner CM. Impaired cognition and the risk of Parkinson disease: Trouble in mind. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

Darweesh SKL, Wolters FJ, Postuma RB, et al. Association between poor cognitive functioning and risk of incident parkinsonism: The Rotterdam Study. JAMA Neurol. 2017 Sep 25 [Epub ahead of print].

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

Applications are due March 2, 2018, for the Wylie Scholar Award, co-sponsored by Vascular Cures and the SVS Foundation. The three-year, $150,000 grant is awarded to a promising vascular surgeon-scientist in North America and is designed to support outstanding surgeon-scientists conducting innovative academic research in the early stages of their careers.

This year's recipient, Dr. Sean English, is conducting research on AAA. Dr. Mohamed Zayed, MD, PhD, the 2015 recipient, is investigating why diabetics develop a unique lipid profile leading to PAD. For each $150,000 award, Wylie Scholars have received $3.3 million in subsequent national research funding, for a return on investment of nearly 22 to 1. 

Applications are due March 2, 2018, for the Wylie Scholar Award, co-sponsored by Vascular Cures and the SVS Foundation. The three-year, $150,000 grant is awarded to a promising vascular surgeon-scientist in North America and is designed to support outstanding surgeon-scientists conducting innovative academic research in the early stages of their careers.

This year's recipient, Dr. Sean English, is conducting research on AAA. Dr. Mohamed Zayed, MD, PhD, the 2015 recipient, is investigating why diabetics develop a unique lipid profile leading to PAD. For each $150,000 award, Wylie Scholars have received $3.3 million in subsequent national research funding, for a return on investment of nearly 22 to 1. 

Applications are due March 2, 2018, for the Wylie Scholar Award, co-sponsored by Vascular Cures and the SVS Foundation. The three-year, $150,000 grant is awarded to a promising vascular surgeon-scientist in North America and is designed to support outstanding surgeon-scientists conducting innovative academic research in the early stages of their careers.

This year's recipient, Dr. Sean English, is conducting research on AAA. Dr. Mohamed Zayed, MD, PhD, the 2015 recipient, is investigating why diabetics develop a unique lipid profile leading to PAD. For each $150,000 award, Wylie Scholars have received $3.3 million in subsequent national research funding, for a return on investment of nearly 22 to 1. 

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented

This measure is aimed at capturing the percentage of patients aged 18 years and older who were screened for high blood pressure and given a follow-up plan.

What you need to do: Check the patient’s blood pressure and recommend follow-up care – lifestyle modifications, additional testing, or medication, as appropriate – and document that plan.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 90845, 90880, 92002, 92004, 92012, 92014, 96118, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99281, 99282, 99283, 99284, 99285, 99215, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, D7140, D7210, G0101, G0402, G0438, G0439 without telehealth modifier: GQ or GT.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, code G8783 indicates that a normal blood pressure reading was documented and follow-up is not required, while code G8950 indicates that the patient had a pre-hypertensive or hypertensive blood pressure reading documented and the appropriate follow-up was documented. Exclusion code G9744 should be used if the patient is not eligible due to an active diagnosis of hypertension.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented

This measure is aimed at capturing the percentage of patients aged 18 years and older who were screened for high blood pressure and given a follow-up plan.

What you need to do: Check the patient’s blood pressure and recommend follow-up care – lifestyle modifications, additional testing, or medication, as appropriate – and document that plan.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 90845, 90880, 92002, 92004, 92012, 92014, 96118, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99281, 99282, 99283, 99284, 99285, 99215, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, D7140, D7210, G0101, G0402, G0438, G0439 without telehealth modifier: GQ or GT.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, code G8783 indicates that a normal blood pressure reading was documented and follow-up is not required, while code G8950 indicates that the patient had a pre-hypertensive or hypertensive blood pressure reading documented and the appropriate follow-up was documented. Exclusion code G9744 should be used if the patient is not eligible due to an active diagnosis of hypertension.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented

This measure is aimed at capturing the percentage of patients aged 18 years and older who were screened for high blood pressure and given a follow-up plan.

What you need to do: Check the patient’s blood pressure and recommend follow-up care – lifestyle modifications, additional testing, or medication, as appropriate – and document that plan.

Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 90845, 90880, 92002, 92004, 92012, 92014, 96118, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99281, 99282, 99283, 99284, 99285, 99215, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99318, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, D7140, D7210, G0101, G0402, G0438, G0439 without telehealth modifier: GQ or GT.

To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, code G8783 indicates that a normal blood pressure reading was documented and follow-up is not required, while code G8950 indicates that the patient had a pre-hypertensive or hypertensive blood pressure reading documented and the appropriate follow-up was documented. Exclusion code G9744 should be used if the patient is not eligible due to an active diagnosis of hypertension.

CMS has a full list measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

Many improvements in health care today involve care coordination across the entire health care system. Active management of an orthopedic surgery service from a system perspective allows for improvements that can favorably impact readmissions and length of stay (LOS) for patients.¹ The following is an example of a systemwide process improvement in total knee replacement (TKR) surgery that dramatically decreased 30-day readmissions and shortened the LOS during a 12-month period.\

Background

The VA is the largest integrated health care system in the U.S. VA hospitals use the VA Surgical Quality Improvement Program (VASQIP) to monitor surgical services. Initially known as the National Surgery Quality Improvement Program (NSQIP), the program began in 1994 to help provide reliable, valid information on patient presurgical factors, processes of care during surgery, and 30-day morbidity and mortality rates in VA hospitals.² Since its inception, NSQIP has spread to the private sector and is now widely used throughout the U.S.

Using on-site data acquisition by specially trained and dedicated registered nurses, information on each surgical case is input into a quality program. Quarterly reports are distributed to each hospital, and a comparison of mortality, LOS, 30-day readmissions to the hospital, and other data are analyzed and presented by quarter and rolling 12-month time frames. Use of VASQIP data allows improvement of the structures and processes of care throughout the VA, providing safer surgery for veterans.

At the Phoenix VA Health Care System (PVAHCS) in Arizona, the third quarter 2014 report showed the rolling 12-month average LOS for orthopedic TKR patients was 3.5 days and corresponding 30-day readmissions were 7.9%. Using a systems improvement approach, the authors set a goal of reducing these metrics by 10%.

The orthopedic service engaged members of the hospitalist, anesthesia, physical therapy (PT), nursing, social work, primary care, and pharmacy services, as well as hospital administration. Twelve months later, the LOS for TKR patients declined 20% to 2.8 days. Corresponding 30-day readmissions declined for the patients with knee replacement to 3.4%—a 57% reduction in 1 year. Mortality for these 177 cases was zero.

To accomplish these improvements, the authors divided the surgical procedure into preoperative, perioperative, and postoperative time frames and looked at process improvement during each of these periods. The following is a summary of the various processes that the authors feel contributed to the reduced LOS and 30-day readmission rate. Although some of these interventions were in place before the study period, all the processes were standardized for TKRs through surgeon consensus, and each of the surgeons adopted all the processes during the study period.

Preoperative Processes

In the VA primary care-based model orthopedic surgery is accessed through a consult process in the electronic health record. The orthopedic surgery service reviews each new consult and makes recommendations for optimization at the time the consult was received. This process was used to work closely with primary care providers to preoperatively prepare patients. The orthopedic surgery service advocates smoking cessation, substance abuse treatment, weight loss with an ideal body mass index of ≤ 35, and diabetes mellitus (DM) management with a ≤ 7 hemoglobin A_1c value.^3-7

This management did not result in fewer patients receiving TKR. In fact, the volume of TKR patients increased by 8% over the study period. Although part of this increase could have been due to increased scheduling efficiency, the orthopedic surgery service worked closely with primary care, nutrition, and medicine services to optimize these patients so they could be placed on the schedule for surgery.

Preoperative Education

Physical therapy and the orthopedic preprocedure clinic provided preoperative education to patients, covering preoperative chlorhexidine body washes, home safety, use of a walker, anticipated LOS, use of ambulatory sequential compressive devices, use of a knee cooling device, as well as PT protocols during hospitalization.⁸ This helped increase postoperative patient adherence and helped patients anticipate an appropriate LOS. Health care providers worked with patients to understand their home environment and plan for caregivers to assist them in the immediate postoperative period.

Intraoperative Processes

Reducing Blood Loss

The orthopedic surgery service reviewed literature related to the efficacy and safety of tranexamic acid. Based on the literature, the orthopedic surgery service arrived at a consensus agreement to implement a topical tranexamic acid dose of 3 g/100 cc saline for each TKR. Presentation of the pertinent literature to the pharmacy service allowed placement of this medication on the formulary for intraoperative use in the TKR cases.

Specific processes were implemented that involved the orthopedic service ordering tranexamic acid in advance for each patient, pharmacy mixing the solution and having it ready in a timely manner, and the operating room sending a messenger to the pharmacy to pick up a sterile container of the tranexamic acid/saline solution. Postoperative blood loss and transfusions decreased. Less anemia contributed to better performance and less fatigue in PT, which helped move patients down a pathway for quicker discharge.^9,10

DVT Mechanical Prophylaxis

The orthopedic surgery service was concerned about adherence with stationary sequential compressive devices for mechanical thromboembolic prophylaxis. Patients had to remove them for PT, ambulation in the halls, and visiting the restroom, and then nurses had to replace them. A literature review examined a mobile compressive device that could be maintained during ambulation, and a demonstration for the orthopedic surgery service was arranged. The orthopedic service decided to change to the newer device, and the mobile compression device was presented to the PVAHCS Therapeutics Committee. Subsequently the new device was implemented after the appropriate in-service of the various clinic, PT, ward, surgery, preoperative, and postoperative personnel.¹¹ The device was initiated in the holding area prior to surgery, continued throughout the hospitalization, and taken home by the patient for 2 weeks of use following surgery. Patients were instructed to return the device to clinic at their 2-week follow-up appointment.

Infection Control

A dilute betadine lavage was instituted for each surgical case, using the pulsatile lavage followed by a lactated Ringer solution rinse prior to TKR implantation. Additionally, the wound was lavaged prior to closure with this dilute betadine solution.¹²

Pain Control

Immediately before surgery, patients received oral morphine sulfate and celecoxib. A local 2% lidocaine with epinephrine injection was used at the surgical incision and joint after the skin prep and immediately prior to the skin incision. Patients received a mixture of ropivicaine .5%/20 mL, morphine sulfate 10 mg, and toradol 30 mg at the capsular region prior to implantation of the total knee prosthesis. At the end of the procedure, an additional 20 mL of 2% lidocaine was injected into the joint once the capsule was closed. This improved postoperative pain, decreased postoperative opioid dosing, and allowed for earlier ambulation with PT.¹³

PostOperative Processes

Deep Vein Thrombosis (DVT) Chemoprophylaxis

Once the chest physician guidelines-approved stand-alone mobile compressive devices was implemented, orthopedic surgery service revisited the chemoprophylaxis for routine low-risk patients. Use of subcutaneously daily injections of 2.5 mg fondiparinux was switched to 81 mg enteric-coated aspirin administered orally twice daily. The authors believe this further reduced the postoperative bleeding and transfusion risks. There was not an increase in DVT or pulmonary embolism complications.^14,15

Physical Therapy

Partnering with PT, a 2-day LOS protocol was established. Patients were introduced to this protocol in a preoperative PT teaching class, and it was reinforced during the hospital stay. Patients who had earlier cases in the day were seen by PT the day of surgery when staffing and scheduling permitted. Early ambulation contributed significantly to earlier discharge for patients.¹⁶ Early ambulation also has been shown to decrease thromboembolic complications in orthopedic total joint patients.

Pain and Nausea Management

Parenteral narcotics were avoided, and oral narcotics were implemented with a graduated dosing based on a 10-point pain scale. For most patients, this was adequate and avoided the nausea frequently seen with the injectable narcotics.

Use of a postoperative cooling device that circulated cool water through a pad over the patient’s knee was instituted to assist with pain control. The patient received instruction on this device at the preoperative education sessions and was given the device to continue at home postdischarge.

Hospitalist Comanagement

Comanagement of orthopedic patients with hospitalists has become a standard practice nationally. The orthopedic surgery service works closely with the hospitalist team who see each total joint patient on postoperative admission to the ward. The orthopedic team handles all aspects of PT, wound management, pain control, and DVT prophylaxis. The hospitalist focuses on the remainder of comorbid conditions such as DM, chronic obstructive pulmonary disease, and underlying cardiac conditions.

The American Society of Anesthesiologists (ASA) average score was 2.8 for these procedures. Despite comprehensive preoperative screening, older patients with more comorbidities (higher ASA score) are more prone to emerging complications.¹⁷ Integration of the hospitalist team into the care of every orthopedic total joint patient facilitates prompt recognition and mitigation of these complications as they occur, directly reducing overall severity and LOS and allowing safe recovery from the surgical procedure.^18,19

Conclusion

At the start of this system improvement, the previous 12-month data showed 164 knee replacements with a 4.9-day VA national LOS and 3.5- day PVAHCS LOS. At the end of the 12-month system improvement, the VA national LOS for TKR was 4.8 days, and at PVAHCS it was 2.8 days.

The 30-day readmission rate was 8.4% nationally and 7.9% at PVAHCS. After the system improvements, the national 30-day readmission rate was 7.1%, while the PVAHCS rate dropped to less than half the national rate: 3.4%.

It is important to note, that the improvements in the aforementioned multiple processes could not have been possible without a dedicated effort from the multiple stakeholders involved. Hospitalists, primary care, PT, pharmacy, operating room staff, anesthesia, preprocedure staff, floor nurses, the Commodities and Therapeutics Committee, and administration all partnered with the orthopedic surgery service to produce the improvements in LOS and corresponding reduction in 30-day readmissions.

These data suggest that there does not need to be an inherent tradeoff between LOS and 30-day readmissions. Rather, both measures can be managed independently to produce improvements across the service. A team approach to process improvement can allow for increased efficiency while providing safer care for patients.

Many improvements in health care today involve care coordination across the entire health care system. Active management of an orthopedic surgery service from a system perspective allows for improvements that can favorably impact readmissions and length of stay (LOS) for patients.¹ The following is an example of a systemwide process improvement in total knee replacement (TKR) surgery that dramatically decreased 30-day readmissions and shortened the LOS during a 12-month period.\

Background

The VA is the largest integrated health care system in the U.S. VA hospitals use the VA Surgical Quality Improvement Program (VASQIP) to monitor surgical services. Initially known as the National Surgery Quality Improvement Program (NSQIP), the program began in 1994 to help provide reliable, valid information on patient presurgical factors, processes of care during surgery, and 30-day morbidity and mortality rates in VA hospitals.² Since its inception, NSQIP has spread to the private sector and is now widely used throughout the U.S.

Using on-site data acquisition by specially trained and dedicated registered nurses, information on each surgical case is input into a quality program. Quarterly reports are distributed to each hospital, and a comparison of mortality, LOS, 30-day readmissions to the hospital, and other data are analyzed and presented by quarter and rolling 12-month time frames. Use of VASQIP data allows improvement of the structures and processes of care throughout the VA, providing safer surgery for veterans.

At the Phoenix VA Health Care System (PVAHCS) in Arizona, the third quarter 2014 report showed the rolling 12-month average LOS for orthopedic TKR patients was 3.5 days and corresponding 30-day readmissions were 7.9%. Using a systems improvement approach, the authors set a goal of reducing these metrics by 10%.

The orthopedic service engaged members of the hospitalist, anesthesia, physical therapy (PT), nursing, social work, primary care, and pharmacy services, as well as hospital administration. Twelve months later, the LOS for TKR patients declined 20% to 2.8 days. Corresponding 30-day readmissions declined for the patients with knee replacement to 3.4%—a 57% reduction in 1 year. Mortality for these 177 cases was zero.

To accomplish these improvements, the authors divided the surgical procedure into preoperative, perioperative, and postoperative time frames and looked at process improvement during each of these periods. The following is a summary of the various processes that the authors feel contributed to the reduced LOS and 30-day readmission rate. Although some of these interventions were in place before the study period, all the processes were standardized for TKRs through surgeon consensus, and each of the surgeons adopted all the processes during the study period.

Preoperative Processes

In the VA primary care-based model orthopedic surgery is accessed through a consult process in the electronic health record. The orthopedic surgery service reviews each new consult and makes recommendations for optimization at the time the consult was received. This process was used to work closely with primary care providers to preoperatively prepare patients. The orthopedic surgery service advocates smoking cessation, substance abuse treatment, weight loss with an ideal body mass index of ≤ 35, and diabetes mellitus (DM) management with a ≤ 7 hemoglobin A_1c value.^3-7

This management did not result in fewer patients receiving TKR. In fact, the volume of TKR patients increased by 8% over the study period. Although part of this increase could have been due to increased scheduling efficiency, the orthopedic surgery service worked closely with primary care, nutrition, and medicine services to optimize these patients so they could be placed on the schedule for surgery.

Preoperative Education

Physical therapy and the orthopedic preprocedure clinic provided preoperative education to patients, covering preoperative chlorhexidine body washes, home safety, use of a walker, anticipated LOS, use of ambulatory sequential compressive devices, use of a knee cooling device, as well as PT protocols during hospitalization.⁸ This helped increase postoperative patient adherence and helped patients anticipate an appropriate LOS. Health care providers worked with patients to understand their home environment and plan for caregivers to assist them in the immediate postoperative period.

Intraoperative Processes

Reducing Blood Loss

The orthopedic surgery service reviewed literature related to the efficacy and safety of tranexamic acid. Based on the literature, the orthopedic surgery service arrived at a consensus agreement to implement a topical tranexamic acid dose of 3 g/100 cc saline for each TKR. Presentation of the pertinent literature to the pharmacy service allowed placement of this medication on the formulary for intraoperative use in the TKR cases.

Specific processes were implemented that involved the orthopedic service ordering tranexamic acid in advance for each patient, pharmacy mixing the solution and having it ready in a timely manner, and the operating room sending a messenger to the pharmacy to pick up a sterile container of the tranexamic acid/saline solution. Postoperative blood loss and transfusions decreased. Less anemia contributed to better performance and less fatigue in PT, which helped move patients down a pathway for quicker discharge.^9,10

DVT Mechanical Prophylaxis

The orthopedic surgery service was concerned about adherence with stationary sequential compressive devices for mechanical thromboembolic prophylaxis. Patients had to remove them for PT, ambulation in the halls, and visiting the restroom, and then nurses had to replace them. A literature review examined a mobile compressive device that could be maintained during ambulation, and a demonstration for the orthopedic surgery service was arranged. The orthopedic service decided to change to the newer device, and the mobile compression device was presented to the PVAHCS Therapeutics Committee. Subsequently the new device was implemented after the appropriate in-service of the various clinic, PT, ward, surgery, preoperative, and postoperative personnel.¹¹ The device was initiated in the holding area prior to surgery, continued throughout the hospitalization, and taken home by the patient for 2 weeks of use following surgery. Patients were instructed to return the device to clinic at their 2-week follow-up appointment.

Infection Control

A dilute betadine lavage was instituted for each surgical case, using the pulsatile lavage followed by a lactated Ringer solution rinse prior to TKR implantation. Additionally, the wound was lavaged prior to closure with this dilute betadine solution.¹²

Pain Control

Immediately before surgery, patients received oral morphine sulfate and celecoxib. A local 2% lidocaine with epinephrine injection was used at the surgical incision and joint after the skin prep and immediately prior to the skin incision. Patients received a mixture of ropivicaine .5%/20 mL, morphine sulfate 10 mg, and toradol 30 mg at the capsular region prior to implantation of the total knee prosthesis. At the end of the procedure, an additional 20 mL of 2% lidocaine was injected into the joint once the capsule was closed. This improved postoperative pain, decreased postoperative opioid dosing, and allowed for earlier ambulation with PT.¹³

PostOperative Processes

Deep Vein Thrombosis (DVT) Chemoprophylaxis

Once the chest physician guidelines-approved stand-alone mobile compressive devices was implemented, orthopedic surgery service revisited the chemoprophylaxis for routine low-risk patients. Use of subcutaneously daily injections of 2.5 mg fondiparinux was switched to 81 mg enteric-coated aspirin administered orally twice daily. The authors believe this further reduced the postoperative bleeding and transfusion risks. There was not an increase in DVT or pulmonary embolism complications.^14,15

Physical Therapy

Partnering with PT, a 2-day LOS protocol was established. Patients were introduced to this protocol in a preoperative PT teaching class, and it was reinforced during the hospital stay. Patients who had earlier cases in the day were seen by PT the day of surgery when staffing and scheduling permitted. Early ambulation contributed significantly to earlier discharge for patients.¹⁶ Early ambulation also has been shown to decrease thromboembolic complications in orthopedic total joint patients.

Pain and Nausea Management

Parenteral narcotics were avoided, and oral narcotics were implemented with a graduated dosing based on a 10-point pain scale. For most patients, this was adequate and avoided the nausea frequently seen with the injectable narcotics.

Use of a postoperative cooling device that circulated cool water through a pad over the patient’s knee was instituted to assist with pain control. The patient received instruction on this device at the preoperative education sessions and was given the device to continue at home postdischarge.

Hospitalist Comanagement

Comanagement of orthopedic patients with hospitalists has become a standard practice nationally. The orthopedic surgery service works closely with the hospitalist team who see each total joint patient on postoperative admission to the ward. The orthopedic team handles all aspects of PT, wound management, pain control, and DVT prophylaxis. The hospitalist focuses on the remainder of comorbid conditions such as DM, chronic obstructive pulmonary disease, and underlying cardiac conditions.

The American Society of Anesthesiologists (ASA) average score was 2.8 for these procedures. Despite comprehensive preoperative screening, older patients with more comorbidities (higher ASA score) are more prone to emerging complications.¹⁷ Integration of the hospitalist team into the care of every orthopedic total joint patient facilitates prompt recognition and mitigation of these complications as they occur, directly reducing overall severity and LOS and allowing safe recovery from the surgical procedure.^18,19

Conclusion

At the start of this system improvement, the previous 12-month data showed 164 knee replacements with a 4.9-day VA national LOS and 3.5- day PVAHCS LOS. At the end of the 12-month system improvement, the VA national LOS for TKR was 4.8 days, and at PVAHCS it was 2.8 days.

The 30-day readmission rate was 8.4% nationally and 7.9% at PVAHCS. After the system improvements, the national 30-day readmission rate was 7.1%, while the PVAHCS rate dropped to less than half the national rate: 3.4%.

It is important to note, that the improvements in the aforementioned multiple processes could not have been possible without a dedicated effort from the multiple stakeholders involved. Hospitalists, primary care, PT, pharmacy, operating room staff, anesthesia, preprocedure staff, floor nurses, the Commodities and Therapeutics Committee, and administration all partnered with the orthopedic surgery service to produce the improvements in LOS and corresponding reduction in 30-day readmissions.

These data suggest that there does not need to be an inherent tradeoff between LOS and 30-day readmissions. Rather, both measures can be managed independently to produce improvements across the service. A team approach to process improvement can allow for increased efficiency while providing safer care for patients.

Many improvements in health care today involve care coordination across the entire health care system. Active management of an orthopedic surgery service from a system perspective allows for improvements that can favorably impact readmissions and length of stay (LOS) for patients.¹ The following is an example of a systemwide process improvement in total knee replacement (TKR) surgery that dramatically decreased 30-day readmissions and shortened the LOS during a 12-month period.\

Background

The VA is the largest integrated health care system in the U.S. VA hospitals use the VA Surgical Quality Improvement Program (VASQIP) to monitor surgical services. Initially known as the National Surgery Quality Improvement Program (NSQIP), the program began in 1994 to help provide reliable, valid information on patient presurgical factors, processes of care during surgery, and 30-day morbidity and mortality rates in VA hospitals.² Since its inception, NSQIP has spread to the private sector and is now widely used throughout the U.S.

Using on-site data acquisition by specially trained and dedicated registered nurses, information on each surgical case is input into a quality program. Quarterly reports are distributed to each hospital, and a comparison of mortality, LOS, 30-day readmissions to the hospital, and other data are analyzed and presented by quarter and rolling 12-month time frames. Use of VASQIP data allows improvement of the structures and processes of care throughout the VA, providing safer surgery for veterans.

At the Phoenix VA Health Care System (PVAHCS) in Arizona, the third quarter 2014 report showed the rolling 12-month average LOS for orthopedic TKR patients was 3.5 days and corresponding 30-day readmissions were 7.9%. Using a systems improvement approach, the authors set a goal of reducing these metrics by 10%.

The orthopedic service engaged members of the hospitalist, anesthesia, physical therapy (PT), nursing, social work, primary care, and pharmacy services, as well as hospital administration. Twelve months later, the LOS for TKR patients declined 20% to 2.8 days. Corresponding 30-day readmissions declined for the patients with knee replacement to 3.4%—a 57% reduction in 1 year. Mortality for these 177 cases was zero.

To accomplish these improvements, the authors divided the surgical procedure into preoperative, perioperative, and postoperative time frames and looked at process improvement during each of these periods. The following is a summary of the various processes that the authors feel contributed to the reduced LOS and 30-day readmission rate. Although some of these interventions were in place before the study period, all the processes were standardized for TKRs through surgeon consensus, and each of the surgeons adopted all the processes during the study period.

Preoperative Processes

In the VA primary care-based model orthopedic surgery is accessed through a consult process in the electronic health record. The orthopedic surgery service reviews each new consult and makes recommendations for optimization at the time the consult was received. This process was used to work closely with primary care providers to preoperatively prepare patients. The orthopedic surgery service advocates smoking cessation, substance abuse treatment, weight loss with an ideal body mass index of ≤ 35, and diabetes mellitus (DM) management with a ≤ 7 hemoglobin A_1c value.^3-7

This management did not result in fewer patients receiving TKR. In fact, the volume of TKR patients increased by 8% over the study period. Although part of this increase could have been due to increased scheduling efficiency, the orthopedic surgery service worked closely with primary care, nutrition, and medicine services to optimize these patients so they could be placed on the schedule for surgery.

Preoperative Education

Physical therapy and the orthopedic preprocedure clinic provided preoperative education to patients, covering preoperative chlorhexidine body washes, home safety, use of a walker, anticipated LOS, use of ambulatory sequential compressive devices, use of a knee cooling device, as well as PT protocols during hospitalization.⁸ This helped increase postoperative patient adherence and helped patients anticipate an appropriate LOS. Health care providers worked with patients to understand their home environment and plan for caregivers to assist them in the immediate postoperative period.

Intraoperative Processes

Reducing Blood Loss

The orthopedic surgery service reviewed literature related to the efficacy and safety of tranexamic acid. Based on the literature, the orthopedic surgery service arrived at a consensus agreement to implement a topical tranexamic acid dose of 3 g/100 cc saline for each TKR. Presentation of the pertinent literature to the pharmacy service allowed placement of this medication on the formulary for intraoperative use in the TKR cases.

Specific processes were implemented that involved the orthopedic service ordering tranexamic acid in advance for each patient, pharmacy mixing the solution and having it ready in a timely manner, and the operating room sending a messenger to the pharmacy to pick up a sterile container of the tranexamic acid/saline solution. Postoperative blood loss and transfusions decreased. Less anemia contributed to better performance and less fatigue in PT, which helped move patients down a pathway for quicker discharge.^9,10

DVT Mechanical Prophylaxis

The orthopedic surgery service was concerned about adherence with stationary sequential compressive devices for mechanical thromboembolic prophylaxis. Patients had to remove them for PT, ambulation in the halls, and visiting the restroom, and then nurses had to replace them. A literature review examined a mobile compressive device that could be maintained during ambulation, and a demonstration for the orthopedic surgery service was arranged. The orthopedic service decided to change to the newer device, and the mobile compression device was presented to the PVAHCS Therapeutics Committee. Subsequently the new device was implemented after the appropriate in-service of the various clinic, PT, ward, surgery, preoperative, and postoperative personnel.¹¹ The device was initiated in the holding area prior to surgery, continued throughout the hospitalization, and taken home by the patient for 2 weeks of use following surgery. Patients were instructed to return the device to clinic at their 2-week follow-up appointment.

Infection Control

A dilute betadine lavage was instituted for each surgical case, using the pulsatile lavage followed by a lactated Ringer solution rinse prior to TKR implantation. Additionally, the wound was lavaged prior to closure with this dilute betadine solution.¹²

Pain Control

Immediately before surgery, patients received oral morphine sulfate and celecoxib. A local 2% lidocaine with epinephrine injection was used at the surgical incision and joint after the skin prep and immediately prior to the skin incision. Patients received a mixture of ropivicaine .5%/20 mL, morphine sulfate 10 mg, and toradol 30 mg at the capsular region prior to implantation of the total knee prosthesis. At the end of the procedure, an additional 20 mL of 2% lidocaine was injected into the joint once the capsule was closed. This improved postoperative pain, decreased postoperative opioid dosing, and allowed for earlier ambulation with PT.¹³

PostOperative Processes

Deep Vein Thrombosis (DVT) Chemoprophylaxis

Once the chest physician guidelines-approved stand-alone mobile compressive devices was implemented, orthopedic surgery service revisited the chemoprophylaxis for routine low-risk patients. Use of subcutaneously daily injections of 2.5 mg fondiparinux was switched to 81 mg enteric-coated aspirin administered orally twice daily. The authors believe this further reduced the postoperative bleeding and transfusion risks. There was not an increase in DVT or pulmonary embolism complications.^14,15

Physical Therapy

Partnering with PT, a 2-day LOS protocol was established. Patients were introduced to this protocol in a preoperative PT teaching class, and it was reinforced during the hospital stay. Patients who had earlier cases in the day were seen by PT the day of surgery when staffing and scheduling permitted. Early ambulation contributed significantly to earlier discharge for patients.¹⁶ Early ambulation also has been shown to decrease thromboembolic complications in orthopedic total joint patients.

Pain and Nausea Management

Parenteral narcotics were avoided, and oral narcotics were implemented with a graduated dosing based on a 10-point pain scale. For most patients, this was adequate and avoided the nausea frequently seen with the injectable narcotics.

Use of a postoperative cooling device that circulated cool water through a pad over the patient’s knee was instituted to assist with pain control. The patient received instruction on this device at the preoperative education sessions and was given the device to continue at home postdischarge.

Hospitalist Comanagement

Comanagement of orthopedic patients with hospitalists has become a standard practice nationally. The orthopedic surgery service works closely with the hospitalist team who see each total joint patient on postoperative admission to the ward. The orthopedic team handles all aspects of PT, wound management, pain control, and DVT prophylaxis. The hospitalist focuses on the remainder of comorbid conditions such as DM, chronic obstructive pulmonary disease, and underlying cardiac conditions.

The American Society of Anesthesiologists (ASA) average score was 2.8 for these procedures. Despite comprehensive preoperative screening, older patients with more comorbidities (higher ASA score) are more prone to emerging complications.¹⁷ Integration of the hospitalist team into the care of every orthopedic total joint patient facilitates prompt recognition and mitigation of these complications as they occur, directly reducing overall severity and LOS and allowing safe recovery from the surgical procedure.^18,19

Conclusion

At the start of this system improvement, the previous 12-month data showed 164 knee replacements with a 4.9-day VA national LOS and 3.5- day PVAHCS LOS. At the end of the 12-month system improvement, the VA national LOS for TKR was 4.8 days, and at PVAHCS it was 2.8 days.

The 30-day readmission rate was 8.4% nationally and 7.9% at PVAHCS. After the system improvements, the national 30-day readmission rate was 7.1%, while the PVAHCS rate dropped to less than half the national rate: 3.4%.

It is important to note, that the improvements in the aforementioned multiple processes could not have been possible without a dedicated effort from the multiple stakeholders involved. Hospitalists, primary care, PT, pharmacy, operating room staff, anesthesia, preprocedure staff, floor nurses, the Commodities and Therapeutics Committee, and administration all partnered with the orthopedic surgery service to produce the improvements in LOS and corresponding reduction in 30-day readmissions.

These data suggest that there does not need to be an inherent tradeoff between LOS and 30-day readmissions. Rather, both measures can be managed independently to produce improvements across the service. A team approach to process improvement can allow for increased efficiency while providing safer care for patients.

Insurance approval rates for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are strikingly low, according to a study published in Circulation.

Two approved PCSK9i drugs, alirocumab and evolocumab, were approved for coverage just 47% of the time. Because of their high price tag – about $14,000 per year – researchers had expected low rates of insurance coverage for the novel drugs, which encourage degradation of low-density lipoprotein cholesterol by blocking preserving LDL-C receptors in hepatocytes. However, they were surprised at the size of the problem.

“I think we knew that physicians were having challenges, but the number [of coverage approvals] was maybe lower than we expected,” Robert Yeh, MD, the study’s lead investigator, said in an interview. “Physicians and patients need to be aware that in perhaps the majority of cases, when they decide these drugs are going to be ones they want to prescribe, there may be a long procedure ahead of them, and they may ultimately not succeed in getting those medications.”

PCSK9 inhibitors are specifically approved for patients with familial hypercholesterolemia, or those with atherosclerotic cardiovascular disease who are unable to achieve satisfactory lipid levels through dietary measures and statin use.

Yet insurance coverage rates were low, even when patients met labeled indications. When the researchers examined the factors associated with insurance coverage, the most important factor was the type of insurance: Commercial third-party insurers approved the drugs about 24% of the time, while Medicare approved them nearly 61% of the time (P less than .01).

Older age, prescriptions by a cardiologist or other specialist, and a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) were also associated with higher rates of coverage by insurers (Circulation. 2017 Oct 30. doi: 10.1161/CIRCULATIONAHA.117.028430).

The researchers analyzed data from 9,357 patients with a prescription for a PCSK9 inhibitor. About 60% of the patients had a diagnosis of clinical ASCVD. In all, 4,397 patients (47%) had their prescriptions for PCSK9 inhibitor therapy covered, and 53% of coverage requests were rejected. Nearly 65% of patients who received approval went on to fill their prescription.

There was no association between LDL-C level and the likelihood of approval. In the 32 cases in which the LDL-C levels were 330 mg/dL or greater, 59% of patients were not approved for coverage.

Noncommercial payers were more likely to approve the medication (odds ratio, 12.32; 95% confidence interval, 7.09-21.39), as was Medicare (OR, 5.37; 95% CI, 4.23-6.80).

A recent cost-effectiveness analysis of evolocumab added to standard therapy showed that an annual cost of $9,669 would achieve an incremental cost-effectiveness ratio of $150,000 per quality-adjusted life year gained among patients with LDL levels 70 mg/dL or greater. (JAMA Cardiol. 2017;2[10]:1069-78). Evolocumab is currently listed at $14,523, putting it above that value.

“Now that clinical trial outcome data demonstrating reductions in major cardiovascular events and formal cost-effectiveness studies have identified value-based prices for these medications, it would be hoped that progress can be made such that a greater proportion of eligible patients can be treated,” Gregg C. Fonarow, MD, professor of cardiovascular medicine and science director at the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and the lead author of the cost-effectiveness study, said in an interview.

Both sets of findings cut to the heart of the debate over pricing of new medications. PCSK9 inhibitors have a clear benefit in lowering LDL and reducing risk of heart attack, but the drugs’ price tags may limit their availability.

“We need to not be afraid to discuss these issues in plain terms that are not emotional, so that we can get a better sense of what is the amount to spend on a therapy, even when it is effective but potentially pricey,” said Dr. Yeh, director of the Richard and Susan Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center, Boston. “This is a really important business, philosophical, medical, and ethical debate.”

The study received no external funding. Dr. Yeh reported having no financial disclosures. Dr. Fonarow has consulted for Amgen.

Insurance approval rates for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are strikingly low, according to a study published in Circulation.

Two approved PCSK9i drugs, alirocumab and evolocumab, were approved for coverage just 47% of the time. Because of their high price tag – about $14,000 per year – researchers had expected low rates of insurance coverage for the novel drugs, which encourage degradation of low-density lipoprotein cholesterol by blocking preserving LDL-C receptors in hepatocytes. However, they were surprised at the size of the problem.

“I think we knew that physicians were having challenges, but the number [of coverage approvals] was maybe lower than we expected,” Robert Yeh, MD, the study’s lead investigator, said in an interview. “Physicians and patients need to be aware that in perhaps the majority of cases, when they decide these drugs are going to be ones they want to prescribe, there may be a long procedure ahead of them, and they may ultimately not succeed in getting those medications.”

PCSK9 inhibitors are specifically approved for patients with familial hypercholesterolemia, or those with atherosclerotic cardiovascular disease who are unable to achieve satisfactory lipid levels through dietary measures and statin use.

Yet insurance coverage rates were low, even when patients met labeled indications. When the researchers examined the factors associated with insurance coverage, the most important factor was the type of insurance: Commercial third-party insurers approved the drugs about 24% of the time, while Medicare approved them nearly 61% of the time (P less than .01).

Older age, prescriptions by a cardiologist or other specialist, and a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) were also associated with higher rates of coverage by insurers (Circulation. 2017 Oct 30. doi: 10.1161/CIRCULATIONAHA.117.028430).

The researchers analyzed data from 9,357 patients with a prescription for a PCSK9 inhibitor. About 60% of the patients had a diagnosis of clinical ASCVD. In all, 4,397 patients (47%) had their prescriptions for PCSK9 inhibitor therapy covered, and 53% of coverage requests were rejected. Nearly 65% of patients who received approval went on to fill their prescription.

There was no association between LDL-C level and the likelihood of approval. In the 32 cases in which the LDL-C levels were 330 mg/dL or greater, 59% of patients were not approved for coverage.

Noncommercial payers were more likely to approve the medication (odds ratio, 12.32; 95% confidence interval, 7.09-21.39), as was Medicare (OR, 5.37; 95% CI, 4.23-6.80).

A recent cost-effectiveness analysis of evolocumab added to standard therapy showed that an annual cost of $9,669 would achieve an incremental cost-effectiveness ratio of $150,000 per quality-adjusted life year gained among patients with LDL levels 70 mg/dL or greater. (JAMA Cardiol. 2017;2[10]:1069-78). Evolocumab is currently listed at $14,523, putting it above that value.

“Now that clinical trial outcome data demonstrating reductions in major cardiovascular events and formal cost-effectiveness studies have identified value-based prices for these medications, it would be hoped that progress can be made such that a greater proportion of eligible patients can be treated,” Gregg C. Fonarow, MD, professor of cardiovascular medicine and science director at the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and the lead author of the cost-effectiveness study, said in an interview.

Both sets of findings cut to the heart of the debate over pricing of new medications. PCSK9 inhibitors have a clear benefit in lowering LDL and reducing risk of heart attack, but the drugs’ price tags may limit their availability.

“We need to not be afraid to discuss these issues in plain terms that are not emotional, so that we can get a better sense of what is the amount to spend on a therapy, even when it is effective but potentially pricey,” said Dr. Yeh, director of the Richard and Susan Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center, Boston. “This is a really important business, philosophical, medical, and ethical debate.”

The study received no external funding. Dr. Yeh reported having no financial disclosures. Dr. Fonarow has consulted for Amgen.

Insurance approval rates for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are strikingly low, according to a study published in Circulation.

Two approved PCSK9i drugs, alirocumab and evolocumab, were approved for coverage just 47% of the time. Because of their high price tag – about $14,000 per year – researchers had expected low rates of insurance coverage for the novel drugs, which encourage degradation of low-density lipoprotein cholesterol by blocking preserving LDL-C receptors in hepatocytes. However, they were surprised at the size of the problem.

“I think we knew that physicians were having challenges, but the number [of coverage approvals] was maybe lower than we expected,” Robert Yeh, MD, the study’s lead investigator, said in an interview. “Physicians and patients need to be aware that in perhaps the majority of cases, when they decide these drugs are going to be ones they want to prescribe, there may be a long procedure ahead of them, and they may ultimately not succeed in getting those medications.”

PCSK9 inhibitors are specifically approved for patients with familial hypercholesterolemia, or those with atherosclerotic cardiovascular disease who are unable to achieve satisfactory lipid levels through dietary measures and statin use.

Yet insurance coverage rates were low, even when patients met labeled indications. When the researchers examined the factors associated with insurance coverage, the most important factor was the type of insurance: Commercial third-party insurers approved the drugs about 24% of the time, while Medicare approved them nearly 61% of the time (P less than .01).

Older age, prescriptions by a cardiologist or other specialist, and a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) were also associated with higher rates of coverage by insurers (Circulation. 2017 Oct 30. doi: 10.1161/CIRCULATIONAHA.117.028430).

The researchers analyzed data from 9,357 patients with a prescription for a PCSK9 inhibitor. About 60% of the patients had a diagnosis of clinical ASCVD. In all, 4,397 patients (47%) had their prescriptions for PCSK9 inhibitor therapy covered, and 53% of coverage requests were rejected. Nearly 65% of patients who received approval went on to fill their prescription.

There was no association between LDL-C level and the likelihood of approval. In the 32 cases in which the LDL-C levels were 330 mg/dL or greater, 59% of patients were not approved for coverage.

Noncommercial payers were more likely to approve the medication (odds ratio, 12.32; 95% confidence interval, 7.09-21.39), as was Medicare (OR, 5.37; 95% CI, 4.23-6.80).

A recent cost-effectiveness analysis of evolocumab added to standard therapy showed that an annual cost of $9,669 would achieve an incremental cost-effectiveness ratio of $150,000 per quality-adjusted life year gained among patients with LDL levels 70 mg/dL or greater. (JAMA Cardiol. 2017;2[10]:1069-78). Evolocumab is currently listed at $14,523, putting it above that value.

“Now that clinical trial outcome data demonstrating reductions in major cardiovascular events and formal cost-effectiveness studies have identified value-based prices for these medications, it would be hoped that progress can be made such that a greater proportion of eligible patients can be treated,” Gregg C. Fonarow, MD, professor of cardiovascular medicine and science director at the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and the lead author of the cost-effectiveness study, said in an interview.

Both sets of findings cut to the heart of the debate over pricing of new medications. PCSK9 inhibitors have a clear benefit in lowering LDL and reducing risk of heart attack, but the drugs’ price tags may limit their availability.

“We need to not be afraid to discuss these issues in plain terms that are not emotional, so that we can get a better sense of what is the amount to spend on a therapy, even when it is effective but potentially pricey,” said Dr. Yeh, director of the Richard and Susan Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center, Boston. “This is a really important business, philosophical, medical, and ethical debate.”

The study received no external funding. Dr. Yeh reported having no financial disclosures. Dr. Fonarow has consulted for Amgen.