Outside the clinic room, I paced the hallway and pressed the phone to my ear, waiting for the resident to pick up.

“I have patient SB in clinic for her appointment now. I’m hoping to get preliminary results of her bone marrow biopsy.”

I had known SB well from her month-long inpatient stay on our leukemia service. She had come in with a white blood cell count through the roof – a relapse of her leukemia, 4 years out from her bone marrow transplant. It was devastating. After a few cycles of chemotherapy and a bone marrow biopsy yesterday to see if it had worked, she was here now to get her results and decide next steps.

“Hello!” I said and we hugged. Her mother and father accompanied her, sitting still with their hands folded nervously. SB had multiple complications during her hospitalization, and we went through how each was doing. Did she get her new heart medication? Did she do okay on the antibiotics? Was the rash improving? With each question, she and her parents seemed more nervous.

There was an elephant in that exam room. Asking a cancer patient in limbo if she refilled her heart medications becomes as trivial as asking her about the weather. SB and her parents were here for one thing, from which everything else was a distraction. The only question that mattered was the one splitting their world in two: Is their daughter in remission or not?

“She’s here with her parents now,” I said outside the door. “What do you think?” The resident told me he had looked at the case this morning, and it looked like 3% blasts. I smiled – anything under 5% is good, considered a remission. But the pathology resident still hadn’t reviewed the sample with his attending.

Inside the room, after exhausting all other conversation, I hesitated. Should I tell SB the preliminary results? Or should I wait for the final diagnosis?

I’d been burned before. Once, I told a patient with a new diagnosis of esophageal cancer that it was early stage. It was not. Upon additional radiology review, the surrounding lymph nodes were enlarged, and they were ultimately found to be metastases. That initial conversation – and the subsequent one, in which I had to walk back my reassurance that the cancer was contained – was seared into my mind.

I learned from it. Giving preliminary results can be dangerous. What if we say all clear and then learn days later it isn’t so? Or what if we reveal the cancer is progressing, causing despair and re-evaluation of life’s priorities, only to find out it was a false alarm? False alarms are terrifying, and false reassurance is cruel, yet all the while, excessive waiting can feel excruciating for the person whose very existence is suspended.

As hematologists and oncologists, we scroll through CT scans, and we look at slides ourselves. But we also value and depend on the expertise of our colleagues in other departments like pathology and radiology who have their own workflow. It’s a process; it’s for quality assurance that we don’t get immediate results, and that’s a good thing.

It depends on the patient, but often I find the most straightforward solution is to say exactly what is true. For some, the combination of incredibly high stakes coupled with extended wait times becomes agonizing. They might incorrectly read into unrelated, benign actions – if my pager goes off or I look at the computer screen a moment too long – as clues into something I know and am not sharing. They might be so distracted we cannot address anything else.

So I’ve walked back from my initial “do not share anything” reaction to “it’s sometimes okay” – as long as the patient understands the nuances of what preliminary results do and do not mean. The problem with my esophageal cancer patient was not that I had shared preliminary results; it was that I hadn’t framed them as such. I had simply stated the findings, portraying them as certain.

Now, I tend to break the fourth wall. I explain that it’s the resident’s read, that it isn’t final, and that it can be amended. Do you still want to know?

Most people say yes.

SB and her parents were in that boat. They had driven 3 hours to make this appointment. They didn’t want to drive home empty handed.

“It’s preliminary,” I carefully qualified.

“Okay.”

“The final results may be different.”

“Okay, yes. We understand.”

The three of them held hands. They were holding their breath.

“It looks like remission.”

SB cried. Her mother threw her arms around my neck. “You know, she broke down when you stepped out,” her father whispered to me. “She was sure it meant bad news.”

I tried to be happy for them and with them, but now I was the one holding my breath. I hoped I wouldn’t have to take it all away.

For the next 24 hours, I compulsively checked SB’s chart, hoping final results would populate that would be consistent with what I had shared.

The next day, the pathologist called me, and I called SB.

“I have the final results,” I said, followed by my favorite phrase in hematology and oncology. “I have good news.”

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

Outside the clinic room, I paced the hallway and pressed the phone to my ear, waiting for the resident to pick up.

“I have patient SB in clinic for her appointment now. I’m hoping to get preliminary results of her bone marrow biopsy.”

I had known SB well from her month-long inpatient stay on our leukemia service. She had come in with a white blood cell count through the roof – a relapse of her leukemia, 4 years out from her bone marrow transplant. It was devastating. After a few cycles of chemotherapy and a bone marrow biopsy yesterday to see if it had worked, she was here now to get her results and decide next steps.

“Hello!” I said and we hugged. Her mother and father accompanied her, sitting still with their hands folded nervously. SB had multiple complications during her hospitalization, and we went through how each was doing. Did she get her new heart medication? Did she do okay on the antibiotics? Was the rash improving? With each question, she and her parents seemed more nervous.

There was an elephant in that exam room. Asking a cancer patient in limbo if she refilled her heart medications becomes as trivial as asking her about the weather. SB and her parents were here for one thing, from which everything else was a distraction. The only question that mattered was the one splitting their world in two: Is their daughter in remission or not?

“She’s here with her parents now,” I said outside the door. “What do you think?” The resident told me he had looked at the case this morning, and it looked like 3% blasts. I smiled – anything under 5% is good, considered a remission. But the pathology resident still hadn’t reviewed the sample with his attending.

Inside the room, after exhausting all other conversation, I hesitated. Should I tell SB the preliminary results? Or should I wait for the final diagnosis?

I’d been burned before. Once, I told a patient with a new diagnosis of esophageal cancer that it was early stage. It was not. Upon additional radiology review, the surrounding lymph nodes were enlarged, and they were ultimately found to be metastases. That initial conversation – and the subsequent one, in which I had to walk back my reassurance that the cancer was contained – was seared into my mind.

I learned from it. Giving preliminary results can be dangerous. What if we say all clear and then learn days later it isn’t so? Or what if we reveal the cancer is progressing, causing despair and re-evaluation of life’s priorities, only to find out it was a false alarm? False alarms are terrifying, and false reassurance is cruel, yet all the while, excessive waiting can feel excruciating for the person whose very existence is suspended.

As hematologists and oncologists, we scroll through CT scans, and we look at slides ourselves. But we also value and depend on the expertise of our colleagues in other departments like pathology and radiology who have their own workflow. It’s a process; it’s for quality assurance that we don’t get immediate results, and that’s a good thing.

It depends on the patient, but often I find the most straightforward solution is to say exactly what is true. For some, the combination of incredibly high stakes coupled with extended wait times becomes agonizing. They might incorrectly read into unrelated, benign actions – if my pager goes off or I look at the computer screen a moment too long – as clues into something I know and am not sharing. They might be so distracted we cannot address anything else.

So I’ve walked back from my initial “do not share anything” reaction to “it’s sometimes okay” – as long as the patient understands the nuances of what preliminary results do and do not mean. The problem with my esophageal cancer patient was not that I had shared preliminary results; it was that I hadn’t framed them as such. I had simply stated the findings, portraying them as certain.

Now, I tend to break the fourth wall. I explain that it’s the resident’s read, that it isn’t final, and that it can be amended. Do you still want to know?

Most people say yes.

SB and her parents were in that boat. They had driven 3 hours to make this appointment. They didn’t want to drive home empty handed.

“It’s preliminary,” I carefully qualified.

“Okay.”

“The final results may be different.”

“Okay, yes. We understand.”

The three of them held hands. They were holding their breath.

“It looks like remission.”

SB cried. Her mother threw her arms around my neck. “You know, she broke down when you stepped out,” her father whispered to me. “She was sure it meant bad news.”

I tried to be happy for them and with them, but now I was the one holding my breath. I hoped I wouldn’t have to take it all away.

For the next 24 hours, I compulsively checked SB’s chart, hoping final results would populate that would be consistent with what I had shared.

The next day, the pathologist called me, and I called SB.

“I have the final results,” I said, followed by my favorite phrase in hematology and oncology. “I have good news.”

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

Outside the clinic room, I paced the hallway and pressed the phone to my ear, waiting for the resident to pick up.

“I have patient SB in clinic for her appointment now. I’m hoping to get preliminary results of her bone marrow biopsy.”

I had known SB well from her month-long inpatient stay on our leukemia service. She had come in with a white blood cell count through the roof – a relapse of her leukemia, 4 years out from her bone marrow transplant. It was devastating. After a few cycles of chemotherapy and a bone marrow biopsy yesterday to see if it had worked, she was here now to get her results and decide next steps.

“Hello!” I said and we hugged. Her mother and father accompanied her, sitting still with their hands folded nervously. SB had multiple complications during her hospitalization, and we went through how each was doing. Did she get her new heart medication? Did she do okay on the antibiotics? Was the rash improving? With each question, she and her parents seemed more nervous.

There was an elephant in that exam room. Asking a cancer patient in limbo if she refilled her heart medications becomes as trivial as asking her about the weather. SB and her parents were here for one thing, from which everything else was a distraction. The only question that mattered was the one splitting their world in two: Is their daughter in remission or not?

“She’s here with her parents now,” I said outside the door. “What do you think?” The resident told me he had looked at the case this morning, and it looked like 3% blasts. I smiled – anything under 5% is good, considered a remission. But the pathology resident still hadn’t reviewed the sample with his attending.

Inside the room, after exhausting all other conversation, I hesitated. Should I tell SB the preliminary results? Or should I wait for the final diagnosis?

I’d been burned before. Once, I told a patient with a new diagnosis of esophageal cancer that it was early stage. It was not. Upon additional radiology review, the surrounding lymph nodes were enlarged, and they were ultimately found to be metastases. That initial conversation – and the subsequent one, in which I had to walk back my reassurance that the cancer was contained – was seared into my mind.

I learned from it. Giving preliminary results can be dangerous. What if we say all clear and then learn days later it isn’t so? Or what if we reveal the cancer is progressing, causing despair and re-evaluation of life’s priorities, only to find out it was a false alarm? False alarms are terrifying, and false reassurance is cruel, yet all the while, excessive waiting can feel excruciating for the person whose very existence is suspended.

As hematologists and oncologists, we scroll through CT scans, and we look at slides ourselves. But we also value and depend on the expertise of our colleagues in other departments like pathology and radiology who have their own workflow. It’s a process; it’s for quality assurance that we don’t get immediate results, and that’s a good thing.

It depends on the patient, but often I find the most straightforward solution is to say exactly what is true. For some, the combination of incredibly high stakes coupled with extended wait times becomes agonizing. They might incorrectly read into unrelated, benign actions – if my pager goes off or I look at the computer screen a moment too long – as clues into something I know and am not sharing. They might be so distracted we cannot address anything else.

So I’ve walked back from my initial “do not share anything” reaction to “it’s sometimes okay” – as long as the patient understands the nuances of what preliminary results do and do not mean. The problem with my esophageal cancer patient was not that I had shared preliminary results; it was that I hadn’t framed them as such. I had simply stated the findings, portraying them as certain.

Now, I tend to break the fourth wall. I explain that it’s the resident’s read, that it isn’t final, and that it can be amended. Do you still want to know?

Most people say yes.

SB and her parents were in that boat. They had driven 3 hours to make this appointment. They didn’t want to drive home empty handed.

“It’s preliminary,” I carefully qualified.

“Okay.”

“The final results may be different.”

“Okay, yes. We understand.”

The three of them held hands. They were holding their breath.

“It looks like remission.”

SB cried. Her mother threw her arms around my neck. “You know, she broke down when you stepped out,” her father whispered to me. “She was sure it meant bad news.”

I tried to be happy for them and with them, but now I was the one holding my breath. I hoped I wouldn’t have to take it all away.

For the next 24 hours, I compulsively checked SB’s chart, hoping final results would populate that would be consistent with what I had shared.

The next day, the pathologist called me, and I called SB.

“I have the final results,” I said, followed by my favorite phrase in hematology and oncology. “I have good news.”

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

My father was a general surgeon in a very small town in West Virginia. He was very successful and his patients loved him. He loved them, too, and chose to practice well into his 70s. In retrospect, he should not have.

Perhaps brilliant in his day, he was less so at the end of his career. I realized his deficiencies when I was in residency. I wondered if, despite his undeniable experience, his age was compromising his clinical acumen.

There are data available that support my suspicions. Investigators from the Department of Health Policy and Management at Harvard T.H. Chan School of Public Health reviewed a random sample of Medicare beneficiaries admitted to a hospital between 2011 and 2014. They hypothesized that physician age may affect outcomes such as 30-day mortality, readmissions, and cost of care. Among the more than 700,000 admissions by more than 18,000 hospitalists, the 30-day mortality rates were significantly higher for physicians aged 60 years and older, compared with younger physicians. Importantly though, there was no difference in mortality for older, but high-volume, physicians, compared with younger ones.

These results were published in the BMJ (2017 May 16;357:j1797. doi: 10.1136/bmj.j1797) by the same group that described a similar reduction in mortality among female versus male internists (JAMA Intern Med. 2017 Feb 1;177[2]:206-13). Both studies attracted widespread media attention.

The BMJ study analyzed outcomes among hospitalists who exclusively manage inpatients. Hematologists, in contrast, are largely based in the outpatient setting or in a lab. Yet, hematologists are often called upon to cover inpatient units of very sick patients. We care for patients with acute leukemia, thrombotic thrombocytopenic purpura, and graft versus host disease, among other debilitating diseases. In that sense, I believe data generated from hospitalists probably apply to inpatient hematology as well.

Having just been the attending on one of these services, I am uncomfortably certain that they apply. I proudly boast that I once attended for 6 months in a year. I was good at it and enjoyed it. With time, though, we hired additional staff and I acquired administrative duties that decreased my attending service time. I now attend for 2 weeks, twice a year.

During the last one of these service times, I began to suspect that I was not as sharp as I once was. I don’t think I missed anything, I just didn’t seem to catch changes in clinical status as quickly as I once did. I was less comfortable with the new medications I was prescribing. I was depending more on the clinical pharmacist and the hematology fellow to keep track of side effects and dose adjustments. I was worried – more than ever – that I would make a mistake. The last thing I want to be is dangerous.


As department chairman, though, it is part of my job to ensure that no one else is dangerous either. The Joint Commission mandates Ongoing Professional Practice Evaluation (OPPE), which is intended to help assess a practitioner’s clinical competence. Yet, the commission recognizes that “Cognitive specialties (internal medicine, family practice, psychiatry, med specialties ...) are very difficult” in terms of identifying meaningful data that can be evaluated.

We do not have adequate tools to assess clinical competency. As a result, we are generally aware that physicians do a poor job of policing our own, in no small part because of a reluctance to identify and confront less competent physicians. Where police departments are accused of hiding behind a blue wall of silence, are physicians guilty of maintaining a white wall of silence?

Of course we are. How many clinically shaky fellows do we graduate into our profession every year? How many of us are aware of colleagues who are unskilled, but are reluctant to speak up about them? Our sins are documented in books such as “Wall of Silence: The Untold Story of the Medical Mistakes that Kill and Injure Millions of Americans” by Rosemary Gibson and Janardan Prasad Singh and “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care,” by Marty Makary.

Concern for my own competence notwithstanding, medicine as a profession requires reflection on its role in allowing substandard patient care to continue.

Punishment doesn’t seem to be the best way to right wrongs. The punished may not learn the lesson and the unpunished will be less forthcoming with their own errors.

Taking a lesson from highly reliable industries such as airlines, the medical profession is addressing medical errors better. For example, my institution has mandated thorough checklists before any and all invasive procedures, including bone marrow biopsies. Through a morbidity and mortality review of a case of hepatitis, we developed an automatic method of ordering hepatitis panels in every patient treated with monoclonal antibodies. Making systemic changes to prevent error avoids having to punish those who make errors, while holding accountable those who skirt the built-in safeguards.

We are less successful at applying similar error mitigation techniques to individual physicians who may not be clinically excellent. Examples abound of physicians who provide substandard care, but are allowed to continue. The repercussions continue at Wake Forest Baptist Medical Center, where a pathologist misdiagnosed some cancer cases over at least a 2-year period of time. Physicians, as a group, are not as good at certifying competency as are nurses, advanced practice providers, and pharmacists.

With many academic hematologists having relatively small practices, getting older, and getting burned out, the potential for patient harm as a result of medical error increases. Further, these physicians may not realize their increased risk and may be indignant when confronted.

I am interested in best practices that address this difficult and contentious issue. I hope our readers will offer their policies and procedures so that we can learn from each other. Patients should not have to worry about their doctors’ competency and doctors should be able to hold each other accountable by removing the white wall of silence.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at kalaycm@ccf.org.

My father was a general surgeon in a very small town in West Virginia. He was very successful and his patients loved him. He loved them, too, and chose to practice well into his 70s. In retrospect, he should not have.

Perhaps brilliant in his day, he was less so at the end of his career. I realized his deficiencies when I was in residency. I wondered if, despite his undeniable experience, his age was compromising his clinical acumen.

There are data available that support my suspicions. Investigators from the Department of Health Policy and Management at Harvard T.H. Chan School of Public Health reviewed a random sample of Medicare beneficiaries admitted to a hospital between 2011 and 2014. They hypothesized that physician age may affect outcomes such as 30-day mortality, readmissions, and cost of care. Among the more than 700,000 admissions by more than 18,000 hospitalists, the 30-day mortality rates were significantly higher for physicians aged 60 years and older, compared with younger physicians. Importantly though, there was no difference in mortality for older, but high-volume, physicians, compared with younger ones.

These results were published in the BMJ (2017 May 16;357:j1797. doi: 10.1136/bmj.j1797) by the same group that described a similar reduction in mortality among female versus male internists (JAMA Intern Med. 2017 Feb 1;177[2]:206-13). Both studies attracted widespread media attention.

The BMJ study analyzed outcomes among hospitalists who exclusively manage inpatients. Hematologists, in contrast, are largely based in the outpatient setting or in a lab. Yet, hematologists are often called upon to cover inpatient units of very sick patients. We care for patients with acute leukemia, thrombotic thrombocytopenic purpura, and graft versus host disease, among other debilitating diseases. In that sense, I believe data generated from hospitalists probably apply to inpatient hematology as well.

Having just been the attending on one of these services, I am uncomfortably certain that they apply. I proudly boast that I once attended for 6 months in a year. I was good at it and enjoyed it. With time, though, we hired additional staff and I acquired administrative duties that decreased my attending service time. I now attend for 2 weeks, twice a year.

During the last one of these service times, I began to suspect that I was not as sharp as I once was. I don’t think I missed anything, I just didn’t seem to catch changes in clinical status as quickly as I once did. I was less comfortable with the new medications I was prescribing. I was depending more on the clinical pharmacist and the hematology fellow to keep track of side effects and dose adjustments. I was worried – more than ever – that I would make a mistake. The last thing I want to be is dangerous.


As department chairman, though, it is part of my job to ensure that no one else is dangerous either. The Joint Commission mandates Ongoing Professional Practice Evaluation (OPPE), which is intended to help assess a practitioner’s clinical competence. Yet, the commission recognizes that “Cognitive specialties (internal medicine, family practice, psychiatry, med specialties ...) are very difficult” in terms of identifying meaningful data that can be evaluated.

We do not have adequate tools to assess clinical competency. As a result, we are generally aware that physicians do a poor job of policing our own, in no small part because of a reluctance to identify and confront less competent physicians. Where police departments are accused of hiding behind a blue wall of silence, are physicians guilty of maintaining a white wall of silence?

Of course we are. How many clinically shaky fellows do we graduate into our profession every year? How many of us are aware of colleagues who are unskilled, but are reluctant to speak up about them? Our sins are documented in books such as “Wall of Silence: The Untold Story of the Medical Mistakes that Kill and Injure Millions of Americans” by Rosemary Gibson and Janardan Prasad Singh and “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care,” by Marty Makary.

Concern for my own competence notwithstanding, medicine as a profession requires reflection on its role in allowing substandard patient care to continue.

Punishment doesn’t seem to be the best way to right wrongs. The punished may not learn the lesson and the unpunished will be less forthcoming with their own errors.

Taking a lesson from highly reliable industries such as airlines, the medical profession is addressing medical errors better. For example, my institution has mandated thorough checklists before any and all invasive procedures, including bone marrow biopsies. Through a morbidity and mortality review of a case of hepatitis, we developed an automatic method of ordering hepatitis panels in every patient treated with monoclonal antibodies. Making systemic changes to prevent error avoids having to punish those who make errors, while holding accountable those who skirt the built-in safeguards.

We are less successful at applying similar error mitigation techniques to individual physicians who may not be clinically excellent. Examples abound of physicians who provide substandard care, but are allowed to continue. The repercussions continue at Wake Forest Baptist Medical Center, where a pathologist misdiagnosed some cancer cases over at least a 2-year period of time. Physicians, as a group, are not as good at certifying competency as are nurses, advanced practice providers, and pharmacists.

With many academic hematologists having relatively small practices, getting older, and getting burned out, the potential for patient harm as a result of medical error increases. Further, these physicians may not realize their increased risk and may be indignant when confronted.

I am interested in best practices that address this difficult and contentious issue. I hope our readers will offer their policies and procedures so that we can learn from each other. Patients should not have to worry about their doctors’ competency and doctors should be able to hold each other accountable by removing the white wall of silence.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at kalaycm@ccf.org.

My father was a general surgeon in a very small town in West Virginia. He was very successful and his patients loved him. He loved them, too, and chose to practice well into his 70s. In retrospect, he should not have.

Perhaps brilliant in his day, he was less so at the end of his career. I realized his deficiencies when I was in residency. I wondered if, despite his undeniable experience, his age was compromising his clinical acumen.

There are data available that support my suspicions. Investigators from the Department of Health Policy and Management at Harvard T.H. Chan School of Public Health reviewed a random sample of Medicare beneficiaries admitted to a hospital between 2011 and 2014. They hypothesized that physician age may affect outcomes such as 30-day mortality, readmissions, and cost of care. Among the more than 700,000 admissions by more than 18,000 hospitalists, the 30-day mortality rates were significantly higher for physicians aged 60 years and older, compared with younger physicians. Importantly though, there was no difference in mortality for older, but high-volume, physicians, compared with younger ones.

These results were published in the BMJ (2017 May 16;357:j1797. doi: 10.1136/bmj.j1797) by the same group that described a similar reduction in mortality among female versus male internists (JAMA Intern Med. 2017 Feb 1;177[2]:206-13). Both studies attracted widespread media attention.

The BMJ study analyzed outcomes among hospitalists who exclusively manage inpatients. Hematologists, in contrast, are largely based in the outpatient setting or in a lab. Yet, hematologists are often called upon to cover inpatient units of very sick patients. We care for patients with acute leukemia, thrombotic thrombocytopenic purpura, and graft versus host disease, among other debilitating diseases. In that sense, I believe data generated from hospitalists probably apply to inpatient hematology as well.

Having just been the attending on one of these services, I am uncomfortably certain that they apply. I proudly boast that I once attended for 6 months in a year. I was good at it and enjoyed it. With time, though, we hired additional staff and I acquired administrative duties that decreased my attending service time. I now attend for 2 weeks, twice a year.

During the last one of these service times, I began to suspect that I was not as sharp as I once was. I don’t think I missed anything, I just didn’t seem to catch changes in clinical status as quickly as I once did. I was less comfortable with the new medications I was prescribing. I was depending more on the clinical pharmacist and the hematology fellow to keep track of side effects and dose adjustments. I was worried – more than ever – that I would make a mistake. The last thing I want to be is dangerous.


As department chairman, though, it is part of my job to ensure that no one else is dangerous either. The Joint Commission mandates Ongoing Professional Practice Evaluation (OPPE), which is intended to help assess a practitioner’s clinical competence. Yet, the commission recognizes that “Cognitive specialties (internal medicine, family practice, psychiatry, med specialties ...) are very difficult” in terms of identifying meaningful data that can be evaluated.

We do not have adequate tools to assess clinical competency. As a result, we are generally aware that physicians do a poor job of policing our own, in no small part because of a reluctance to identify and confront less competent physicians. Where police departments are accused of hiding behind a blue wall of silence, are physicians guilty of maintaining a white wall of silence?

Of course we are. How many clinically shaky fellows do we graduate into our profession every year? How many of us are aware of colleagues who are unskilled, but are reluctant to speak up about them? Our sins are documented in books such as “Wall of Silence: The Untold Story of the Medical Mistakes that Kill and Injure Millions of Americans” by Rosemary Gibson and Janardan Prasad Singh and “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care,” by Marty Makary.

Concern for my own competence notwithstanding, medicine as a profession requires reflection on its role in allowing substandard patient care to continue.

Punishment doesn’t seem to be the best way to right wrongs. The punished may not learn the lesson and the unpunished will be less forthcoming with their own errors.

Taking a lesson from highly reliable industries such as airlines, the medical profession is addressing medical errors better. For example, my institution has mandated thorough checklists before any and all invasive procedures, including bone marrow biopsies. Through a morbidity and mortality review of a case of hepatitis, we developed an automatic method of ordering hepatitis panels in every patient treated with monoclonal antibodies. Making systemic changes to prevent error avoids having to punish those who make errors, while holding accountable those who skirt the built-in safeguards.

We are less successful at applying similar error mitigation techniques to individual physicians who may not be clinically excellent. Examples abound of physicians who provide substandard care, but are allowed to continue. The repercussions continue at Wake Forest Baptist Medical Center, where a pathologist misdiagnosed some cancer cases over at least a 2-year period of time. Physicians, as a group, are not as good at certifying competency as are nurses, advanced practice providers, and pharmacists.

With many academic hematologists having relatively small practices, getting older, and getting burned out, the potential for patient harm as a result of medical error increases. Further, these physicians may not realize their increased risk and may be indignant when confronted.

I am interested in best practices that address this difficult and contentious issue. I hope our readers will offer their policies and procedures so that we can learn from each other. Patients should not have to worry about their doctors’ competency and doctors should be able to hold each other accountable by removing the white wall of silence.

Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at kalaycm@ccf.org.

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

Abdominal paracentesis is a common and increasingly performed procedure in the United States. According to Medicare Physician Supplier Procedure Summary Master Files, an estimated 150,000 paracenteses were performed on Medicare fee-for-service beneficiaries in 2008 alone; such a number represents more than a two-fold increase from the same service population in 1993.¹ This increasing trend was again noted by the Nationwide Inpatient Sample data, which identified a 10% increase in hospitalized patients with a diagnosis of cirrhosis receiving paracentesis from 2004 (50%) to 2012 (61%; P < .0001).²

Although these data demonstrate that paracentesis is being performed frequently, paracentesis may be underutilized in hospitalized cirrhotics with ascites. In addition, in-hospital mortality of cirrhotics with ascites is higher among those who do not undergo paracentesis than among those who do (9% vs 6%; P = .03).^3,4

While complications associated with paracentesis are rare, serious complications, including death, have been documented.^5-10 The most common serious complication of paracentesis is bleeding, although puncture of the bowel and other abdominal organs has also been observed. Over the past few decades, ultrasound has been increasingly used with paracentesis due to the ability of ultrasound to improve detection of ascites^11,12 and to avoid blood vessels^10,13-15 and bowels.¹⁶

Three-quarters of all paracenteses are currently performed by interventional radiologists.¹ However, paracenteses are often required off-hours,¹⁷ when interventional radiologists are less readily available. Weekend admissions have less frequent performance of early paracentesis than weekday admissions, and delaying paracentesis may increase mortality.^3,18 High proficiency in ultrasound-guided paracentesis is achievable by nonradiologists^19-28 with equal or better patient outcomes after appropriate training.²⁹

The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided paracentesis at the bedside by practicing hospitalists.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced-practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist, and all Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the five working group members themselves. Key clinical questions and draft recommendations were then prepared, and a systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were initially searched from 1975 to October 2015. Google Scholar was also searched without limiters. An updated search was conducted from November 2015 to November 2017, search strings for which are included in Appendix 3. All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of screened articles were reviewed and articles on ultrasound guidance for paracentesis were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided paracentesis were screened and selected. Final article selection was based on working group consensus. The selected literature was incorporated into the draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus to establish recommendations.³⁰ The voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) problem priority and importance; (2) level of quality of evidence; (3) benefit/harm balance; (4) benefit/burden balance; and (5) certainty/concerns about preferences/equity acceptability/feasibility. Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) during February 2018 and April 2018 (Appendix 4) and voting on appropriateness was conducted using a 9-point Likert scale. The three zones based on the 9-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points), and the degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1, and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” A strong recommendation required 80% of the votes within one integer of the median, following RAND rules, and disagreement was defined as >30% of panelists voting outside of the zone of the median.

Literature search

A total of 794 references were pooled and screened from literature searches conducted by a certified medical librarian in October 2015 (604 citations) and updated in November 2017 (118 citations), and working group members’ personal bibliographies and searches (72 citations; Appendix 3, Figure 2). Final selection included 91 articles that were abstracted into a data table and incorporated into the draft recommendations.

Four domains (terminology, clinical outcomes, technique, and training) with 13 draft recommendations were generated based on the literature review by the paracentesis working group. After two rounds of panel voting, one recommendation did not achieve consensus based on the RAND rules, and 12 statements received final approval. The degree of consensus based on the median score and dispersion of voting around the median are shown in Appendix 5. All 12 statements achieved consensus as strong recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology

Abdominal paracentesis is a procedure in which fluid is aspirated from the intraperitoneal space by percutaneous insertion of a needle with or without a catheter through the abdominal wall. Throughout this document, the term “paracentesis” refers to “abdominal paracentesis.”

In this document, ultrasound-guided paracentesis refers to the use of static ultrasound guidance to mark a needle insertion site immediately prior to performing the procedure. Real-time (dynamic) ultrasound guidance refers to tracking of the needle tip with ultrasound as it traverses the abdominal wall to enter the peritoneal cavity. Landmark-based paracentesis refers to paracentesis based on physical examination alone.

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

Rationale. The occurrence of both minor and serious life-threatening complications from paracentesis has been well described.^5-10,31,32 A recent retrospective study that evaluated 515 landmark-guided paracenteses noted that the most common minor complication was persistent ascites leakage (5%) and that the most common serious complication was postprocedural bleeding (1%).⁸ Studies have shown that abdominal wall hematoma and hemoperitoneum are common hemorrhagic complications of paracentesis, although inferior epigastric artery pseudoaneurysm has also been described.^9,33,34

Current literature suggests that ultrasound-guided paracentesis is a safe procedure, even with reduced platelet counts or elevated international normalized ratio.^35-42 Most comparative studies have shown that ultrasound guidance reduces the risk of bleeding complications compared with the use of landmarks alone,^{7,31,32,43-45} although a few studies did not find a significant difference between techniques.^20,36,46 One large retrospective observational study that analyzed the administrative data of 69,859 paracenteses from more than 600 hospitals demonstrated that ultrasound guidance reduced the odds of bleeding complications by 68% (OR, 0.32; 95% CI, 0.25–0.41). Bleeding complication rates with and without the use of ultrasound guidance were 0.27% (CI 0.26-0.29) versus 1.25% (CI 1.21-1.29; P < .0001), respectively. More importantly, in this study, paracentesis complicated by bleeding was associated with a higher in-hospital mortality rate compared to paracentesis that were not complicated by bleeding (12.9% vs 3.7%; P < .0001).⁴³

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

Rationale. Abdominal physical examination is not a reliable method for determining the presence or volume of intraperitoneal free fluid, as no specific physical examination finding has consistently shown both high sensitivity and specificity for detecting intraperitoneal free fluid.^{11,12,20,31,47-51} Patient factors limiting the diagnostic accuracy of physical examination include body habitus, abdominal wall edema, and gaseous bowel distention.

In comparative studies, ultrasound has been found to be significantly more sensitive and specific than physical examination in detecting peritoneal free fluid.^11,12 Ultrasound can detect as little as 100 mL of peritoneal free fluid,^52,53 and larger volumes of fluid have higher diagnostic accuracy.^53-55 In one randomized trial of 100 patients suspected of having ascites, patients were randomized to landmark-based and ultrasound-guided paracentesis groups. Of the 56 patients in the ultrasound-guided group, 14 patients suspected of having ascites on physical examination were found to have no or an insufficient volume of ascites to attempt paracentesis.²⁰ Another study with 41 ultrasound examinations on cancer patients suspected of having intraperitoneal free fluid by history and physical examination demonstrated that only 19 (46%) were considered to have a sufficient volume of ascites by ultrasound to attempt paracentesis.³⁸

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Rationale. In addition to avoiding drainage attempts in patients with an insufficient volume of intraperitoneal free fluid, ultrasound can increase the success rate of attempted procedures by localizing the largest fluid collection and guiding selection of an optimal needle insertion site. The success rates of landmark-based paracentesis in patients suspected of having intraperitoneal free fluid by physical examination are not well described in the literature, but multiple studies report success rates of 95%-100% for paracentesis when using ultrasound guidance to select a needle insertion site.^20,38,56,57 In one randomized trial comparing ultrasound-guided versus landmark-based paracentesis, ultrasound-guided paracentesis revealed a significantly higher success rate (95% of procedures performed) compared with landmark-based parancentesis (61% of procedures performed). Moreover, 87% of the initial failures in the landmark-based group underwent subsequent successful paracentesis when ultrasound guidance was used. Ultrasound revealed that the rest of the patients (13%) did not have enough fluid to attempt ultrasound-guided paracentesis.²⁰

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

Rationale. The presence and characteristics of intraperitoneal fluid collections are important determinants of whether paracentesis, another procedure, or no procedure should be performed in a given clinical scenario. One study reported that the overall diagnostic accuracy of physical examination for detecting ascites was only 58%,⁵⁰ and many providers are unable to detect ascites by physical examination until 1L of fluid has accumulated. One small study showed that at least 500 ml of fluid must accumulate before shifting dullness could be detected.⁵⁸ By contrast, ultrasound has been shown to reliably detect as little as 100 mL of peritoneal free fluid ^52,53 and has been proven to be superior to physical examination in several studies.^11,12 Therefore, ultrasound can be used to qualitatively determine whether a sufficient volume of intraperitoneal free fluid is present to safely perform paracentesis.

Studies have shown that ultrasound can also be used to differentiate ascites from other pathologies (eg, matted bowel loops, metastases, abscesses) in patients with suspected ascites on history and physical examination.¹⁶ In addition, ultrasound can help to better understand the etiology and distribution of the ascites.^59-61 Sonographic measurements allow semiquantitative assessment of the volume of intraperitoneal free fluid, which may correlate with the amount of fluid removed in therapeutic paracentesis procedures.^62,63 Furthermore, depth of a fluid collection by ultrasound may be an independent risk factor for the presence of spontaneous bacterial peritonitis (SBP), with one small study showing a higher risk of SBP with larger fluid collections than with small ones.⁶⁴

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

Rationale. When providers perform paracentesis using ultrasound guidance, any fluid collection that is directly visualized and accessible may be considered for drainage. The presence of ascites using ultrasound is best detected using a low-frequency transducer, such as phased array or curvilinear transducer, which provides deep penetration into the abdomen and pelvis to assess peritoneal free fluid.^{13,14,45,51,65} An optimal needle insertion site should be determined based on a combination of visualization of largest fluid collection, avoidance of underlying abdominal organs, and thickness of abdominal wall.^13,31,66,67

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. The anatomy of the superficial blood vessels of the abdominal wall, especially the lateral branches, varies greatly.^68-70 Although uncommon, inadvertent laceration of an inferior epigastric artery or one of its large branches is associated with significant morbidity and mortality.^{10,15,69,71-73} A review of 126 cases of rectus sheath hematomas, which most likely occur due to laceration of the inferior or superior epigastric artery, at a single institution from 1992 to 2002 showed a mortality rate of 1.6%, even with aggressive intervention.⁷⁴ Besides the inferior epigastric arteries, several other blood vessels are at risk of injury during paracentesis, including the inferior epigastric veins, thoracoepigastric veins, subcostal artery and vein branches, deep circumflex iliac artery and vein, and recanalized subumbilical vasculature.^75-77 Laceration of any of the abdominal wall blood vessels could result in catastrophic bleeding.

Identification of abdominal wall blood vessels is most commonly performed with a high-frequency transducer using color flow Doppler ultrasound.^10,13-15 A low-frequency transducer capable of color flow Doppler ultrasound may be utilized in patients with a thick abdominal wall.

Studies suggest that detection of abdominal wall blood vessels with ultrasound may reduce the risk of bleeding complications. One study showed that 43% of patients had a vascular structure present at one or more of the three traditional landmark paracentesis sites.⁷⁸ Another study directly compared bleeding rates between an approach utilizing a low-frequency transducer to identify the largest collection of fluid only versus a two-transducer approach utilizing both low and high-frequency transducers to identify the largest collection of fluid and evaluate for any superficial blood vessels. In this study, which included 5,777 paracenteses, paracentesis-related minor bleeding rates were similar in both groups, but major bleeding rates were less in the group utilizing color flow Doppler to evaluate for superficial vessels (0.3% vs 0.08%); differences found between groups, however, did not reach statistical significance (P = .07).⁷⁹

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. Most ultrasound machines have a slice thickness of <4 mm at the focal zone.⁸⁰ Considering that an ultrasound beam represents a very thin 2-dimentional cross-section of the underlying tissues, visualization in only one plane could lead to inadvertent puncture of nearby critical structures such as loops of bowel or edges of solid organs. Therefore, it is important to evaluate the needle insertion site and surrounding areas in multiple planes by tilting the transducer and rotating the transducer to orthogonal planes.⁶¹ Additionally, evaluation with color flow Doppler could be performed in a similar fashion to ensure that no large blood vessels are along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

Rationale. Free-flowing peritoneal fluid and abdominal organs, especially loops of small bowel, can easily shift when a patient changes position or takes a deep breath.^13,16,53 Therefore, if the patient changes position or there is a delay between marking the needle insertion site and performing the procedure, the patient should be reevaluated with ultrasound to ensure that the marked needle insertion site is still safe for paracentesis.⁷⁸ After marking the needle insertion site, the skin surface should be wiped completely clean of gel, and the probe should be removed from the area before sterilizing the skin surface.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Rationale. Use of real-time ultrasound guidance for paracentesis has been described to drain abdominal fluid collections.^13,20,62 Several studies have commented that real-time ultrasound guidance for paracentesis may be necessary in obese patients, in patients with small fluid collections, or when performing the procedure near critical structures, such as loops of small bowel, liver, or spleen.^57,81 Real-time ultrasound guidance for paracentesis requires additional training in needle tracking techniques and specialized equipment to maintain sterility.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

Rationale. Healthcare providers must gain multiple skills to safely perform ultrasound-guided paracentesis. Trainees must learn how to operate the ultrasound machine to identify the most appropriate needle insertion site based on the abdominal wall thickness, fluid collection size, proximity to nearby abdominal organs, and presence of blood vessels. Education regarding the use of ultrasound guidance for paracentesis is both desired ^82,83 and being increasingly taught to health care providers who perform paracentesis.^20,84-86

Several approaches have shown high uptake of essential skills to perform ultrasound-guided paracentesis after short training sessions. One study showed that first-year medical students can be taught to use POCUS to accurately diagnose ascites after three 30-minute teaching sessions.¹⁹ Another study showed that emergency medicine residents can achieve high levels of proficiency in the preprocedural ultrasound evaluation for paracentesis with only one hour of didactic training.²⁰ Other studies also support the concept that adequate proficiency is achievable within brief, focused training sessions.^21-28 However, these skills can decay significantly over time without ongoing education.⁸⁷

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

Rationale. Simulation-based practice should be used when available, as it has been shown to increase competence in bedside diagnostic ultrasonography and procedural techniques for ultrasound-guided procedures, including paracentesis.^{22,25,29,88,89} One study showed that internal medicine residents were able to achieve a high level of proficiency to perform ultrasound-guided paracentesis after a three-hour simulation-based mastery learning session.⁸⁸ A follow-up study suggested that, after sufficient simulation-based training, a nonradiologist can perform ultrasound-guided paracentesis as safely as an interventional radiologist.²⁹

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

Rationale. Competence in ultrasound-guided paracentesis requires acquisition of clinical knowledge of paracentesis, skills in basic abdominal ultrasonography, and manual techniques to perform the procedure. Competence in ultrasound-guided paracentesis cannot be assumed for those graduating from internal medicine residency in the United States. While clinical knowledge of paracentesis remains a core competency of graduating internal medicine residents per the American Board of Internal Medicine, demonstration of competence in performing ultrasound-guided or landmark-based paracentesis is not currently mandated.⁹⁰ A recent national survey of internal medicine residency program directors revealed that the curricula and resources available to train residents in bedside diagnostic ultrasound and ultrasound-guided procedures, including paracentesis, remain quite variable. ⁸³

While it has not been well studied, competence in ultrasound for paracentesis, as with all other skills involved in bedside procedures, is likely best evaluated through direct observation on actual patients.⁹¹ As such, individualized systems to evaluate competency in ultrasound-guided paracentesis should be established for each site where it is performed. A list of consensus-derived ultrasound competencies for ultrasound-guided paracentesis has been proposed, and this list may serve as a guide for both training curriculum development and practitioner evaluation.^86,91,92

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

First, while some data suggest that the use of ultrasound guidance for paracentesis may reduce the inpatient length of stay and overall costs, this suggestion has not been studied rigorously. In a retrospective review of 1,297 abdominal paracenteses by Patel et al., ultrasound-guided paracentesis was associated with a lower incidence of adverse events compared with landmark-based paracentesis (1.4% vs 4.7%; P = .01). The adjusted analysis from this study showed significant reductions in adverse events (OR 0.35; 95%CI 0.165-0.739; P = .006) and hospitalization costs ($8,761 ± $5,956 vs $9,848 ± $6,581; P < .001) for paracentesis with ultrasound guidance versus without such guidance. Additionally, the adjusted average length of stay was 0.2 days shorter for paracentesis with ultrasound guidance versus that without guidance (5.6 days vs 5.8 days; P < .0001).⁴⁴ Similar conclusions were reached by Mercaldi et al., who conducted a retrospective study of 69,859 patients who underwent paracentesis. Fewer bleeding complications occurred when paracentesis was performed with ultrasound guidance (0.27%) versus without ultrasound guidance (1.27%). Hospitalization costs increased by $19,066 (P < .0001) and length of stay increased by 4.3 days (P < .0001) for patients when paracentesis was complicated by bleeding.⁴³  Because both of these studies were retrospective reviews of administrative databases, associations between procedures, complications, and use of ultrasound may be limited by erroneous coding and documentation.

Second, regarding technique, it is unknown whether the use of real-time ultrasound guidance confers additional benefits compared with use of static ultrasound to mark a suitable needle insertion site. In clinical practice, real-time ultrasound guidance is used to sample small fluid collections, particularly when loops of bowel or a solid organ are nearby. It is possible that higher procedural success rates and lower complication rates may be demonstrated in these scenarios in future studies.

Third, the optimal approach to train providers to perform ultrasound-guided paracentesis is unknown. While short training sessions have shown high uptake of essential skills to perform ultrasound-guided paracentesis, data regarding the effectiveness of training using a comprehensive competency assessment are limited. Simulation-based mastery learning as a means to obtain competency for paracentesis has been described in one study,⁸⁸ but the translation of competency demonstrated by simulation to actual patient outcomes has not been studied. Furthermore, the most effective method to train providers who are proficient in landmark-based paracentesis to achieve competency in ultrasound-guided paracentesis has not been well studied.

Fourth, the optimal technique for identifying blood vessels in the abdominal wall is unknown. We have proposed that color flow Doppler should be used to identify and avoid puncture of superficial vessels, but power Doppler is three times more sensitive at detecting blood vessels, especially at low velocities, such as in veins independent of direction or flow.⁹³ Hence using power Doppler instead of color flow Doppler may further improve the ability to identify and avoid superficial vessels along the needle trajectory.⁹²

Finally, the impact of ultrasound use on patient experience has yet to be studied. Some studies in the literature show high patient satisfaction with use of ultrasound at the bedside,^94,95 but patient satisfaction with ultrasound-guided paracentesis has not been compared directly with the landmark-based technique.

The use of ultrasound guidance for paracentesis has been associated with higher success rates and lower complication rates. Ultrasound is superior to physical examination in assessing the presence and volume of ascites, and determining the optimal needle insertion site to avoid inadvertent injury to abdominal wall blood vessels. Hospitalists can attain competence in ultrasound-guided paracentesis through the use of various training methods, including lectures, simulation-based practice, and hands-on training. Ongoing use and training over time is necessary to maintain competence.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Michael Blaivas, Dan Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, David M. Tierney

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

Abdominal paracentesis is a common and increasingly performed procedure in the United States. According to Medicare Physician Supplier Procedure Summary Master Files, an estimated 150,000 paracenteses were performed on Medicare fee-for-service beneficiaries in 2008 alone; such a number represents more than a two-fold increase from the same service population in 1993.¹ This increasing trend was again noted by the Nationwide Inpatient Sample data, which identified a 10% increase in hospitalized patients with a diagnosis of cirrhosis receiving paracentesis from 2004 (50%) to 2012 (61%; P < .0001).²

Although these data demonstrate that paracentesis is being performed frequently, paracentesis may be underutilized in hospitalized cirrhotics with ascites. In addition, in-hospital mortality of cirrhotics with ascites is higher among those who do not undergo paracentesis than among those who do (9% vs 6%; P = .03).^3,4

While complications associated with paracentesis are rare, serious complications, including death, have been documented.^5-10 The most common serious complication of paracentesis is bleeding, although puncture of the bowel and other abdominal organs has also been observed. Over the past few decades, ultrasound has been increasingly used with paracentesis due to the ability of ultrasound to improve detection of ascites^11,12 and to avoid blood vessels^10,13-15 and bowels.¹⁶

Three-quarters of all paracenteses are currently performed by interventional radiologists.¹ However, paracenteses are often required off-hours,¹⁷ when interventional radiologists are less readily available. Weekend admissions have less frequent performance of early paracentesis than weekday admissions, and delaying paracentesis may increase mortality.^3,18 High proficiency in ultrasound-guided paracentesis is achievable by nonradiologists^19-28 with equal or better patient outcomes after appropriate training.²⁹

The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided paracentesis at the bedside by practicing hospitalists.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced-practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist, and all Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the five working group members themselves. Key clinical questions and draft recommendations were then prepared, and a systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were initially searched from 1975 to October 2015. Google Scholar was also searched without limiters. An updated search was conducted from November 2015 to November 2017, search strings for which are included in Appendix 3. All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of screened articles were reviewed and articles on ultrasound guidance for paracentesis were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided paracentesis were screened and selected. Final article selection was based on working group consensus. The selected literature was incorporated into the draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus to establish recommendations.³⁰ The voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) problem priority and importance; (2) level of quality of evidence; (3) benefit/harm balance; (4) benefit/burden balance; and (5) certainty/concerns about preferences/equity acceptability/feasibility. Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) during February 2018 and April 2018 (Appendix 4) and voting on appropriateness was conducted using a 9-point Likert scale. The three zones based on the 9-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points), and the degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1, and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” A strong recommendation required 80% of the votes within one integer of the median, following RAND rules, and disagreement was defined as >30% of panelists voting outside of the zone of the median.

Literature search

A total of 794 references were pooled and screened from literature searches conducted by a certified medical librarian in October 2015 (604 citations) and updated in November 2017 (118 citations), and working group members’ personal bibliographies and searches (72 citations; Appendix 3, Figure 2). Final selection included 91 articles that were abstracted into a data table and incorporated into the draft recommendations.

Four domains (terminology, clinical outcomes, technique, and training) with 13 draft recommendations were generated based on the literature review by the paracentesis working group. After two rounds of panel voting, one recommendation did not achieve consensus based on the RAND rules, and 12 statements received final approval. The degree of consensus based on the median score and dispersion of voting around the median are shown in Appendix 5. All 12 statements achieved consensus as strong recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology

Abdominal paracentesis is a procedure in which fluid is aspirated from the intraperitoneal space by percutaneous insertion of a needle with or without a catheter through the abdominal wall. Throughout this document, the term “paracentesis” refers to “abdominal paracentesis.”

In this document, ultrasound-guided paracentesis refers to the use of static ultrasound guidance to mark a needle insertion site immediately prior to performing the procedure. Real-time (dynamic) ultrasound guidance refers to tracking of the needle tip with ultrasound as it traverses the abdominal wall to enter the peritoneal cavity. Landmark-based paracentesis refers to paracentesis based on physical examination alone.

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

Rationale. The occurrence of both minor and serious life-threatening complications from paracentesis has been well described.^5-10,31,32 A recent retrospective study that evaluated 515 landmark-guided paracenteses noted that the most common minor complication was persistent ascites leakage (5%) and that the most common serious complication was postprocedural bleeding (1%).⁸ Studies have shown that abdominal wall hematoma and hemoperitoneum are common hemorrhagic complications of paracentesis, although inferior epigastric artery pseudoaneurysm has also been described.^9,33,34

Current literature suggests that ultrasound-guided paracentesis is a safe procedure, even with reduced platelet counts or elevated international normalized ratio.^35-42 Most comparative studies have shown that ultrasound guidance reduces the risk of bleeding complications compared with the use of landmarks alone,^{7,31,32,43-45} although a few studies did not find a significant difference between techniques.^20,36,46 One large retrospective observational study that analyzed the administrative data of 69,859 paracenteses from more than 600 hospitals demonstrated that ultrasound guidance reduced the odds of bleeding complications by 68% (OR, 0.32; 95% CI, 0.25–0.41). Bleeding complication rates with and without the use of ultrasound guidance were 0.27% (CI 0.26-0.29) versus 1.25% (CI 1.21-1.29; P < .0001), respectively. More importantly, in this study, paracentesis complicated by bleeding was associated with a higher in-hospital mortality rate compared to paracentesis that were not complicated by bleeding (12.9% vs 3.7%; P < .0001).⁴³

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

Rationale. Abdominal physical examination is not a reliable method for determining the presence or volume of intraperitoneal free fluid, as no specific physical examination finding has consistently shown both high sensitivity and specificity for detecting intraperitoneal free fluid.^{11,12,20,31,47-51} Patient factors limiting the diagnostic accuracy of physical examination include body habitus, abdominal wall edema, and gaseous bowel distention.

In comparative studies, ultrasound has been found to be significantly more sensitive and specific than physical examination in detecting peritoneal free fluid.^11,12 Ultrasound can detect as little as 100 mL of peritoneal free fluid,^52,53 and larger volumes of fluid have higher diagnostic accuracy.^53-55 In one randomized trial of 100 patients suspected of having ascites, patients were randomized to landmark-based and ultrasound-guided paracentesis groups. Of the 56 patients in the ultrasound-guided group, 14 patients suspected of having ascites on physical examination were found to have no or an insufficient volume of ascites to attempt paracentesis.²⁰ Another study with 41 ultrasound examinations on cancer patients suspected of having intraperitoneal free fluid by history and physical examination demonstrated that only 19 (46%) were considered to have a sufficient volume of ascites by ultrasound to attempt paracentesis.³⁸

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Rationale. In addition to avoiding drainage attempts in patients with an insufficient volume of intraperitoneal free fluid, ultrasound can increase the success rate of attempted procedures by localizing the largest fluid collection and guiding selection of an optimal needle insertion site. The success rates of landmark-based paracentesis in patients suspected of having intraperitoneal free fluid by physical examination are not well described in the literature, but multiple studies report success rates of 95%-100% for paracentesis when using ultrasound guidance to select a needle insertion site.^20,38,56,57 In one randomized trial comparing ultrasound-guided versus landmark-based paracentesis, ultrasound-guided paracentesis revealed a significantly higher success rate (95% of procedures performed) compared with landmark-based parancentesis (61% of procedures performed). Moreover, 87% of the initial failures in the landmark-based group underwent subsequent successful paracentesis when ultrasound guidance was used. Ultrasound revealed that the rest of the patients (13%) did not have enough fluid to attempt ultrasound-guided paracentesis.²⁰

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

Rationale. The presence and characteristics of intraperitoneal fluid collections are important determinants of whether paracentesis, another procedure, or no procedure should be performed in a given clinical scenario. One study reported that the overall diagnostic accuracy of physical examination for detecting ascites was only 58%,⁵⁰ and many providers are unable to detect ascites by physical examination until 1L of fluid has accumulated. One small study showed that at least 500 ml of fluid must accumulate before shifting dullness could be detected.⁵⁸ By contrast, ultrasound has been shown to reliably detect as little as 100 mL of peritoneal free fluid ^52,53 and has been proven to be superior to physical examination in several studies.^11,12 Therefore, ultrasound can be used to qualitatively determine whether a sufficient volume of intraperitoneal free fluid is present to safely perform paracentesis.

Studies have shown that ultrasound can also be used to differentiate ascites from other pathologies (eg, matted bowel loops, metastases, abscesses) in patients with suspected ascites on history and physical examination.¹⁶ In addition, ultrasound can help to better understand the etiology and distribution of the ascites.^59-61 Sonographic measurements allow semiquantitative assessment of the volume of intraperitoneal free fluid, which may correlate with the amount of fluid removed in therapeutic paracentesis procedures.^62,63 Furthermore, depth of a fluid collection by ultrasound may be an independent risk factor for the presence of spontaneous bacterial peritonitis (SBP), with one small study showing a higher risk of SBP with larger fluid collections than with small ones.⁶⁴

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

Rationale. When providers perform paracentesis using ultrasound guidance, any fluid collection that is directly visualized and accessible may be considered for drainage. The presence of ascites using ultrasound is best detected using a low-frequency transducer, such as phased array or curvilinear transducer, which provides deep penetration into the abdomen and pelvis to assess peritoneal free fluid.^{13,14,45,51,65} An optimal needle insertion site should be determined based on a combination of visualization of largest fluid collection, avoidance of underlying abdominal organs, and thickness of abdominal wall.^13,31,66,67

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. The anatomy of the superficial blood vessels of the abdominal wall, especially the lateral branches, varies greatly.^68-70 Although uncommon, inadvertent laceration of an inferior epigastric artery or one of its large branches is associated with significant morbidity and mortality.^{10,15,69,71-73} A review of 126 cases of rectus sheath hematomas, which most likely occur due to laceration of the inferior or superior epigastric artery, at a single institution from 1992 to 2002 showed a mortality rate of 1.6%, even with aggressive intervention.⁷⁴ Besides the inferior epigastric arteries, several other blood vessels are at risk of injury during paracentesis, including the inferior epigastric veins, thoracoepigastric veins, subcostal artery and vein branches, deep circumflex iliac artery and vein, and recanalized subumbilical vasculature.^75-77 Laceration of any of the abdominal wall blood vessels could result in catastrophic bleeding.

Identification of abdominal wall blood vessels is most commonly performed with a high-frequency transducer using color flow Doppler ultrasound.^10,13-15 A low-frequency transducer capable of color flow Doppler ultrasound may be utilized in patients with a thick abdominal wall.

Studies suggest that detection of abdominal wall blood vessels with ultrasound may reduce the risk of bleeding complications. One study showed that 43% of patients had a vascular structure present at one or more of the three traditional landmark paracentesis sites.⁷⁸ Another study directly compared bleeding rates between an approach utilizing a low-frequency transducer to identify the largest collection of fluid only versus a two-transducer approach utilizing both low and high-frequency transducers to identify the largest collection of fluid and evaluate for any superficial blood vessels. In this study, which included 5,777 paracenteses, paracentesis-related minor bleeding rates were similar in both groups, but major bleeding rates were less in the group utilizing color flow Doppler to evaluate for superficial vessels (0.3% vs 0.08%); differences found between groups, however, did not reach statistical significance (P = .07).⁷⁹

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. Most ultrasound machines have a slice thickness of <4 mm at the focal zone.⁸⁰ Considering that an ultrasound beam represents a very thin 2-dimentional cross-section of the underlying tissues, visualization in only one plane could lead to inadvertent puncture of nearby critical structures such as loops of bowel or edges of solid organs. Therefore, it is important to evaluate the needle insertion site and surrounding areas in multiple planes by tilting the transducer and rotating the transducer to orthogonal planes.⁶¹ Additionally, evaluation with color flow Doppler could be performed in a similar fashion to ensure that no large blood vessels are along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

Rationale. Free-flowing peritoneal fluid and abdominal organs, especially loops of small bowel, can easily shift when a patient changes position or takes a deep breath.^13,16,53 Therefore, if the patient changes position or there is a delay between marking the needle insertion site and performing the procedure, the patient should be reevaluated with ultrasound to ensure that the marked needle insertion site is still safe for paracentesis.⁷⁸ After marking the needle insertion site, the skin surface should be wiped completely clean of gel, and the probe should be removed from the area before sterilizing the skin surface.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Rationale. Use of real-time ultrasound guidance for paracentesis has been described to drain abdominal fluid collections.^13,20,62 Several studies have commented that real-time ultrasound guidance for paracentesis may be necessary in obese patients, in patients with small fluid collections, or when performing the procedure near critical structures, such as loops of small bowel, liver, or spleen.^57,81 Real-time ultrasound guidance for paracentesis requires additional training in needle tracking techniques and specialized equipment to maintain sterility.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

Rationale. Healthcare providers must gain multiple skills to safely perform ultrasound-guided paracentesis. Trainees must learn how to operate the ultrasound machine to identify the most appropriate needle insertion site based on the abdominal wall thickness, fluid collection size, proximity to nearby abdominal organs, and presence of blood vessels. Education regarding the use of ultrasound guidance for paracentesis is both desired ^82,83 and being increasingly taught to health care providers who perform paracentesis.^20,84-86

Several approaches have shown high uptake of essential skills to perform ultrasound-guided paracentesis after short training sessions. One study showed that first-year medical students can be taught to use POCUS to accurately diagnose ascites after three 30-minute teaching sessions.¹⁹ Another study showed that emergency medicine residents can achieve high levels of proficiency in the preprocedural ultrasound evaluation for paracentesis with only one hour of didactic training.²⁰ Other studies also support the concept that adequate proficiency is achievable within brief, focused training sessions.^21-28 However, these skills can decay significantly over time without ongoing education.⁸⁷

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

Rationale. Simulation-based practice should be used when available, as it has been shown to increase competence in bedside diagnostic ultrasonography and procedural techniques for ultrasound-guided procedures, including paracentesis.^{22,25,29,88,89} One study showed that internal medicine residents were able to achieve a high level of proficiency to perform ultrasound-guided paracentesis after a three-hour simulation-based mastery learning session.⁸⁸ A follow-up study suggested that, after sufficient simulation-based training, a nonradiologist can perform ultrasound-guided paracentesis as safely as an interventional radiologist.²⁹

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

Rationale. Competence in ultrasound-guided paracentesis requires acquisition of clinical knowledge of paracentesis, skills in basic abdominal ultrasonography, and manual techniques to perform the procedure. Competence in ultrasound-guided paracentesis cannot be assumed for those graduating from internal medicine residency in the United States. While clinical knowledge of paracentesis remains a core competency of graduating internal medicine residents per the American Board of Internal Medicine, demonstration of competence in performing ultrasound-guided or landmark-based paracentesis is not currently mandated.⁹⁰ A recent national survey of internal medicine residency program directors revealed that the curricula and resources available to train residents in bedside diagnostic ultrasound and ultrasound-guided procedures, including paracentesis, remain quite variable. ⁸³

While it has not been well studied, competence in ultrasound for paracentesis, as with all other skills involved in bedside procedures, is likely best evaluated through direct observation on actual patients.⁹¹ As such, individualized systems to evaluate competency in ultrasound-guided paracentesis should be established for each site where it is performed. A list of consensus-derived ultrasound competencies for ultrasound-guided paracentesis has been proposed, and this list may serve as a guide for both training curriculum development and practitioner evaluation.^86,91,92

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

First, while some data suggest that the use of ultrasound guidance for paracentesis may reduce the inpatient length of stay and overall costs, this suggestion has not been studied rigorously. In a retrospective review of 1,297 abdominal paracenteses by Patel et al., ultrasound-guided paracentesis was associated with a lower incidence of adverse events compared with landmark-based paracentesis (1.4% vs 4.7%; P = .01). The adjusted analysis from this study showed significant reductions in adverse events (OR 0.35; 95%CI 0.165-0.739; P = .006) and hospitalization costs ($8,761 ± $5,956 vs $9,848 ± $6,581; P < .001) for paracentesis with ultrasound guidance versus without such guidance. Additionally, the adjusted average length of stay was 0.2 days shorter for paracentesis with ultrasound guidance versus that without guidance (5.6 days vs 5.8 days; P < .0001).⁴⁴ Similar conclusions were reached by Mercaldi et al., who conducted a retrospective study of 69,859 patients who underwent paracentesis. Fewer bleeding complications occurred when paracentesis was performed with ultrasound guidance (0.27%) versus without ultrasound guidance (1.27%). Hospitalization costs increased by $19,066 (P < .0001) and length of stay increased by 4.3 days (P < .0001) for patients when paracentesis was complicated by bleeding.⁴³  Because both of these studies were retrospective reviews of administrative databases, associations between procedures, complications, and use of ultrasound may be limited by erroneous coding and documentation.

Second, regarding technique, it is unknown whether the use of real-time ultrasound guidance confers additional benefits compared with use of static ultrasound to mark a suitable needle insertion site. In clinical practice, real-time ultrasound guidance is used to sample small fluid collections, particularly when loops of bowel or a solid organ are nearby. It is possible that higher procedural success rates and lower complication rates may be demonstrated in these scenarios in future studies.

Third, the optimal approach to train providers to perform ultrasound-guided paracentesis is unknown. While short training sessions have shown high uptake of essential skills to perform ultrasound-guided paracentesis, data regarding the effectiveness of training using a comprehensive competency assessment are limited. Simulation-based mastery learning as a means to obtain competency for paracentesis has been described in one study,⁸⁸ but the translation of competency demonstrated by simulation to actual patient outcomes has not been studied. Furthermore, the most effective method to train providers who are proficient in landmark-based paracentesis to achieve competency in ultrasound-guided paracentesis has not been well studied.

Fourth, the optimal technique for identifying blood vessels in the abdominal wall is unknown. We have proposed that color flow Doppler should be used to identify and avoid puncture of superficial vessels, but power Doppler is three times more sensitive at detecting blood vessels, especially at low velocities, such as in veins independent of direction or flow.⁹³ Hence using power Doppler instead of color flow Doppler may further improve the ability to identify and avoid superficial vessels along the needle trajectory.⁹²

Finally, the impact of ultrasound use on patient experience has yet to be studied. Some studies in the literature show high patient satisfaction with use of ultrasound at the bedside,^94,95 but patient satisfaction with ultrasound-guided paracentesis has not been compared directly with the landmark-based technique.

The use of ultrasound guidance for paracentesis has been associated with higher success rates and lower complication rates. Ultrasound is superior to physical examination in assessing the presence and volume of ascites, and determining the optimal needle insertion site to avoid inadvertent injury to abdominal wall blood vessels. Hospitalists can attain competence in ultrasound-guided paracentesis through the use of various training methods, including lectures, simulation-based practice, and hands-on training. Ongoing use and training over time is necessary to maintain competence.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Michael Blaivas, Dan Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, David M. Tierney

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

Abdominal paracentesis is a common and increasingly performed procedure in the United States. According to Medicare Physician Supplier Procedure Summary Master Files, an estimated 150,000 paracenteses were performed on Medicare fee-for-service beneficiaries in 2008 alone; such a number represents more than a two-fold increase from the same service population in 1993.¹ This increasing trend was again noted by the Nationwide Inpatient Sample data, which identified a 10% increase in hospitalized patients with a diagnosis of cirrhosis receiving paracentesis from 2004 (50%) to 2012 (61%; P < .0001).²

Although these data demonstrate that paracentesis is being performed frequently, paracentesis may be underutilized in hospitalized cirrhotics with ascites. In addition, in-hospital mortality of cirrhotics with ascites is higher among those who do not undergo paracentesis than among those who do (9% vs 6%; P = .03).^3,4

While complications associated with paracentesis are rare, serious complications, including death, have been documented.^5-10 The most common serious complication of paracentesis is bleeding, although puncture of the bowel and other abdominal organs has also been observed. Over the past few decades, ultrasound has been increasingly used with paracentesis due to the ability of ultrasound to improve detection of ascites^11,12 and to avoid blood vessels^10,13-15 and bowels.¹⁶

Three-quarters of all paracenteses are currently performed by interventional radiologists.¹ However, paracenteses are often required off-hours,¹⁷ when interventional radiologists are less readily available. Weekend admissions have less frequent performance of early paracentesis than weekday admissions, and delaying paracentesis may increase mortality.^3,18 High proficiency in ultrasound-guided paracentesis is achievable by nonradiologists^19-28 with equal or better patient outcomes after appropriate training.²⁹

The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided paracentesis at the bedside by practicing hospitalists.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced-practice providers with expertise in POCUS. Expert panel members were divided into working group members, external peer reviewers, and a methodologist, and all Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the five working group members themselves. Key clinical questions and draft recommendations were then prepared, and a systematic literature search was conducted by a medical librarian based on the findings of the initial literature search and draft recommendations. The Medline, Embase, CINAHL, and Cochrane medical databases were initially searched from 1975 to October 2015. Google Scholar was also searched without limiters. An updated search was conducted from November 2015 to November 2017, search strings for which are included in Appendix 3. All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of screened articles were reviewed and articles on ultrasound guidance for paracentesis were selected. The following article types were excluded: non-English language, nonhuman, age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided paracentesis were screened and selected. Final article selection was based on working group consensus. The selected literature was incorporated into the draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus to establish recommendations.³⁰ The voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering five transforming factors: (1) problem priority and importance; (2) level of quality of evidence; (3) benefit/harm balance; (4) benefit/burden balance; and (5) certainty/concerns about preferences/equity acceptability/feasibility. Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) during February 2018 and April 2018 (Appendix 4) and voting on appropriateness was conducted using a 9-point Likert scale. The three zones based on the 9-point Likert scale were inappropriate (1-3 points), uncertain (4-6 points), and appropriate (7-9 points), and the degree of consensus was assessed using the RAND algorithm (Appendix 1, Figure 1, and Table 1). Establishing a recommendation required at least 70% agreement that a recommendation was “appropriate.” A strong recommendation required 80% of the votes within one integer of the median, following RAND rules, and disagreement was defined as >30% of panelists voting outside of the zone of the median.

Literature search

A total of 794 references were pooled and screened from literature searches conducted by a certified medical librarian in October 2015 (604 citations) and updated in November 2017 (118 citations), and working group members’ personal bibliographies and searches (72 citations; Appendix 3, Figure 2). Final selection included 91 articles that were abstracted into a data table and incorporated into the draft recommendations.

Four domains (terminology, clinical outcomes, technique, and training) with 13 draft recommendations were generated based on the literature review by the paracentesis working group. After two rounds of panel voting, one recommendation did not achieve consensus based on the RAND rules, and 12 statements received final approval. The degree of consensus based on the median score and dispersion of voting around the median are shown in Appendix 5. All 12 statements achieved consensus as strong recommendations. The strength of each recommendation and degree of consensus are summarized in Table 3.

Terminology

Abdominal paracentesis is a procedure in which fluid is aspirated from the intraperitoneal space by percutaneous insertion of a needle with or without a catheter through the abdominal wall. Throughout this document, the term “paracentesis” refers to “abdominal paracentesis.”

In this document, ultrasound-guided paracentesis refers to the use of static ultrasound guidance to mark a needle insertion site immediately prior to performing the procedure. Real-time (dynamic) ultrasound guidance refers to tracking of the needle tip with ultrasound as it traverses the abdominal wall to enter the peritoneal cavity. Landmark-based paracentesis refers to paracentesis based on physical examination alone.

RECOMMENDATIONS

Clinical outcomes

1. We recommend that ultrasound guidance should be used for paracentesis to reduce the risk of serious complications, the most common being bleeding.

Rationale. The occurrence of both minor and serious life-threatening complications from paracentesis has been well described.^5-10,31,32 A recent retrospective study that evaluated 515 landmark-guided paracenteses noted that the most common minor complication was persistent ascites leakage (5%) and that the most common serious complication was postprocedural bleeding (1%).⁸ Studies have shown that abdominal wall hematoma and hemoperitoneum are common hemorrhagic complications of paracentesis, although inferior epigastric artery pseudoaneurysm has also been described.^9,33,34

Current literature suggests that ultrasound-guided paracentesis is a safe procedure, even with reduced platelet counts or elevated international normalized ratio.^35-42 Most comparative studies have shown that ultrasound guidance reduces the risk of bleeding complications compared with the use of landmarks alone,^{7,31,32,43-45} although a few studies did not find a significant difference between techniques.^20,36,46 One large retrospective observational study that analyzed the administrative data of 69,859 paracenteses from more than 600 hospitals demonstrated that ultrasound guidance reduced the odds of bleeding complications by 68% (OR, 0.32; 95% CI, 0.25–0.41). Bleeding complication rates with and without the use of ultrasound guidance were 0.27% (CI 0.26-0.29) versus 1.25% (CI 1.21-1.29; P < .0001), respectively. More importantly, in this study, paracentesis complicated by bleeding was associated with a higher in-hospital mortality rate compared to paracentesis that were not complicated by bleeding (12.9% vs 3.7%; P < .0001).⁴³

2. We recommend that ultrasound guidance should be used to avoid attempting paracentesis in patients with an insufficient volume of intraperitoneal free fluid to drain.

Rationale. Abdominal physical examination is not a reliable method for determining the presence or volume of intraperitoneal free fluid, as no specific physical examination finding has consistently shown both high sensitivity and specificity for detecting intraperitoneal free fluid.^{11,12,20,31,47-51} Patient factors limiting the diagnostic accuracy of physical examination include body habitus, abdominal wall edema, and gaseous bowel distention.

In comparative studies, ultrasound has been found to be significantly more sensitive and specific than physical examination in detecting peritoneal free fluid.^11,12 Ultrasound can detect as little as 100 mL of peritoneal free fluid,^52,53 and larger volumes of fluid have higher diagnostic accuracy.^53-55 In one randomized trial of 100 patients suspected of having ascites, patients were randomized to landmark-based and ultrasound-guided paracentesis groups. Of the 56 patients in the ultrasound-guided group, 14 patients suspected of having ascites on physical examination were found to have no or an insufficient volume of ascites to attempt paracentesis.²⁰ Another study with 41 ultrasound examinations on cancer patients suspected of having intraperitoneal free fluid by history and physical examination demonstrated that only 19 (46%) were considered to have a sufficient volume of ascites by ultrasound to attempt paracentesis.³⁸

3. We recommend that ultrasound guidance should be used for paracentesis to improve the success rates of the overall procedure.

Rationale. In addition to avoiding drainage attempts in patients with an insufficient volume of intraperitoneal free fluid, ultrasound can increase the success rate of attempted procedures by localizing the largest fluid collection and guiding selection of an optimal needle insertion site. The success rates of landmark-based paracentesis in patients suspected of having intraperitoneal free fluid by physical examination are not well described in the literature, but multiple studies report success rates of 95%-100% for paracentesis when using ultrasound guidance to select a needle insertion site.^20,38,56,57 In one randomized trial comparing ultrasound-guided versus landmark-based paracentesis, ultrasound-guided paracentesis revealed a significantly higher success rate (95% of procedures performed) compared with landmark-based parancentesis (61% of procedures performed). Moreover, 87% of the initial failures in the landmark-based group underwent subsequent successful paracentesis when ultrasound guidance was used. Ultrasound revealed that the rest of the patients (13%) did not have enough fluid to attempt ultrasound-guided paracentesis.²⁰

Technique

4. We recommend that ultrasound should be used to assess the characteristics of intraperitoneal free fluid to guide clinical decision making of where paracentesis can be safely performed.

Rationale. The presence and characteristics of intraperitoneal fluid collections are important determinants of whether paracentesis, another procedure, or no procedure should be performed in a given clinical scenario. One study reported that the overall diagnostic accuracy of physical examination for detecting ascites was only 58%,⁵⁰ and many providers are unable to detect ascites by physical examination until 1L of fluid has accumulated. One small study showed that at least 500 ml of fluid must accumulate before shifting dullness could be detected.⁵⁸ By contrast, ultrasound has been shown to reliably detect as little as 100 mL of peritoneal free fluid ^52,53 and has been proven to be superior to physical examination in several studies.^11,12 Therefore, ultrasound can be used to qualitatively determine whether a sufficient volume of intraperitoneal free fluid is present to safely perform paracentesis.

Studies have shown that ultrasound can also be used to differentiate ascites from other pathologies (eg, matted bowel loops, metastases, abscesses) in patients with suspected ascites on history and physical examination.¹⁶ In addition, ultrasound can help to better understand the etiology and distribution of the ascites.^59-61 Sonographic measurements allow semiquantitative assessment of the volume of intraperitoneal free fluid, which may correlate with the amount of fluid removed in therapeutic paracentesis procedures.^62,63 Furthermore, depth of a fluid collection by ultrasound may be an independent risk factor for the presence of spontaneous bacterial peritonitis (SBP), with one small study showing a higher risk of SBP with larger fluid collections than with small ones.⁶⁴

5. We recommend that ultrasound should be used to identify a needle insertion site based on size of the fluid collection, thickness of the abdominal wall, and proximity to abdominal organs.

Rationale. When providers perform paracentesis using ultrasound guidance, any fluid collection that is directly visualized and accessible may be considered for drainage. The presence of ascites using ultrasound is best detected using a low-frequency transducer, such as phased array or curvilinear transducer, which provides deep penetration into the abdomen and pelvis to assess peritoneal free fluid.^{13,14,45,51,65} An optimal needle insertion site should be determined based on a combination of visualization of largest fluid collection, avoidance of underlying abdominal organs, and thickness of abdominal wall.^13,31,66,67

6. We recommend the needle insertion site should be evaluated using color flow Doppler ultrasound to identify and avoid abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. The anatomy of the superficial blood vessels of the abdominal wall, especially the lateral branches, varies greatly.^68-70 Although uncommon, inadvertent laceration of an inferior epigastric artery or one of its large branches is associated with significant morbidity and mortality.^{10,15,69,71-73} A review of 126 cases of rectus sheath hematomas, which most likely occur due to laceration of the inferior or superior epigastric artery, at a single institution from 1992 to 2002 showed a mortality rate of 1.6%, even with aggressive intervention.⁷⁴ Besides the inferior epigastric arteries, several other blood vessels are at risk of injury during paracentesis, including the inferior epigastric veins, thoracoepigastric veins, subcostal artery and vein branches, deep circumflex iliac artery and vein, and recanalized subumbilical vasculature.^75-77 Laceration of any of the abdominal wall blood vessels could result in catastrophic bleeding.

Identification of abdominal wall blood vessels is most commonly performed with a high-frequency transducer using color flow Doppler ultrasound.^10,13-15 A low-frequency transducer capable of color flow Doppler ultrasound may be utilized in patients with a thick abdominal wall.

Studies suggest that detection of abdominal wall blood vessels with ultrasound may reduce the risk of bleeding complications. One study showed that 43% of patients had a vascular structure present at one or more of the three traditional landmark paracentesis sites.⁷⁸ Another study directly compared bleeding rates between an approach utilizing a low-frequency transducer to identify the largest collection of fluid only versus a two-transducer approach utilizing both low and high-frequency transducers to identify the largest collection of fluid and evaluate for any superficial blood vessels. In this study, which included 5,777 paracenteses, paracentesis-related minor bleeding rates were similar in both groups, but major bleeding rates were less in the group utilizing color flow Doppler to evaluate for superficial vessels (0.3% vs 0.08%); differences found between groups, however, did not reach statistical significance (P = .07).⁷⁹

7. We recommend that a needle insertion site should be evaluated in multiple planes to ensure clearance from underlying abdominal organs and detect any abdominal wall blood vessels along the anticipated needle trajectory.

Rationale. Most ultrasound machines have a slice thickness of <4 mm at the focal zone.⁸⁰ Considering that an ultrasound beam represents a very thin 2-dimentional cross-section of the underlying tissues, visualization in only one plane could lead to inadvertent puncture of nearby critical structures such as loops of bowel or edges of solid organs. Therefore, it is important to evaluate the needle insertion site and surrounding areas in multiple planes by tilting the transducer and rotating the transducer to orthogonal planes.⁶¹ Additionally, evaluation with color flow Doppler could be performed in a similar fashion to ensure that no large blood vessels are along the anticipated needle trajectory.

8. We recommend that a needle insertion site should be marked with ultrasound immediately before performing the procedure, and the patient should remain in the same position between marking the site and performing the procedure.

Rationale. Free-flowing peritoneal fluid and abdominal organs, especially loops of small bowel, can easily shift when a patient changes position or takes a deep breath.^13,16,53 Therefore, if the patient changes position or there is a delay between marking the needle insertion site and performing the procedure, the patient should be reevaluated with ultrasound to ensure that the marked needle insertion site is still safe for paracentesis.⁷⁸ After marking the needle insertion site, the skin surface should be wiped completely clean of gel, and the probe should be removed from the area before sterilizing the skin surface.

9. We recommend that using real-time ultrasound guidance for paracentesis should be considered when the fluid collection is small or difficult to access.

Rationale. Use of real-time ultrasound guidance for paracentesis has been described to drain abdominal fluid collections.^13,20,62 Several studies have commented that real-time ultrasound guidance for paracentesis may be necessary in obese patients, in patients with small fluid collections, or when performing the procedure near critical structures, such as loops of small bowel, liver, or spleen.^57,81 Real-time ultrasound guidance for paracentesis requires additional training in needle tracking techniques and specialized equipment to maintain sterility.

Training

10. We recommend that dedicated training sessions, including didactics, supervised practice on patients, and simulation-based practice, should be used to teach novices how to perform ultrasound-guided paracentesis.

Rationale. Healthcare providers must gain multiple skills to safely perform ultrasound-guided paracentesis. Trainees must learn how to operate the ultrasound machine to identify the most appropriate needle insertion site based on the abdominal wall thickness, fluid collection size, proximity to nearby abdominal organs, and presence of blood vessels. Education regarding the use of ultrasound guidance for paracentesis is both desired ^82,83 and being increasingly taught to health care providers who perform paracentesis.^20,84-86

Several approaches have shown high uptake of essential skills to perform ultrasound-guided paracentesis after short training sessions. One study showed that first-year medical students can be taught to use POCUS to accurately diagnose ascites after three 30-minute teaching sessions.¹⁹ Another study showed that emergency medicine residents can achieve high levels of proficiency in the preprocedural ultrasound evaluation for paracentesis with only one hour of didactic training.²⁰ Other studies also support the concept that adequate proficiency is achievable within brief, focused training sessions.^21-28 However, these skills can decay significantly over time without ongoing education.⁸⁷

11. We recommend that simulation-based practice should be used, when available, to facilitate acquisition of the required knowledge and skills to perform ultrasound-guided paracentesis.

Rationale. Simulation-based practice should be used when available, as it has been shown to increase competence in bedside diagnostic ultrasonography and procedural techniques for ultrasound-guided procedures, including paracentesis.^{22,25,29,88,89} One study showed that internal medicine residents were able to achieve a high level of proficiency to perform ultrasound-guided paracentesis after a three-hour simulation-based mastery learning session.⁸⁸ A follow-up study suggested that, after sufficient simulation-based training, a nonradiologist can perform ultrasound-guided paracentesis as safely as an interventional radiologist.²⁹

12. We recommend that competence in performing ultrasound-guided paracentesis should be demonstrated prior to independently performing the procedure on patients.

Rationale. Competence in ultrasound-guided paracentesis requires acquisition of clinical knowledge of paracentesis, skills in basic abdominal ultrasonography, and manual techniques to perform the procedure. Competence in ultrasound-guided paracentesis cannot be assumed for those graduating from internal medicine residency in the United States. While clinical knowledge of paracentesis remains a core competency of graduating internal medicine residents per the American Board of Internal Medicine, demonstration of competence in performing ultrasound-guided or landmark-based paracentesis is not currently mandated.⁹⁰ A recent national survey of internal medicine residency program directors revealed that the curricula and resources available to train residents in bedside diagnostic ultrasound and ultrasound-guided procedures, including paracentesis, remain quite variable. ⁸³

While it has not been well studied, competence in ultrasound for paracentesis, as with all other skills involved in bedside procedures, is likely best evaluated through direct observation on actual patients.⁹¹ As such, individualized systems to evaluate competency in ultrasound-guided paracentesis should be established for each site where it is performed. A list of consensus-derived ultrasound competencies for ultrasound-guided paracentesis has been proposed, and this list may serve as a guide for both training curriculum development and practitioner evaluation.^86,91,92

In the process of developing these recommendations, we identified several important gaps in the literature regarding the use of ultrasound guidance for paracentesis.

First, while some data suggest that the use of ultrasound guidance for paracentesis may reduce the inpatient length of stay and overall costs, this suggestion has not been studied rigorously. In a retrospective review of 1,297 abdominal paracenteses by Patel et al., ultrasound-guided paracentesis was associated with a lower incidence of adverse events compared with landmark-based paracentesis (1.4% vs 4.7%; P = .01). The adjusted analysis from this study showed significant reductions in adverse events (OR 0.35; 95%CI 0.165-0.739; P = .006) and hospitalization costs ($8,761 ± $5,956 vs $9,848 ± $6,581; P < .001) for paracentesis with ultrasound guidance versus without such guidance. Additionally, the adjusted average length of stay was 0.2 days shorter for paracentesis with ultrasound guidance versus that without guidance (5.6 days vs 5.8 days; P < .0001).⁴⁴ Similar conclusions were reached by Mercaldi et al., who conducted a retrospective study of 69,859 patients who underwent paracentesis. Fewer bleeding complications occurred when paracentesis was performed with ultrasound guidance (0.27%) versus without ultrasound guidance (1.27%). Hospitalization costs increased by $19,066 (P < .0001) and length of stay increased by 4.3 days (P < .0001) for patients when paracentesis was complicated by bleeding.⁴³  Because both of these studies were retrospective reviews of administrative databases, associations between procedures, complications, and use of ultrasound may be limited by erroneous coding and documentation.

Second, regarding technique, it is unknown whether the use of real-time ultrasound guidance confers additional benefits compared with use of static ultrasound to mark a suitable needle insertion site. In clinical practice, real-time ultrasound guidance is used to sample small fluid collections, particularly when loops of bowel or a solid organ are nearby. It is possible that higher procedural success rates and lower complication rates may be demonstrated in these scenarios in future studies.

Third, the optimal approach to train providers to perform ultrasound-guided paracentesis is unknown. While short training sessions have shown high uptake of essential skills to perform ultrasound-guided paracentesis, data regarding the effectiveness of training using a comprehensive competency assessment are limited. Simulation-based mastery learning as a means to obtain competency for paracentesis has been described in one study,⁸⁸ but the translation of competency demonstrated by simulation to actual patient outcomes has not been studied. Furthermore, the most effective method to train providers who are proficient in landmark-based paracentesis to achieve competency in ultrasound-guided paracentesis has not been well studied.

Fourth, the optimal technique for identifying blood vessels in the abdominal wall is unknown. We have proposed that color flow Doppler should be used to identify and avoid puncture of superficial vessels, but power Doppler is three times more sensitive at detecting blood vessels, especially at low velocities, such as in veins independent of direction or flow.⁹³ Hence using power Doppler instead of color flow Doppler may further improve the ability to identify and avoid superficial vessels along the needle trajectory.⁹²

Finally, the impact of ultrasound use on patient experience has yet to be studied. Some studies in the literature show high patient satisfaction with use of ultrasound at the bedside,^94,95 but patient satisfaction with ultrasound-guided paracentesis has not been compared directly with the landmark-based technique.

The use of ultrasound guidance for paracentesis has been associated with higher success rates and lower complication rates. Ultrasound is superior to physical examination in assessing the presence and volume of ascites, and determining the optimal needle insertion site to avoid inadvertent injury to abdominal wall blood vessels. Hospitalists can attain competence in ultrasound-guided paracentesis through the use of various training methods, including lectures, simulation-based practice, and hands-on training. Ongoing use and training over time is necessary to maintain competence.

Acknowledgments

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

SHM Point-of-care Ultrasound Task Force: CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Mathews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar Puncture Working Group: Nilam J. Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Daniel Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Collaborators of the Society of Hospital Medicine Point-of-care Ultrasound Task Force

Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Michael Blaivas, Dan Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Paul Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, David M. Tierney

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

All 5 appendices are viewable online at https://www.journalofhospitalmedicine.com.

Red blood cells

In a first-in-human trial, sutimlimab rapidly halted hemolysis, corrected anemia, precluded the need for transfusion, and caused no serious adverse effects in patients with cold agglutinin disease.

Sutimlimab also “induced clinically meaningful increases in hemoglobin levels, even in patients with multiple previous lines of therapy,” according to investigators.

The European Medicines Agency and the U.S. Food and Drug Administration (FDA) awarded sutimlimab orphan drug status based on these results. The FDA also granted sutimlimab breakthrough therapy designation.

Sutimlimab is a humanized anti-C1s IgG4 monoclonal antibody that blocks the classical complement pathway–specific protease C1s and prevents further hemolysis in patients with cold agglutinin disease.

Cold agglutinin disease is a rare, acquired chronic autoimmune hemolytic condition that destroys red blood cells. It leads to chronic anemia, severe fatigue, and potentially fatal thrombotic events. No drug has yet been approved to treat cold agglutinin disease.

The phase 1 trial of sutimlimab (formerly BIVV009 and TNT009) in cold agglutinin disease was conducted at the Medical University of Vienna in Austria and reported in Blood.

The study (NCT02502903) involved 10 patients, ages 56 to 76, who were previously treated with multiple lines of therapy, including two patients who failed treatment with eculizumab.

Of the 10 patients, eight were female, eight were Caucasian, one was Asian, and one was Hispanic. Patients had cold agglutinin disease for a median of 5 years (range, 1 – 20).

At baseline, the median hemoglobin level was 7.8 g/dL, the median number of reticulocytes was 133 x 10⁹/L, the median bilirubin was 2.0 mg/dL, and the median haptoglobin was less than 12 mg/dL.

The patients received an initial dose of 10 mg/kg intravenous sutimlimab as a test dose to allow rapid wash-out of the drug if unforeseen adverse effects occurred with the first infusion.

One to 4 days later, they received the full dose of 60 mg/kg, followed by three additional weekly doses.

Investigators observed the patients for 49 to 53 days.

Results

Within the first week, patients’ median hemoglobin levels increased by 1.6 g/dL (P=0.007), and the median best response was an increase of 3.9 g/dL (P=0.005) after 6 weeks.

Seven patients had increased hemoglobin levels by more than 2 g/dL, and this included those who recently failed to respond or relapsed after rituximab, rituximab plus bendamustine, or eculizumab.

In five patients, hemoglobin increased by 4 g/dL or more. In four patients, it completely normalized to 12 g/dL.

In the first 24 hours after sutimlimab infusion, reticulocyte counts increased by a median of 41% and then gradually declined as hemoglobin levels rose.

In four patients, haptoglobin levels normalized within 1 to 2 weeks. In eight patients who had abnormal bilirubin levels at baseline, sutimlimab decreased the median bilirubin levels by 61%, normalizing levels in most patients within 24 hours of the first infusion (P=0.007).

When sutimlimab was washed out, bilirubin levels increased again, which demonstrated the recurrence of hemolysis.

Approximately 3 to 4 weeks after the last dose of sutimlimab, hemolysis and anemia recurred in all responders.

When patients were re-exposed to sutimlimab, rapid and complete inhibition of hemolysis occurred once again.

None of the patients required packed red blood cell transfusions during treatment.

Safety

The investigators reported that all infusions were well tolerated without premedication and without relevant drug-related adverse effects.

They reported few adverse events during the trial. All were mild or moderate in severity, and most were considered unrelated or unlikely related to sutimlimab.

Two adverse events—one mild purpural rash on both hands and one case of moderate hair loss (each occurring in one patient)—were possibly related to sutimlimab.

While the investigators considered the safety data encouraging, they recommended interpreting the data “cautiously in light of the limited duration of the trial.”

“Provided that safety results remain positive, sutimlimab could become the first approved treatment for cold agglutinin disease,” said corresponding author Bernd Jilma, MD, of the Medical University of Vienna in Austria.

“The drug clearly addresses an unmet medical need, as we have seen rapid, strong responses in patients for whom multiple prior therapies have failed.”

This study was funded by True North Therapeutics, Inc, now part of Bioverativ, a Sanofi company.

Some of the authors disclosed financial relationships, including employment, with True North Therapeutics and Bioverativ.

A phase 3 trial of sutimlimab is underway with top-line results due in 2019. 

Red blood cells

In a first-in-human trial, sutimlimab rapidly halted hemolysis, corrected anemia, precluded the need for transfusion, and caused no serious adverse effects in patients with cold agglutinin disease.

Sutimlimab also “induced clinically meaningful increases in hemoglobin levels, even in patients with multiple previous lines of therapy,” according to investigators.

The European Medicines Agency and the U.S. Food and Drug Administration (FDA) awarded sutimlimab orphan drug status based on these results. The FDA also granted sutimlimab breakthrough therapy designation.

Sutimlimab is a humanized anti-C1s IgG4 monoclonal antibody that blocks the classical complement pathway–specific protease C1s and prevents further hemolysis in patients with cold agglutinin disease.

Cold agglutinin disease is a rare, acquired chronic autoimmune hemolytic condition that destroys red blood cells. It leads to chronic anemia, severe fatigue, and potentially fatal thrombotic events. No drug has yet been approved to treat cold agglutinin disease.

The phase 1 trial of sutimlimab (formerly BIVV009 and TNT009) in cold agglutinin disease was conducted at the Medical University of Vienna in Austria and reported in Blood.

The study (NCT02502903) involved 10 patients, ages 56 to 76, who were previously treated with multiple lines of therapy, including two patients who failed treatment with eculizumab.

Of the 10 patients, eight were female, eight were Caucasian, one was Asian, and one was Hispanic. Patients had cold agglutinin disease for a median of 5 years (range, 1 – 20).

At baseline, the median hemoglobin level was 7.8 g/dL, the median number of reticulocytes was 133 x 10⁹/L, the median bilirubin was 2.0 mg/dL, and the median haptoglobin was less than 12 mg/dL.

The patients received an initial dose of 10 mg/kg intravenous sutimlimab as a test dose to allow rapid wash-out of the drug if unforeseen adverse effects occurred with the first infusion.

One to 4 days later, they received the full dose of 60 mg/kg, followed by three additional weekly doses.

Investigators observed the patients for 49 to 53 days.

Results

Within the first week, patients’ median hemoglobin levels increased by 1.6 g/dL (P=0.007), and the median best response was an increase of 3.9 g/dL (P=0.005) after 6 weeks.

Seven patients had increased hemoglobin levels by more than 2 g/dL, and this included those who recently failed to respond or relapsed after rituximab, rituximab plus bendamustine, or eculizumab.

In five patients, hemoglobin increased by 4 g/dL or more. In four patients, it completely normalized to 12 g/dL.

In the first 24 hours after sutimlimab infusion, reticulocyte counts increased by a median of 41% and then gradually declined as hemoglobin levels rose.

In four patients, haptoglobin levels normalized within 1 to 2 weeks. In eight patients who had abnormal bilirubin levels at baseline, sutimlimab decreased the median bilirubin levels by 61%, normalizing levels in most patients within 24 hours of the first infusion (P=0.007).

When sutimlimab was washed out, bilirubin levels increased again, which demonstrated the recurrence of hemolysis.

Approximately 3 to 4 weeks after the last dose of sutimlimab, hemolysis and anemia recurred in all responders.

When patients were re-exposed to sutimlimab, rapid and complete inhibition of hemolysis occurred once again.

None of the patients required packed red blood cell transfusions during treatment.

Safety

The investigators reported that all infusions were well tolerated without premedication and without relevant drug-related adverse effects.

They reported few adverse events during the trial. All were mild or moderate in severity, and most were considered unrelated or unlikely related to sutimlimab.

Two adverse events—one mild purpural rash on both hands and one case of moderate hair loss (each occurring in one patient)—were possibly related to sutimlimab.

While the investigators considered the safety data encouraging, they recommended interpreting the data “cautiously in light of the limited duration of the trial.”

“Provided that safety results remain positive, sutimlimab could become the first approved treatment for cold agglutinin disease,” said corresponding author Bernd Jilma, MD, of the Medical University of Vienna in Austria.

“The drug clearly addresses an unmet medical need, as we have seen rapid, strong responses in patients for whom multiple prior therapies have failed.”

This study was funded by True North Therapeutics, Inc, now part of Bioverativ, a Sanofi company.

Some of the authors disclosed financial relationships, including employment, with True North Therapeutics and Bioverativ.

A phase 3 trial of sutimlimab is underway with top-line results due in 2019. 

Red blood cells

In a first-in-human trial, sutimlimab rapidly halted hemolysis, corrected anemia, precluded the need for transfusion, and caused no serious adverse effects in patients with cold agglutinin disease.

Sutimlimab also “induced clinically meaningful increases in hemoglobin levels, even in patients with multiple previous lines of therapy,” according to investigators.

The European Medicines Agency and the U.S. Food and Drug Administration (FDA) awarded sutimlimab orphan drug status based on these results. The FDA also granted sutimlimab breakthrough therapy designation.

Sutimlimab is a humanized anti-C1s IgG4 monoclonal antibody that blocks the classical complement pathway–specific protease C1s and prevents further hemolysis in patients with cold agglutinin disease.

Cold agglutinin disease is a rare, acquired chronic autoimmune hemolytic condition that destroys red blood cells. It leads to chronic anemia, severe fatigue, and potentially fatal thrombotic events. No drug has yet been approved to treat cold agglutinin disease.

The phase 1 trial of sutimlimab (formerly BIVV009 and TNT009) in cold agglutinin disease was conducted at the Medical University of Vienna in Austria and reported in Blood.

The study (NCT02502903) involved 10 patients, ages 56 to 76, who were previously treated with multiple lines of therapy, including two patients who failed treatment with eculizumab.

Of the 10 patients, eight were female, eight were Caucasian, one was Asian, and one was Hispanic. Patients had cold agglutinin disease for a median of 5 years (range, 1 – 20).

At baseline, the median hemoglobin level was 7.8 g/dL, the median number of reticulocytes was 133 x 10⁹/L, the median bilirubin was 2.0 mg/dL, and the median haptoglobin was less than 12 mg/dL.

The patients received an initial dose of 10 mg/kg intravenous sutimlimab as a test dose to allow rapid wash-out of the drug if unforeseen adverse effects occurred with the first infusion.

One to 4 days later, they received the full dose of 60 mg/kg, followed by three additional weekly doses.

Investigators observed the patients for 49 to 53 days.

Results

Within the first week, patients’ median hemoglobin levels increased by 1.6 g/dL (P=0.007), and the median best response was an increase of 3.9 g/dL (P=0.005) after 6 weeks.

Seven patients had increased hemoglobin levels by more than 2 g/dL, and this included those who recently failed to respond or relapsed after rituximab, rituximab plus bendamustine, or eculizumab.

In five patients, hemoglobin increased by 4 g/dL or more. In four patients, it completely normalized to 12 g/dL.

In the first 24 hours after sutimlimab infusion, reticulocyte counts increased by a median of 41% and then gradually declined as hemoglobin levels rose.

In four patients, haptoglobin levels normalized within 1 to 2 weeks. In eight patients who had abnormal bilirubin levels at baseline, sutimlimab decreased the median bilirubin levels by 61%, normalizing levels in most patients within 24 hours of the first infusion (P=0.007).

When sutimlimab was washed out, bilirubin levels increased again, which demonstrated the recurrence of hemolysis.

Approximately 3 to 4 weeks after the last dose of sutimlimab, hemolysis and anemia recurred in all responders.

When patients were re-exposed to sutimlimab, rapid and complete inhibition of hemolysis occurred once again.

None of the patients required packed red blood cell transfusions during treatment.

Safety

The investigators reported that all infusions were well tolerated without premedication and without relevant drug-related adverse effects.

They reported few adverse events during the trial. All were mild or moderate in severity, and most were considered unrelated or unlikely related to sutimlimab.

Two adverse events—one mild purpural rash on both hands and one case of moderate hair loss (each occurring in one patient)—were possibly related to sutimlimab.

While the investigators considered the safety data encouraging, they recommended interpreting the data “cautiously in light of the limited duration of the trial.”

“Provided that safety results remain positive, sutimlimab could become the first approved treatment for cold agglutinin disease,” said corresponding author Bernd Jilma, MD, of the Medical University of Vienna in Austria.

“The drug clearly addresses an unmet medical need, as we have seen rapid, strong responses in patients for whom multiple prior therapies have failed.”

This study was funded by True North Therapeutics, Inc, now part of Bioverativ, a Sanofi company.

Some of the authors disclosed financial relationships, including employment, with True North Therapeutics and Bioverativ.

A phase 3 trial of sutimlimab is underway with top-line results due in 2019. 

On the first day of my psychiatry clerkship, I sat at a table with another student, 2 residents, and our attending physician. This wasn’t my first clinical rotation, but it was my first formal exposure to psychiatry, and I was excited and a bit anxious because I was considering psychiatry as an area of specialty training for myself. I’d been assigned 1 patient that morning: a 42-year-old man admitted for alcohol withdrawal. Our team, the psychiatry consultation-liaison team, was asked to evaluate the patient’s depressed mood in the context of withdrawal. As I began to present the patient’s story, I spoke of how terrible this man’s life had been, and how depressed he had recently become; this depression, I said, was likely exacerbated by alcohol use, but he was dealing with his depression by drinking more. He now wanted to quit for good. My attending, whom I had just met, interrupted me: “Misery,” she said with an intense look, “is a gift to an addicted person.”

I have ruminated on those surprising words ever since, and in that time I have begun to understand something about misery through the eyes of my patients. Sick people often are miserable; physical ailments can wreck hopes and plans and suck the joy from seemingly everything. Individuals who are ill or in pain often are suffering psychologically as well as physically. This suffering has been especially apparent to me in patients withdrawing from addictive substances: alcohol, cocaine, heroin, nicotine. I have been begged, cursed, praised, thanked, and more based on my ability or inability to relieve someone’s suffering caused by the lack of a certain substance: Please, just one cigarette. Please, something for this pain. Please, something to drink. As a medical student, I did one of 2 things: stood there helpless, or promised I would do the best I could, knowing my resident or attending would likely tell them no.

Withdrawal from addictive substances is, unsurprisingly, not pleasant. Alcohol withdrawal is one of the few that can be fatal, due to its ability to cause autonomic instability and seizures. Withdrawing from alcohol is also unpleasant due to hallucinosis and tremors, on top of the very real cravings for the substance itself. My patient knew this; he had withdrawn from alcohol in the past. As he talked to me, though, it became clear he had finally decided this was the end. In the past, others encouraged him to stop drinking; this time he was doing it for himself. His life had become so dismal that he was willing to undergo the agony of withdrawal to be free from his addiction.

Was his suffering, then, his misery, a gift? As I came to know my attending better, I also came to understand what these jarring words meant to her. They were her version of the old adage: It’s only when you hit rock bottom that you can start climbing back out. It isn’t the misery of withdrawing, but the misery inflicted by the substance that might provide an unexpected opportunity to start fixing things. For my patient, this particular trip to the hospital—which happened to intersect in space and time with me, a third-year medical student keen to learn and to help—was rock bottom, and he knew it. His life had been destroyed by his addiction, and here, at this intersection, the destruction was so great that he was finally willing to make a change for the better.

It is counterintuitive to think of misery as a gift, but then again, this patient—and more broadly, all patients whose lives are tormented by addiction and substance abuse—are often on the receiving end of counterintuitive advice, and it is frequently the only way to enact lasting change. Consider, for example, Alcoholics’ Anonymous, which works for far more individuals than one might expect. It does not seem possible that a small group without formal training could keep people sober simply by talking openly about their struggles; yet every day throughout the world, it does just that.

Patients struggling with addiction—labeled as addicts and drug-seekers by most of the world—are often written off as “difficult patients.” Perhaps because of my inexperience, I didn’t see this man as difficult, or as just another case of alcohol withdrawal. Although it may often be easier to define someone by his or her disease, I believe in choosing to see the human underneath the label. To me, these patients are not difficult; they are broken and miserable, and they desperately need help. Knowing this, I am forced to consider just how bad things have gotten for them, and how hard it must be to make a change. Their brokenness may be an opportunity to start down a new path, but only if we extend that invitation. Such an invitation may be the first step to turning genuine misery into a gift.

When I’m asked why I have chosen psychiatry, willingly entering such a “difficult field,” I think about my experience on that consult service and this patient. I know that I’m still just beginning my journey, and that even more difficult moments and patients lie ahead. But difficulty depends on one’s perspective; certainly that patient, trying to free himself from addiction’s grasp, was “going through a difficult time.” This is of course a platitude; the word “misery” gets much closer to the truth. I usually answer with some variation of the following: Medicine, especially psychiatry, is about caring for those who need it most: hurting, vulnerable people rejected by friends, family, and society. Our business is misery; sometimes we track in the broken, the beat down, the rock bottom. We get down in the depths with our patients to offer comfort and hope. We look at an addict, but we see a human being. We try to see the world from his or her perspective. This isn’t always pleasant—sometimes, it’s downright miserable—but to see the world through the eyes of another is, always, a gift.

On the first day of my psychiatry clerkship, I sat at a table with another student, 2 residents, and our attending physician. This wasn’t my first clinical rotation, but it was my first formal exposure to psychiatry, and I was excited and a bit anxious because I was considering psychiatry as an area of specialty training for myself. I’d been assigned 1 patient that morning: a 42-year-old man admitted for alcohol withdrawal. Our team, the psychiatry consultation-liaison team, was asked to evaluate the patient’s depressed mood in the context of withdrawal. As I began to present the patient’s story, I spoke of how terrible this man’s life had been, and how depressed he had recently become; this depression, I said, was likely exacerbated by alcohol use, but he was dealing with his depression by drinking more. He now wanted to quit for good. My attending, whom I had just met, interrupted me: “Misery,” she said with an intense look, “is a gift to an addicted person.”

I have ruminated on those surprising words ever since, and in that time I have begun to understand something about misery through the eyes of my patients. Sick people often are miserable; physical ailments can wreck hopes and plans and suck the joy from seemingly everything. Individuals who are ill or in pain often are suffering psychologically as well as physically. This suffering has been especially apparent to me in patients withdrawing from addictive substances: alcohol, cocaine, heroin, nicotine. I have been begged, cursed, praised, thanked, and more based on my ability or inability to relieve someone’s suffering caused by the lack of a certain substance: Please, just one cigarette. Please, something for this pain. Please, something to drink. As a medical student, I did one of 2 things: stood there helpless, or promised I would do the best I could, knowing my resident or attending would likely tell them no.

Withdrawal from addictive substances is, unsurprisingly, not pleasant. Alcohol withdrawal is one of the few that can be fatal, due to its ability to cause autonomic instability and seizures. Withdrawing from alcohol is also unpleasant due to hallucinosis and tremors, on top of the very real cravings for the substance itself. My patient knew this; he had withdrawn from alcohol in the past. As he talked to me, though, it became clear he had finally decided this was the end. In the past, others encouraged him to stop drinking; this time he was doing it for himself. His life had become so dismal that he was willing to undergo the agony of withdrawal to be free from his addiction.

Was his suffering, then, his misery, a gift? As I came to know my attending better, I also came to understand what these jarring words meant to her. They were her version of the old adage: It’s only when you hit rock bottom that you can start climbing back out. It isn’t the misery of withdrawing, but the misery inflicted by the substance that might provide an unexpected opportunity to start fixing things. For my patient, this particular trip to the hospital—which happened to intersect in space and time with me, a third-year medical student keen to learn and to help—was rock bottom, and he knew it. His life had been destroyed by his addiction, and here, at this intersection, the destruction was so great that he was finally willing to make a change for the better.

It is counterintuitive to think of misery as a gift, but then again, this patient—and more broadly, all patients whose lives are tormented by addiction and substance abuse—are often on the receiving end of counterintuitive advice, and it is frequently the only way to enact lasting change. Consider, for example, Alcoholics’ Anonymous, which works for far more individuals than one might expect. It does not seem possible that a small group without formal training could keep people sober simply by talking openly about their struggles; yet every day throughout the world, it does just that.

Patients struggling with addiction—labeled as addicts and drug-seekers by most of the world—are often written off as “difficult patients.” Perhaps because of my inexperience, I didn’t see this man as difficult, or as just another case of alcohol withdrawal. Although it may often be easier to define someone by his or her disease, I believe in choosing to see the human underneath the label. To me, these patients are not difficult; they are broken and miserable, and they desperately need help. Knowing this, I am forced to consider just how bad things have gotten for them, and how hard it must be to make a change. Their brokenness may be an opportunity to start down a new path, but only if we extend that invitation. Such an invitation may be the first step to turning genuine misery into a gift.

When I’m asked why I have chosen psychiatry, willingly entering such a “difficult field,” I think about my experience on that consult service and this patient. I know that I’m still just beginning my journey, and that even more difficult moments and patients lie ahead. But difficulty depends on one’s perspective; certainly that patient, trying to free himself from addiction’s grasp, was “going through a difficult time.” This is of course a platitude; the word “misery” gets much closer to the truth. I usually answer with some variation of the following: Medicine, especially psychiatry, is about caring for those who need it most: hurting, vulnerable people rejected by friends, family, and society. Our business is misery; sometimes we track in the broken, the beat down, the rock bottom. We get down in the depths with our patients to offer comfort and hope. We look at an addict, but we see a human being. We try to see the world from his or her perspective. This isn’t always pleasant—sometimes, it’s downright miserable—but to see the world through the eyes of another is, always, a gift.

On the first day of my psychiatry clerkship, I sat at a table with another student, 2 residents, and our attending physician. This wasn’t my first clinical rotation, but it was my first formal exposure to psychiatry, and I was excited and a bit anxious because I was considering psychiatry as an area of specialty training for myself. I’d been assigned 1 patient that morning: a 42-year-old man admitted for alcohol withdrawal. Our team, the psychiatry consultation-liaison team, was asked to evaluate the patient’s depressed mood in the context of withdrawal. As I began to present the patient’s story, I spoke of how terrible this man’s life had been, and how depressed he had recently become; this depression, I said, was likely exacerbated by alcohol use, but he was dealing with his depression by drinking more. He now wanted to quit for good. My attending, whom I had just met, interrupted me: “Misery,” she said with an intense look, “is a gift to an addicted person.”

I have ruminated on those surprising words ever since, and in that time I have begun to understand something about misery through the eyes of my patients. Sick people often are miserable; physical ailments can wreck hopes and plans and suck the joy from seemingly everything. Individuals who are ill or in pain often are suffering psychologically as well as physically. This suffering has been especially apparent to me in patients withdrawing from addictive substances: alcohol, cocaine, heroin, nicotine. I have been begged, cursed, praised, thanked, and more based on my ability or inability to relieve someone’s suffering caused by the lack of a certain substance: Please, just one cigarette. Please, something for this pain. Please, something to drink. As a medical student, I did one of 2 things: stood there helpless, or promised I would do the best I could, knowing my resident or attending would likely tell them no.

Withdrawal from addictive substances is, unsurprisingly, not pleasant. Alcohol withdrawal is one of the few that can be fatal, due to its ability to cause autonomic instability and seizures. Withdrawing from alcohol is also unpleasant due to hallucinosis and tremors, on top of the very real cravings for the substance itself. My patient knew this; he had withdrawn from alcohol in the past. As he talked to me, though, it became clear he had finally decided this was the end. In the past, others encouraged him to stop drinking; this time he was doing it for himself. His life had become so dismal that he was willing to undergo the agony of withdrawal to be free from his addiction.

Was his suffering, then, his misery, a gift? As I came to know my attending better, I also came to understand what these jarring words meant to her. They were her version of the old adage: It’s only when you hit rock bottom that you can start climbing back out. It isn’t the misery of withdrawing, but the misery inflicted by the substance that might provide an unexpected opportunity to start fixing things. For my patient, this particular trip to the hospital—which happened to intersect in space and time with me, a third-year medical student keen to learn and to help—was rock bottom, and he knew it. His life had been destroyed by his addiction, and here, at this intersection, the destruction was so great that he was finally willing to make a change for the better.

It is counterintuitive to think of misery as a gift, but then again, this patient—and more broadly, all patients whose lives are tormented by addiction and substance abuse—are often on the receiving end of counterintuitive advice, and it is frequently the only way to enact lasting change. Consider, for example, Alcoholics’ Anonymous, which works for far more individuals than one might expect. It does not seem possible that a small group without formal training could keep people sober simply by talking openly about their struggles; yet every day throughout the world, it does just that.

Patients struggling with addiction—labeled as addicts and drug-seekers by most of the world—are often written off as “difficult patients.” Perhaps because of my inexperience, I didn’t see this man as difficult, or as just another case of alcohol withdrawal. Although it may often be easier to define someone by his or her disease, I believe in choosing to see the human underneath the label. To me, these patients are not difficult; they are broken and miserable, and they desperately need help. Knowing this, I am forced to consider just how bad things have gotten for them, and how hard it must be to make a change. Their brokenness may be an opportunity to start down a new path, but only if we extend that invitation. Such an invitation may be the first step to turning genuine misery into a gift.

When I’m asked why I have chosen psychiatry, willingly entering such a “difficult field,” I think about my experience on that consult service and this patient. I know that I’m still just beginning my journey, and that even more difficult moments and patients lie ahead. But difficulty depends on one’s perspective; certainly that patient, trying to free himself from addiction’s grasp, was “going through a difficult time.” This is of course a platitude; the word “misery” gets much closer to the truth. I usually answer with some variation of the following: Medicine, especially psychiatry, is about caring for those who need it most: hurting, vulnerable people rejected by friends, family, and society. Our business is misery; sometimes we track in the broken, the beat down, the rock bottom. We get down in the depths with our patients to offer comfort and hope. We look at an addict, but we see a human being. We try to see the world from his or her perspective. This isn’t always pleasant—sometimes, it’s downright miserable—but to see the world through the eyes of another is, always, a gift.

Our 24-hour society has made night shift work essential to people in many professions, including medical specialties. Working nights disrupts homeostatic and circadian rhythms, which leads to an accumulation of sleep debt (ie, the cumulative effect of not getting enough sleep).¹ This debt can affect performance by impairing processing speed, concentration, mood, and physical health.¹ Night shift work takes place during the period of the sleep-wake cycle that is programmed for sleep; after the shift, workers need to sleep during the period that is least conducive to sleep.¹ Research indicates that a night shift worker’s sleep can be improved by scheduling light exposure and optimizing the timing of when they start their shifts.² However, this may not be practical because night shifts usually are scheduled at particular intervals and cannot be tailored to the individual worker’s preference. Additionally, in the short term, full circadian adaptation to night shifts is impossible.¹

Because sleep and performance are complex phenomena that are difficult to control, there is no single solution to maximizing these factors when one works nights.¹ The most effective approach to combating the effects of night shift work is individualized and multimodal.¹ However, whether you are working a night shift or are caring for a patient who does, the following nonpharmacologic strategies can help improve sleep and performance until the body naturally adapts to working this type of schedule^1,3:

Minimize sleep debt before starting aseries of night shifts by not setting an alarm on the morning before the first night shift and by napping in the afternoon for approximately 45 minutes.

Take a nap during a work break (if work demands allow you to do so). However, nap for <30 minutes to avoid slow-wave sleep and subsequent grogginess when awakening.

Expose yourself to bright light immediately upon waking and for 15 minutes 2 or 3 times during a shift to promote alertness.

Drink caffeinated beverages before and during the shift to help improve concentration and reasoning (if there is no medical contraindication to consuming caffeine). However, avoid caffeine for at least 3 hours prior to going to sleep.

Add additional checks to critical tasks, such as ordering medications, during the shift, especially during the physiological nadir in the early hours of the morning.

Continue to: Create a cool, dark, quiet environment for sleep...

Create a cool, dark, quiet environment for sleep using a comfortable mattress and pillow, blackout blinds, ear plugs, and a noise machine. Also, avoid using your smartphone or tablet while trying to go to sleep. Minimize exposure to bright light on the drive home, and stick to a routine (eg, for meals and exercise).

Avoid working too many consecutive night shifts (if possible) because this can increase sleep deprivation. Also, limiting the number of night shifts and scheduling days off can speed recovery from sleep deprivation.

Our 24-hour society has made night shift work essential to people in many professions, including medical specialties. Working nights disrupts homeostatic and circadian rhythms, which leads to an accumulation of sleep debt (ie, the cumulative effect of not getting enough sleep).¹ This debt can affect performance by impairing processing speed, concentration, mood, and physical health.¹ Night shift work takes place during the period of the sleep-wake cycle that is programmed for sleep; after the shift, workers need to sleep during the period that is least conducive to sleep.¹ Research indicates that a night shift worker’s sleep can be improved by scheduling light exposure and optimizing the timing of when they start their shifts.² However, this may not be practical because night shifts usually are scheduled at particular intervals and cannot be tailored to the individual worker’s preference. Additionally, in the short term, full circadian adaptation to night shifts is impossible.¹

Because sleep and performance are complex phenomena that are difficult to control, there is no single solution to maximizing these factors when one works nights.¹ The most effective approach to combating the effects of night shift work is individualized and multimodal.¹ However, whether you are working a night shift or are caring for a patient who does, the following nonpharmacologic strategies can help improve sleep and performance until the body naturally adapts to working this type of schedule^1,3:

Minimize sleep debt before starting aseries of night shifts by not setting an alarm on the morning before the first night shift and by napping in the afternoon for approximately 45 minutes.

Take a nap during a work break (if work demands allow you to do so). However, nap for <30 minutes to avoid slow-wave sleep and subsequent grogginess when awakening.

Expose yourself to bright light immediately upon waking and for 15 minutes 2 or 3 times during a shift to promote alertness.

Drink caffeinated beverages before and during the shift to help improve concentration and reasoning (if there is no medical contraindication to consuming caffeine). However, avoid caffeine for at least 3 hours prior to going to sleep.

Add additional checks to critical tasks, such as ordering medications, during the shift, especially during the physiological nadir in the early hours of the morning.

Continue to: Create a cool, dark, quiet environment for sleep...

Create a cool, dark, quiet environment for sleep using a comfortable mattress and pillow, blackout blinds, ear plugs, and a noise machine. Also, avoid using your smartphone or tablet while trying to go to sleep. Minimize exposure to bright light on the drive home, and stick to a routine (eg, for meals and exercise).

Avoid working too many consecutive night shifts (if possible) because this can increase sleep deprivation. Also, limiting the number of night shifts and scheduling days off can speed recovery from sleep deprivation.

Our 24-hour society has made night shift work essential to people in many professions, including medical specialties. Working nights disrupts homeostatic and circadian rhythms, which leads to an accumulation of sleep debt (ie, the cumulative effect of not getting enough sleep).¹ This debt can affect performance by impairing processing speed, concentration, mood, and physical health.¹ Night shift work takes place during the period of the sleep-wake cycle that is programmed for sleep; after the shift, workers need to sleep during the period that is least conducive to sleep.¹ Research indicates that a night shift worker’s sleep can be improved by scheduling light exposure and optimizing the timing of when they start their shifts.² However, this may not be practical because night shifts usually are scheduled at particular intervals and cannot be tailored to the individual worker’s preference. Additionally, in the short term, full circadian adaptation to night shifts is impossible.¹

Because sleep and performance are complex phenomena that are difficult to control, there is no single solution to maximizing these factors when one works nights.¹ The most effective approach to combating the effects of night shift work is individualized and multimodal.¹ However, whether you are working a night shift or are caring for a patient who does, the following nonpharmacologic strategies can help improve sleep and performance until the body naturally adapts to working this type of schedule^1,3:

Minimize sleep debt before starting aseries of night shifts by not setting an alarm on the morning before the first night shift and by napping in the afternoon for approximately 45 minutes.

Take a nap during a work break (if work demands allow you to do so). However, nap for <30 minutes to avoid slow-wave sleep and subsequent grogginess when awakening.

Expose yourself to bright light immediately upon waking and for 15 minutes 2 or 3 times during a shift to promote alertness.

Drink caffeinated beverages before and during the shift to help improve concentration and reasoning (if there is no medical contraindication to consuming caffeine). However, avoid caffeine for at least 3 hours prior to going to sleep.

Add additional checks to critical tasks, such as ordering medications, during the shift, especially during the physiological nadir in the early hours of the morning.

Continue to: Create a cool, dark, quiet environment for sleep...

Create a cool, dark, quiet environment for sleep using a comfortable mattress and pillow, blackout blinds, ear plugs, and a noise machine. Also, avoid using your smartphone or tablet while trying to go to sleep. Minimize exposure to bright light on the drive home, and stick to a routine (eg, for meals and exercise).

Avoid working too many consecutive night shifts (if possible) because this can increase sleep deprivation. Also, limiting the number of night shifts and scheduling days off can speed recovery from sleep deprivation.

CASE

Mr. C, a veteran in his 60s who has posttraumatic stress disorder (PTSD), presents to your clinic for a 45-minute follow-up visit. He has a remote history of depression and a 20-year history of substance use disorder (SUD); he uses heroin, at least 3 bags a day by insufflation. You review his response to his currently prescribed PTSD treatment regimen, ask if he is experiencing any adverse effects, and perform a mental status exam and a review of systems. You offer Mr. C detoxification and rehabilitation treatment for his heroin use, but he refuses. With 15 minutes left in the appointment, you consider conducting motivational interviewing (MI) to help him reconsider getting treatment for his SUD.

Even when delivered as a brief, one-time intervention, MI can be effective in getting patients to change their behavior.¹ First created in part by psychologists William Miller, PhD, and Stephen Rollnick, PhD,² MI is based on the premise that a patient’s ambivalence to change is normal and that all patients vary in their readiness to change. MI can be brief, and can be more helpful than providing only proscriptive advice, which sometimes can be counterproductitive.³

To effectively implement MI during a brief visit, it is helpful to keep in mind 3 mnemonics: RULE, PACE, and OARS.

RULE

RULE can be used to remember the core principles of MI.⁴ First, Resist the righting reflex, which means we should resist giving suggestions to our patients for their problems. While we may mean well, offering suggestions might actually make the patient less likely to make a positive change. Understand the patient’s motivation by being a curious listener and attempting to elicit the patient’s own underlying motivation for change. Listen with a patient-centered, empathic approach. Lastly, Empower the patient. He must understand that he is in control of his actions, and any change he desires will require him to take steps toward that change.

PACE

PACE is the “spirit” or mindset that clinicians should have when conducting MI.^4,5 Always work in Partnership with the patient; this allows the patient and clinician to collaborate on the same level. While the physician is a clinical expert, the patient is an expert in prior efforts at trying to change his or her circumstances for the better. Make the therapeutic environment as positive as possible so that your patient will find it comfortable to discuss change. The patient should see the clinician as a guide who offers information about paths the patient may choose, not someone who decides the destination.⁵ While as physicians we must continue to educate our patients about the harms of behaviors such as excessive drinking or substance use, we recognize that ultimately the decision is the patient’s. Make every effort to draw from the patients’ goals and values, so that the patient, and not the clinician, can argue for why change is needed. This Acceptance helps foster an attitude that we are on the patient’s side and that his past choices in life do not negatively affect our perception of him. The patient should be accepted for who he is, and not met with disapproval over any personal decisions that he made.⁵ Exercise Compassion towards the patient’s struggles and experiences,⁵ and never be punitive. Make every attempt to have discussions that can be Evocative for the patient. Strong feelings and memories can be particularly salient to discuss, especially if they could help change the patient’s attitude towards maladaptive behaviors.

OARS

OARS can be used to help remember core skills of MI.⁵ These include asking Open-ended questions to get the patient to think before responding, providing frequent Affirmations of the patient’s positive traits, using Reflective listening techniques while your patient talks about his disorder, and providing succinct Summaries of the experiences expressed by your patient throughout the encounter to invite continued exploration of his behaviors.

Getting patients to talk about change

Use RULE, PACE, and OARS to elicit “change talk,”⁴ so that your patient makes his own arguments for change. Here ambivalence is good, in that an ambivalent patient may be open to discuss reasons for making changes. It is important to remember not to use the righting reflex to give suggestions to change.

Continue to: CASE...

You use the last 15 minutes of Mr. C’s visit to conduct MI and acknowledge his ambivalence to change. Mr. C reveals that his motivation for change centers on how he perceives himself as a disappointment to his daughter because of his continuous drug use. At the end of the encounter, Mr. C is in tears but has a renewed motivation to stop using heroin. He agrees to enter substance abuse treatment.

CASE

Mr. C, a veteran in his 60s who has posttraumatic stress disorder (PTSD), presents to your clinic for a 45-minute follow-up visit. He has a remote history of depression and a 20-year history of substance use disorder (SUD); he uses heroin, at least 3 bags a day by insufflation. You review his response to his currently prescribed PTSD treatment regimen, ask if he is experiencing any adverse effects, and perform a mental status exam and a review of systems. You offer Mr. C detoxification and rehabilitation treatment for his heroin use, but he refuses. With 15 minutes left in the appointment, you consider conducting motivational interviewing (MI) to help him reconsider getting treatment for his SUD.

Even when delivered as a brief, one-time intervention, MI can be effective in getting patients to change their behavior.¹ First created in part by psychologists William Miller, PhD, and Stephen Rollnick, PhD,² MI is based on the premise that a patient’s ambivalence to change is normal and that all patients vary in their readiness to change. MI can be brief, and can be more helpful than providing only proscriptive advice, which sometimes can be counterproductitive.³

To effectively implement MI during a brief visit, it is helpful to keep in mind 3 mnemonics: RULE, PACE, and OARS.

RULE

RULE can be used to remember the core principles of MI.⁴ First, Resist the righting reflex, which means we should resist giving suggestions to our patients for their problems. While we may mean well, offering suggestions might actually make the patient less likely to make a positive change. Understand the patient’s motivation by being a curious listener and attempting to elicit the patient’s own underlying motivation for change. Listen with a patient-centered, empathic approach. Lastly, Empower the patient. He must understand that he is in control of his actions, and any change he desires will require him to take steps toward that change.

PACE

PACE is the “spirit” or mindset that clinicians should have when conducting MI.^4,5 Always work in Partnership with the patient; this allows the patient and clinician to collaborate on the same level. While the physician is a clinical expert, the patient is an expert in prior efforts at trying to change his or her circumstances for the better. Make the therapeutic environment as positive as possible so that your patient will find it comfortable to discuss change. The patient should see the clinician as a guide who offers information about paths the patient may choose, not someone who decides the destination.⁵ While as physicians we must continue to educate our patients about the harms of behaviors such as excessive drinking or substance use, we recognize that ultimately the decision is the patient’s. Make every effort to draw from the patients’ goals and values, so that the patient, and not the clinician, can argue for why change is needed. This Acceptance helps foster an attitude that we are on the patient’s side and that his past choices in life do not negatively affect our perception of him. The patient should be accepted for who he is, and not met with disapproval over any personal decisions that he made.⁵ Exercise Compassion towards the patient’s struggles and experiences,⁵ and never be punitive. Make every attempt to have discussions that can be Evocative for the patient. Strong feelings and memories can be particularly salient to discuss, especially if they could help change the patient’s attitude towards maladaptive behaviors.

OARS

OARS can be used to help remember core skills of MI.⁵ These include asking Open-ended questions to get the patient to think before responding, providing frequent Affirmations of the patient’s positive traits, using Reflective listening techniques while your patient talks about his disorder, and providing succinct Summaries of the experiences expressed by your patient throughout the encounter to invite continued exploration of his behaviors.

Getting patients to talk about change

Use RULE, PACE, and OARS to elicit “change talk,”⁴ so that your patient makes his own arguments for change. Here ambivalence is good, in that an ambivalent patient may be open to discuss reasons for making changes. It is important to remember not to use the righting reflex to give suggestions to change.

Continue to: CASE...

You use the last 15 minutes of Mr. C’s visit to conduct MI and acknowledge his ambivalence to change. Mr. C reveals that his motivation for change centers on how he perceives himself as a disappointment to his daughter because of his continuous drug use. At the end of the encounter, Mr. C is in tears but has a renewed motivation to stop using heroin. He agrees to enter substance abuse treatment.

CASE

Mr. C, a veteran in his 60s who has posttraumatic stress disorder (PTSD), presents to your clinic for a 45-minute follow-up visit. He has a remote history of depression and a 20-year history of substance use disorder (SUD); he uses heroin, at least 3 bags a day by insufflation. You review his response to his currently prescribed PTSD treatment regimen, ask if he is experiencing any adverse effects, and perform a mental status exam and a review of systems. You offer Mr. C detoxification and rehabilitation treatment for his heroin use, but he refuses. With 15 minutes left in the appointment, you consider conducting motivational interviewing (MI) to help him reconsider getting treatment for his SUD.

Even when delivered as a brief, one-time intervention, MI can be effective in getting patients to change their behavior.¹ First created in part by psychologists William Miller, PhD, and Stephen Rollnick, PhD,² MI is based on the premise that a patient’s ambivalence to change is normal and that all patients vary in their readiness to change. MI can be brief, and can be more helpful than providing only proscriptive advice, which sometimes can be counterproductitive.³

To effectively implement MI during a brief visit, it is helpful to keep in mind 3 mnemonics: RULE, PACE, and OARS.

RULE

RULE can be used to remember the core principles of MI.⁴ First, Resist the righting reflex, which means we should resist giving suggestions to our patients for their problems. While we may mean well, offering suggestions might actually make the patient less likely to make a positive change. Understand the patient’s motivation by being a curious listener and attempting to elicit the patient’s own underlying motivation for change. Listen with a patient-centered, empathic approach. Lastly, Empower the patient. He must understand that he is in control of his actions, and any change he desires will require him to take steps toward that change.

PACE

PACE is the “spirit” or mindset that clinicians should have when conducting MI.^4,5 Always work in Partnership with the patient; this allows the patient and clinician to collaborate on the same level. While the physician is a clinical expert, the patient is an expert in prior efforts at trying to change his or her circumstances for the better. Make the therapeutic environment as positive as possible so that your patient will find it comfortable to discuss change. The patient should see the clinician as a guide who offers information about paths the patient may choose, not someone who decides the destination.⁵ While as physicians we must continue to educate our patients about the harms of behaviors such as excessive drinking or substance use, we recognize that ultimately the decision is the patient’s. Make every effort to draw from the patients’ goals and values, so that the patient, and not the clinician, can argue for why change is needed. This Acceptance helps foster an attitude that we are on the patient’s side and that his past choices in life do not negatively affect our perception of him. The patient should be accepted for who he is, and not met with disapproval over any personal decisions that he made.⁵ Exercise Compassion towards the patient’s struggles and experiences,⁵ and never be punitive. Make every attempt to have discussions that can be Evocative for the patient. Strong feelings and memories can be particularly salient to discuss, especially if they could help change the patient’s attitude towards maladaptive behaviors.

OARS

OARS can be used to help remember core skills of MI.⁵ These include asking Open-ended questions to get the patient to think before responding, providing frequent Affirmations of the patient’s positive traits, using Reflective listening techniques while your patient talks about his disorder, and providing succinct Summaries of the experiences expressed by your patient throughout the encounter to invite continued exploration of his behaviors.

Getting patients to talk about change

Use RULE, PACE, and OARS to elicit “change talk,”⁴ so that your patient makes his own arguments for change. Here ambivalence is good, in that an ambivalent patient may be open to discuss reasons for making changes. It is important to remember not to use the righting reflex to give suggestions to change.

Continue to: CASE...

You use the last 15 minutes of Mr. C’s visit to conduct MI and acknowledge his ambivalence to change. Mr. C reveals that his motivation for change centers on how he perceives himself as a disappointment to his daughter because of his continuous drug use. At the end of the encounter, Mr. C is in tears but has a renewed motivation to stop using heroin. He agrees to enter substance abuse treatment.

CASE Altered mental status after stroke workup

Ms. L, age 91, is admitted to the hospital for a neurologic evaluation of a recent episode of left-sided weakness that occurred 1 week ago. This left-sided weakness resolved without intervention within 2 hours while at home. This presentation is typical of a transient ischemic attack (TIA). She has a history of hypertension, bradycardia, and pacemaker implantation. On initial evaluation, her memory is intact, and she is able to walk normally. Her score on the St. Louis University Mental Status (SLUMS) exam is 25, which suggests normal cognitive functioning for her academic background. A CT scan of the head reveals a subacute stroke of the right posterior limb of the internal capsule consistent with recent TIA.

Ms. L is admitted for a routine stroke workup and prepares to undergo a CT angiogram (CTA) with the use of the iodinated agent iopamidol (100 mL, 76%) to evaluate patency of cerebral vessels. Her baseline blood urea nitrogen (BUN) and creatinine levels are within normal limits.

A day after undergoing CTA, Ms. L starts mumbling to herself, has unpredictable mood outbursts, and is not oriented to time, place, or person.

[polldaddy:10199351]

The authors’ observations

Due to her acute altered mental status (AMS), Ms. L underwent an emergent CT scan of the head to rule out any acute intracranial hemorrhages or thromboembolic events. The results of this test were negative. Urinalysis, BUN, creatinine, basic chemistry, and complete blood count panels were unrevealing. On a repeat SLUMS exam, Ms. L scored 9, indicating cognitive impairment.

Ms. L also underwent a comprehensive metabolic profile, which excluded any electrolyte abnormalities, or any hepatic or renal causes of AMS. There was no sign of dehydration, acidosis, hypoglycemia, hypoxemia, hypotension, or bradycardia/tachycardia. A urinalysis, chest X-ray, complete blood count, and 2 blood cultures conducted 24 hours apart did not reveal any signs of infection. There were no recent changes in her medications and she was not taking any sleep medications or other psychiatric medications that might precipitate a withdrawal syndrome.

There have been multiple reports of contrast-induced nephropathy (CIN), which may be evidenced by high BUN-to-creatinine ratios and could cause AMS in geriatric patients. However, CIN was ruled out as a potential cause in our patient because her BUN-to-creatinine was unremarkable.

Continue to: Routine EEG was clinically...

Routine EEG was clinically inconclusive. Diffusion-weighted MRI may have been helpful to identify ischemic strokes that a CT scan of the head might miss,¹ but we were unable to conduct this test because Ms. L had a pacemaker. Barber et al² suggested that in the setting of acute stroke, the use of MRI may not have an added advantage over the CT scan of the head.

[polldaddy:10199352]

TREATMENT Rapid improvement with supportive therapy

Intravenous fluids are administered as supportive therapy to Ms. L for suspected contrast-induced encephalopathy (CIE). The next day, Ms. L experiences a notable improvement in cognition, beyond that attributed to IV hydration. By 3 days post-contrast injection, her SLUMS score increases to 15. By 72 hours after contrast administration, Ms. L’s cognition returns to baseline. She is monitored for 24 hours after returning to baseline cognitive functioning. After observing her to be in no physical or medical distress and at baseline functioning, she is discharged home under the care of her son with outpatient follow-up and rehab services.

The authors’ observations

For Ms. L, the differential diagnosis included post-ictal phenomenon, new-onset ischemic or hemorrhagic changes, hyperperfusion syndrome, and CIE.

Seizures were ruled out because EEG was inconclusive, and Ms. L did not have the clinical features one would expect in an ictal episode. Transient ischemic attack is, by definition, an ischemic event with clinical return to baseline within 24 hours. Although a CT scan of the head may not be the most sensitive way to detect early ischemic changes and small ischemic zones, the self-limiting course and complete resolution of Ms. L’s symptoms with return to baseline is indicative of a more benign pathology, such as CIE. New hemorrhagic conversions have a dramatic presentation on radiologic studies. Historically, CIE presentations on imaging have been closely associated with the hyperattentuation seen in subarachnoid hemorrhage (SAH). The absence of typical radiologic and clinical findings in our case ruled out SAH.

Continue to: Typical CT scan findings in CIE include...

Typical CT scan findings in CIE include abnormal cortical contrast enhancement and edema, subarachnoid contrast enhancement, and striatal contrast enhancement (Figure 1, Figure 2, and Figure 3). Since the first clinical description, reports of 39 CT-/MRI-confirmed cases of CIE have been published in English language medical literature, with documented clinical follow-up³ and a median recovery time of 2.5 days. In a case report by Ito et al,⁴ there were no supportive radiographic findings. Ours is the second documented case that showed no radiologic signs of CIE. With a paucity of other etiologic evidence, negative lab tests for other causes of delirium, and the rapid resolution of Ms. L’s AMS after providing IV fluids as supportive treatment, a temporal correlation can be deduced, which implicates iodine-based contrast as the inciting factor.

Iodine-based contrast agents have been used since the 1920s. Today, >75 million procedures requiring iodine dyes are performed annually worldwide.⁵ This level of routine iodine contrast usage compels a mention of risk factors and complications from using such dyes. As a general rule, contrast agent reactions can be categorized as immediate (<1 day) or delayed (1 to 7 days after contrast administration). Immediate reactions are immunoglobulin E (IgE)-mediated anaphylactic reactions. Delayed reactions involve a T-cell mediated response that ranges from pruritus and urticaria (approximately 70%) to cardiac complications such as cardiovascular shock, arrhythmia, arrest, and Kounis syndrome. Other less prevalent complications include hypotension, bronchospasm, and CIN. Patients with the following factors may be at higher risk for contrast-induced reactions:

• asthma
• cardiac arrhythmias
• central myasthenia gravis
• >70 years of age
• pheochromocytoma
• sickle cell anemia
• hyperthyroidism
• dehydration
• hypotension.

Although some older literature reported correlations between seafood and shellfish allergies and iodine contrast reactions, more recent reports suggest there may not be a direct correlation, or any correlation at all.^5,6

Iodinated CIE is a rare complication of contrast angiography. It was first reported in 1970 as transient cortical blindness after coronary angiography.⁷ Clinical manifestations include encephalopathy evidenced by AMS, affected orientation, and acute psychotic changes, including paranoia and hallucinations, seizures, cortical blindness, and focal neurologic deficits. Neuroimaging has been pivotal in confirming the diagnosis and in excluding thromboembolic and hemorrhagic complications of angiography.⁸

Encephalopathy has been documented after administration of iopromide,^9,10iohexol,¹¹ioxilan,⁴ and metrizamide. The mechanism of neurotoxicity is unclear, but several theories have been formulated. The contrast agent may disturb the blood-brain barrier and enter the brain. This may be a primary mechanism leading to encephalopathy when the hypertonic contrast agent draws water out of the endothelial cells of brain capillaries, arterioles, and venules. This may cause the endothelial cells to shrink and to separate at tight junctions directly affecting the blood-brain barrier. Alternatively, the increase in intraluminal pressure caused by injection of the contrast agent, in concert with contrast agent-induced cerebral vasodilatation, might contribute to increasing vascular wall tension, further separating tight junctions. A third theory suggests that vesicular transport may be a mechanism of osmotic barrier opening. Further studies would be required to investigate these mechanisms.

Continue to: Regardless of the mechanism...

Regardless of the mechanism, all the above-mentioned studies note a reversal of radiologic and neurologic findings without any deficits within 48 to 72 hours (median recovery time of 2.5 days).³ All reported cases of CIE, including ours, were found to be completely reversible without any neurologic or radiologic deficits after resolution (48 to 72 hours post-contrast administration).

Clinicians should have a high index of suspicion for CIE in patients with recent iodine-based contrast exposure. From a practical standpoint, such a mechanism could be easily missed because while use of a single-administration contrast agent may appear in procedure notes or medication administration records, it might not necessarily appear in documentation of currently administered medications. Also, such cases might not always present with unique radiologic findings, as illustrated by Ms. L’s case.

Bottom Line

Have a high index of suspicion for contrast-induced encephalopathy, especially in geriatric patients, even in the absence of radiologic findings. A full delirium/dementia workup is warranted to rule out other life-threatening causes of altered mental status. Timely recognition could enable implementation of medicationsparing approaches to the disorder, such as IV fluids and frequent reorientation.

Related Resources

• Donepudi B, Trottier S. A seizure and hemiplegia following contrast exposure: Understanding contrast-induced encephalopathy. Case Rep Med. 2018;2018:9278526. doi:10.1155/2018/9278526.
• Hamra M, Bakhit Y, Khan M, et al. Case report and literature review on contrast-induced encephalopathy. Future Cardiol. 2017;13(4):331-335.

Drug Brand Names

Iohexol • Omnipaque
Iopamidol • Isovue-370
Iopromide • Ultravist
Ioxilan • Oxilan

CASE Altered mental status after stroke workup

Ms. L, age 91, is admitted to the hospital for a neurologic evaluation of a recent episode of left-sided weakness that occurred 1 week ago. This left-sided weakness resolved without intervention within 2 hours while at home. This presentation is typical of a transient ischemic attack (TIA). She has a history of hypertension, bradycardia, and pacemaker implantation. On initial evaluation, her memory is intact, and she is able to walk normally. Her score on the St. Louis University Mental Status (SLUMS) exam is 25, which suggests normal cognitive functioning for her academic background. A CT scan of the head reveals a subacute stroke of the right posterior limb of the internal capsule consistent with recent TIA.

Ms. L is admitted for a routine stroke workup and prepares to undergo a CT angiogram (CTA) with the use of the iodinated agent iopamidol (100 mL, 76%) to evaluate patency of cerebral vessels. Her baseline blood urea nitrogen (BUN) and creatinine levels are within normal limits.

A day after undergoing CTA, Ms. L starts mumbling to herself, has unpredictable mood outbursts, and is not oriented to time, place, or person.

[polldaddy:10199351]

The authors’ observations

Due to her acute altered mental status (AMS), Ms. L underwent an emergent CT scan of the head to rule out any acute intracranial hemorrhages or thromboembolic events. The results of this test were negative. Urinalysis, BUN, creatinine, basic chemistry, and complete blood count panels were unrevealing. On a repeat SLUMS exam, Ms. L scored 9, indicating cognitive impairment.

Ms. L also underwent a comprehensive metabolic profile, which excluded any electrolyte abnormalities, or any hepatic or renal causes of AMS. There was no sign of dehydration, acidosis, hypoglycemia, hypoxemia, hypotension, or bradycardia/tachycardia. A urinalysis, chest X-ray, complete blood count, and 2 blood cultures conducted 24 hours apart did not reveal any signs of infection. There were no recent changes in her medications and she was not taking any sleep medications or other psychiatric medications that might precipitate a withdrawal syndrome.

There have been multiple reports of contrast-induced nephropathy (CIN), which may be evidenced by high BUN-to-creatinine ratios and could cause AMS in geriatric patients. However, CIN was ruled out as a potential cause in our patient because her BUN-to-creatinine was unremarkable.

Continue to: Routine EEG was clinically...

Routine EEG was clinically inconclusive. Diffusion-weighted MRI may have been helpful to identify ischemic strokes that a CT scan of the head might miss,¹ but we were unable to conduct this test because Ms. L had a pacemaker. Barber et al² suggested that in the setting of acute stroke, the use of MRI may not have an added advantage over the CT scan of the head.

[polldaddy:10199352]

TREATMENT Rapid improvement with supportive therapy

Intravenous fluids are administered as supportive therapy to Ms. L for suspected contrast-induced encephalopathy (CIE). The next day, Ms. L experiences a notable improvement in cognition, beyond that attributed to IV hydration. By 3 days post-contrast injection, her SLUMS score increases to 15. By 72 hours after contrast administration, Ms. L’s cognition returns to baseline. She is monitored for 24 hours after returning to baseline cognitive functioning. After observing her to be in no physical or medical distress and at baseline functioning, she is discharged home under the care of her son with outpatient follow-up and rehab services.

The authors’ observations

For Ms. L, the differential diagnosis included post-ictal phenomenon, new-onset ischemic or hemorrhagic changes, hyperperfusion syndrome, and CIE.

Seizures were ruled out because EEG was inconclusive, and Ms. L did not have the clinical features one would expect in an ictal episode. Transient ischemic attack is, by definition, an ischemic event with clinical return to baseline within 24 hours. Although a CT scan of the head may not be the most sensitive way to detect early ischemic changes and small ischemic zones, the self-limiting course and complete resolution of Ms. L’s symptoms with return to baseline is indicative of a more benign pathology, such as CIE. New hemorrhagic conversions have a dramatic presentation on radiologic studies. Historically, CIE presentations on imaging have been closely associated with the hyperattentuation seen in subarachnoid hemorrhage (SAH). The absence of typical radiologic and clinical findings in our case ruled out SAH.

Continue to: Typical CT scan findings in CIE include...

Typical CT scan findings in CIE include abnormal cortical contrast enhancement and edema, subarachnoid contrast enhancement, and striatal contrast enhancement (Figure 1, Figure 2, and Figure 3). Since the first clinical description, reports of 39 CT-/MRI-confirmed cases of CIE have been published in English language medical literature, with documented clinical follow-up³ and a median recovery time of 2.5 days. In a case report by Ito et al,⁴ there were no supportive radiographic findings. Ours is the second documented case that showed no radiologic signs of CIE. With a paucity of other etiologic evidence, negative lab tests for other causes of delirium, and the rapid resolution of Ms. L’s AMS after providing IV fluids as supportive treatment, a temporal correlation can be deduced, which implicates iodine-based contrast as the inciting factor.

Iodine-based contrast agents have been used since the 1920s. Today, >75 million procedures requiring iodine dyes are performed annually worldwide.⁵ This level of routine iodine contrast usage compels a mention of risk factors and complications from using such dyes. As a general rule, contrast agent reactions can be categorized as immediate (<1 day) or delayed (1 to 7 days after contrast administration). Immediate reactions are immunoglobulin E (IgE)-mediated anaphylactic reactions. Delayed reactions involve a T-cell mediated response that ranges from pruritus and urticaria (approximately 70%) to cardiac complications such as cardiovascular shock, arrhythmia, arrest, and Kounis syndrome. Other less prevalent complications include hypotension, bronchospasm, and CIN. Patients with the following factors may be at higher risk for contrast-induced reactions:

• asthma
• cardiac arrhythmias
• central myasthenia gravis
• >70 years of age
• pheochromocytoma
• sickle cell anemia
• hyperthyroidism
• dehydration
• hypotension.

Although some older literature reported correlations between seafood and shellfish allergies and iodine contrast reactions, more recent reports suggest there may not be a direct correlation, or any correlation at all.^5,6

Iodinated CIE is a rare complication of contrast angiography. It was first reported in 1970 as transient cortical blindness after coronary angiography.⁷ Clinical manifestations include encephalopathy evidenced by AMS, affected orientation, and acute psychotic changes, including paranoia and hallucinations, seizures, cortical blindness, and focal neurologic deficits. Neuroimaging has been pivotal in confirming the diagnosis and in excluding thromboembolic and hemorrhagic complications of angiography.⁸

Encephalopathy has been documented after administration of iopromide,^9,10iohexol,¹¹ioxilan,⁴ and metrizamide. The mechanism of neurotoxicity is unclear, but several theories have been formulated. The contrast agent may disturb the blood-brain barrier and enter the brain. This may be a primary mechanism leading to encephalopathy when the hypertonic contrast agent draws water out of the endothelial cells of brain capillaries, arterioles, and venules. This may cause the endothelial cells to shrink and to separate at tight junctions directly affecting the blood-brain barrier. Alternatively, the increase in intraluminal pressure caused by injection of the contrast agent, in concert with contrast agent-induced cerebral vasodilatation, might contribute to increasing vascular wall tension, further separating tight junctions. A third theory suggests that vesicular transport may be a mechanism of osmotic barrier opening. Further studies would be required to investigate these mechanisms.

Continue to: Regardless of the mechanism...

Regardless of the mechanism, all the above-mentioned studies note a reversal of radiologic and neurologic findings without any deficits within 48 to 72 hours (median recovery time of 2.5 days).³ All reported cases of CIE, including ours, were found to be completely reversible without any neurologic or radiologic deficits after resolution (48 to 72 hours post-contrast administration).

Clinicians should have a high index of suspicion for CIE in patients with recent iodine-based contrast exposure. From a practical standpoint, such a mechanism could be easily missed because while use of a single-administration contrast agent may appear in procedure notes or medication administration records, it might not necessarily appear in documentation of currently administered medications. Also, such cases might not always present with unique radiologic findings, as illustrated by Ms. L’s case.

Bottom Line

Have a high index of suspicion for contrast-induced encephalopathy, especially in geriatric patients, even in the absence of radiologic findings. A full delirium/dementia workup is warranted to rule out other life-threatening causes of altered mental status. Timely recognition could enable implementation of medicationsparing approaches to the disorder, such as IV fluids and frequent reorientation.

Related Resources

• Donepudi B, Trottier S. A seizure and hemiplegia following contrast exposure: Understanding contrast-induced encephalopathy. Case Rep Med. 2018;2018:9278526. doi:10.1155/2018/9278526.
• Hamra M, Bakhit Y, Khan M, et al. Case report and literature review on contrast-induced encephalopathy. Future Cardiol. 2017;13(4):331-335.

Drug Brand Names

Iohexol • Omnipaque
Iopamidol • Isovue-370
Iopromide • Ultravist
Ioxilan • Oxilan

CASE Altered mental status after stroke workup

Ms. L, age 91, is admitted to the hospital for a neurologic evaluation of a recent episode of left-sided weakness that occurred 1 week ago. This left-sided weakness resolved without intervention within 2 hours while at home. This presentation is typical of a transient ischemic attack (TIA). She has a history of hypertension, bradycardia, and pacemaker implantation. On initial evaluation, her memory is intact, and she is able to walk normally. Her score on the St. Louis University Mental Status (SLUMS) exam is 25, which suggests normal cognitive functioning for her academic background. A CT scan of the head reveals a subacute stroke of the right posterior limb of the internal capsule consistent with recent TIA.

Ms. L is admitted for a routine stroke workup and prepares to undergo a CT angiogram (CTA) with the use of the iodinated agent iopamidol (100 mL, 76%) to evaluate patency of cerebral vessels. Her baseline blood urea nitrogen (BUN) and creatinine levels are within normal limits.

A day after undergoing CTA, Ms. L starts mumbling to herself, has unpredictable mood outbursts, and is not oriented to time, place, or person.

[polldaddy:10199351]

The authors’ observations

Due to her acute altered mental status (AMS), Ms. L underwent an emergent CT scan of the head to rule out any acute intracranial hemorrhages or thromboembolic events. The results of this test were negative. Urinalysis, BUN, creatinine, basic chemistry, and complete blood count panels were unrevealing. On a repeat SLUMS exam, Ms. L scored 9, indicating cognitive impairment.

Ms. L also underwent a comprehensive metabolic profile, which excluded any electrolyte abnormalities, or any hepatic or renal causes of AMS. There was no sign of dehydration, acidosis, hypoglycemia, hypoxemia, hypotension, or bradycardia/tachycardia. A urinalysis, chest X-ray, complete blood count, and 2 blood cultures conducted 24 hours apart did not reveal any signs of infection. There were no recent changes in her medications and she was not taking any sleep medications or other psychiatric medications that might precipitate a withdrawal syndrome.

There have been multiple reports of contrast-induced nephropathy (CIN), which may be evidenced by high BUN-to-creatinine ratios and could cause AMS in geriatric patients. However, CIN was ruled out as a potential cause in our patient because her BUN-to-creatinine was unremarkable.

Continue to: Routine EEG was clinically...

Routine EEG was clinically inconclusive. Diffusion-weighted MRI may have been helpful to identify ischemic strokes that a CT scan of the head might miss,¹ but we were unable to conduct this test because Ms. L had a pacemaker. Barber et al² suggested that in the setting of acute stroke, the use of MRI may not have an added advantage over the CT scan of the head.

[polldaddy:10199352]

TREATMENT Rapid improvement with supportive therapy

Intravenous fluids are administered as supportive therapy to Ms. L for suspected contrast-induced encephalopathy (CIE). The next day, Ms. L experiences a notable improvement in cognition, beyond that attributed to IV hydration. By 3 days post-contrast injection, her SLUMS score increases to 15. By 72 hours after contrast administration, Ms. L’s cognition returns to baseline. She is monitored for 24 hours after returning to baseline cognitive functioning. After observing her to be in no physical or medical distress and at baseline functioning, she is discharged home under the care of her son with outpatient follow-up and rehab services.

The authors’ observations

For Ms. L, the differential diagnosis included post-ictal phenomenon, new-onset ischemic or hemorrhagic changes, hyperperfusion syndrome, and CIE.

Seizures were ruled out because EEG was inconclusive, and Ms. L did not have the clinical features one would expect in an ictal episode. Transient ischemic attack is, by definition, an ischemic event with clinical return to baseline within 24 hours. Although a CT scan of the head may not be the most sensitive way to detect early ischemic changes and small ischemic zones, the self-limiting course and complete resolution of Ms. L’s symptoms with return to baseline is indicative of a more benign pathology, such as CIE. New hemorrhagic conversions have a dramatic presentation on radiologic studies. Historically, CIE presentations on imaging have been closely associated with the hyperattentuation seen in subarachnoid hemorrhage (SAH). The absence of typical radiologic and clinical findings in our case ruled out SAH.

Continue to: Typical CT scan findings in CIE include...

Typical CT scan findings in CIE include abnormal cortical contrast enhancement and edema, subarachnoid contrast enhancement, and striatal contrast enhancement (Figure 1, Figure 2, and Figure 3). Since the first clinical description, reports of 39 CT-/MRI-confirmed cases of CIE have been published in English language medical literature, with documented clinical follow-up³ and a median recovery time of 2.5 days. In a case report by Ito et al,⁴ there were no supportive radiographic findings. Ours is the second documented case that showed no radiologic signs of CIE. With a paucity of other etiologic evidence, negative lab tests for other causes of delirium, and the rapid resolution of Ms. L’s AMS after providing IV fluids as supportive treatment, a temporal correlation can be deduced, which implicates iodine-based contrast as the inciting factor.

Iodine-based contrast agents have been used since the 1920s. Today, >75 million procedures requiring iodine dyes are performed annually worldwide.⁵ This level of routine iodine contrast usage compels a mention of risk factors and complications from using such dyes. As a general rule, contrast agent reactions can be categorized as immediate (<1 day) or delayed (1 to 7 days after contrast administration). Immediate reactions are immunoglobulin E (IgE)-mediated anaphylactic reactions. Delayed reactions involve a T-cell mediated response that ranges from pruritus and urticaria (approximately 70%) to cardiac complications such as cardiovascular shock, arrhythmia, arrest, and Kounis syndrome. Other less prevalent complications include hypotension, bronchospasm, and CIN. Patients with the following factors may be at higher risk for contrast-induced reactions:

• asthma
• cardiac arrhythmias
• central myasthenia gravis
• >70 years of age
• pheochromocytoma
• sickle cell anemia
• hyperthyroidism
• dehydration
• hypotension.

Although some older literature reported correlations between seafood and shellfish allergies and iodine contrast reactions, more recent reports suggest there may not be a direct correlation, or any correlation at all.^5,6

Iodinated CIE is a rare complication of contrast angiography. It was first reported in 1970 as transient cortical blindness after coronary angiography.⁷ Clinical manifestations include encephalopathy evidenced by AMS, affected orientation, and acute psychotic changes, including paranoia and hallucinations, seizures, cortical blindness, and focal neurologic deficits. Neuroimaging has been pivotal in confirming the diagnosis and in excluding thromboembolic and hemorrhagic complications of angiography.⁸

Encephalopathy has been documented after administration of iopromide,^9,10iohexol,¹¹ioxilan,⁴ and metrizamide. The mechanism of neurotoxicity is unclear, but several theories have been formulated. The contrast agent may disturb the blood-brain barrier and enter the brain. This may be a primary mechanism leading to encephalopathy when the hypertonic contrast agent draws water out of the endothelial cells of brain capillaries, arterioles, and venules. This may cause the endothelial cells to shrink and to separate at tight junctions directly affecting the blood-brain barrier. Alternatively, the increase in intraluminal pressure caused by injection of the contrast agent, in concert with contrast agent-induced cerebral vasodilatation, might contribute to increasing vascular wall tension, further separating tight junctions. A third theory suggests that vesicular transport may be a mechanism of osmotic barrier opening. Further studies would be required to investigate these mechanisms.

Continue to: Regardless of the mechanism...

Regardless of the mechanism, all the above-mentioned studies note a reversal of radiologic and neurologic findings without any deficits within 48 to 72 hours (median recovery time of 2.5 days).³ All reported cases of CIE, including ours, were found to be completely reversible without any neurologic or radiologic deficits after resolution (48 to 72 hours post-contrast administration).

Clinicians should have a high index of suspicion for CIE in patients with recent iodine-based contrast exposure. From a practical standpoint, such a mechanism could be easily missed because while use of a single-administration contrast agent may appear in procedure notes or medication administration records, it might not necessarily appear in documentation of currently administered medications. Also, such cases might not always present with unique radiologic findings, as illustrated by Ms. L’s case.

Bottom Line

Have a high index of suspicion for contrast-induced encephalopathy, especially in geriatric patients, even in the absence of radiologic findings. A full delirium/dementia workup is warranted to rule out other life-threatening causes of altered mental status. Timely recognition could enable implementation of medicationsparing approaches to the disorder, such as IV fluids and frequent reorientation.

Related Resources

• Donepudi B, Trottier S. A seizure and hemiplegia following contrast exposure: Understanding contrast-induced encephalopathy. Case Rep Med. 2018;2018:9278526. doi:10.1155/2018/9278526.
• Hamra M, Bakhit Y, Khan M, et al. Case report and literature review on contrast-induced encephalopathy. Future Cardiol. 2017;13(4):331-335.

Drug Brand Names

Iohexol • Omnipaque
Iopamidol • Isovue-370
Iopromide • Ultravist
Ioxilan • Oxilan

Death by drug overdose is the number one cause of death in Americans 50 years of age and younger.¹ In 2016, there were 63,632 drug overdose deaths in the United States² Opioids were involved in 42,249 of these deaths, which represents 66.4% of all drug overdose deaths.² From 2015 to 2016, the age-adjusted rate of overdose deaths increased significantly by 21.5% from 16.3 per 100,000 to 19.8 per 100,000.² This means that every day, more than 115 people in the United States die after overdosing on opioids. The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.

The gold standard treatment is medication-assisted treatment (MAT)—the use of FDA-approved medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach.³ When it comes to MAT options for opioid use disorder (OUD), there are 3 medications, each with its own caveats.

Methadone is an opioid mu-receptor full agonist that prevents withdrawal but does not block other narcotics. It requires daily dosing as a liquid formulation that is dispensed only in regulated clinics.

Buprenorphine is a mu-receptor high affinity partial agonist/antagonist that blocks the majority of other narcotics while reducing withdrawal risk. It requires daily dosing as either a dissolving tablet or cheek film. Recently it has also become available as a 6-month implant as well as a 1-month subcutaneous injection. Buprenorphine is also available as a combined medication with naloxone; naloxone is an opioid antagonist.

Naltrexone is a mu-receptor antagonist that blocks the effects of most narcotics. It does not lead to dependence, and is administered daily as a pill or monthly as a deep IM injection of its extended-release formulation.

The first 2 medications are tightly regulated options that are not available in many areas of the United States. Naltrexone, when provided as a daily pill, has adherence issues. As with any illness, lack of adherence to treatment is problematic; in the case of patients with OUD, this includes a high risk of overdose and death.

The use of injectable extended-release naltrexone (XR-NTX) may be a way to address nonadherence and thus prevent relapse. One of the challenges limiting naltrexone’s applicability has been the length of time required for an “opioid washout” of the mu receptors prior to administering naltrexone, which is a mu blocker. The washout can take as long as 7 to 10 days. This interval is not feasible for patients receiving inpatient treatment, and patients receiving treatment as outpatients are vulnerable to relapse during this time. Recently, there have been several attempts to shorten this gap through various experimental protocols based on incremental doses of NTX to facilitate withdrawal while managing symptoms.

Continue to: When selecting appropriate candidates for NTX treatment...

When selecting appropriate candidates for NTX treatment, clinicians should consider individuals who are:

• not interested in or able to receive agonist maintenance treatment (ie, patients who do not have access to an appropriate clinic in their area, or who are restricted to agonist treatment by probation/parole)
• highly abstinence-oriented (eg, active in a 12-step program)
• in professions where agonists are controversial (eg, healthcare and airlines)
• detoxified and abstinent but at risk for relapse.

Individuals who have failed agonist treatment (eg, who experience cravings for opioids and use opioids while receiving it, or are nonadherent or diverting/misusing the medication), who have a less severe form of OUD (short history and low level of use), or who use sporadically are also optimal candidates for NTX. Aside from the relapse-vulnerable washout gap prior to induction, one of the concerns with antagonist treatments is treatment retention; anecdotal clinical reports suggest that individuals often discontinue antagonists in favor of agonists.

Several studies have investigated this by comparing XR-NTX with buprenorphine-naloxone (BUP-NX). Here we summarize 3 studies^4-6 to describe which patients might be optimal candidates for XR-NTX, its success in comparison with BUP-NX, and challenges in induction of NTX, with a focus on emerging protocols (Table).

1. Tanum l, Solli KK, Latif ZH, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: a randomized clinical noninferiority trial. JAMA Psychiatry. 2017;74(12):1197-1205.

This study aimed to determine whether XR-NTX was not inferior to BUP-NX in the treatment of OUD.

Study design

• N = 159, multicenter, randomized, 12-week outpatient study in Norway
• After detoxification, participants were randomized to receive BUP-NX, 4 to 24 mg/d, or XR-NTX, 380 mg/month.

Continue to: Outcomes

Outcomes

• Comparable treatment retention between groups
• Comparable opioid-negative urine drug screens (UDS)
• Significantly lower opioid use in the XR-NTX group.

Conclusion

• XR-NTX was as effective as BUP-NX in maintaining short-term abstinence from heroin and other illicit opioids, and thus should be considered as a treatment option for opioid-dependent individuals.

While this study showed similar efficacy for XR-NTX and BUP-NX, it is important to note that the randomization occurred after patients were detoxified. As a full opioid antagonist, XR-NTX can precipitate severe withdrawal, so patients need to be completely detoxified before starting XR-NTX, in contrast to BUP-NX, which patients can start even while still in mild withdrawal. Additional studies are needed in which individuals are randomized before detoxification, which would make it possible to measure the success of induction.

2. Lee JD, Nunes, EV, Novo P, et al. Compar­ative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018;391(10118):309-318.

This study evaluated XR-NTX vs BUP-NX among adults with OUD who were actively using heroin at baseline and were admitted to community detoxification and treatment programs. Although the study began on inpatient units, it aimed to replicate usual community outpatient conditions across a 24-week outpatient treatment phase of this open-label, comparative effectiveness trial. Researchers assessed the effects on relapse-free survival, opioid use rates, and overdose events.

Study design

• N = 570, multicenter, randomized, 24-week study in the United States
• Detoxification methods: no opioids (clonidine or adjunctive medications), 3- to 5-day methadone taper, and 3- to 14-day BUP taper
• Protocol requirement: opioid-negative UDS before XR-NTX induction
• XR-NTX induction success ranged from 50% at a short-methadone-taper unit to 95% at an extended-opioid-free inpatient program. Nearly all induction failures quickly relapsed
• More participants inducted on BUP-NX group than XR-NTX group (94% vs 72%, respectively).

Continue to: Outcomes

Outcomes (once successfully inducted to treatment [n = 474])

• Comparable relapse events
• Comparable opioid-negative urine drug screens and opioid-abstinent days
• Opioid craving initially less with XR-NTX.

Conclusion

• It was more difficult to initiate patients on XR-NTX than BUP-NX, which negatively affected overall relapse rates. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.

Regarding induction on NTX, patients must be detoxified and opioid-free for at least 7 days. If this medication is given to patients who are physically dependent and/or have opioids in their system, NTX will displace opioids off the receptor and precipitate a severe withdrawal (rather than a slow and gradual spontaneous withdrawal).

Several studies have examined the severity of opioid withdrawal (using Self Opioid Withdrawal Scale scoring) of patients undergoing detoxification with symptomatic management (eg, clonidine, loperamide, etc.), agonist-managed (eg, with a BUP taper), and without any assistance. As expected, the latter yielded the highest scoring and most uncomfortable experiences. Using scores from the first 2 groups, a threshold of symptom tolerability was established where patients remained somewhat comfortable during the process. During detoxification from heroin, administering any dose of NTX during the first 48 to 72 hours after the last use placed patients in a withdrawal of a magnitude above the limit of tolerability. At 48 to 72 hours, however, a very low NTX dose (3 to 6 mg) was found to be well tolerated, and withdrawal symptoms were easily managed supportively to accelerate the detoxification process. Several studies have attempted to devise protocols based on these findings in order to facilitate rapid induction onto NTX. The following study offers encouragement:

Continue to: 3. Sullivan M, Bisaga A, Pavlicova M...

3. Sullivan M, Bisaga A, Pavlicova M, et al. Long-acting injectable naltrexone induction: a randomized trial of outpatient opioid detoxification with naltrexone versus buprenorphine. Am J Psychiatry. 2017;174:459-467.

Study design

• N = 150 adults with OUD, randomized to outpatient opioid detoxification
• Patients were randomized to BUP- or NTX-facilitated detoxification, followed by XR-NTX
• BUP detoxification group underwent a 7-day BUP taper followed by a opioid-free week
• NTX group received a 1-day BUP dose followed by 6 days of ascending doses of oral NTX, along with clonidine and other adjunctive medications.

Outcomes

• NTX-assisted detoxification was significantly more successful for XR-NTX induction (56.1% vs 32.7%).

Conclusion

• Compared with the BUP-assisted detoxification group, NTX-assisted detoxification appears to make it significantly more likely for patients to be successfully inducted to XR-NTX.

The evidence discussed here holds promise in addressing some of the major issues surrounding MAT. For suitable candidates, XR-NTX seems to be as efficacious an option as agonist (BUP) MAT, and its induction limitations could be overcome by using NTX-facilitated detoxification protocols.

Death by drug overdose is the number one cause of death in Americans 50 years of age and younger.¹ In 2016, there were 63,632 drug overdose deaths in the United States² Opioids were involved in 42,249 of these deaths, which represents 66.4% of all drug overdose deaths.² From 2015 to 2016, the age-adjusted rate of overdose deaths increased significantly by 21.5% from 16.3 per 100,000 to 19.8 per 100,000.² This means that every day, more than 115 people in the United States die after overdosing on opioids. The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.

The gold standard treatment is medication-assisted treatment (MAT)—the use of FDA-approved medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach.³ When it comes to MAT options for opioid use disorder (OUD), there are 3 medications, each with its own caveats.

Methadone is an opioid mu-receptor full agonist that prevents withdrawal but does not block other narcotics. It requires daily dosing as a liquid formulation that is dispensed only in regulated clinics.

Buprenorphine is a mu-receptor high affinity partial agonist/antagonist that blocks the majority of other narcotics while reducing withdrawal risk. It requires daily dosing as either a dissolving tablet or cheek film. Recently it has also become available as a 6-month implant as well as a 1-month subcutaneous injection. Buprenorphine is also available as a combined medication with naloxone; naloxone is an opioid antagonist.

Naltrexone is a mu-receptor antagonist that blocks the effects of most narcotics. It does not lead to dependence, and is administered daily as a pill or monthly as a deep IM injection of its extended-release formulation.

The first 2 medications are tightly regulated options that are not available in many areas of the United States. Naltrexone, when provided as a daily pill, has adherence issues. As with any illness, lack of adherence to treatment is problematic; in the case of patients with OUD, this includes a high risk of overdose and death.

The use of injectable extended-release naltrexone (XR-NTX) may be a way to address nonadherence and thus prevent relapse. One of the challenges limiting naltrexone’s applicability has been the length of time required for an “opioid washout” of the mu receptors prior to administering naltrexone, which is a mu blocker. The washout can take as long as 7 to 10 days. This interval is not feasible for patients receiving inpatient treatment, and patients receiving treatment as outpatients are vulnerable to relapse during this time. Recently, there have been several attempts to shorten this gap through various experimental protocols based on incremental doses of NTX to facilitate withdrawal while managing symptoms.

Continue to: When selecting appropriate candidates for NTX treatment...

When selecting appropriate candidates for NTX treatment, clinicians should consider individuals who are:

• not interested in or able to receive agonist maintenance treatment (ie, patients who do not have access to an appropriate clinic in their area, or who are restricted to agonist treatment by probation/parole)
• highly abstinence-oriented (eg, active in a 12-step program)
• in professions where agonists are controversial (eg, healthcare and airlines)
• detoxified and abstinent but at risk for relapse.

Individuals who have failed agonist treatment (eg, who experience cravings for opioids and use opioids while receiving it, or are nonadherent or diverting/misusing the medication), who have a less severe form of OUD (short history and low level of use), or who use sporadically are also optimal candidates for NTX. Aside from the relapse-vulnerable washout gap prior to induction, one of the concerns with antagonist treatments is treatment retention; anecdotal clinical reports suggest that individuals often discontinue antagonists in favor of agonists.

Several studies have investigated this by comparing XR-NTX with buprenorphine-naloxone (BUP-NX). Here we summarize 3 studies^4-6 to describe which patients might be optimal candidates for XR-NTX, its success in comparison with BUP-NX, and challenges in induction of NTX, with a focus on emerging protocols (Table).

1. Tanum l, Solli KK, Latif ZH, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: a randomized clinical noninferiority trial. JAMA Psychiatry. 2017;74(12):1197-1205.

This study aimed to determine whether XR-NTX was not inferior to BUP-NX in the treatment of OUD.

Study design

• N = 159, multicenter, randomized, 12-week outpatient study in Norway
• After detoxification, participants were randomized to receive BUP-NX, 4 to 24 mg/d, or XR-NTX, 380 mg/month.

Continue to: Outcomes

Outcomes

• Comparable treatment retention between groups
• Comparable opioid-negative urine drug screens (UDS)
• Significantly lower opioid use in the XR-NTX group.

Conclusion

• XR-NTX was as effective as BUP-NX in maintaining short-term abstinence from heroin and other illicit opioids, and thus should be considered as a treatment option for opioid-dependent individuals.

While this study showed similar efficacy for XR-NTX and BUP-NX, it is important to note that the randomization occurred after patients were detoxified. As a full opioid antagonist, XR-NTX can precipitate severe withdrawal, so patients need to be completely detoxified before starting XR-NTX, in contrast to BUP-NX, which patients can start even while still in mild withdrawal. Additional studies are needed in which individuals are randomized before detoxification, which would make it possible to measure the success of induction.

2. Lee JD, Nunes, EV, Novo P, et al. Compar­ative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018;391(10118):309-318.

This study evaluated XR-NTX vs BUP-NX among adults with OUD who were actively using heroin at baseline and were admitted to community detoxification and treatment programs. Although the study began on inpatient units, it aimed to replicate usual community outpatient conditions across a 24-week outpatient treatment phase of this open-label, comparative effectiveness trial. Researchers assessed the effects on relapse-free survival, opioid use rates, and overdose events.

Study design

• N = 570, multicenter, randomized, 24-week study in the United States
• Detoxification methods: no opioids (clonidine or adjunctive medications), 3- to 5-day methadone taper, and 3- to 14-day BUP taper
• Protocol requirement: opioid-negative UDS before XR-NTX induction
• XR-NTX induction success ranged from 50% at a short-methadone-taper unit to 95% at an extended-opioid-free inpatient program. Nearly all induction failures quickly relapsed
• More participants inducted on BUP-NX group than XR-NTX group (94% vs 72%, respectively).

Continue to: Outcomes

Outcomes (once successfully inducted to treatment [n = 474])

• Comparable relapse events
• Comparable opioid-negative urine drug screens and opioid-abstinent days
• Opioid craving initially less with XR-NTX.

Conclusion

• It was more difficult to initiate patients on XR-NTX than BUP-NX, which negatively affected overall relapse rates. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.

Regarding induction on NTX, patients must be detoxified and opioid-free for at least 7 days. If this medication is given to patients who are physically dependent and/or have opioids in their system, NTX will displace opioids off the receptor and precipitate a severe withdrawal (rather than a slow and gradual spontaneous withdrawal).

Several studies have examined the severity of opioid withdrawal (using Self Opioid Withdrawal Scale scoring) of patients undergoing detoxification with symptomatic management (eg, clonidine, loperamide, etc.), agonist-managed (eg, with a BUP taper), and without any assistance. As expected, the latter yielded the highest scoring and most uncomfortable experiences. Using scores from the first 2 groups, a threshold of symptom tolerability was established where patients remained somewhat comfortable during the process. During detoxification from heroin, administering any dose of NTX during the first 48 to 72 hours after the last use placed patients in a withdrawal of a magnitude above the limit of tolerability. At 48 to 72 hours, however, a very low NTX dose (3 to 6 mg) was found to be well tolerated, and withdrawal symptoms were easily managed supportively to accelerate the detoxification process. Several studies have attempted to devise protocols based on these findings in order to facilitate rapid induction onto NTX. The following study offers encouragement:

Continue to: 3. Sullivan M, Bisaga A, Pavlicova M...

3. Sullivan M, Bisaga A, Pavlicova M, et al. Long-acting injectable naltrexone induction: a randomized trial of outpatient opioid detoxification with naltrexone versus buprenorphine. Am J Psychiatry. 2017;174:459-467.

Study design

• N = 150 adults with OUD, randomized to outpatient opioid detoxification
• Patients were randomized to BUP- or NTX-facilitated detoxification, followed by XR-NTX
• BUP detoxification group underwent a 7-day BUP taper followed by a opioid-free week
• NTX group received a 1-day BUP dose followed by 6 days of ascending doses of oral NTX, along with clonidine and other adjunctive medications.

Outcomes

• NTX-assisted detoxification was significantly more successful for XR-NTX induction (56.1% vs 32.7%).

Conclusion

• Compared with the BUP-assisted detoxification group, NTX-assisted detoxification appears to make it significantly more likely for patients to be successfully inducted to XR-NTX.

The evidence discussed here holds promise in addressing some of the major issues surrounding MAT. For suitable candidates, XR-NTX seems to be as efficacious an option as agonist (BUP) MAT, and its induction limitations could be overcome by using NTX-facilitated detoxification protocols.

Death by drug overdose is the number one cause of death in Americans 50 years of age and younger.¹ In 2016, there were 63,632 drug overdose deaths in the United States² Opioids were involved in 42,249 of these deaths, which represents 66.4% of all drug overdose deaths.² From 2015 to 2016, the age-adjusted rate of overdose deaths increased significantly by 21.5% from 16.3 per 100,000 to 19.8 per 100,000.² This means that every day, more than 115 people in the United States die after overdosing on opioids. The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.

The gold standard treatment is medication-assisted treatment (MAT)—the use of FDA-approved medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach.³ When it comes to MAT options for opioid use disorder (OUD), there are 3 medications, each with its own caveats.

Methadone is an opioid mu-receptor full agonist that prevents withdrawal but does not block other narcotics. It requires daily dosing as a liquid formulation that is dispensed only in regulated clinics.

Buprenorphine is a mu-receptor high affinity partial agonist/antagonist that blocks the majority of other narcotics while reducing withdrawal risk. It requires daily dosing as either a dissolving tablet or cheek film. Recently it has also become available as a 6-month implant as well as a 1-month subcutaneous injection. Buprenorphine is also available as a combined medication with naloxone; naloxone is an opioid antagonist.

Naltrexone is a mu-receptor antagonist that blocks the effects of most narcotics. It does not lead to dependence, and is administered daily as a pill or monthly as a deep IM injection of its extended-release formulation.

The first 2 medications are tightly regulated options that are not available in many areas of the United States. Naltrexone, when provided as a daily pill, has adherence issues. As with any illness, lack of adherence to treatment is problematic; in the case of patients with OUD, this includes a high risk of overdose and death.

The use of injectable extended-release naltrexone (XR-NTX) may be a way to address nonadherence and thus prevent relapse. One of the challenges limiting naltrexone’s applicability has been the length of time required for an “opioid washout” of the mu receptors prior to administering naltrexone, which is a mu blocker. The washout can take as long as 7 to 10 days. This interval is not feasible for patients receiving inpatient treatment, and patients receiving treatment as outpatients are vulnerable to relapse during this time. Recently, there have been several attempts to shorten this gap through various experimental protocols based on incremental doses of NTX to facilitate withdrawal while managing symptoms.

Continue to: When selecting appropriate candidates for NTX treatment...

When selecting appropriate candidates for NTX treatment, clinicians should consider individuals who are:

• not interested in or able to receive agonist maintenance treatment (ie, patients who do not have access to an appropriate clinic in their area, or who are restricted to agonist treatment by probation/parole)
• highly abstinence-oriented (eg, active in a 12-step program)
• in professions where agonists are controversial (eg, healthcare and airlines)
• detoxified and abstinent but at risk for relapse.

Individuals who have failed agonist treatment (eg, who experience cravings for opioids and use opioids while receiving it, or are nonadherent or diverting/misusing the medication), who have a less severe form of OUD (short history and low level of use), or who use sporadically are also optimal candidates for NTX. Aside from the relapse-vulnerable washout gap prior to induction, one of the concerns with antagonist treatments is treatment retention; anecdotal clinical reports suggest that individuals often discontinue antagonists in favor of agonists.

Several studies have investigated this by comparing XR-NTX with buprenorphine-naloxone (BUP-NX). Here we summarize 3 studies^4-6 to describe which patients might be optimal candidates for XR-NTX, its success in comparison with BUP-NX, and challenges in induction of NTX, with a focus on emerging protocols (Table).

1. Tanum l, Solli KK, Latif ZH, et al. Effectiveness of injectable extended-release naltrexone vs daily buprenorphine-naloxone for opioid dependence: a randomized clinical noninferiority trial. JAMA Psychiatry. 2017;74(12):1197-1205.

This study aimed to determine whether XR-NTX was not inferior to BUP-NX in the treatment of OUD.

Study design

• N = 159, multicenter, randomized, 12-week outpatient study in Norway
• After detoxification, participants were randomized to receive BUP-NX, 4 to 24 mg/d, or XR-NTX, 380 mg/month.

Continue to: Outcomes

Outcomes

• Comparable treatment retention between groups
• Comparable opioid-negative urine drug screens (UDS)
• Significantly lower opioid use in the XR-NTX group.

Conclusion

• XR-NTX was as effective as BUP-NX in maintaining short-term abstinence from heroin and other illicit opioids, and thus should be considered as a treatment option for opioid-dependent individuals.

While this study showed similar efficacy for XR-NTX and BUP-NX, it is important to note that the randomization occurred after patients were detoxified. As a full opioid antagonist, XR-NTX can precipitate severe withdrawal, so patients need to be completely detoxified before starting XR-NTX, in contrast to BUP-NX, which patients can start even while still in mild withdrawal. Additional studies are needed in which individuals are randomized before detoxification, which would make it possible to measure the success of induction.

2. Lee JD, Nunes, EV, Novo P, et al. Compar­ative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018;391(10118):309-318.

This study evaluated XR-NTX vs BUP-NX among adults with OUD who were actively using heroin at baseline and were admitted to community detoxification and treatment programs. Although the study began on inpatient units, it aimed to replicate usual community outpatient conditions across a 24-week outpatient treatment phase of this open-label, comparative effectiveness trial. Researchers assessed the effects on relapse-free survival, opioid use rates, and overdose events.

Study design

• N = 570, multicenter, randomized, 24-week study in the United States
• Detoxification methods: no opioids (clonidine or adjunctive medications), 3- to 5-day methadone taper, and 3- to 14-day BUP taper
• Protocol requirement: opioid-negative UDS before XR-NTX induction
• XR-NTX induction success ranged from 50% at a short-methadone-taper unit to 95% at an extended-opioid-free inpatient program. Nearly all induction failures quickly relapsed
• More participants inducted on BUP-NX group than XR-NTX group (94% vs 72%, respectively).

Continue to: Outcomes

Outcomes (once successfully inducted to treatment [n = 474])

• Comparable relapse events
• Comparable opioid-negative urine drug screens and opioid-abstinent days
• Opioid craving initially less with XR-NTX.

Conclusion

• It was more difficult to initiate patients on XR-NTX than BUP-NX, which negatively affected overall relapse rates. However, once initiated, both medications were equally safe and effective. Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications.

Regarding induction on NTX, patients must be detoxified and opioid-free for at least 7 days. If this medication is given to patients who are physically dependent and/or have opioids in their system, NTX will displace opioids off the receptor and precipitate a severe withdrawal (rather than a slow and gradual spontaneous withdrawal).

Several studies have examined the severity of opioid withdrawal (using Self Opioid Withdrawal Scale scoring) of patients undergoing detoxification with symptomatic management (eg, clonidine, loperamide, etc.), agonist-managed (eg, with a BUP taper), and without any assistance. As expected, the latter yielded the highest scoring and most uncomfortable experiences. Using scores from the first 2 groups, a threshold of symptom tolerability was established where patients remained somewhat comfortable during the process. During detoxification from heroin, administering any dose of NTX during the first 48 to 72 hours after the last use placed patients in a withdrawal of a magnitude above the limit of tolerability. At 48 to 72 hours, however, a very low NTX dose (3 to 6 mg) was found to be well tolerated, and withdrawal symptoms were easily managed supportively to accelerate the detoxification process. Several studies have attempted to devise protocols based on these findings in order to facilitate rapid induction onto NTX. The following study offers encouragement:

Continue to: 3. Sullivan M, Bisaga A, Pavlicova M...

3. Sullivan M, Bisaga A, Pavlicova M, et al. Long-acting injectable naltrexone induction: a randomized trial of outpatient opioid detoxification with naltrexone versus buprenorphine. Am J Psychiatry. 2017;174:459-467.

Study design

• N = 150 adults with OUD, randomized to outpatient opioid detoxification
• Patients were randomized to BUP- or NTX-facilitated detoxification, followed by XR-NTX
• BUP detoxification group underwent a 7-day BUP taper followed by a opioid-free week
• NTX group received a 1-day BUP dose followed by 6 days of ascending doses of oral NTX, along with clonidine and other adjunctive medications.

Outcomes

• NTX-assisted detoxification was significantly more successful for XR-NTX induction (56.1% vs 32.7%).

Conclusion

• Compared with the BUP-assisted detoxification group, NTX-assisted detoxification appears to make it significantly more likely for patients to be successfully inducted to XR-NTX.

The evidence discussed here holds promise in addressing some of the major issues surrounding MAT. For suitable candidates, XR-NTX seems to be as efficacious an option as agonist (BUP) MAT, and its induction limitations could be overcome by using NTX-facilitated detoxification protocols.