John Nelson, MD, MHM

There are lots of places to learn methods to improve patient satisfaction, including my thoughts from the January 2009 issue. Run an Internet search on “improve patient satisfaction” to get a huge number of articles, many of which have useful information and inspiration.

If you’re in a high-functioning hospitalist group, you’ve already read a lot on the topic, listened to presentations by someone at your hospital and elsewhere, and reliably reported and analyzed satisfaction survey results including HCAHPS questions and others. Maybe you’ve even engaged a consultant to help.

You might already have in place a number of strategies, such as reliably providing a business card with your photo, always sitting down in the patient’s room, asking “Is there anything else I can do?” before ending your time with a patient, etc. You’re doing all these things and more, but perhaps you’ve barely moved the needle on your satisfaction scores.

Despite your efforts, I bet your hospitalist group’s aggregate score is among the lowest of any physician group at your hospital.

You’re not alone.

What can you do about this?

High-Value Strategy: Phoning Patients after Discharge

I’m lucky enough to practice with some of the smartest, most professional, and most personable hospitalists you could ever meet. Yet our satisfaction scores are among the lowest for physicians at our hospital. Despite all of the improvement strategies we put in place over the last few years, our scores have barely budged. But that all changed once we instituted a formal program of phoning patients after discharge. That produced the largest uptick in our scores we’ve ever seen.

I can’t guarantee that our results are generalizable. But I have all the anecdotal information I need to be willing to invest the resources to make the calls. They improve scores. Likely more than any other single strategy. And they seem to have a positive effect on all survey questions, from how well the doctor explained things (nearly always the lowest of the HCAHPS scores for hospitalists) to the patient’s opinion of the hospital food.

Though initially resistant to expending the time and energy to make the calls, most in our group have said that they regularly feel really gratified by the response they get from patients or families. I think it is much better if a hospitalist who cared for the patient makes the calls, and I suspect (I have no proof) that calls made by a nurse or clerk are much less effective at improving patient satisfaction. And the call can serve as a valuable clinical encounter to briefly troubleshoot a problem or review a test result that was pending at discharge.

Simple Strategies

• More than 80% of these calls should last less than three minutes. Most patients or family members will report things are going OK and thank you profusely for the call. “No doctor has ever called before,” many will say. “Can we get you the next time Mom is hospitalized?”
• You could reduce the number of calls needed if you limit them to patients eligible for a survey; this typically is only about half of a hospitalist’s patient census. For example, patients on observation status and those discharged somewhere other than to home (e.g. to a skilled-nursing facility) are not eligible for a survey.
• It’s usually best not to tell a patient or family to expect the call. Surprising them makes them more delighted when you do call, and a patient told to expect a call but doesn’t get one will be less satisfied than if never told to expect it. Best if no one at the hospital knows you’re making the calls, because someone might brag about you and tell the patient to expect the call.
• For patients seen by several hospitalists, decide ahead of time which doctor makes the call. The doctor who discharged the patient is probably the simplest protocol.
• Develop a system to track patients who have been discharged. Every morning, we get a printout of all patients discharged the prior day. We try to call all patients the day after discharge to ensure that we reach them before they’ve had a chance to complete a satisfaction survey and before the discharging doctor rotates off.
• Develop a protocol to document the calls. Calls that lead to any new advice or therapies (e.g. see your primary-care physician sooner than planned) must be documented in the medical record, e.g., by dictating an addendum to the discharge summary. Don’t let the system get too complicated or keep you from making the calls.
• Use your judgment about whether to call the patient or just call a family member directly; it’s often better to do the latter.
• If you reach a voicemail (about 50% of the calls I make), leave a message and don’t keep calling back to reach a person.

Sample Scripts

Here are some simple scripts to use for post-discharge calls. If you reach the patient or family member:

• “This is Dr. X from Superior Hospital. I was just thinking about you/your mother/your father and wanted to know how things have gone since you/she/he left the hospital.”
• Ask about something related to the reason for their stay. “How is your appetite?” or “You haven’t had any more fever, have you?” or “Have you made your appointment with Dr. PCP yet?”
• “I hope things go really well for you, but if you ever need the hospital again, we’d be happy to care for you at Superior Hospital.”

If you get a voicemail:

• “This is Dr. X from Superior Hospital. I’ve been thinking about you/your mother/father since you/she/he left the hospital, and I am calling just to check on how things are going.” (For HIPPA reasons, don’t use the patient’s name when leaving a voicemail.)
• Mention some medical concern specific to the patient, e.g., “Your culture test turned out OK and I hope you’ve been able to get the antibiotic I prescribed.”
• “You don’t need to call me back, but if you have questions or want to provide an update, I can be reached at 555-123-4567.” (It’s very important to include this last sentence and a number where you can be reached. If omitted, many patients/families will think you must have called to convey something really important and will be distressed until able to reach you.)

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course.

John Nelson, MD, MHM

There are lots of places to learn methods to improve patient satisfaction, including my thoughts from the January 2009 issue. Run an Internet search on “improve patient satisfaction” to get a huge number of articles, many of which have useful information and inspiration.

If you’re in a high-functioning hospitalist group, you’ve already read a lot on the topic, listened to presentations by someone at your hospital and elsewhere, and reliably reported and analyzed satisfaction survey results including HCAHPS questions and others. Maybe you’ve even engaged a consultant to help.

You might already have in place a number of strategies, such as reliably providing a business card with your photo, always sitting down in the patient’s room, asking “Is there anything else I can do?” before ending your time with a patient, etc. You’re doing all these things and more, but perhaps you’ve barely moved the needle on your satisfaction scores.

Despite your efforts, I bet your hospitalist group’s aggregate score is among the lowest of any physician group at your hospital.

You’re not alone.

What can you do about this?

High-Value Strategy: Phoning Patients after Discharge

I’m lucky enough to practice with some of the smartest, most professional, and most personable hospitalists you could ever meet. Yet our satisfaction scores are among the lowest for physicians at our hospital. Despite all of the improvement strategies we put in place over the last few years, our scores have barely budged. But that all changed once we instituted a formal program of phoning patients after discharge. That produced the largest uptick in our scores we’ve ever seen.

I can’t guarantee that our results are generalizable. But I have all the anecdotal information I need to be willing to invest the resources to make the calls. They improve scores. Likely more than any other single strategy. And they seem to have a positive effect on all survey questions, from how well the doctor explained things (nearly always the lowest of the HCAHPS scores for hospitalists) to the patient’s opinion of the hospital food.

Though initially resistant to expending the time and energy to make the calls, most in our group have said that they regularly feel really gratified by the response they get from patients or families. I think it is much better if a hospitalist who cared for the patient makes the calls, and I suspect (I have no proof) that calls made by a nurse or clerk are much less effective at improving patient satisfaction. And the call can serve as a valuable clinical encounter to briefly troubleshoot a problem or review a test result that was pending at discharge.

Simple Strategies

• More than 80% of these calls should last less than three minutes. Most patients or family members will report things are going OK and thank you profusely for the call. “No doctor has ever called before,” many will say. “Can we get you the next time Mom is hospitalized?”
• You could reduce the number of calls needed if you limit them to patients eligible for a survey; this typically is only about half of a hospitalist’s patient census. For example, patients on observation status and those discharged somewhere other than to home (e.g. to a skilled-nursing facility) are not eligible for a survey.
• It’s usually best not to tell a patient or family to expect the call. Surprising them makes them more delighted when you do call, and a patient told to expect a call but doesn’t get one will be less satisfied than if never told to expect it. Best if no one at the hospital knows you’re making the calls, because someone might brag about you and tell the patient to expect the call.
• For patients seen by several hospitalists, decide ahead of time which doctor makes the call. The doctor who discharged the patient is probably the simplest protocol.
• Develop a system to track patients who have been discharged. Every morning, we get a printout of all patients discharged the prior day. We try to call all patients the day after discharge to ensure that we reach them before they’ve had a chance to complete a satisfaction survey and before the discharging doctor rotates off.
• Develop a protocol to document the calls. Calls that lead to any new advice or therapies (e.g. see your primary-care physician sooner than planned) must be documented in the medical record, e.g., by dictating an addendum to the discharge summary. Don’t let the system get too complicated or keep you from making the calls.
• Use your judgment about whether to call the patient or just call a family member directly; it’s often better to do the latter.
• If you reach a voicemail (about 50% of the calls I make), leave a message and don’t keep calling back to reach a person.

Sample Scripts

Here are some simple scripts to use for post-discharge calls. If you reach the patient or family member:

• “This is Dr. X from Superior Hospital. I was just thinking about you/your mother/your father and wanted to know how things have gone since you/she/he left the hospital.”
• Ask about something related to the reason for their stay. “How is your appetite?” or “You haven’t had any more fever, have you?” or “Have you made your appointment with Dr. PCP yet?”
• “I hope things go really well for you, but if you ever need the hospital again, we’d be happy to care for you at Superior Hospital.”

If you get a voicemail:

• “This is Dr. X from Superior Hospital. I’ve been thinking about you/your mother/father since you/she/he left the hospital, and I am calling just to check on how things are going.” (For HIPPA reasons, don’t use the patient’s name when leaving a voicemail.)
• Mention some medical concern specific to the patient, e.g., “Your culture test turned out OK and I hope you’ve been able to get the antibiotic I prescribed.”
• “You don’t need to call me back, but if you have questions or want to provide an update, I can be reached at 555-123-4567.” (It’s very important to include this last sentence and a number where you can be reached. If omitted, many patients/families will think you must have called to convey something really important and will be distressed until able to reach you.)

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course.

John Nelson, MD, MHM

There are lots of places to learn methods to improve patient satisfaction, including my thoughts from the January 2009 issue. Run an Internet search on “improve patient satisfaction” to get a huge number of articles, many of which have useful information and inspiration.

If you’re in a high-functioning hospitalist group, you’ve already read a lot on the topic, listened to presentations by someone at your hospital and elsewhere, and reliably reported and analyzed satisfaction survey results including HCAHPS questions and others. Maybe you’ve even engaged a consultant to help.

You might already have in place a number of strategies, such as reliably providing a business card with your photo, always sitting down in the patient’s room, asking “Is there anything else I can do?” before ending your time with a patient, etc. You’re doing all these things and more, but perhaps you’ve barely moved the needle on your satisfaction scores.

Despite your efforts, I bet your hospitalist group’s aggregate score is among the lowest of any physician group at your hospital.

You’re not alone.

What can you do about this?

High-Value Strategy: Phoning Patients after Discharge

I’m lucky enough to practice with some of the smartest, most professional, and most personable hospitalists you could ever meet. Yet our satisfaction scores are among the lowest for physicians at our hospital. Despite all of the improvement strategies we put in place over the last few years, our scores have barely budged. But that all changed once we instituted a formal program of phoning patients after discharge. That produced the largest uptick in our scores we’ve ever seen.

I can’t guarantee that our results are generalizable. But I have all the anecdotal information I need to be willing to invest the resources to make the calls. They improve scores. Likely more than any other single strategy. And they seem to have a positive effect on all survey questions, from how well the doctor explained things (nearly always the lowest of the HCAHPS scores for hospitalists) to the patient’s opinion of the hospital food.

Though initially resistant to expending the time and energy to make the calls, most in our group have said that they regularly feel really gratified by the response they get from patients or families. I think it is much better if a hospitalist who cared for the patient makes the calls, and I suspect (I have no proof) that calls made by a nurse or clerk are much less effective at improving patient satisfaction. And the call can serve as a valuable clinical encounter to briefly troubleshoot a problem or review a test result that was pending at discharge.

Simple Strategies

• More than 80% of these calls should last less than three minutes. Most patients or family members will report things are going OK and thank you profusely for the call. “No doctor has ever called before,” many will say. “Can we get you the next time Mom is hospitalized?”
• You could reduce the number of calls needed if you limit them to patients eligible for a survey; this typically is only about half of a hospitalist’s patient census. For example, patients on observation status and those discharged somewhere other than to home (e.g. to a skilled-nursing facility) are not eligible for a survey.
• It’s usually best not to tell a patient or family to expect the call. Surprising them makes them more delighted when you do call, and a patient told to expect a call but doesn’t get one will be less satisfied than if never told to expect it. Best if no one at the hospital knows you’re making the calls, because someone might brag about you and tell the patient to expect the call.
• For patients seen by several hospitalists, decide ahead of time which doctor makes the call. The doctor who discharged the patient is probably the simplest protocol.
• Develop a system to track patients who have been discharged. Every morning, we get a printout of all patients discharged the prior day. We try to call all patients the day after discharge to ensure that we reach them before they’ve had a chance to complete a satisfaction survey and before the discharging doctor rotates off.
• Develop a protocol to document the calls. Calls that lead to any new advice or therapies (e.g. see your primary-care physician sooner than planned) must be documented in the medical record, e.g., by dictating an addendum to the discharge summary. Don’t let the system get too complicated or keep you from making the calls.
• Use your judgment about whether to call the patient or just call a family member directly; it’s often better to do the latter.
• If you reach a voicemail (about 50% of the calls I make), leave a message and don’t keep calling back to reach a person.

Sample Scripts

Here are some simple scripts to use for post-discharge calls. If you reach the patient or family member:

• “This is Dr. X from Superior Hospital. I was just thinking about you/your mother/your father and wanted to know how things have gone since you/she/he left the hospital.”
• Ask about something related to the reason for their stay. “How is your appetite?” or “You haven’t had any more fever, have you?” or “Have you made your appointment with Dr. PCP yet?”
• “I hope things go really well for you, but if you ever need the hospital again, we’d be happy to care for you at Superior Hospital.”

If you get a voicemail:

• “This is Dr. X from Superior Hospital. I’ve been thinking about you/your mother/father since you/she/he left the hospital, and I am calling just to check on how things are going.” (For HIPPA reasons, don’t use the patient’s name when leaving a voicemail.)
• Mention some medical concern specific to the patient, e.g., “Your culture test turned out OK and I hope you’ve been able to get the antibiotic I prescribed.”
• “You don’t need to call me back, but if you have questions or want to provide an update, I can be reached at 555-123-4567.” (It’s very important to include this last sentence and a number where you can be reached. If omitted, many patients/families will think you must have called to convey something really important and will be distressed until able to reach you.)

Dr. Nelson has been a practicing hospitalist since 1988. He is co-founder and past president of SHM, and principal in Nelson Flores Hospital Medicine Consultants. He is co-director for SHM’s “Best Practices in Managing a Hospital Medicine Program” course.

Dr. Hospitalist

One of our providers wants to use adult hospitalists for coverage of inpatient orthopedic surgery patients. Is this acceptable practice? Are there qualifiers?

—Libby Gardner

Dr. Hospitalist responds:

Let’s see how far we can tackle this open-ended question. There has been lots of discussion on the topic of comanagement in the past by people eminently more qualified than I am. Still, it never hurts to take a fresh look at things.

For one, on the subject of admissions, I am a firm believer that hospitalists should admit all adult hip fractures. The overwhelming majority of the time, these patients are elderly with comorbid conditions. Sure, they are going to get their hip fixed, because the alternative usually is unacceptable, but some thought needs to go into the process.

The orthopedic surgeon sees a hip that needs fixing and not much else. When such issues as renal failure, afib, congestive heart failure, prior DVT, dementia, and all the other common conditions are present, we as adult hospitalists should take charge of the case. That is the best way to ensure that the patient receives optimal medical care and the documentation that goes along with it. I love our orthopedic surgeons, but I don’t want them primarily admitting, managing, and discharging my elderly patients. Let the surgeon do what they do best—operate—and leave the rest to us as hospitalists.

On the subject of orthopedic trauma, I take the exact opposite approach—this is not something where we have daily expertise. A young, healthy patient with trauma should be admitted by the orthopedic service; that patient population’s complications are much more likely to be directly related to their trauma.

When it comes to elective surgery when the admitting surgeon (orthopedic or otherwise) wants the help of a hospitalist, then I think it is of paramount importance to establish clear “rules of engagement” (see “The Comanagement Conundrum,” April 2011, p. 1). I think with good expectations, you can have a fantastic relationship with your surgeons. Without them, it becomes a nightmare. As a real-life example, here are my HM group’s rules for elective orthopedic surgery:

• Orthopedics handles all pain medications and VTE prophylaxis, including discharge prescriptions;
• Medicine does the admission and medication reconciliation (“med rec”) at discharge;
• There is shared discussion on the need for transfusion; and
• There is shared discussion on the need for VTE prophylaxis when a patient already is on chronic anticoagulation.

We do not vary from this protocol. I never adjust a patient’s pain medications—even the floor nurses know this. Because I’m doing the admit and med rec, it also means that the patient doesn’t have their HCTZ continued after 600cc of EBL and spinal anesthesia. It works because the rules are clear and the communication is consistent.

This does not mean that we cover the orthopedic service at night; they are equally responsible for their patients under the items outlined above. In my view—and this might sound simplistic—the surgeon caused the post-op pain, so they should be responsible for managing it. With regard to VTE prophylaxis, I might take a more nuanced view, but for our surgeons, they own the wound and the post-op follow-up, so they get the choice on what agent to use.

Would I accept an arrangement in which I covered all the orthopedic issues out of regular hours? Nope—not when they have primary responsibility for the case; they should always be directly available to the nurse. I think that anything else would be a system ripe for abuse.

Our exact rules will not work for every situation, but I would strongly encourage the two basic tenets from above: No. 1, the hospitalist should primarily admit and manage elderly hip fractures, and No. 2, there should be clear rules of engagement with your orthopedic or surgery group. It’s a discussion worth having during daylight hours, because trying to figure out the rules at 3 in the morning rarely ends well.

Dr. Hospitalist

One of our providers wants to use adult hospitalists for coverage of inpatient orthopedic surgery patients. Is this acceptable practice? Are there qualifiers?

—Libby Gardner

Dr. Hospitalist responds:

Let’s see how far we can tackle this open-ended question. There has been lots of discussion on the topic of comanagement in the past by people eminently more qualified than I am. Still, it never hurts to take a fresh look at things.

For one, on the subject of admissions, I am a firm believer that hospitalists should admit all adult hip fractures. The overwhelming majority of the time, these patients are elderly with comorbid conditions. Sure, they are going to get their hip fixed, because the alternative usually is unacceptable, but some thought needs to go into the process.

The orthopedic surgeon sees a hip that needs fixing and not much else. When such issues as renal failure, afib, congestive heart failure, prior DVT, dementia, and all the other common conditions are present, we as adult hospitalists should take charge of the case. That is the best way to ensure that the patient receives optimal medical care and the documentation that goes along with it. I love our orthopedic surgeons, but I don’t want them primarily admitting, managing, and discharging my elderly patients. Let the surgeon do what they do best—operate—and leave the rest to us as hospitalists.

On the subject of orthopedic trauma, I take the exact opposite approach—this is not something where we have daily expertise. A young, healthy patient with trauma should be admitted by the orthopedic service; that patient population’s complications are much more likely to be directly related to their trauma.

When it comes to elective surgery when the admitting surgeon (orthopedic or otherwise) wants the help of a hospitalist, then I think it is of paramount importance to establish clear “rules of engagement” (see “The Comanagement Conundrum,” April 2011, p. 1). I think with good expectations, you can have a fantastic relationship with your surgeons. Without them, it becomes a nightmare. As a real-life example, here are my HM group’s rules for elective orthopedic surgery:

• Orthopedics handles all pain medications and VTE prophylaxis, including discharge prescriptions;
• Medicine does the admission and medication reconciliation (“med rec”) at discharge;
• There is shared discussion on the need for transfusion; and
• There is shared discussion on the need for VTE prophylaxis when a patient already is on chronic anticoagulation.

We do not vary from this protocol. I never adjust a patient’s pain medications—even the floor nurses know this. Because I’m doing the admit and med rec, it also means that the patient doesn’t have their HCTZ continued after 600cc of EBL and spinal anesthesia. It works because the rules are clear and the communication is consistent.

This does not mean that we cover the orthopedic service at night; they are equally responsible for their patients under the items outlined above. In my view—and this might sound simplistic—the surgeon caused the post-op pain, so they should be responsible for managing it. With regard to VTE prophylaxis, I might take a more nuanced view, but for our surgeons, they own the wound and the post-op follow-up, so they get the choice on what agent to use.

Would I accept an arrangement in which I covered all the orthopedic issues out of regular hours? Nope—not when they have primary responsibility for the case; they should always be directly available to the nurse. I think that anything else would be a system ripe for abuse.

Our exact rules will not work for every situation, but I would strongly encourage the two basic tenets from above: No. 1, the hospitalist should primarily admit and manage elderly hip fractures, and No. 2, there should be clear rules of engagement with your orthopedic or surgery group. It’s a discussion worth having during daylight hours, because trying to figure out the rules at 3 in the morning rarely ends well.

Dr. Hospitalist

One of our providers wants to use adult hospitalists for coverage of inpatient orthopedic surgery patients. Is this acceptable practice? Are there qualifiers?

—Libby Gardner

Dr. Hospitalist responds:

Let’s see how far we can tackle this open-ended question. There has been lots of discussion on the topic of comanagement in the past by people eminently more qualified than I am. Still, it never hurts to take a fresh look at things.

For one, on the subject of admissions, I am a firm believer that hospitalists should admit all adult hip fractures. The overwhelming majority of the time, these patients are elderly with comorbid conditions. Sure, they are going to get their hip fixed, because the alternative usually is unacceptable, but some thought needs to go into the process.

The orthopedic surgeon sees a hip that needs fixing and not much else. When such issues as renal failure, afib, congestive heart failure, prior DVT, dementia, and all the other common conditions are present, we as adult hospitalists should take charge of the case. That is the best way to ensure that the patient receives optimal medical care and the documentation that goes along with it. I love our orthopedic surgeons, but I don’t want them primarily admitting, managing, and discharging my elderly patients. Let the surgeon do what they do best—operate—and leave the rest to us as hospitalists.

On the subject of orthopedic trauma, I take the exact opposite approach—this is not something where we have daily expertise. A young, healthy patient with trauma should be admitted by the orthopedic service; that patient population’s complications are much more likely to be directly related to their trauma.

When it comes to elective surgery when the admitting surgeon (orthopedic or otherwise) wants the help of a hospitalist, then I think it is of paramount importance to establish clear “rules of engagement” (see “The Comanagement Conundrum,” April 2011, p. 1). I think with good expectations, you can have a fantastic relationship with your surgeons. Without them, it becomes a nightmare. As a real-life example, here are my HM group’s rules for elective orthopedic surgery:

• Orthopedics handles all pain medications and VTE prophylaxis, including discharge prescriptions;
• Medicine does the admission and medication reconciliation (“med rec”) at discharge;
• There is shared discussion on the need for transfusion; and
• There is shared discussion on the need for VTE prophylaxis when a patient already is on chronic anticoagulation.

We do not vary from this protocol. I never adjust a patient’s pain medications—even the floor nurses know this. Because I’m doing the admit and med rec, it also means that the patient doesn’t have their HCTZ continued after 600cc of EBL and spinal anesthesia. It works because the rules are clear and the communication is consistent.

This does not mean that we cover the orthopedic service at night; they are equally responsible for their patients under the items outlined above. In my view—and this might sound simplistic—the surgeon caused the post-op pain, so they should be responsible for managing it. With regard to VTE prophylaxis, I might take a more nuanced view, but for our surgeons, they own the wound and the post-op follow-up, so they get the choice on what agent to use.

Would I accept an arrangement in which I covered all the orthopedic issues out of regular hours? Nope—not when they have primary responsibility for the case; they should always be directly available to the nurse. I think that anything else would be a system ripe for abuse.

Our exact rules will not work for every situation, but I would strongly encourage the two basic tenets from above: No. 1, the hospitalist should primarily admit and manage elderly hip fractures, and No. 2, there should be clear rules of engagement with your orthopedic or surgery group. It’s a discussion worth having during daylight hours, because trying to figure out the rules at 3 in the morning rarely ends well.

By any measure, Pediatric Hospital Medicine 2012 was a smashing success. More than 600 attendees descended upon Cincinnati and the Northern Kentucky Convention Center for the seventh annual conference, co-sponsored by the Academic Pediatric Association (APA), the American Academy of Pediatrics (AAP), and SHM. That represents an increase of more than 30% over the previous attendance record, set last year; similar milestones were achieved by the nearly 300 first-time attendees and more than 100 trainees that were present.

Highlights included a keynote speech from HM pioneer Bob Wachter, MD, MHM, professor and chief of the division of hospital medicine, chief of the medical service at the University of California San Francisco Medical Center, and chair of the American Board of Internal Medicine. Dr. Wachter reviewed both the evolution of the field as well as the current and future state of the specialty. Well-attended plenary sessions illustrated the breadth and depth of interests of pediatric hospitalists, as Samir Shah, MD, and Kenneth B. Roberts, MD, reviewed recently published guidelines for community-acquired pneumonia and urinary tract guidelines, respectively, and Joseph Gilhooly, MD, chair of the Pediatric Residency Review Committee, discussed the future of residency education.

Woven throughout the three-and-a-half-day conference were facilitated discussions about the future of the field, specifically the issue of certification. The Strategic Planning Committee (STP), co-chaired by Suzanne Swanson Mendez, MD, and Christopher Maloney, MD, provided attendees with a broad range of perspectives on numerous future options for subspecialty certification or the status quo. Through an audience response system, the most popular option appeared to be a two-year fellowship.

The presidents of all three sponsor groups—APA’s David Jaffe, MD, AAP’s Robert Block, MD, and SHM’s Shaun Frost, MD, SFHM—commented on the remarkable growth of the field and reviewed the “value adds” of each of the societies for its members. One clear takeaway was the value that each of these societies places in its members and the important role of pediatric hospitalists in the future.

Workshops and breakout sessions commanded a significant amount of interest with a record number of tracks and sessions. Attendees flocked to the always popular “Clinical Conundrums,” as well as focused-topic sessions on Mycoplasma pneumoniae, birth-acquired herpes (HSV), and apparent life-threatening events (ALTE). Innovative, hands-on workshops involved technology, whether through bedside ultrasound, tablets, or medical equipment for children with medical complexities. The practice-management track provided attendees with eminently useful workshops on negotiation and work-life balance.

While the quality-improvement (QI), research, and education tracks covered foundational curricula similar to that of previous years, a refreshing array of young and enthusiastic speakers demonstrated the field’s commitment to growth and development.

Always a showcase for the latest and breaking developments, the panoply of research platforms, from plenaries to breakouts to poster sessions, convincingly demonstrated the clear evolution of a specialized body of knowledge in pediatric HM. A new and immensely popular “Clinical Conundrums” poster session further showcased the evolving extent of clinical expertise in the field.

Breakout lunches furthered the development of collaborative efforts within the specialty, as large numbers of attendees charted the future of pediatric hospitalists in medical education, celebrated the growth and standardization of fellowship programs (with a website!), and coordinated activities within the Pediatric Research in Inpatient Settings (PRIS) and Value in Inpatient Pediatrics (VIP) networks.

Conference program co-chairs Tamara Simon, MD, and Jeff Simmons, MD, received accolades and applause for all of the milestone achievements this year. As the field looks to build upon this success, it will come as no surprise that next year’s conference will convene in New Orleans, The Big Easy—an appropriate moniker for a group that has made rapid progress appear natural.

Dr. Shen is pediatric editor of The Hospitalist.

By any measure, Pediatric Hospital Medicine 2012 was a smashing success. More than 600 attendees descended upon Cincinnati and the Northern Kentucky Convention Center for the seventh annual conference, co-sponsored by the Academic Pediatric Association (APA), the American Academy of Pediatrics (AAP), and SHM. That represents an increase of more than 30% over the previous attendance record, set last year; similar milestones were achieved by the nearly 300 first-time attendees and more than 100 trainees that were present.

Highlights included a keynote speech from HM pioneer Bob Wachter, MD, MHM, professor and chief of the division of hospital medicine, chief of the medical service at the University of California San Francisco Medical Center, and chair of the American Board of Internal Medicine. Dr. Wachter reviewed both the evolution of the field as well as the current and future state of the specialty. Well-attended plenary sessions illustrated the breadth and depth of interests of pediatric hospitalists, as Samir Shah, MD, and Kenneth B. Roberts, MD, reviewed recently published guidelines for community-acquired pneumonia and urinary tract guidelines, respectively, and Joseph Gilhooly, MD, chair of the Pediatric Residency Review Committee, discussed the future of residency education.

Woven throughout the three-and-a-half-day conference were facilitated discussions about the future of the field, specifically the issue of certification. The Strategic Planning Committee (STP), co-chaired by Suzanne Swanson Mendez, MD, and Christopher Maloney, MD, provided attendees with a broad range of perspectives on numerous future options for subspecialty certification or the status quo. Through an audience response system, the most popular option appeared to be a two-year fellowship.

The presidents of all three sponsor groups—APA’s David Jaffe, MD, AAP’s Robert Block, MD, and SHM’s Shaun Frost, MD, SFHM—commented on the remarkable growth of the field and reviewed the “value adds” of each of the societies for its members. One clear takeaway was the value that each of these societies places in its members and the important role of pediatric hospitalists in the future.

Workshops and breakout sessions commanded a significant amount of interest with a record number of tracks and sessions. Attendees flocked to the always popular “Clinical Conundrums,” as well as focused-topic sessions on Mycoplasma pneumoniae, birth-acquired herpes (HSV), and apparent life-threatening events (ALTE). Innovative, hands-on workshops involved technology, whether through bedside ultrasound, tablets, or medical equipment for children with medical complexities. The practice-management track provided attendees with eminently useful workshops on negotiation and work-life balance.

While the quality-improvement (QI), research, and education tracks covered foundational curricula similar to that of previous years, a refreshing array of young and enthusiastic speakers demonstrated the field’s commitment to growth and development.

Always a showcase for the latest and breaking developments, the panoply of research platforms, from plenaries to breakouts to poster sessions, convincingly demonstrated the clear evolution of a specialized body of knowledge in pediatric HM. A new and immensely popular “Clinical Conundrums” poster session further showcased the evolving extent of clinical expertise in the field.

Breakout lunches furthered the development of collaborative efforts within the specialty, as large numbers of attendees charted the future of pediatric hospitalists in medical education, celebrated the growth and standardization of fellowship programs (with a website!), and coordinated activities within the Pediatric Research in Inpatient Settings (PRIS) and Value in Inpatient Pediatrics (VIP) networks.

Conference program co-chairs Tamara Simon, MD, and Jeff Simmons, MD, received accolades and applause for all of the milestone achievements this year. As the field looks to build upon this success, it will come as no surprise that next year’s conference will convene in New Orleans, The Big Easy—an appropriate moniker for a group that has made rapid progress appear natural.

Dr. Shen is pediatric editor of The Hospitalist.

By any measure, Pediatric Hospital Medicine 2012 was a smashing success. More than 600 attendees descended upon Cincinnati and the Northern Kentucky Convention Center for the seventh annual conference, co-sponsored by the Academic Pediatric Association (APA), the American Academy of Pediatrics (AAP), and SHM. That represents an increase of more than 30% over the previous attendance record, set last year; similar milestones were achieved by the nearly 300 first-time attendees and more than 100 trainees that were present.

Highlights included a keynote speech from HM pioneer Bob Wachter, MD, MHM, professor and chief of the division of hospital medicine, chief of the medical service at the University of California San Francisco Medical Center, and chair of the American Board of Internal Medicine. Dr. Wachter reviewed both the evolution of the field as well as the current and future state of the specialty. Well-attended plenary sessions illustrated the breadth and depth of interests of pediatric hospitalists, as Samir Shah, MD, and Kenneth B. Roberts, MD, reviewed recently published guidelines for community-acquired pneumonia and urinary tract guidelines, respectively, and Joseph Gilhooly, MD, chair of the Pediatric Residency Review Committee, discussed the future of residency education.

Woven throughout the three-and-a-half-day conference were facilitated discussions about the future of the field, specifically the issue of certification. The Strategic Planning Committee (STP), co-chaired by Suzanne Swanson Mendez, MD, and Christopher Maloney, MD, provided attendees with a broad range of perspectives on numerous future options for subspecialty certification or the status quo. Through an audience response system, the most popular option appeared to be a two-year fellowship.

The presidents of all three sponsor groups—APA’s David Jaffe, MD, AAP’s Robert Block, MD, and SHM’s Shaun Frost, MD, SFHM—commented on the remarkable growth of the field and reviewed the “value adds” of each of the societies for its members. One clear takeaway was the value that each of these societies places in its members and the important role of pediatric hospitalists in the future.

Workshops and breakout sessions commanded a significant amount of interest with a record number of tracks and sessions. Attendees flocked to the always popular “Clinical Conundrums,” as well as focused-topic sessions on Mycoplasma pneumoniae, birth-acquired herpes (HSV), and apparent life-threatening events (ALTE). Innovative, hands-on workshops involved technology, whether through bedside ultrasound, tablets, or medical equipment for children with medical complexities. The practice-management track provided attendees with eminently useful workshops on negotiation and work-life balance.

While the quality-improvement (QI), research, and education tracks covered foundational curricula similar to that of previous years, a refreshing array of young and enthusiastic speakers demonstrated the field’s commitment to growth and development.

Always a showcase for the latest and breaking developments, the panoply of research platforms, from plenaries to breakouts to poster sessions, convincingly demonstrated the clear evolution of a specialized body of knowledge in pediatric HM. A new and immensely popular “Clinical Conundrums” poster session further showcased the evolving extent of clinical expertise in the field.

Breakout lunches furthered the development of collaborative efforts within the specialty, as large numbers of attendees charted the future of pediatric hospitalists in medical education, celebrated the growth and standardization of fellowship programs (with a website!), and coordinated activities within the Pediatric Research in Inpatient Settings (PRIS) and Value in Inpatient Pediatrics (VIP) networks.

Conference program co-chairs Tamara Simon, MD, and Jeff Simmons, MD, received accolades and applause for all of the milestone achievements this year. As the field looks to build upon this success, it will come as no surprise that next year’s conference will convene in New Orleans, The Big Easy—an appropriate moniker for a group that has made rapid progress appear natural.

Dr. Shen is pediatric editor of The Hospitalist.

Dr. Pinson:

Thank you for your inquiry to my June column, which outlined physician reporting of ICD-9-CM diagnoses. Confusion arises because there are two mechanisms for reporting facility-based claims: the professional (physician) bill and the facility bill. ICD-9-CM has been adopted under HIPAA for all healthcare settings. Several components of the ICD-9-CM manual offer instructions on its use. “How to Use the ICD-9-CM for Physicians (Volumes 1&2)” identifies “10 Steps to Correct Coding.”^2,3 Step 1 explicitly denotes the inability to use “rule out,” “suspected,” “probable,” or “questionable” diagnoses, and applies to all professional claims submitted on CMS1500 or electronic equivalent.³

The “ICD-9-CM Official Guidelines for Coding and Reporting” are a set of rules developed to accompany and complement the official conventions and instructions provided within ICD-9-CM and approved by the four organizations that make up the Cooperating Parties for the ICD-9-CM: the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), the Centers for Medicare & Medicaid Services (CMS), and NCHS. These guidelines are included on the official government version of the ICD-9-CM, and also appear in “Coding Clinic for ICD-9-CM” published by the AHA.³

While Section I of these guidelines applies to all locations, Sections II and III refer to the selection of the principal diagnosis (the condition established after study to be chiefly responsible for the admission) reported by facilities for DRG payment on CMS1450 or its electronic equivalent.² Since DRG payment is based on the average resources used to treat inpatients, it is allowable to code a properly documented, “uncertain” condition as if it existed or was established. It does not apply to the outpatient setting. Outpatient, facility-based (Section IV) claims follow the same standards as professional claims, which should not list any diagnosis documented as “probable,” “suspected,” “questionable,” “rule out” or “working diagnosis,” or other similar terms indicating uncertainty.

Carol Pohlig, BSN, RN, CPC, ACS, is a contributing writer to The Hospitalist.

References

1. Hart AC, Stegman MS, Ford B, eds. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page vi.
2. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 23, Section 10A. Centers for Medicare and Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf. Accessed July 24, 2012.
3. Hart AC, Stegman MS, Ford B. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page 1.

Dr. Pinson:

Thank you for your inquiry to my June column, which outlined physician reporting of ICD-9-CM diagnoses. Confusion arises because there are two mechanisms for reporting facility-based claims: the professional (physician) bill and the facility bill. ICD-9-CM has been adopted under HIPAA for all healthcare settings. Several components of the ICD-9-CM manual offer instructions on its use. “How to Use the ICD-9-CM for Physicians (Volumes 1&2)” identifies “10 Steps to Correct Coding.”^2,3 Step 1 explicitly denotes the inability to use “rule out,” “suspected,” “probable,” or “questionable” diagnoses, and applies to all professional claims submitted on CMS1500 or electronic equivalent.³

The “ICD-9-CM Official Guidelines for Coding and Reporting” are a set of rules developed to accompany and complement the official conventions and instructions provided within ICD-9-CM and approved by the four organizations that make up the Cooperating Parties for the ICD-9-CM: the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), the Centers for Medicare & Medicaid Services (CMS), and NCHS. These guidelines are included on the official government version of the ICD-9-CM, and also appear in “Coding Clinic for ICD-9-CM” published by the AHA.³

While Section I of these guidelines applies to all locations, Sections II and III refer to the selection of the principal diagnosis (the condition established after study to be chiefly responsible for the admission) reported by facilities for DRG payment on CMS1450 or its electronic equivalent.² Since DRG payment is based on the average resources used to treat inpatients, it is allowable to code a properly documented, “uncertain” condition as if it existed or was established. It does not apply to the outpatient setting. Outpatient, facility-based (Section IV) claims follow the same standards as professional claims, which should not list any diagnosis documented as “probable,” “suspected,” “questionable,” “rule out” or “working diagnosis,” or other similar terms indicating uncertainty.

Carol Pohlig, BSN, RN, CPC, ACS, is a contributing writer to The Hospitalist.

References

1. Hart AC, Stegman MS, Ford B, eds. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page vi.
2. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 23, Section 10A. Centers for Medicare and Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf. Accessed July 24, 2012.
3. Hart AC, Stegman MS, Ford B. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page 1.

Dr. Pinson:

Thank you for your inquiry to my June column, which outlined physician reporting of ICD-9-CM diagnoses. Confusion arises because there are two mechanisms for reporting facility-based claims: the professional (physician) bill and the facility bill. ICD-9-CM has been adopted under HIPAA for all healthcare settings. Several components of the ICD-9-CM manual offer instructions on its use. “How to Use the ICD-9-CM for Physicians (Volumes 1&2)” identifies “10 Steps to Correct Coding.”^2,3 Step 1 explicitly denotes the inability to use “rule out,” “suspected,” “probable,” or “questionable” diagnoses, and applies to all professional claims submitted on CMS1500 or electronic equivalent.³

The “ICD-9-CM Official Guidelines for Coding and Reporting” are a set of rules developed to accompany and complement the official conventions and instructions provided within ICD-9-CM and approved by the four organizations that make up the Cooperating Parties for the ICD-9-CM: the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), the Centers for Medicare & Medicaid Services (CMS), and NCHS. These guidelines are included on the official government version of the ICD-9-CM, and also appear in “Coding Clinic for ICD-9-CM” published by the AHA.³

While Section I of these guidelines applies to all locations, Sections II and III refer to the selection of the principal diagnosis (the condition established after study to be chiefly responsible for the admission) reported by facilities for DRG payment on CMS1450 or its electronic equivalent.² Since DRG payment is based on the average resources used to treat inpatients, it is allowable to code a properly documented, “uncertain” condition as if it existed or was established. It does not apply to the outpatient setting. Outpatient, facility-based (Section IV) claims follow the same standards as professional claims, which should not list any diagnosis documented as “probable,” “suspected,” “questionable,” “rule out” or “working diagnosis,” or other similar terms indicating uncertainty.

Carol Pohlig, BSN, RN, CPC, ACS, is a contributing writer to The Hospitalist.

References

1. Hart AC, Stegman MS, Ford B, eds. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page vi.
2. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 23, Section 10A. Centers for Medicare and Medicaid Services website. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf. Accessed July 24, 2012.
3. Hart AC, Stegman MS, Ford B. ICD-9-CM for Physicians Volumes 1 & 2 2012 Expert Edition. OptimumInsight; 2011. Page 1.

Your June 2012 article “Medical Necessity” (p. 22) is extremely interesting and helpful. However, I would very much like to know the official, authoritative, or regulatory source or guidance of the following:

“Physicians never should report a code that represents a probable, suspected, or ‘rule out’ condition. Although facility billing might consider these unconfirmed circumstances (when necessary), physician billing prohibits this practice.”

The “ICD-9-CM Official Guidelines for Coding and Reporting Sections II.H and III.C” state:¹

Uncertain Diagnosis

If the diagnosis documented at the time of discharge is qualified as “probable,” “suspected,” “likely,” “questionable,” “possible,” or “still to be ruled out,” or other similar terms indicating uncertainty, code the condition as if it existed or was established. The bases for these guidelines are the diagnostic workup, arrangements for further workup or observation, and initial therapeutic approach that correspond most closely with the established diagnosis. (Note: This guideline is applicable only to inpatient admissions to short-term, acute-care, long-term care, and psychiatric hospitals.)

In contrast, Section IV.I, regarding outpatient services, states:

Uncertain Diagnosis

Do not code diagnoses documented as “probable,” “suspected,” “questionable,” “rule out,” or “working diagnosis,” or other similar terms indicating uncertainty. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as symptoms, signs, abnormal test results, or other reason for the visit. (Please note that this differs from the coding practices used by short-term, acute-care, long-term care, and psychiatric hospitals.)

I believe that all physicians’ claims for professional services in any setting must use ICD-9-CM for diagnosis coding and must follow these official coding guidelines. The guidelines state:

“Adherence to these guidelines when assigning ICD-9-CM diagnosis and procedure codes is required under the Health Insurance Portability and Accountability Act (HIPAA). The diagnosis codes (Volumes 1-2) have been adopted under HIPAA for all healthcare settings. Volume 3 procedure codes have been adopted for inpatient procedures reported by hospitals.”

There doesn’t appear to be any distinction in these guidelines between physician and facility diagnostic coding, and hospitalists (as well as other admitting physicians) are managing “inpatient admissions,” unless they are working in observation care, which is considered “outpatient” by Medicare. The reference in Sections II.H and III.C to “at the time of discharge” sounds problematic for physician claims for daily inpatient services unless the claim is not submitted until after discharge, at which time it can be determined whether the condition(s) is still qualified as “uncertain.”

Nothing in the guidelines seems to prohibit hospitalists (or other admitting physicians) from assigning “uncertain” diagnoses on claims for inpatient services (in contrast to observation and other outpatient services). If there is any other authoritative regulatory guidance that clarifies or supersedes the official guidelines, I would certainly like to see it.

Thanks so much for helping me with this difficult and confusing billing situation.

Richard D. Pinson, MD, FACP, Chattanooga, Tenn.

Your June 2012 article “Medical Necessity” (p. 22) is extremely interesting and helpful. However, I would very much like to know the official, authoritative, or regulatory source or guidance of the following:

“Physicians never should report a code that represents a probable, suspected, or ‘rule out’ condition. Although facility billing might consider these unconfirmed circumstances (when necessary), physician billing prohibits this practice.”

The “ICD-9-CM Official Guidelines for Coding and Reporting Sections II.H and III.C” state:¹

Uncertain Diagnosis

If the diagnosis documented at the time of discharge is qualified as “probable,” “suspected,” “likely,” “questionable,” “possible,” or “still to be ruled out,” or other similar terms indicating uncertainty, code the condition as if it existed or was established. The bases for these guidelines are the diagnostic workup, arrangements for further workup or observation, and initial therapeutic approach that correspond most closely with the established diagnosis. (Note: This guideline is applicable only to inpatient admissions to short-term, acute-care, long-term care, and psychiatric hospitals.)

In contrast, Section IV.I, regarding outpatient services, states:

Uncertain Diagnosis

Do not code diagnoses documented as “probable,” “suspected,” “questionable,” “rule out,” or “working diagnosis,” or other similar terms indicating uncertainty. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as symptoms, signs, abnormal test results, or other reason for the visit. (Please note that this differs from the coding practices used by short-term, acute-care, long-term care, and psychiatric hospitals.)

I believe that all physicians’ claims for professional services in any setting must use ICD-9-CM for diagnosis coding and must follow these official coding guidelines. The guidelines state:

“Adherence to these guidelines when assigning ICD-9-CM diagnosis and procedure codes is required under the Health Insurance Portability and Accountability Act (HIPAA). The diagnosis codes (Volumes 1-2) have been adopted under HIPAA for all healthcare settings. Volume 3 procedure codes have been adopted for inpatient procedures reported by hospitals.”

There doesn’t appear to be any distinction in these guidelines between physician and facility diagnostic coding, and hospitalists (as well as other admitting physicians) are managing “inpatient admissions,” unless they are working in observation care, which is considered “outpatient” by Medicare. The reference in Sections II.H and III.C to “at the time of discharge” sounds problematic for physician claims for daily inpatient services unless the claim is not submitted until after discharge, at which time it can be determined whether the condition(s) is still qualified as “uncertain.”

Nothing in the guidelines seems to prohibit hospitalists (or other admitting physicians) from assigning “uncertain” diagnoses on claims for inpatient services (in contrast to observation and other outpatient services). If there is any other authoritative regulatory guidance that clarifies or supersedes the official guidelines, I would certainly like to see it.

Thanks so much for helping me with this difficult and confusing billing situation.

Richard D. Pinson, MD, FACP, Chattanooga, Tenn.

Your June 2012 article “Medical Necessity” (p. 22) is extremely interesting and helpful. However, I would very much like to know the official, authoritative, or regulatory source or guidance of the following:

“Physicians never should report a code that represents a probable, suspected, or ‘rule out’ condition. Although facility billing might consider these unconfirmed circumstances (when necessary), physician billing prohibits this practice.”

The “ICD-9-CM Official Guidelines for Coding and Reporting Sections II.H and III.C” state:¹

Uncertain Diagnosis

If the diagnosis documented at the time of discharge is qualified as “probable,” “suspected,” “likely,” “questionable,” “possible,” or “still to be ruled out,” or other similar terms indicating uncertainty, code the condition as if it existed or was established. The bases for these guidelines are the diagnostic workup, arrangements for further workup or observation, and initial therapeutic approach that correspond most closely with the established diagnosis. (Note: This guideline is applicable only to inpatient admissions to short-term, acute-care, long-term care, and psychiatric hospitals.)

In contrast, Section IV.I, regarding outpatient services, states:

Uncertain Diagnosis

Do not code diagnoses documented as “probable,” “suspected,” “questionable,” “rule out,” or “working diagnosis,” or other similar terms indicating uncertainty. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as symptoms, signs, abnormal test results, or other reason for the visit. (Please note that this differs from the coding practices used by short-term, acute-care, long-term care, and psychiatric hospitals.)

I believe that all physicians’ claims for professional services in any setting must use ICD-9-CM for diagnosis coding and must follow these official coding guidelines. The guidelines state:

“Adherence to these guidelines when assigning ICD-9-CM diagnosis and procedure codes is required under the Health Insurance Portability and Accountability Act (HIPAA). The diagnosis codes (Volumes 1-2) have been adopted under HIPAA for all healthcare settings. Volume 3 procedure codes have been adopted for inpatient procedures reported by hospitals.”

There doesn’t appear to be any distinction in these guidelines between physician and facility diagnostic coding, and hospitalists (as well as other admitting physicians) are managing “inpatient admissions,” unless they are working in observation care, which is considered “outpatient” by Medicare. The reference in Sections II.H and III.C to “at the time of discharge” sounds problematic for physician claims for daily inpatient services unless the claim is not submitted until after discharge, at which time it can be determined whether the condition(s) is still qualified as “uncertain.”

Nothing in the guidelines seems to prohibit hospitalists (or other admitting physicians) from assigning “uncertain” diagnoses on claims for inpatient services (in contrast to observation and other outpatient services). If there is any other authoritative regulatory guidance that clarifies or supersedes the official guidelines, I would certainly like to see it.

Thanks so much for helping me with this difficult and confusing billing situation.

Richard D. Pinson, MD, FACP, Chattanooga, Tenn.

Laura Vento, MSN, RN, first took an interest in the teach-back process when her father had a liver transplant. Following a prolonged hospitalization, Vento’s dad was sent home with little understanding of how to take care of himself; most notably, he had no wound-care education. And when she reviewed his medications, Vento found serious discrepancies with his anti-rejection drug prescriptions.

Her mind was filled with questions: “What kind of transition of care was this? How well am I as a nurse preparing my patients for discharge?” says Vento, a clinical nurse leader on an acute-care medical unit at the University of California at San Diego (UCSD) Medical Center. “I have since learned that shocking numbers of [hospitalized] patients receive little or no education about how to care for themselves.”

About the same time as her dad’s recovery, Vento’s nurse manager heard about SHM’s Project BOOST. They applied for a grant to support training hospital staff in the teach-back system, an integral Project BOOST strategy for educating patients about their post-discharge care needs.

At UCSD, teach-back was incorporated into a larger process of improving care transitions and preventing avoidable readmissions. In addition to the new communication techniques, the process also includes risk assessment, post-discharge follow-up phone calls, and other strategies, supported by a hospitalwide, multidisciplinary education council.

Following a four-hour teach-back curriculum presented to nursing staff, “we did role modeling and role plays,” Vento says. “We followed up with a teach-back coach, me, going to patients’ bedsides with the nurses, because the workshop content alone was not enough without the patient interaction. We needed to verify the nurses’ competency.”

From its initial piloting on two units, teach-back is being hard-wired into UCSD’s electronic health record, with guides to ask for five basic teach-back checks: reason for admission, self-care needs, when to call a physician or 9ll, scheduled follow-up appointments, and changes to the medication list. The education council is now rolling out teach-back to nurses across the system. For her efforts in disseminating the strategy the past two years, Vento was named the UCSD health system’s Nurse of the Year for 2011.

And yet, despite this systemwide recognition, “the focus up to this point has mostly been on the nurses, who are responsible for the bulk of patient education,” says UCSD hospitalist and Project BOOST mentor Jennifer Quartarolo, MD, SFHM. “It’s probably been underutilized by other members of the care team.”

Despite competing demands on physicians’ time, Dr. Quartarolo says hospitalists need to improve their patient education skills. “Teach-back can help us effectively communicate the key teaching points that we’d like our hospitalized patients and their caregivers to take home with them,” she says.

Laura Vento, MSN, RN, first took an interest in the teach-back process when her father had a liver transplant. Following a prolonged hospitalization, Vento’s dad was sent home with little understanding of how to take care of himself; most notably, he had no wound-care education. And when she reviewed his medications, Vento found serious discrepancies with his anti-rejection drug prescriptions.

Her mind was filled with questions: “What kind of transition of care was this? How well am I as a nurse preparing my patients for discharge?” says Vento, a clinical nurse leader on an acute-care medical unit at the University of California at San Diego (UCSD) Medical Center. “I have since learned that shocking numbers of [hospitalized] patients receive little or no education about how to care for themselves.”

About the same time as her dad’s recovery, Vento’s nurse manager heard about SHM’s Project BOOST. They applied for a grant to support training hospital staff in the teach-back system, an integral Project BOOST strategy for educating patients about their post-discharge care needs.

At UCSD, teach-back was incorporated into a larger process of improving care transitions and preventing avoidable readmissions. In addition to the new communication techniques, the process also includes risk assessment, post-discharge follow-up phone calls, and other strategies, supported by a hospitalwide, multidisciplinary education council.

Following a four-hour teach-back curriculum presented to nursing staff, “we did role modeling and role plays,” Vento says. “We followed up with a teach-back coach, me, going to patients’ bedsides with the nurses, because the workshop content alone was not enough without the patient interaction. We needed to verify the nurses’ competency.”

From its initial piloting on two units, teach-back is being hard-wired into UCSD’s electronic health record, with guides to ask for five basic teach-back checks: reason for admission, self-care needs, when to call a physician or 9ll, scheduled follow-up appointments, and changes to the medication list. The education council is now rolling out teach-back to nurses across the system. For her efforts in disseminating the strategy the past two years, Vento was named the UCSD health system’s Nurse of the Year for 2011.

And yet, despite this systemwide recognition, “the focus up to this point has mostly been on the nurses, who are responsible for the bulk of patient education,” says UCSD hospitalist and Project BOOST mentor Jennifer Quartarolo, MD, SFHM. “It’s probably been underutilized by other members of the care team.”

Despite competing demands on physicians’ time, Dr. Quartarolo says hospitalists need to improve their patient education skills. “Teach-back can help us effectively communicate the key teaching points that we’d like our hospitalized patients and their caregivers to take home with them,” she says.

Laura Vento, MSN, RN, first took an interest in the teach-back process when her father had a liver transplant. Following a prolonged hospitalization, Vento’s dad was sent home with little understanding of how to take care of himself; most notably, he had no wound-care education. And when she reviewed his medications, Vento found serious discrepancies with his anti-rejection drug prescriptions.

Her mind was filled with questions: “What kind of transition of care was this? How well am I as a nurse preparing my patients for discharge?” says Vento, a clinical nurse leader on an acute-care medical unit at the University of California at San Diego (UCSD) Medical Center. “I have since learned that shocking numbers of [hospitalized] patients receive little or no education about how to care for themselves.”

About the same time as her dad’s recovery, Vento’s nurse manager heard about SHM’s Project BOOST. They applied for a grant to support training hospital staff in the teach-back system, an integral Project BOOST strategy for educating patients about their post-discharge care needs.

At UCSD, teach-back was incorporated into a larger process of improving care transitions and preventing avoidable readmissions. In addition to the new communication techniques, the process also includes risk assessment, post-discharge follow-up phone calls, and other strategies, supported by a hospitalwide, multidisciplinary education council.

Following a four-hour teach-back curriculum presented to nursing staff, “we did role modeling and role plays,” Vento says. “We followed up with a teach-back coach, me, going to patients’ bedsides with the nurses, because the workshop content alone was not enough without the patient interaction. We needed to verify the nurses’ competency.”

From its initial piloting on two units, teach-back is being hard-wired into UCSD’s electronic health record, with guides to ask for five basic teach-back checks: reason for admission, self-care needs, when to call a physician or 9ll, scheduled follow-up appointments, and changes to the medication list. The education council is now rolling out teach-back to nurses across the system. For her efforts in disseminating the strategy the past two years, Vento was named the UCSD health system’s Nurse of the Year for 2011.

And yet, despite this systemwide recognition, “the focus up to this point has mostly been on the nurses, who are responsible for the bulk of patient education,” says UCSD hospitalist and Project BOOST mentor Jennifer Quartarolo, MD, SFHM. “It’s probably been underutilized by other members of the care team.”

Despite competing demands on physicians’ time, Dr. Quartarolo says hospitalists need to improve their patient education skills. “Teach-back can help us effectively communicate the key teaching points that we’d like our hospitalized patients and their caregivers to take home with them,” she says.

Most medical decisions come down to weighing risks and benefits, and trying to ensure that the balance falls to the good.

About 18 months ago, the diminutive medical and surgical niche that’s fetal surgery (fewer than 1,000 U.S. fetal surgical procedures are done annually) came out with the blockbuster finding that fetal surgery to repair myelomeningoceles and blunt the complications of spina bifida was relatively safe and produced substantial benefits, compared with more conventional treatments that affected infants and children undergo when treatment starts after birth.

Courtesy Wikimedia Commons/http://www.visi.com/~reuteler/leonardo.html/United States Public Domain

To help ensure an adequate number of cases in MOMS (Management of Myelomeningocele Study) to produce a meaningful result in a reasonable amount of time, the couple of dozen or so U.S. medical centers that offer fetal surgery agreed to limit fetal-myelomeningocele repair to three U.S. locations: the Children’s Hospital of Philadelphia (CHOP); Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn.; and the University of California, San Francisco (UCSF). Even when all U.S. cases were funneled into these three sites during 8 years, the study enrolled all of 183 cases. The landmark 2011 report on outcomes in MOMS 1 year following birth had data on the first 158 cases (78 fetuses that underwent in utero myelomeningocele repair and 80 control pregnancies for which interventions occurred after birth).

The fetal-myelomeningocele repair world quickly began to change once the New England Journal paper came out in March 2011. The surgery was no longer investigational, and other U.S. centers could get into the act, if they wanted, and if they dared.

During the nearly 18 months since then, about five new programs jumped into the myelomeningocele-repair pool. That number is a little uncertain because no one keeps "official" tabs on who does the surgery, nor is there any official tally of how many fetal repairs are done, or their results. What is clear is that in the 18 months since the MOMS report, roughly 100 fetal myelomeningocele repairs were done in the United States, more than during 8 years of MOMS from February 2003 through the end of 2010.

And, at least as of now, no information is on record for how those 100 or so most recent cases have fared, including the outcomes from the new programs. That’s largely because it takes at least a year following delivery of a repaired fetus to have outcome results with follow-up similar to MOMS, and if you do the math, that means the outcomes from even the first post-MOMS cases are just now trickling in.

The risk-benefit balance at work here is this: Can new centers offer fetal myelomeningocele repairs – an understandably challenging technical undertaking – to boost access to mothers and their affected fetuses, while at the same time ensuring that their outcomes are at least as good as what happened in MOMS? It’s a question that’s not yet been answered.

It’s also a question that so troubled officials at the Eunice Kennedy Shriver National Institute of Child Health and Human Development – the U.S. agency that funded MOMS – that soon after the MOMS result came out, the institute took the unusual step of organizing a panel of experts to come up with guidelines on what a program should have in place if it wanted to venture into the fetal-myelomeningocele repair business. Those recommendations are still in process and are expected out before the end of this year. A preview was offered in June by some UCSF clinicians, but I’ve been told that their summary of the pending guidelines is not completely up to date.

The wider-access issue is very real. I spoke about it with Dr. Foong-Yen Lim, surgical director of the fetal care center at Cincinnati Children’s Hospital, one of the newbie programs that began offering this fetal surgery post MOMS, and that as of mid-August had done 10 cases. Having fetal-myelomeningocele repair available at more U.S. sites is important because during MOMS, when only three sites were available, he knew of cases in which the parents of affected fetuses opted not to go out of town for fetal repair because they could not afford it or could not deal with the relocation. Of course, some patients also might have not wanted to commit to being part a study knowing that once in, they had a 50-50 chance of randomization to standard care.

Dr. Lim told me how deeply he felt the responsibility he and his associates took on when they decided to start offering fetal-myelomeningocele repair and thereby boost access for affected families in the Cincinnati area. "People who take on this procedure need to ask themselves ‘Are we doing as good a job as the other places?’ " he said. He also told me that Cincinnati Children’s counselors make it clear to prospective families that if they prefer, they could travel to CHOP, Vanderbilt, or UCSF, the U.S. sites with the most experience and best-documented track records.

It’s all a balance of risk and benefit.

–Mitchel L. Zoler (on Twitter @mitchelzoler)

Most medical decisions come down to weighing risks and benefits, and trying to ensure that the balance falls to the good.

About 18 months ago, the diminutive medical and surgical niche that’s fetal surgery (fewer than 1,000 U.S. fetal surgical procedures are done annually) came out with the blockbuster finding that fetal surgery to repair myelomeningoceles and blunt the complications of spina bifida was relatively safe and produced substantial benefits, compared with more conventional treatments that affected infants and children undergo when treatment starts after birth.

Courtesy Wikimedia Commons/http://www.visi.com/~reuteler/leonardo.html/United States Public Domain

To help ensure an adequate number of cases in MOMS (Management of Myelomeningocele Study) to produce a meaningful result in a reasonable amount of time, the couple of dozen or so U.S. medical centers that offer fetal surgery agreed to limit fetal-myelomeningocele repair to three U.S. locations: the Children’s Hospital of Philadelphia (CHOP); Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn.; and the University of California, San Francisco (UCSF). Even when all U.S. cases were funneled into these three sites during 8 years, the study enrolled all of 183 cases. The landmark 2011 report on outcomes in MOMS 1 year following birth had data on the first 158 cases (78 fetuses that underwent in utero myelomeningocele repair and 80 control pregnancies for which interventions occurred after birth).

The fetal-myelomeningocele repair world quickly began to change once the New England Journal paper came out in March 2011. The surgery was no longer investigational, and other U.S. centers could get into the act, if they wanted, and if they dared.

During the nearly 18 months since then, about five new programs jumped into the myelomeningocele-repair pool. That number is a little uncertain because no one keeps "official" tabs on who does the surgery, nor is there any official tally of how many fetal repairs are done, or their results. What is clear is that in the 18 months since the MOMS report, roughly 100 fetal myelomeningocele repairs were done in the United States, more than during 8 years of MOMS from February 2003 through the end of 2010.

And, at least as of now, no information is on record for how those 100 or so most recent cases have fared, including the outcomes from the new programs. That’s largely because it takes at least a year following delivery of a repaired fetus to have outcome results with follow-up similar to MOMS, and if you do the math, that means the outcomes from even the first post-MOMS cases are just now trickling in.

The risk-benefit balance at work here is this: Can new centers offer fetal myelomeningocele repairs – an understandably challenging technical undertaking – to boost access to mothers and their affected fetuses, while at the same time ensuring that their outcomes are at least as good as what happened in MOMS? It’s a question that’s not yet been answered.

It’s also a question that so troubled officials at the Eunice Kennedy Shriver National Institute of Child Health and Human Development – the U.S. agency that funded MOMS – that soon after the MOMS result came out, the institute took the unusual step of organizing a panel of experts to come up with guidelines on what a program should have in place if it wanted to venture into the fetal-myelomeningocele repair business. Those recommendations are still in process and are expected out before the end of this year. A preview was offered in June by some UCSF clinicians, but I’ve been told that their summary of the pending guidelines is not completely up to date.

The wider-access issue is very real. I spoke about it with Dr. Foong-Yen Lim, surgical director of the fetal care center at Cincinnati Children’s Hospital, one of the newbie programs that began offering this fetal surgery post MOMS, and that as of mid-August had done 10 cases. Having fetal-myelomeningocele repair available at more U.S. sites is important because during MOMS, when only three sites were available, he knew of cases in which the parents of affected fetuses opted not to go out of town for fetal repair because they could not afford it or could not deal with the relocation. Of course, some patients also might have not wanted to commit to being part a study knowing that once in, they had a 50-50 chance of randomization to standard care.

Dr. Lim told me how deeply he felt the responsibility he and his associates took on when they decided to start offering fetal-myelomeningocele repair and thereby boost access for affected families in the Cincinnati area. "People who take on this procedure need to ask themselves ‘Are we doing as good a job as the other places?’ " he said. He also told me that Cincinnati Children’s counselors make it clear to prospective families that if they prefer, they could travel to CHOP, Vanderbilt, or UCSF, the U.S. sites with the most experience and best-documented track records.

It’s all a balance of risk and benefit.

–Mitchel L. Zoler (on Twitter @mitchelzoler)

Most medical decisions come down to weighing risks and benefits, and trying to ensure that the balance falls to the good.

About 18 months ago, the diminutive medical and surgical niche that’s fetal surgery (fewer than 1,000 U.S. fetal surgical procedures are done annually) came out with the blockbuster finding that fetal surgery to repair myelomeningoceles and blunt the complications of spina bifida was relatively safe and produced substantial benefits, compared with more conventional treatments that affected infants and children undergo when treatment starts after birth.

Courtesy Wikimedia Commons/http://www.visi.com/~reuteler/leonardo.html/United States Public Domain

To help ensure an adequate number of cases in MOMS (Management of Myelomeningocele Study) to produce a meaningful result in a reasonable amount of time, the couple of dozen or so U.S. medical centers that offer fetal surgery agreed to limit fetal-myelomeningocele repair to three U.S. locations: the Children’s Hospital of Philadelphia (CHOP); Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn.; and the University of California, San Francisco (UCSF). Even when all U.S. cases were funneled into these three sites during 8 years, the study enrolled all of 183 cases. The landmark 2011 report on outcomes in MOMS 1 year following birth had data on the first 158 cases (78 fetuses that underwent in utero myelomeningocele repair and 80 control pregnancies for which interventions occurred after birth).

The fetal-myelomeningocele repair world quickly began to change once the New England Journal paper came out in March 2011. The surgery was no longer investigational, and other U.S. centers could get into the act, if they wanted, and if they dared.

During the nearly 18 months since then, about five new programs jumped into the myelomeningocele-repair pool. That number is a little uncertain because no one keeps "official" tabs on who does the surgery, nor is there any official tally of how many fetal repairs are done, or their results. What is clear is that in the 18 months since the MOMS report, roughly 100 fetal myelomeningocele repairs were done in the United States, more than during 8 years of MOMS from February 2003 through the end of 2010.

And, at least as of now, no information is on record for how those 100 or so most recent cases have fared, including the outcomes from the new programs. That’s largely because it takes at least a year following delivery of a repaired fetus to have outcome results with follow-up similar to MOMS, and if you do the math, that means the outcomes from even the first post-MOMS cases are just now trickling in.

The risk-benefit balance at work here is this: Can new centers offer fetal myelomeningocele repairs – an understandably challenging technical undertaking – to boost access to mothers and their affected fetuses, while at the same time ensuring that their outcomes are at least as good as what happened in MOMS? It’s a question that’s not yet been answered.

It’s also a question that so troubled officials at the Eunice Kennedy Shriver National Institute of Child Health and Human Development – the U.S. agency that funded MOMS – that soon after the MOMS result came out, the institute took the unusual step of organizing a panel of experts to come up with guidelines on what a program should have in place if it wanted to venture into the fetal-myelomeningocele repair business. Those recommendations are still in process and are expected out before the end of this year. A preview was offered in June by some UCSF clinicians, but I’ve been told that their summary of the pending guidelines is not completely up to date.

The wider-access issue is very real. I spoke about it with Dr. Foong-Yen Lim, surgical director of the fetal care center at Cincinnati Children’s Hospital, one of the newbie programs that began offering this fetal surgery post MOMS, and that as of mid-August had done 10 cases. Having fetal-myelomeningocele repair available at more U.S. sites is important because during MOMS, when only three sites were available, he knew of cases in which the parents of affected fetuses opted not to go out of town for fetal repair because they could not afford it or could not deal with the relocation. Of course, some patients also might have not wanted to commit to being part a study knowing that once in, they had a 50-50 chance of randomization to standard care.

Dr. Lim told me how deeply he felt the responsibility he and his associates took on when they decided to start offering fetal-myelomeningocele repair and thereby boost access for affected families in the Cincinnati area. "People who take on this procedure need to ask themselves ‘Are we doing as good a job as the other places?’ " he said. He also told me that Cincinnati Children’s counselors make it clear to prospective families that if they prefer, they could travel to CHOP, Vanderbilt, or UCSF, the U.S. sites with the most experience and best-documented track records.

It’s all a balance of risk and benefit.

–Mitchel L. Zoler (on Twitter @mitchelzoler)

Electrocardiography to test a child’s heart prior to sports participation can help identify some – but not all – causes of sudden cardiac death.

Offering this test is not without debate, however, whether your patient is a young athlete about to start a sports program or a student about to start stimulant medication for attention-deficit/hyperactivity disorder.

Your clinical judgment remains paramount, as ECG screening before sports is not mandated in the United States, but placing your patient in one of the following three categories can help guide diagnosis and management:

Photo courtesy Loyola University Chicago Stritch School of Medicine

• Asymptomatic child, normal physical exam. Most of the patients you see for a sports evaluation will be asymptomatic. Perform the physical examination and take a thorough history, with a specific look for any signs of sudden cardiac death such as family history or previous symptoms. In general, this evaluation will suffice and you will not need to order blood assays or other tests. If you want to augment your evaluation by ordering an ECG, you will be ahead of the curve. Most pediatricians manage these kids whether they order an ECG or not. If you’re uncertain or uncomfortable for any reason at this point, consider referral.

• Symptomatic child. Children in this group may describe palpitations, chest pain, and/or an instance when they felt they were about to pass out (syncope or presyncope). The symptomatic child should be evaluated further if you have any clinical concerns, and ECG is a good starting point. Unless you feel very comfortable, consider specialist consultation and comanagement of these patients. Watch especially for exercise-related syncope. For me, passing out with exercise is a red flag because it’s one of the few specific signs of structural heart disease. At a minimum, evaluations of rhythm (ECG) and structure (echocardiography) are indicated, and sometimes an electrophysiology work-up can be helpful.

• Asymptomatic child, some examination findings. Some asymptomatic children have a potentially relevant clinical finding, such as a murmur. Most innocent murmurs are monitored appropriately in the primary care setting, but referral is more strongly suggested for murmurs of concern, which include holosystolic murmurs, grade 3-6 murmurs, and diastolic murmurs. An ECG is still an excellent starting point, but you have a choice. Some pediatric cardiologists also would recommend an echocardiogram or just a referral to them for further work-up. You don’t always have to rush to echocardiography. (Some would argue there are too many echoes ordered right off the bat, and I think there are too few initial ECGs ordered.)

Much of your management strategy depends on your comfort level. Most pediatricians can read an ECG and immediately know that something is not right if they see a significantly prolonged QT interval or WPW (Wolff-Parkinson-White syndrome) changes. I’ve learned, however, that most of the pediatricians at our institution would be uncomfortable making the call regarding some of the more subtle ECG findings. Many pediatricians’ offices do not have ECG equipment, so the patient will be sent elsewhere anyway.

Screening Before an ADHD Regimen

Consideration of ECG screening also comes up prior to prescription of an ADHD stimulant medication.

Unfortunately, a small number of deaths have been associated with use of these medications. Some of those patients had underlying congenital and structural heart disease that some believe could have been identified with a simple ECG. Most people would agree to some sort of cardiovascular monitoring, such as blood pressure or heart rate measurements. Complicating matters is the increased risk of ADHD in children with congenital heart anomalies.

Proceeding with an ECG screen doesn’t rule out prescribing the ADHD medicine, according to the recommendation, but it might be worthwhile to have a pediatric cardiologist manage any particular clinical concerns.

False-Positive Results

ECGs are safe and very inexpensive if you already have the equipment. The biggest debate about ECGs in the world of sports medicine centers on high false-positive rates. Depending on how the ECG is read and which criteria you use, the false positive rate can be as low as 2% or as high as 15%. Using the right criteria removes some of the unnecessary false positives and can reduce the rate to a more acceptable 2%-5%. In my opinion, that rate is low enough to justify offering low-cost ECGs for those who would like to be screened.

Interestingly, some of the false-positive findings are not as concerning among young athletes. Examples are an incomplete right bundle branch block, early repolarization, isolated QRS voltage criteria for left ventricular hypertrophy, and first-degree atrioventricular block. Some experts argue that if we remove these specific findings, we will be left primarily with the most concerning ones and thus can improve the false-positive rate.

This greater reliability may be reflected by emerging ECG-screening programs across this country. We at Loyola University Health System are in the process of trying to develop one of the first ECG-screening programs at a medical center. Precedents from ECG guidelines for older athletes may be adaptable to protect pediatric patients; about half of large university athletic programs perform ECG screening. In addition, the majority of professional athletes undergo cardiac evaluations.

Dr. Jayanthi is with the department of family medicine and the department of orthopaedic surgery and rehabilitation and also the medical director of primary care sports medicine at Loyola University Chicago in Maywood, Ill. Dr. Jayanthi said that he had no relevant financial disclosures.

Electrocardiography to test a child’s heart prior to sports participation can help identify some – but not all – causes of sudden cardiac death.

Offering this test is not without debate, however, whether your patient is a young athlete about to start a sports program or a student about to start stimulant medication for attention-deficit/hyperactivity disorder.

Your clinical judgment remains paramount, as ECG screening before sports is not mandated in the United States, but placing your patient in one of the following three categories can help guide diagnosis and management:

Photo courtesy Loyola University Chicago Stritch School of Medicine

• Asymptomatic child, normal physical exam. Most of the patients you see for a sports evaluation will be asymptomatic. Perform the physical examination and take a thorough history, with a specific look for any signs of sudden cardiac death such as family history or previous symptoms. In general, this evaluation will suffice and you will not need to order blood assays or other tests. If you want to augment your evaluation by ordering an ECG, you will be ahead of the curve. Most pediatricians manage these kids whether they order an ECG or not. If you’re uncertain or uncomfortable for any reason at this point, consider referral.

• Symptomatic child. Children in this group may describe palpitations, chest pain, and/or an instance when they felt they were about to pass out (syncope or presyncope). The symptomatic child should be evaluated further if you have any clinical concerns, and ECG is a good starting point. Unless you feel very comfortable, consider specialist consultation and comanagement of these patients. Watch especially for exercise-related syncope. For me, passing out with exercise is a red flag because it’s one of the few specific signs of structural heart disease. At a minimum, evaluations of rhythm (ECG) and structure (echocardiography) are indicated, and sometimes an electrophysiology work-up can be helpful.

• Asymptomatic child, some examination findings. Some asymptomatic children have a potentially relevant clinical finding, such as a murmur. Most innocent murmurs are monitored appropriately in the primary care setting, but referral is more strongly suggested for murmurs of concern, which include holosystolic murmurs, grade 3-6 murmurs, and diastolic murmurs. An ECG is still an excellent starting point, but you have a choice. Some pediatric cardiologists also would recommend an echocardiogram or just a referral to them for further work-up. You don’t always have to rush to echocardiography. (Some would argue there are too many echoes ordered right off the bat, and I think there are too few initial ECGs ordered.)

Much of your management strategy depends on your comfort level. Most pediatricians can read an ECG and immediately know that something is not right if they see a significantly prolonged QT interval or WPW (Wolff-Parkinson-White syndrome) changes. I’ve learned, however, that most of the pediatricians at our institution would be uncomfortable making the call regarding some of the more subtle ECG findings. Many pediatricians’ offices do not have ECG equipment, so the patient will be sent elsewhere anyway.

Screening Before an ADHD Regimen

Consideration of ECG screening also comes up prior to prescription of an ADHD stimulant medication.

Unfortunately, a small number of deaths have been associated with use of these medications. Some of those patients had underlying congenital and structural heart disease that some believe could have been identified with a simple ECG. Most people would agree to some sort of cardiovascular monitoring, such as blood pressure or heart rate measurements. Complicating matters is the increased risk of ADHD in children with congenital heart anomalies.

Proceeding with an ECG screen doesn’t rule out prescribing the ADHD medicine, according to the recommendation, but it might be worthwhile to have a pediatric cardiologist manage any particular clinical concerns.

False-Positive Results

ECGs are safe and very inexpensive if you already have the equipment. The biggest debate about ECGs in the world of sports medicine centers on high false-positive rates. Depending on how the ECG is read and which criteria you use, the false positive rate can be as low as 2% or as high as 15%. Using the right criteria removes some of the unnecessary false positives and can reduce the rate to a more acceptable 2%-5%. In my opinion, that rate is low enough to justify offering low-cost ECGs for those who would like to be screened.

Interestingly, some of the false-positive findings are not as concerning among young athletes. Examples are an incomplete right bundle branch block, early repolarization, isolated QRS voltage criteria for left ventricular hypertrophy, and first-degree atrioventricular block. Some experts argue that if we remove these specific findings, we will be left primarily with the most concerning ones and thus can improve the false-positive rate.

This greater reliability may be reflected by emerging ECG-screening programs across this country. We at Loyola University Health System are in the process of trying to develop one of the first ECG-screening programs at a medical center. Precedents from ECG guidelines for older athletes may be adaptable to protect pediatric patients; about half of large university athletic programs perform ECG screening. In addition, the majority of professional athletes undergo cardiac evaluations.

Dr. Jayanthi is with the department of family medicine and the department of orthopaedic surgery and rehabilitation and also the medical director of primary care sports medicine at Loyola University Chicago in Maywood, Ill. Dr. Jayanthi said that he had no relevant financial disclosures.

Electrocardiography to test a child’s heart prior to sports participation can help identify some – but not all – causes of sudden cardiac death.

Offering this test is not without debate, however, whether your patient is a young athlete about to start a sports program or a student about to start stimulant medication for attention-deficit/hyperactivity disorder.

Your clinical judgment remains paramount, as ECG screening before sports is not mandated in the United States, but placing your patient in one of the following three categories can help guide diagnosis and management:

Photo courtesy Loyola University Chicago Stritch School of Medicine

• Asymptomatic child, normal physical exam. Most of the patients you see for a sports evaluation will be asymptomatic. Perform the physical examination and take a thorough history, with a specific look for any signs of sudden cardiac death such as family history or previous symptoms. In general, this evaluation will suffice and you will not need to order blood assays or other tests. If you want to augment your evaluation by ordering an ECG, you will be ahead of the curve. Most pediatricians manage these kids whether they order an ECG or not. If you’re uncertain or uncomfortable for any reason at this point, consider referral.

• Symptomatic child. Children in this group may describe palpitations, chest pain, and/or an instance when they felt they were about to pass out (syncope or presyncope). The symptomatic child should be evaluated further if you have any clinical concerns, and ECG is a good starting point. Unless you feel very comfortable, consider specialist consultation and comanagement of these patients. Watch especially for exercise-related syncope. For me, passing out with exercise is a red flag because it’s one of the few specific signs of structural heart disease. At a minimum, evaluations of rhythm (ECG) and structure (echocardiography) are indicated, and sometimes an electrophysiology work-up can be helpful.

• Asymptomatic child, some examination findings. Some asymptomatic children have a potentially relevant clinical finding, such as a murmur. Most innocent murmurs are monitored appropriately in the primary care setting, but referral is more strongly suggested for murmurs of concern, which include holosystolic murmurs, grade 3-6 murmurs, and diastolic murmurs. An ECG is still an excellent starting point, but you have a choice. Some pediatric cardiologists also would recommend an echocardiogram or just a referral to them for further work-up. You don’t always have to rush to echocardiography. (Some would argue there are too many echoes ordered right off the bat, and I think there are too few initial ECGs ordered.)

Much of your management strategy depends on your comfort level. Most pediatricians can read an ECG and immediately know that something is not right if they see a significantly prolonged QT interval or WPW (Wolff-Parkinson-White syndrome) changes. I’ve learned, however, that most of the pediatricians at our institution would be uncomfortable making the call regarding some of the more subtle ECG findings. Many pediatricians’ offices do not have ECG equipment, so the patient will be sent elsewhere anyway.

Screening Before an ADHD Regimen

Consideration of ECG screening also comes up prior to prescription of an ADHD stimulant medication.

Unfortunately, a small number of deaths have been associated with use of these medications. Some of those patients had underlying congenital and structural heart disease that some believe could have been identified with a simple ECG. Most people would agree to some sort of cardiovascular monitoring, such as blood pressure or heart rate measurements. Complicating matters is the increased risk of ADHD in children with congenital heart anomalies.

Proceeding with an ECG screen doesn’t rule out prescribing the ADHD medicine, according to the recommendation, but it might be worthwhile to have a pediatric cardiologist manage any particular clinical concerns.

False-Positive Results

ECGs are safe and very inexpensive if you already have the equipment. The biggest debate about ECGs in the world of sports medicine centers on high false-positive rates. Depending on how the ECG is read and which criteria you use, the false positive rate can be as low as 2% or as high as 15%. Using the right criteria removes some of the unnecessary false positives and can reduce the rate to a more acceptable 2%-5%. In my opinion, that rate is low enough to justify offering low-cost ECGs for those who would like to be screened.

Interestingly, some of the false-positive findings are not as concerning among young athletes. Examples are an incomplete right bundle branch block, early repolarization, isolated QRS voltage criteria for left ventricular hypertrophy, and first-degree atrioventricular block. Some experts argue that if we remove these specific findings, we will be left primarily with the most concerning ones and thus can improve the false-positive rate.

This greater reliability may be reflected by emerging ECG-screening programs across this country. We at Loyola University Health System are in the process of trying to develop one of the first ECG-screening programs at a medical center. Precedents from ECG guidelines for older athletes may be adaptable to protect pediatric patients; about half of large university athletic programs perform ECG screening. In addition, the majority of professional athletes undergo cardiac evaluations.

Dr. Jayanthi is with the department of family medicine and the department of orthopaedic surgery and rehabilitation and also the medical director of primary care sports medicine at Loyola University Chicago in Maywood, Ill. Dr. Jayanthi said that he had no relevant financial disclosures.

The advances in cardiac imaging that have taken place in the last few years have provided amazing visualization of cardiac function in health and disease. Imaging has also enabled us to target areas of the heart for medical and surgical intervention.

The images are so slick that we have been known to e-mail them to our patients to show them how clever we are. I am told that they have been used to liven up cocktail parties. In a larger sense, however, few new concepts have emerged as a result of these imaging advances that physiologists and anatomists have not already elegantly described in the past.

We have been obsessed with the possibility that imaging of the heart and the coronary vessels would unlock the mysteries of acute coronary events and provide predictive information of subsequent myocardial infarction. The advances in computed tomography – first with the exercise electrocardiogram (with and without radiographic imaging), followed by coronary angiography, and most recently with CT coronary angiography – are only the most recent attempts to identify the culprit in this long-running quest for the triggers of acute coronary events.

And yet, the answer eludes us. Even when we were able to image the atherosclerotic plaque itself, we found that new events occurred in seemingly normal vessels. So it is not surprising that the ROMICAT II (Rule Out Myocardial Infarction II) study – the most recent study evaluating emergency department patients with acute chest pain using CT angiography – failed to provide any new insight into the diagnosis and prediction of the acute coronary syndrome. Compared with standard evaluation, CT angiography failed to show any clinical benefit other than shortening the average stay in the ED by 7.6 hours (which is unquestionably a quality benefit if your emergency department is anything like mine).

ROMICAT II did show that coronary events were rare in this highly selected patient population who were aged 40-74 years, had no history of coronary artery disease or ischemic electrocardiographic abnormalities, and had normal troponin assays. In the succeeding 28 days following emergency evaluation, there were no acute coronary events detected, and there were only eight adverse cardiac events observed.

Because of the unlikely occurrence of coronary events, these patients can best be dealt with in a nonemergency setting. Both CT angiography and standard testing led to further tests during the 28-day follow-up, including exercise echocardiograms (with or without nuclear imaging) and coronary angiography in roughly three-fourths of the patients. Revascularization was performed in 10% of the population.

So why are we even testing these patients and exposing them to all of the exigencies of ED and hospital admission? We are clearly not providing any service to them. At the same time, we are exposing them to increased radiation and the hazard of the testing procedures themselves. Some would say that the testing was driven by the risks of malpractice litigation. This study should provide some "cover" for that concern, which is undoubtedly real.

The continuing dependence on imaging technology to solve clinical problems has led to the numbing of our ability to perform cognitive processing of clinical data. Heart failure is no longer a clinical entity; it is an echocardiography image. The acute coronary syndrome is not a clinical syndrome, but rather an acquired image or blood test. Daily ward rounds have evolved into a hierarchical listing of the next imaging test to be performed on the patient in order to solve the clinical problem at hand. Consequently, the approach to the patient is no longer a quest to understand what is probable, but a search for the improbable.

A continuous barrage of publications in the medical and lay press has addressed the dollars wasted on imaging procedures, with seemingly little letup in the use of these technologies. Clearly, in the "zero-sum game" world of modern medicine, these costs will ultimately come out of physician’s income. Beyond that, we should realize that they add very little to the care of our patients and may actually add to their risks.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The advances in cardiac imaging that have taken place in the last few years have provided amazing visualization of cardiac function in health and disease. Imaging has also enabled us to target areas of the heart for medical and surgical intervention.

The images are so slick that we have been known to e-mail them to our patients to show them how clever we are. I am told that they have been used to liven up cocktail parties. In a larger sense, however, few new concepts have emerged as a result of these imaging advances that physiologists and anatomists have not already elegantly described in the past.

We have been obsessed with the possibility that imaging of the heart and the coronary vessels would unlock the mysteries of acute coronary events and provide predictive information of subsequent myocardial infarction. The advances in computed tomography – first with the exercise electrocardiogram (with and without radiographic imaging), followed by coronary angiography, and most recently with CT coronary angiography – are only the most recent attempts to identify the culprit in this long-running quest for the triggers of acute coronary events.

And yet, the answer eludes us. Even when we were able to image the atherosclerotic plaque itself, we found that new events occurred in seemingly normal vessels. So it is not surprising that the ROMICAT II (Rule Out Myocardial Infarction II) study – the most recent study evaluating emergency department patients with acute chest pain using CT angiography – failed to provide any new insight into the diagnosis and prediction of the acute coronary syndrome. Compared with standard evaluation, CT angiography failed to show any clinical benefit other than shortening the average stay in the ED by 7.6 hours (which is unquestionably a quality benefit if your emergency department is anything like mine).

ROMICAT II did show that coronary events were rare in this highly selected patient population who were aged 40-74 years, had no history of coronary artery disease or ischemic electrocardiographic abnormalities, and had normal troponin assays. In the succeeding 28 days following emergency evaluation, there were no acute coronary events detected, and there were only eight adverse cardiac events observed.

Because of the unlikely occurrence of coronary events, these patients can best be dealt with in a nonemergency setting. Both CT angiography and standard testing led to further tests during the 28-day follow-up, including exercise echocardiograms (with or without nuclear imaging) and coronary angiography in roughly three-fourths of the patients. Revascularization was performed in 10% of the population.

So why are we even testing these patients and exposing them to all of the exigencies of ED and hospital admission? We are clearly not providing any service to them. At the same time, we are exposing them to increased radiation and the hazard of the testing procedures themselves. Some would say that the testing was driven by the risks of malpractice litigation. This study should provide some "cover" for that concern, which is undoubtedly real.

The continuing dependence on imaging technology to solve clinical problems has led to the numbing of our ability to perform cognitive processing of clinical data. Heart failure is no longer a clinical entity; it is an echocardiography image. The acute coronary syndrome is not a clinical syndrome, but rather an acquired image or blood test. Daily ward rounds have evolved into a hierarchical listing of the next imaging test to be performed on the patient in order to solve the clinical problem at hand. Consequently, the approach to the patient is no longer a quest to understand what is probable, but a search for the improbable.

A continuous barrage of publications in the medical and lay press has addressed the dollars wasted on imaging procedures, with seemingly little letup in the use of these technologies. Clearly, in the "zero-sum game" world of modern medicine, these costs will ultimately come out of physician’s income. Beyond that, we should realize that they add very little to the care of our patients and may actually add to their risks.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The advances in cardiac imaging that have taken place in the last few years have provided amazing visualization of cardiac function in health and disease. Imaging has also enabled us to target areas of the heart for medical and surgical intervention.

The images are so slick that we have been known to e-mail them to our patients to show them how clever we are. I am told that they have been used to liven up cocktail parties. In a larger sense, however, few new concepts have emerged as a result of these imaging advances that physiologists and anatomists have not already elegantly described in the past.

We have been obsessed with the possibility that imaging of the heart and the coronary vessels would unlock the mysteries of acute coronary events and provide predictive information of subsequent myocardial infarction. The advances in computed tomography – first with the exercise electrocardiogram (with and without radiographic imaging), followed by coronary angiography, and most recently with CT coronary angiography – are only the most recent attempts to identify the culprit in this long-running quest for the triggers of acute coronary events.

And yet, the answer eludes us. Even when we were able to image the atherosclerotic plaque itself, we found that new events occurred in seemingly normal vessels. So it is not surprising that the ROMICAT II (Rule Out Myocardial Infarction II) study – the most recent study evaluating emergency department patients with acute chest pain using CT angiography – failed to provide any new insight into the diagnosis and prediction of the acute coronary syndrome. Compared with standard evaluation, CT angiography failed to show any clinical benefit other than shortening the average stay in the ED by 7.6 hours (which is unquestionably a quality benefit if your emergency department is anything like mine).

ROMICAT II did show that coronary events were rare in this highly selected patient population who were aged 40-74 years, had no history of coronary artery disease or ischemic electrocardiographic abnormalities, and had normal troponin assays. In the succeeding 28 days following emergency evaluation, there were no acute coronary events detected, and there were only eight adverse cardiac events observed.

Because of the unlikely occurrence of coronary events, these patients can best be dealt with in a nonemergency setting. Both CT angiography and standard testing led to further tests during the 28-day follow-up, including exercise echocardiograms (with or without nuclear imaging) and coronary angiography in roughly three-fourths of the patients. Revascularization was performed in 10% of the population.

So why are we even testing these patients and exposing them to all of the exigencies of ED and hospital admission? We are clearly not providing any service to them. At the same time, we are exposing them to increased radiation and the hazard of the testing procedures themselves. Some would say that the testing was driven by the risks of malpractice litigation. This study should provide some "cover" for that concern, which is undoubtedly real.

The continuing dependence on imaging technology to solve clinical problems has led to the numbing of our ability to perform cognitive processing of clinical data. Heart failure is no longer a clinical entity; it is an echocardiography image. The acute coronary syndrome is not a clinical syndrome, but rather an acquired image or blood test. Daily ward rounds have evolved into a hierarchical listing of the next imaging test to be performed on the patient in order to solve the clinical problem at hand. Consequently, the approach to the patient is no longer a quest to understand what is probable, but a search for the improbable.

A continuous barrage of publications in the medical and lay press has addressed the dollars wasted on imaging procedures, with seemingly little letup in the use of these technologies. Clearly, in the "zero-sum game" world of modern medicine, these costs will ultimately come out of physician’s income. Beyond that, we should realize that they add very little to the care of our patients and may actually add to their risks.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

CHICAGO – The impact of acetyl-l-carnitine on chemotherapy-induced peripheral neuropathy may depend largely on the clinical context and patient population, a pair of phase III trials suggests.

Acetyl-l-carnitine (ALC), a natural substance marketed over the counter as a dietary supplement, is popular among cancer patients as a result of preclinical and early-phase data in chemotherapy-related neuropathy and also a study in patients with diabetes-related peripheral neuropathy.

But in a trial among 409 U.S. women receiving adjuvant chemotherapy for breast cancer, those who took ALC not only had no decrease in the development of peripheral neuropathy symptoms relative to peers who were given a placebo, but actually had an increase. And they had a higher rate of serious neuropathy, too.

In contrast, in a trial among more than 200 Chinese patients with various cancers who had peripheral neuropathy from previous chemotherapy, those who took ALC were more likely than those who took a placebo to have an improvement of at least one grade in their neuropathy. They also were more likely to have improvements in fatigue and strength.

Taken together, the two trials, which were reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology, provide yet another cautionary lesson on the complexity of combining conventional and complementary therapies.

"The use of ALC for prevention is not recommended, and I would say, based on [these results], should be cautioned against. It will be interesting to see the carnitine data and to understand, as much as possible, why the trial was negative," commented Debra L. Barton, Ph.D., of the Mayo Clinic in Rochester, Minn., who was invited to discuss the research. "Further studies are needed to really understand if ALC should be used to treat peripheral neuropathy."

ALC for Prevention of Peripheral Neuropathy

In the first trial, Southwest Oncology Group (SWOG) protocol S0715, investigators led by Dr. Dawn L. Hershman randomized women receiving adjuvant taxane chemotherapy for early breast cancer evenly to either oral ALC 1,000 mg three times daily or matching placebo, for 24 weeks.

Compared with their counterparts in the placebo group, women in the ALC group were more likely to have a greater than 5-point adjusted decrease on the neurotoxicity subscale of the Functional Assessment of Cancer Therapy–Taxane (FACT-NTX) instrument at 12 weeks (odds ratio, 1.48; P = .08) and also at 24 weeks (38% vs. 28%; OR, 1.57; P = .05).

This magnitude of worsening is clinically meaningful, maintained Dr. Hershman of Columbia University in New York, "so this is not like a lot of studies where you find a statistically significant difference that’s not clinically meaningful."

In addition, the incidence of grade 3/4 neurotoxicity was 3.8% with ALC, much higher than the 0.5% seen with placebo.

Patients in the ALC group also had scores on the FACT trial outcome index subscale (FACT-TOI), an overall measure of function, that were on average 3.5 points lower (worse) than those among their placebo counterparts (P = .03). There were no significant differences between groups in terms of fatigue and other toxicities.

The investigators have collected biosamples and will be assessing potential biological correlates with peripheral neuropathy outcomes, according to Dr. Hershman.

"We are looking at DNA, oxidative stress, and carnitine levels to better understand the mechanisms of chemotherapy-induced peripheral neuropathy to begin with, because there is not a whole lot known in terms of mechanism," she said. "If we can figure out what makes people worse, then we will maybe be able to figure out how to make people better from a more mechanistic standpoint, because there are very few drugs to treat chemotherapy-induced peripheral neuropathy."

An obvious concern from the trial’s findings is that ALC may somehow potentiate the neurotoxic effects of taxanes. "Based on these data, physicians should be telling patients not to take ALC during adjuvant chemotherapy," Dr. Hershman concluded. "You need to talk to patients. We know from the literature that overwhelmingly large number of patients take supplements during chemotherapy and afterward, many of which have not been tested. It’s important to get that history from patients."

Dr. Barton, the discussant, praised the trial’s rigorous methodology and proposed that there may have been several reasons for the lack of ALC benefit in preventing neuropathy, despite compelling earlier data.

Previous prevention research was done in animals and thus may not translate to humans, she said. And a positive trial for treatment in humans used intravenous administration, which may result in different bioavailability. Finally, "ALC capsules needed to be taken three times a day, and they are rather large, and these patients were, after all, on chemotherapy. They were likely nauseated [and] dyspeptic, and taking what some might call a horse pill three times a day could not have been an easy task. The study did use pill diaries, but we know those aren’t a perfect tool for adherence."

"The great thing is that the study collected blood and they are able to look at carnitine levels," Dr. Barton said. "So if carnitine is up in the group that got acetyl-carnitine and not in the group that got placebo, well, I think that pretty much confirms that this just didn’t work."

ALC for Treatment of Peripheral Neuropathy

In the second trial, protocol ZHAOKE-2007L03540, investigators led by Dr. Yuanjue Sun of the Sixth Affiliated Hospital of Shanghai (China) Jiao Tong University, enrolled 239 patients who had cancer of various types and stages, had completed chemotherapy, and had had at least grade 2 peripheral neuropathy for up to 6 months.

They were randomly assigned to receive either oral ALC at a dose of 3 g/day or matching placebo, for 8 weeks, with outcomes assessed at clinic visits or by telephone.

Analyses showed that compared with their counterparts in the placebo group, patients in the ALC group were more likely to have had an improvement of at least one grade in their neuropathy, both at 8 weeks (51% vs. 24%; P less than .001) and at 12 weeks (58% vs. 40%; P less than .001).

In terms of secondary outcomes, the ALC group was also more likely to have had an improvement in cancer-related fatigue (31% vs. 20%; P = .048), physical strength (29% vs. 13%; P = .02), and electrophysiology in peripheral nerves (75% vs. 58%; P = .02).

The two groups had statistically indistinguishable rates of adverse events (20% vs. 15%) and adverse reactions (6% vs. 5%). The most common events were gastrointestinal ones and skin allergies.

"This is the first time to confirm that ALC has a positive effect to cure chemotherapy-induced peripheral neuropathy in the Chinese population," Dr. Sun commented through a translator.

"I think the very important thing for this trial is, it is a different kind of patient population. Before this, most clinical trials were performed in [whites] or maybe Americans. This is an only-Asian [population]," he noted, and it is possible that there are genetic differences in how ALC is metabolized.

Dr. Barton, the discussant, took a cautionary view, saying that "there are some things to consider before going out and telling patients to consider acetyl-carnitine for their peripheral neuropathy."

It was unclear from the results reported whether the two treatment groups were well balanced and what criteria were used to define improvement for the secondary outcomes, she noted. Additionally, "outcome measures were all provider graded, [and there were] no self-report measures, so it is difficult to understand the impact of treatment on symptoms, particularly from the patient perspective," she noted.

Dr. Hershman, Dr. Sun, and Dr. Barton disclosed no relevant conflicts of interest; the ZHAOKE-2007L03540 trial was sponsored by Lee’s Pharmaceutical Limited.

CHICAGO – The impact of acetyl-l-carnitine on chemotherapy-induced peripheral neuropathy may depend largely on the clinical context and patient population, a pair of phase III trials suggests.

Acetyl-l-carnitine (ALC), a natural substance marketed over the counter as a dietary supplement, is popular among cancer patients as a result of preclinical and early-phase data in chemotherapy-related neuropathy and also a study in patients with diabetes-related peripheral neuropathy.

But in a trial among 409 U.S. women receiving adjuvant chemotherapy for breast cancer, those who took ALC not only had no decrease in the development of peripheral neuropathy symptoms relative to peers who were given a placebo, but actually had an increase. And they had a higher rate of serious neuropathy, too.

In contrast, in a trial among more than 200 Chinese patients with various cancers who had peripheral neuropathy from previous chemotherapy, those who took ALC were more likely than those who took a placebo to have an improvement of at least one grade in their neuropathy. They also were more likely to have improvements in fatigue and strength.

Taken together, the two trials, which were reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology, provide yet another cautionary lesson on the complexity of combining conventional and complementary therapies.

"The use of ALC for prevention is not recommended, and I would say, based on [these results], should be cautioned against. It will be interesting to see the carnitine data and to understand, as much as possible, why the trial was negative," commented Debra L. Barton, Ph.D., of the Mayo Clinic in Rochester, Minn., who was invited to discuss the research. "Further studies are needed to really understand if ALC should be used to treat peripheral neuropathy."

ALC for Prevention of Peripheral Neuropathy

In the first trial, Southwest Oncology Group (SWOG) protocol S0715, investigators led by Dr. Dawn L. Hershman randomized women receiving adjuvant taxane chemotherapy for early breast cancer evenly to either oral ALC 1,000 mg three times daily or matching placebo, for 24 weeks.

Compared with their counterparts in the placebo group, women in the ALC group were more likely to have a greater than 5-point adjusted decrease on the neurotoxicity subscale of the Functional Assessment of Cancer Therapy–Taxane (FACT-NTX) instrument at 12 weeks (odds ratio, 1.48; P = .08) and also at 24 weeks (38% vs. 28%; OR, 1.57; P = .05).

This magnitude of worsening is clinically meaningful, maintained Dr. Hershman of Columbia University in New York, "so this is not like a lot of studies where you find a statistically significant difference that’s not clinically meaningful."

In addition, the incidence of grade 3/4 neurotoxicity was 3.8% with ALC, much higher than the 0.5% seen with placebo.

Patients in the ALC group also had scores on the FACT trial outcome index subscale (FACT-TOI), an overall measure of function, that were on average 3.5 points lower (worse) than those among their placebo counterparts (P = .03). There were no significant differences between groups in terms of fatigue and other toxicities.

The investigators have collected biosamples and will be assessing potential biological correlates with peripheral neuropathy outcomes, according to Dr. Hershman.

"We are looking at DNA, oxidative stress, and carnitine levels to better understand the mechanisms of chemotherapy-induced peripheral neuropathy to begin with, because there is not a whole lot known in terms of mechanism," she said. "If we can figure out what makes people worse, then we will maybe be able to figure out how to make people better from a more mechanistic standpoint, because there are very few drugs to treat chemotherapy-induced peripheral neuropathy."

An obvious concern from the trial’s findings is that ALC may somehow potentiate the neurotoxic effects of taxanes. "Based on these data, physicians should be telling patients not to take ALC during adjuvant chemotherapy," Dr. Hershman concluded. "You need to talk to patients. We know from the literature that overwhelmingly large number of patients take supplements during chemotherapy and afterward, many of which have not been tested. It’s important to get that history from patients."

Dr. Barton, the discussant, praised the trial’s rigorous methodology and proposed that there may have been several reasons for the lack of ALC benefit in preventing neuropathy, despite compelling earlier data.

Previous prevention research was done in animals and thus may not translate to humans, she said. And a positive trial for treatment in humans used intravenous administration, which may result in different bioavailability. Finally, "ALC capsules needed to be taken three times a day, and they are rather large, and these patients were, after all, on chemotherapy. They were likely nauseated [and] dyspeptic, and taking what some might call a horse pill three times a day could not have been an easy task. The study did use pill diaries, but we know those aren’t a perfect tool for adherence."

"The great thing is that the study collected blood and they are able to look at carnitine levels," Dr. Barton said. "So if carnitine is up in the group that got acetyl-carnitine and not in the group that got placebo, well, I think that pretty much confirms that this just didn’t work."

ALC for Treatment of Peripheral Neuropathy

In the second trial, protocol ZHAOKE-2007L03540, investigators led by Dr. Yuanjue Sun of the Sixth Affiliated Hospital of Shanghai (China) Jiao Tong University, enrolled 239 patients who had cancer of various types and stages, had completed chemotherapy, and had had at least grade 2 peripheral neuropathy for up to 6 months.

They were randomly assigned to receive either oral ALC at a dose of 3 g/day or matching placebo, for 8 weeks, with outcomes assessed at clinic visits or by telephone.

Analyses showed that compared with their counterparts in the placebo group, patients in the ALC group were more likely to have had an improvement of at least one grade in their neuropathy, both at 8 weeks (51% vs. 24%; P less than .001) and at 12 weeks (58% vs. 40%; P less than .001).

In terms of secondary outcomes, the ALC group was also more likely to have had an improvement in cancer-related fatigue (31% vs. 20%; P = .048), physical strength (29% vs. 13%; P = .02), and electrophysiology in peripheral nerves (75% vs. 58%; P = .02).

The two groups had statistically indistinguishable rates of adverse events (20% vs. 15%) and adverse reactions (6% vs. 5%). The most common events were gastrointestinal ones and skin allergies.

"This is the first time to confirm that ALC has a positive effect to cure chemotherapy-induced peripheral neuropathy in the Chinese population," Dr. Sun commented through a translator.

"I think the very important thing for this trial is, it is a different kind of patient population. Before this, most clinical trials were performed in [whites] or maybe Americans. This is an only-Asian [population]," he noted, and it is possible that there are genetic differences in how ALC is metabolized.

Dr. Barton, the discussant, took a cautionary view, saying that "there are some things to consider before going out and telling patients to consider acetyl-carnitine for their peripheral neuropathy."

It was unclear from the results reported whether the two treatment groups were well balanced and what criteria were used to define improvement for the secondary outcomes, she noted. Additionally, "outcome measures were all provider graded, [and there were] no self-report measures, so it is difficult to understand the impact of treatment on symptoms, particularly from the patient perspective," she noted.

Dr. Hershman, Dr. Sun, and Dr. Barton disclosed no relevant conflicts of interest; the ZHAOKE-2007L03540 trial was sponsored by Lee’s Pharmaceutical Limited.

CHICAGO – The impact of acetyl-l-carnitine on chemotherapy-induced peripheral neuropathy may depend largely on the clinical context and patient population, a pair of phase III trials suggests.

Acetyl-l-carnitine (ALC), a natural substance marketed over the counter as a dietary supplement, is popular among cancer patients as a result of preclinical and early-phase data in chemotherapy-related neuropathy and also a study in patients with diabetes-related peripheral neuropathy.

But in a trial among 409 U.S. women receiving adjuvant chemotherapy for breast cancer, those who took ALC not only had no decrease in the development of peripheral neuropathy symptoms relative to peers who were given a placebo, but actually had an increase. And they had a higher rate of serious neuropathy, too.

In contrast, in a trial among more than 200 Chinese patients with various cancers who had peripheral neuropathy from previous chemotherapy, those who took ALC were more likely than those who took a placebo to have an improvement of at least one grade in their neuropathy. They also were more likely to have improvements in fatigue and strength.

Taken together, the two trials, which were reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology, provide yet another cautionary lesson on the complexity of combining conventional and complementary therapies.

"The use of ALC for prevention is not recommended, and I would say, based on [these results], should be cautioned against. It will be interesting to see the carnitine data and to understand, as much as possible, why the trial was negative," commented Debra L. Barton, Ph.D., of the Mayo Clinic in Rochester, Minn., who was invited to discuss the research. "Further studies are needed to really understand if ALC should be used to treat peripheral neuropathy."

ALC for Prevention of Peripheral Neuropathy

In the first trial, Southwest Oncology Group (SWOG) protocol S0715, investigators led by Dr. Dawn L. Hershman randomized women receiving adjuvant taxane chemotherapy for early breast cancer evenly to either oral ALC 1,000 mg three times daily or matching placebo, for 24 weeks.

Compared with their counterparts in the placebo group, women in the ALC group were more likely to have a greater than 5-point adjusted decrease on the neurotoxicity subscale of the Functional Assessment of Cancer Therapy–Taxane (FACT-NTX) instrument at 12 weeks (odds ratio, 1.48; P = .08) and also at 24 weeks (38% vs. 28%; OR, 1.57; P = .05).

This magnitude of worsening is clinically meaningful, maintained Dr. Hershman of Columbia University in New York, "so this is not like a lot of studies where you find a statistically significant difference that’s not clinically meaningful."

In addition, the incidence of grade 3/4 neurotoxicity was 3.8% with ALC, much higher than the 0.5% seen with placebo.

Patients in the ALC group also had scores on the FACT trial outcome index subscale (FACT-TOI), an overall measure of function, that were on average 3.5 points lower (worse) than those among their placebo counterparts (P = .03). There were no significant differences between groups in terms of fatigue and other toxicities.

The investigators have collected biosamples and will be assessing potential biological correlates with peripheral neuropathy outcomes, according to Dr. Hershman.

"We are looking at DNA, oxidative stress, and carnitine levels to better understand the mechanisms of chemotherapy-induced peripheral neuropathy to begin with, because there is not a whole lot known in terms of mechanism," she said. "If we can figure out what makes people worse, then we will maybe be able to figure out how to make people better from a more mechanistic standpoint, because there are very few drugs to treat chemotherapy-induced peripheral neuropathy."

An obvious concern from the trial’s findings is that ALC may somehow potentiate the neurotoxic effects of taxanes. "Based on these data, physicians should be telling patients not to take ALC during adjuvant chemotherapy," Dr. Hershman concluded. "You need to talk to patients. We know from the literature that overwhelmingly large number of patients take supplements during chemotherapy and afterward, many of which have not been tested. It’s important to get that history from patients."

Dr. Barton, the discussant, praised the trial’s rigorous methodology and proposed that there may have been several reasons for the lack of ALC benefit in preventing neuropathy, despite compelling earlier data.

Previous prevention research was done in animals and thus may not translate to humans, she said. And a positive trial for treatment in humans used intravenous administration, which may result in different bioavailability. Finally, "ALC capsules needed to be taken three times a day, and they are rather large, and these patients were, after all, on chemotherapy. They were likely nauseated [and] dyspeptic, and taking what some might call a horse pill three times a day could not have been an easy task. The study did use pill diaries, but we know those aren’t a perfect tool for adherence."

"The great thing is that the study collected blood and they are able to look at carnitine levels," Dr. Barton said. "So if carnitine is up in the group that got acetyl-carnitine and not in the group that got placebo, well, I think that pretty much confirms that this just didn’t work."

ALC for Treatment of Peripheral Neuropathy

In the second trial, protocol ZHAOKE-2007L03540, investigators led by Dr. Yuanjue Sun of the Sixth Affiliated Hospital of Shanghai (China) Jiao Tong University, enrolled 239 patients who had cancer of various types and stages, had completed chemotherapy, and had had at least grade 2 peripheral neuropathy for up to 6 months.

They were randomly assigned to receive either oral ALC at a dose of 3 g/day or matching placebo, for 8 weeks, with outcomes assessed at clinic visits or by telephone.

Analyses showed that compared with their counterparts in the placebo group, patients in the ALC group were more likely to have had an improvement of at least one grade in their neuropathy, both at 8 weeks (51% vs. 24%; P less than .001) and at 12 weeks (58% vs. 40%; P less than .001).

In terms of secondary outcomes, the ALC group was also more likely to have had an improvement in cancer-related fatigue (31% vs. 20%; P = .048), physical strength (29% vs. 13%; P = .02), and electrophysiology in peripheral nerves (75% vs. 58%; P = .02).

The two groups had statistically indistinguishable rates of adverse events (20% vs. 15%) and adverse reactions (6% vs. 5%). The most common events were gastrointestinal ones and skin allergies.

"This is the first time to confirm that ALC has a positive effect to cure chemotherapy-induced peripheral neuropathy in the Chinese population," Dr. Sun commented through a translator.

"I think the very important thing for this trial is, it is a different kind of patient population. Before this, most clinical trials were performed in [whites] or maybe Americans. This is an only-Asian [population]," he noted, and it is possible that there are genetic differences in how ALC is metabolized.

Dr. Barton, the discussant, took a cautionary view, saying that "there are some things to consider before going out and telling patients to consider acetyl-carnitine for their peripheral neuropathy."

It was unclear from the results reported whether the two treatment groups were well balanced and what criteria were used to define improvement for the secondary outcomes, she noted. Additionally, "outcome measures were all provider graded, [and there were] no self-report measures, so it is difficult to understand the impact of treatment on symptoms, particularly from the patient perspective," she noted.

Dr. Hershman, Dr. Sun, and Dr. Barton disclosed no relevant conflicts of interest; the ZHAOKE-2007L03540 trial was sponsored by Lee’s Pharmaceutical Limited.