Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Dr. Geppert. I have the pleasure of interviewing Dr. Larry Davis, Distinguished Professor of Neurology at the University of New Mexico School of Medicine in Albuquerque and chief of the NMVAHCS Neurology Service. Welcome, Dr. Davis. Can you describe a teleneurology visit?

Dr. Davis. The NMVAHCS is the only VA located in a large rural state. Location is a real challenge because we treat a lot of veterans who live rurally, and they often have to travel 5 to 6 hours to Albuquerque. When the VA set up its telehealth systems, it was obvious to the NMVAHCS Neurology Service that this was a gold mine. We have many patients who are unable to drive because of their neurologic condition, and they need a caregiver—sometimes a spouse—to drive them to NMVAHCS to see a neurologist, usually in an outpatient setting, often for 30 to 45 minutes, and then drive back 5 hours.

When I get a consult from a rural CBOC, I invite the patient to come to NMVAHCS for the first visit. First, I examine the patient face-to-face so the patient can get to know me. Second, I order special tests or imaging, which are not available in rural areas. Sometimes, for complicated cases, the patient stays overnight.

We discuss the diagnosis with the patient, and make the decision whether the patient is a good candidate for telehealth. If the patient consents and wants to be seen at a local community VA center, we set it up. On a given day, the patient travels—often 15, 20 minutes at most—to the VA facility and goes into a modified examination room. The patient sits in front of a TV screen with a camera focused on him or her. The patient can see me on the screen. In my office I have 2 screens, one has the patient record; the other allows me to see the patient.

Over the years, I have discovered that once I know the patient, it’s just like talking across the table. I can get a history of what has changed either with medications or chronic illness since the last follow-up.

Dr. Geppert. What are the issues and challenges in treating patients with epilepsy, multiple sclerosis, and other neurologic conditions?

Dr. Davis. We have the most difficultly with sensory examinations. I can perform a good motor examination via telehealth, but it is more difficult if I need to look carefully at the patient’s reflexes. We follow individuals with headaches, seizures, multiple sclerosis, Parkinson disease, and a variety of other illnesses. There are not too many we cannot follow that way. If patients have questions, I can look at their medical record and laboratory data while they are on the screen.

The caregiver or spouse can sit next to the patient, so they can be part of the conversation. If the patient is having trouble describing what is going on, the caregiver can offer comments.

Dr. Geppert. If I’m the patient and I’ve had a previous stroke and it looks as though I might have had another, wouldn’t you like to do a neurologic exam but can’t via telehealth?

Dr. Davis. That’s a very good point. When I talk to a patient and I don’t like what I see, I have the ability to ask the patient to come to NMVAHCS. I had one patient who suddenly started getting chest pains during the exam, so we called the CBOC primary care doctor to immediately move the patient to the local hospital. I had another patient who started talking about suicide. I kept the patient on the phone, but we got the primary care doctor in the room. We do have backup.

Dr. Geppert. You mentioned that you often involve family and that you work with local CBOC registered nurses (RNs). Can you tell us how you extend the reach of teleneurology through self-care and family education?

Dr. Davis. We have 2 qualified RN patient educators. One is an expert in Parkinson disease; the other follows up with the patient who has had a stroke, to reduce risk factors for a second stroke.

When I see a patient for a limited time, I deal with the drugs and things like that. I am less focused on what type of chair the patient should sit on, whether the patient might fall, how to safely get up, etc. So I set up a separate appointment with the nurse educator, who goes through all the day-to-day activities that the patient has to be able to do. Patients with Parkinson disease do not like to sit on low sofas, for example. What are the tricks for constipation? If a patient falls, how do you safely get up? The nurse will have the patient get down right in front of the camera and walk them through how to get up.

Dr. Geppert. I know that in many rural areas, especially in our state, there are real shortages of neurologists and psychiatrists. Can you talk about how this helps multiply your ability to care for patients?

Dr. Davis. With the exception of 3 different communities, there are no neurologists within 50 to 100 miles.

Dr. Geppert. Or neuropsychiatrists.

Dr. Davis. Or neuropsychiatrists or even a psychiatry office. So patients are very limited. We have an extremely loyal population of VA patients because it isn’t easy to say, “I’m just going to go down the street and get another doc.”

Dr. Geppert. What type of feedback do you get from patients and family about doing this virtually?

Dr. Davis. We sent a carefully worded satisfaction survey and received 700 responses. We found the following responses: 90% agreed that they received good care during their visit. Ninety-one percent reported that they were able to communicate and 87% would continue their care via teleneurology. Was the teleneurology more convenient than driving here? Yes, 90% said that it was. And did they have overall satisfaction with the visit? Literally 90% reported that they did. It’s a very high satisfaction rate.

We know that patients will say, “Oh, you can see me every 3 months, but I want to come down to see you face-to-face from time-to-time.” When I ask why, the most common answers are either “I live so rurally, there are no stores.” Or “I have family, and I want to come down.” So we then try to set up that face-to-face visit on a Friday.

If they’re traveling, they get their travel pay, but then they get to spend the weekend with a friend or family. There are often secondary reasons. Occasionally, they have to come back for another specialist; we make great efforts to put both those visits on the same day so they don’t have to go back and forth.

Dr. Geppert. So Dr. Davis, you’re a world-famous neurologist, but do you have to have special training or expertise to do teleneurology?

Dr. Davis. It helps to be a good clinician; I’ve been doing this for many years. Because we see patients on a sequence by television, I have to keep track of the time, whereas in the face-to-face clinic if something is really going wrong, I have the ability to shift things around right away and spend more time with that patient. I try to set up longer times for telehealth. I work with a clinical nurse practitioner colleague who takes care of headache patients, and she has a shorter time between visits. I never quite know what’s going to happen, and I want to leave a lot of time for the patient or the spouse to ask questions.

Dr. Geppert. We are both, certainly, senior clinicians and technology is a little different and new. Did you have problems learning to use the teleneurology?

Dr. Davis. Believe it or not, no. The television system is very similar to Skype. It is called Jabber and is encrypted, so it’s safe to transmit. You have to feel comfortable talking to somebody on a TV screen. And the first time I did it, I felt a little awkward. Within a day or two, I was fine.

Dr. Geppert. Federal Practitioner readers may want to start teleneurology or get more involved in it. Are you in touch with other VA and DoD providers?

Dr. Davis. Practitioners can contact me if they want to talk about how we do patient education. We’ve also spent a fair amount of effort developing a handbook that we send out on the ABCs of how to do it.

Dr. Geppert. Do you involve residents in this?

Dr. Davis. No, not at this point. My goal is to do it, but ironically enough, I’m trying to get students who rotate out here to get a feel for what telehealth could be. They don’t do the exam and everything else, but they get a chance to see what telehealth can be. If they want to live in a rural state, they may be involved in it.

Dr. Geppert. If the primary care provider was seeing a patient with multiple sclerosis, which we both know can have symptom flare ups, would they be able to contact you and say, “Hey, Dr. Davis, I’m seeing so and so, and she looks like she’s having some visual problems today.”

Dr. Davis. That’s harder to do because we’re not the only ones using the telehealth system. Telemental health, dietitians, and others are using it all the time, so I have to have a scheduled time to be able to see patients. I’m surprised that more rural states aren’t using it because it really is very enjoyable.

Dr. Geppert. What has the VA learned about telehealth from this program?

Dr. Davis. We know that it actually saves NMVAHCS a lot of money because we don’t pay as much travel pay. The patients like it. The CBOC physicians like it because if I have to, I can type the note right away, and they can read it if the patient is staying there.

Author disclosures
Dr. Hixson has received a collaborative grant from UCB Inc. for research on online epilepsy resources.

Disclaimer
The opinions expressed herein do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

Red blood cells

Amgen has withdrawn its application to expand the existing marketing authorization for darbepoetin alfa (Aranesp), according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The goal with this application was to extend the authorization for darbepoetin alfa to include the treatment of anemia in adults with low-risk or intermediate-1-risk myelodysplastic syndromes (MDS) who have low transfusion demand.

Darbepoetin alfa is currently approved in the European Union (EU) to treat anemia in adults and children with chronic renal failure and adults who are receiving chemotherapy for non-myeloid malignancies.

Amgen withdrew the application for darbepoetin alfa in MDS patients after the CHMP had evaluated initial documentation provided by the company and formulated a list of questions. Amgen had not yet responded to the questions when it notified the CHMP of the withdrawal.

At the time of the withdrawal, the CHMP was of the provisional opinion that darbepoetin alfa could not have been approved for the treatment of anemia in adults with MDS.

This opinion was based on concerns about the data supporting the application—results from the phase 3 ARCADE trial (NCT01362140) and a phase 2 trial (NCT00095264).

The CHMP said changes to the design of the phase 3 trial and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.

In addition, the phase 2 trial, which was conducted in the US, was not in line with EU recommendations for the treatment of MDS patients.

Therefore, at the time of the withdrawal, the CHMP had decided the marketing authorization could not be expanded based on the data provided.

In a letter to the CHMP, Amgen said its decision to withdraw the application is based on the CHMP’s negative opinion.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.

Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.

“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”

After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.

“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.

Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.

“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.

BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.

Robert Lodge/MDEdge News

In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”

New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
 

New device permits real-time stool sample analysis

A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.

Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”

The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.

GI endoscopy capture, storage, and sharing

In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.

“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.

Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.

New NG tube addresses aspiration risk

Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.

Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”

More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.

Virtual tape measure for colonoscopy measures polyp size

There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.

“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.

Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.

New device treats esophageal cancers with electroporation

There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.

“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.

The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.

A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.

“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”

BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.

Robert Lodge/MDEdge News

In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”

New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
 

New device permits real-time stool sample analysis

A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.

Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”

The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.

GI endoscopy capture, storage, and sharing

In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.

“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.

Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.

New NG tube addresses aspiration risk

Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.

Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”

More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.

Virtual tape measure for colonoscopy measures polyp size

There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.

“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.

Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.

New device treats esophageal cancers with electroporation

There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.

“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.

The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.

A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.

“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”

BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.

Robert Lodge/MDEdge News

In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”

New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
 

New device permits real-time stool sample analysis

A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.

Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”

The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.

GI endoscopy capture, storage, and sharing

In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.

“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.

Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.

New NG tube addresses aspiration risk

Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.

Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”

More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.

Virtual tape measure for colonoscopy measures polyp size

There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.

“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.

Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.

New device treats esophageal cancers with electroporation

There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.

“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.

The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.

A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.

“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”

PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.

“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.

Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.

For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.

“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.

Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.

Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.

The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.

PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.

“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.

Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.

For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.

“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.

Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.

Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.

The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.

PHILADELPHIA – Perianal fistulae are a common and difficult-to-treat complication of Crohn’s disease that may often require medical therapy, though not all treatment options have robust data supporting their use in this setting, according to Mark T. Osterman, MD.

“Most studies done on fistulae actually didn’t have that as the primary endpoint – it was a secondary endpoint, so they weren’t really designed to look at fistulae, specifically,” said Dr. Osterman, associate professor of medicine in the division of gastroenterology at the University of Pennsylvania in Philadelphia.

Dr. Osterman shared his own approach to medical treatment of perianal fistulae in a presentation he gave at Digestive Diseases: New Advances, jointly provided by Rutgers and Global Academy for Medical Education.

For simple perianal fistula with no rectal inflammation, a fistulotomy is reasonable, but medical treatment may be preferable, Dr. Osterman said.

“I always favor medical therapy because it attacks the root of the problem, which is the immune system,” he explained.

Helpful treatments in this scenario include antibiotics, along with anti–tumor necrosis factor therapy with or without immunomodulators, he said.

Antibiotic use in this setting is based on uncontrolled data, and efficacy is modest at best, according to Dr. Osterman, who noted that the treatments may reduce fistula drainage but likely do not heal fistulae.

The most commonly used antibiotics are metronidazole and ciprofloxacin given for up to 2-4 months, he added.

PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.

The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.

Andrew D. Bowser/MDedge News

[email protected]

PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.

The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.

Andrew D. Bowser/MDedge News

[email protected]

PHILADELPHIA – While traditional elimination diets for eosinophilic esophagitis are highly restrictive and endoscopically intensive, a new “step-up” approach may offer a superior empiric scheme for identifying food triggers, according to Stuart J. Spechler, MD.

The recently described step-up approach may be preferable to the standard empiric six-food elimination diet, which has a 72% success rate but is challenging to implement, according to Dr. Spechler, chief of the division of gastroenterology, Baylor University Medical Center at Dallas.

Andrew D. Bowser/MDedge News

[email protected]

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

Jupiterimages/Thinkstock

[email protected]

SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

Jupiterimages/Thinkstock

[email protected]

SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

Axial spondyloarthritis (axSpA) disease activity in pregnant women appears to remain mostly stable, with slight worsening in the second trimester, according to results of a prospective study.

“In the largest prospective study to date exploring disease activity during pregnancy in women with axSpA, we found that the majority experienced stable, low disease activity,” Kristin Ursin, MD, of the Trondheim (Norway) University Hospital and her associates wrote in Rheumatology. “In accordance with two previous studies, we found a small increase in disease activity in the second trimester.”

Jupiterimages/Thinkstock

[email protected]

SOURCE: Ursin K et al. Rheumatology. 2018 Mar 14. doi: 10.1093/rheumatology/key047.

A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.

To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.

Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.

The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.

In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”

Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.

Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.

[email protected]

SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.

A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.

To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.

Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.

The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.

In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”

Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.

Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.

[email protected]

SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.

A new study seeks to elucidate disparities in the binge drinking habits of U.S. adults.

To its authors’ knowledge, the study by Dafna Kanny, PhD, and her coinvestigators is the first to assess total binge drinks consumed, in contrast with other studies that have assessed prevalence alone. This total binge drinks consumed measure is calculated by multiplying the intensity of drinking (greatest number of drinks consumed on one binge-drinking occasion) by the frequency of binge drinking.

Using this measure, Dr. Kanny and her coinvestigators found that 17.1% of U.S. adults reported consuming 17.5 billion total binge drinks, or 470 binge drinks per binge drinker in 2015.

The measure also led to insight into drinking patterns among different U.S. demographic groups. For example, while binge drinking was more common among people aged 18-34 years, half of all binge drinks were consumed by people older than 35 years – which reinforces the notion that binge drinking is a lifelong issue. The researchers also found that, while binge drinking was less common among people with lower incomes and educational attainment, they consumed a higher “total annual number of binge drinks per binge drinker” than did people with higher incomes and educational attainment, Dr. Kanny, of the Centers for Disease Control and Prevention, and her coinvestigators, reported in the American Journal of Preventive Medicine.

In addition to finding disparities among demographic groups, the investigators found disparities between different geographical regions of the country. “The highest annual number of total binge drinks per drinker was reported in Arkansas (841.0), Mississippi (831.8), Kentucky (652.8), and Hawaii (611.7),” they wrote. “Notably, total annual binge drinks per binge drinker and per adult were generally higher in the Mississippi River Valley than in other regions.”

Assessing binge-drinking prevalence alone does not capture some disparities in binge-drinking behavior, the coinvestigators concluded. “Monitoring total binge drinks consumed annually and total binge drinks per binge drinker” could not only overcome those limitations but also help implement approaches to reducing binge drinking and alcohol-related harms.

Dr. Kanny and her coinvestigators reported that their findings “do not necessarily represent the official position” of the CDC. They reported no financial disclosures.

[email protected]

SOURCE: Kanny D et al. Am J Prev Med. 2018;54(4):486-96.

Patients with obstructive sleep apnea can be grouped into distinct clinical subtypes that differ in response to positive airway pressure treatment, according to two studies published in the March issue of the journal Sleep.

In the first study, investigators evaluated whether patients in different clinical clusters responded differently to positive airway pressure (PAP) treatment. Authors identified 706 patients with moderate to severe obstructive sleep apnea (OSA) from the Icelandic Sleep Apnea Cohort. All patients completed a sleep study prior to starting PAP treatment, and completed questionnaires to assess symptoms. Patients were grouped into one of three clusters based on symptomatology: disturbed sleep, minimally symptomatic, or sleepy, wrote Grace W. Pien, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and her coauthors.

Tab1962/iStockphoto.com

SOURCES: Pien GW et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx201; Keenan BT et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx214.

Patients with obstructive sleep apnea can be grouped into distinct clinical subtypes that differ in response to positive airway pressure treatment, according to two studies published in the March issue of the journal Sleep.

In the first study, investigators evaluated whether patients in different clinical clusters responded differently to positive airway pressure (PAP) treatment. Authors identified 706 patients with moderate to severe obstructive sleep apnea (OSA) from the Icelandic Sleep Apnea Cohort. All patients completed a sleep study prior to starting PAP treatment, and completed questionnaires to assess symptoms. Patients were grouped into one of three clusters based on symptomatology: disturbed sleep, minimally symptomatic, or sleepy, wrote Grace W. Pien, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and her coauthors.

Tab1962/iStockphoto.com

SOURCES: Pien GW et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx201; Keenan BT et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx214.

Patients with obstructive sleep apnea can be grouped into distinct clinical subtypes that differ in response to positive airway pressure treatment, according to two studies published in the March issue of the journal Sleep.

In the first study, investigators evaluated whether patients in different clinical clusters responded differently to positive airway pressure (PAP) treatment. Authors identified 706 patients with moderate to severe obstructive sleep apnea (OSA) from the Icelandic Sleep Apnea Cohort. All patients completed a sleep study prior to starting PAP treatment, and completed questionnaires to assess symptoms. Patients were grouped into one of three clusters based on symptomatology: disturbed sleep, minimally symptomatic, or sleepy, wrote Grace W. Pien, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and her coauthors.

Tab1962/iStockphoto.com

SOURCES: Pien GW et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx201; Keenan BT et al. Sleep. 2018 Mar. doi: 10.1093/sleep/zsx214.

Socioeconomic status, as measured by insurance status, was associated with survival among patients with non–small cell lung cancer (NSCLC) and pretreatment cancer-associated weight loss, in a retrospective review of medical records.

Investigators identified 1,366 patients with NSCLC who had been consecutively treated at a tertiary care health system between Jan. 1, 2006, and Dec. 31, 2013, and obtained their insurance status from an institutional tumor registry.

Cancer-associated weight loss was present at the time of diagnosis in 30% of the patients. Among those patients with pretreatment weight loss, uninsured patients had worse survival compared with those who had private insurance (hazard ratio, 1.63; 95% confidence interval, 1.14-2.35). However, no association was found for patients without pretreatment weight loss, wrote Steven Lau, MD, of the University of Texas Southwestern Medical Center, Dallas, and his associates. The report was published in the Journal of Oncology Practice.

After the researchers controlled for other prognostic factors, Medicaid insurance (odds ratio, 2.17; 95% CI, 1.42-3.30) and lack of insurance (OR, 2.32; 95% CI, 1.50-3.58) were independently associated with pretreatment weight loss.

“Patients with NSCLC of lower SES as measured by primary payer are disproportionately affected by cancer-associated weight loss, which in turn is prognostic of diminished survival ... These findings suggest early recognition and management of cachexia, even at the time of cancer diagnosis, could result in improved survival,” Dr. Lau and his associates concluded.

The study was supported in part by National Center for Advancing Translational Sciences grants TL1TR001104 and UL1TR001105. Dr. Lau reported employment with LabCorp by an immediate family member. Coauthors reported financial ties to Advenchen Laboratories, Macrogen, Peregrine Pharmaceuticals, and DFINE.

SOURCE: Lau S et al. J Oncol Pract. 2018 Mar 20. doi: 10.1200/JOP.2017.025239

Socioeconomic status, as measured by insurance status, was associated with survival among patients with non–small cell lung cancer (NSCLC) and pretreatment cancer-associated weight loss, in a retrospective review of medical records.

Investigators identified 1,366 patients with NSCLC who had been consecutively treated at a tertiary care health system between Jan. 1, 2006, and Dec. 31, 2013, and obtained their insurance status from an institutional tumor registry.

Cancer-associated weight loss was present at the time of diagnosis in 30% of the patients. Among those patients with pretreatment weight loss, uninsured patients had worse survival compared with those who had private insurance (hazard ratio, 1.63; 95% confidence interval, 1.14-2.35). However, no association was found for patients without pretreatment weight loss, wrote Steven Lau, MD, of the University of Texas Southwestern Medical Center, Dallas, and his associates. The report was published in the Journal of Oncology Practice.

After the researchers controlled for other prognostic factors, Medicaid insurance (odds ratio, 2.17; 95% CI, 1.42-3.30) and lack of insurance (OR, 2.32; 95% CI, 1.50-3.58) were independently associated with pretreatment weight loss.

“Patients with NSCLC of lower SES as measured by primary payer are disproportionately affected by cancer-associated weight loss, which in turn is prognostic of diminished survival ... These findings suggest early recognition and management of cachexia, even at the time of cancer diagnosis, could result in improved survival,” Dr. Lau and his associates concluded.

The study was supported in part by National Center for Advancing Translational Sciences grants TL1TR001104 and UL1TR001105. Dr. Lau reported employment with LabCorp by an immediate family member. Coauthors reported financial ties to Advenchen Laboratories, Macrogen, Peregrine Pharmaceuticals, and DFINE.

SOURCE: Lau S et al. J Oncol Pract. 2018 Mar 20. doi: 10.1200/JOP.2017.025239

Socioeconomic status, as measured by insurance status, was associated with survival among patients with non–small cell lung cancer (NSCLC) and pretreatment cancer-associated weight loss, in a retrospective review of medical records.

Investigators identified 1,366 patients with NSCLC who had been consecutively treated at a tertiary care health system between Jan. 1, 2006, and Dec. 31, 2013, and obtained their insurance status from an institutional tumor registry.

Cancer-associated weight loss was present at the time of diagnosis in 30% of the patients. Among those patients with pretreatment weight loss, uninsured patients had worse survival compared with those who had private insurance (hazard ratio, 1.63; 95% confidence interval, 1.14-2.35). However, no association was found for patients without pretreatment weight loss, wrote Steven Lau, MD, of the University of Texas Southwestern Medical Center, Dallas, and his associates. The report was published in the Journal of Oncology Practice.

After the researchers controlled for other prognostic factors, Medicaid insurance (odds ratio, 2.17; 95% CI, 1.42-3.30) and lack of insurance (OR, 2.32; 95% CI, 1.50-3.58) were independently associated with pretreatment weight loss.

“Patients with NSCLC of lower SES as measured by primary payer are disproportionately affected by cancer-associated weight loss, which in turn is prognostic of diminished survival ... These findings suggest early recognition and management of cachexia, even at the time of cancer diagnosis, could result in improved survival,” Dr. Lau and his associates concluded.

The study was supported in part by National Center for Advancing Translational Sciences grants TL1TR001104 and UL1TR001105. Dr. Lau reported employment with LabCorp by an immediate family member. Coauthors reported financial ties to Advenchen Laboratories, Macrogen, Peregrine Pharmaceuticals, and DFINE.

SOURCE: Lau S et al. J Oncol Pract. 2018 Mar 20. doi: 10.1200/JOP.2017.025239