Tech Summit

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, AGA convened a panel of payer medical directors to shed light on what it takes to get coverage and reimbursement for a new device or procedure. Data is king! Companies need to show durable and sustainable efficacy of their technology through relatively large, well-designed studies that include both commercial and Medicare patient populations, demonstrating an improvement in outcomes over several years duration, and publish the results in peer-reviewed journals.

Payer representatives included:

Arthur Lurvey, MD, FACP, FACE, Contractor Medical Director, Noridian Healthcare Solutions, LLC, which administers Medicare plans

John L. Fox, MD, MHA, Senior Medical Director and Associate Vice President, Medical Affairs, Priority Health, which administers Medicare, Medicaid, and private health plans

John S. Yao, MD, MPH, MBA, MPA, FACP, Staff Vice President of Medical Policy, Anthem Inc., which administers Medicare, federal employee, and private health plans

1) What should a device manufacturer be thinking about when trying to generate the evidence necessary to ensure coverage for a new device?

Dr. Yao

Clearly, we would all like to see well-designed, well-powered, randomized controlled trials with statistically significant results. But we recognize that this is not always possible in the real world. From the coverage perspective, we are looking for objective evidence, which includes not only analytical validity of the device, but also both clinical validity and clinical utility.

Dr. Lurvey

We look at journals, white papers, and technical assessments, particularly by parties who are not associated with the manufacturer – because we know if it comes from the manufacturer they are going to want to make it look good.

As far as publications, we want data published in reputable journals. There are plenty of journals that will publish anything for $500. This isn’t what we’re looking for. We want quality studies published in quality journals. We see a lot of noninferiority trials concluding that “My product is as good as everyone else’s,” but that is not helpful – you should be looking for equivalence at a minimum, or superiority. Another big problem is endpoints – we need clinically meaningful, primary endpoints, not secondary or tertiary endpoints. We look for input from specialty societies, such as AGA.

When we are looking at journal articles by impartial experts, we are influenced by their concluding remarks, especially if they recommend further study. If the experts don’t think it’s ready for prime time, then we don’t either.

We also like to see a wider patient population. Very few studies deal with people older than 65, so we don’t know how effective or harmful your device would be to the Medicare population, people who are older, or medically fragile.

Dr. Fox

Those who design studies need to design them around a clinically meaningful primary endpoint, and physicians will have to decide what that is. We can’t just have a statistically significant endpoint. It has to mean something to patients. We want evidence of outcomes that show this device is making a difference in patients’ lives – not just in patient scores. Do they feel better? Does it cut down on the need for additional procedures or treatments? Is there evidence that it’s a good alternative to a more expensive therapy? Does it produce a better outcome with a lower cost? How are physicians going to use the device, and how will it change their management of patients?

If you can’t come to the table with information like that, I’ll be playing defense against something that isn’t really helping patients and may be costing them more.

2) What do you look for in terms of durability of effect?

Dr. Yao

We want to see technology that can be replicated consistently in a real-world practice setting, not just in the ideal setting of a clinical trial or in tertiary care centers with strict protocols and ideal patient populations.

As far as long-term safety, we get a lot of requests from device manufacturers who have 6-month data. With a brand new innovation, we feel 6 months is not long enough. We would like to see at least 1-2 year follow-up data with good results and no adverse events. For example, there was a very highly anticipated implant for postprostatectomy urinary incontinence where the data initially looked very good. But as longer-term data became available, the reimplantation rate was about 25%, and this turned out to be a very invasive procedure. You don’t get this with only 6 months of observation.

[email protected]

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, AGA convened a panel of payer medical directors to shed light on what it takes to get coverage and reimbursement for a new device or procedure. Data is king! Companies need to show durable and sustainable efficacy of their technology through relatively large, well-designed studies that include both commercial and Medicare patient populations, demonstrating an improvement in outcomes over several years duration, and publish the results in peer-reviewed journals.

Payer representatives included:

Arthur Lurvey, MD, FACP, FACE, Contractor Medical Director, Noridian Healthcare Solutions, LLC, which administers Medicare plans

John L. Fox, MD, MHA, Senior Medical Director and Associate Vice President, Medical Affairs, Priority Health, which administers Medicare, Medicaid, and private health plans

John S. Yao, MD, MPH, MBA, MPA, FACP, Staff Vice President of Medical Policy, Anthem Inc., which administers Medicare, federal employee, and private health plans

1) What should a device manufacturer be thinking about when trying to generate the evidence necessary to ensure coverage for a new device?

Dr. Yao

Clearly, we would all like to see well-designed, well-powered, randomized controlled trials with statistically significant results. But we recognize that this is not always possible in the real world. From the coverage perspective, we are looking for objective evidence, which includes not only analytical validity of the device, but also both clinical validity and clinical utility.

Dr. Lurvey

We look at journals, white papers, and technical assessments, particularly by parties who are not associated with the manufacturer – because we know if it comes from the manufacturer they are going to want to make it look good.

As far as publications, we want data published in reputable journals. There are plenty of journals that will publish anything for $500. This isn’t what we’re looking for. We want quality studies published in quality journals. We see a lot of noninferiority trials concluding that “My product is as good as everyone else’s,” but that is not helpful – you should be looking for equivalence at a minimum, or superiority. Another big problem is endpoints – we need clinically meaningful, primary endpoints, not secondary or tertiary endpoints. We look for input from specialty societies, such as AGA.

When we are looking at journal articles by impartial experts, we are influenced by their concluding remarks, especially if they recommend further study. If the experts don’t think it’s ready for prime time, then we don’t either.

We also like to see a wider patient population. Very few studies deal with people older than 65, so we don’t know how effective or harmful your device would be to the Medicare population, people who are older, or medically fragile.

Dr. Fox

Those who design studies need to design them around a clinically meaningful primary endpoint, and physicians will have to decide what that is. We can’t just have a statistically significant endpoint. It has to mean something to patients. We want evidence of outcomes that show this device is making a difference in patients’ lives – not just in patient scores. Do they feel better? Does it cut down on the need for additional procedures or treatments? Is there evidence that it’s a good alternative to a more expensive therapy? Does it produce a better outcome with a lower cost? How are physicians going to use the device, and how will it change their management of patients?

If you can’t come to the table with information like that, I’ll be playing defense against something that isn’t really helping patients and may be costing them more.

2) What do you look for in terms of durability of effect?

Dr. Yao

We want to see technology that can be replicated consistently in a real-world practice setting, not just in the ideal setting of a clinical trial or in tertiary care centers with strict protocols and ideal patient populations.

As far as long-term safety, we get a lot of requests from device manufacturers who have 6-month data. With a brand new innovation, we feel 6 months is not long enough. We would like to see at least 1-2 year follow-up data with good results and no adverse events. For example, there was a very highly anticipated implant for postprostatectomy urinary incontinence where the data initially looked very good. But as longer-term data became available, the reimplantation rate was about 25%, and this turned out to be a very invasive procedure. You don’t get this with only 6 months of observation.

[email protected]

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, AGA convened a panel of payer medical directors to shed light on what it takes to get coverage and reimbursement for a new device or procedure. Data is king! Companies need to show durable and sustainable efficacy of their technology through relatively large, well-designed studies that include both commercial and Medicare patient populations, demonstrating an improvement in outcomes over several years duration, and publish the results in peer-reviewed journals.

Payer representatives included:

Arthur Lurvey, MD, FACP, FACE, Contractor Medical Director, Noridian Healthcare Solutions, LLC, which administers Medicare plans

John L. Fox, MD, MHA, Senior Medical Director and Associate Vice President, Medical Affairs, Priority Health, which administers Medicare, Medicaid, and private health plans

John S. Yao, MD, MPH, MBA, MPA, FACP, Staff Vice President of Medical Policy, Anthem Inc., which administers Medicare, federal employee, and private health plans

1) What should a device manufacturer be thinking about when trying to generate the evidence necessary to ensure coverage for a new device?

Dr. Yao

Clearly, we would all like to see well-designed, well-powered, randomized controlled trials with statistically significant results. But we recognize that this is not always possible in the real world. From the coverage perspective, we are looking for objective evidence, which includes not only analytical validity of the device, but also both clinical validity and clinical utility.

Dr. Lurvey

We look at journals, white papers, and technical assessments, particularly by parties who are not associated with the manufacturer – because we know if it comes from the manufacturer they are going to want to make it look good.

As far as publications, we want data published in reputable journals. There are plenty of journals that will publish anything for $500. This isn’t what we’re looking for. We want quality studies published in quality journals. We see a lot of noninferiority trials concluding that “My product is as good as everyone else’s,” but that is not helpful – you should be looking for equivalence at a minimum, or superiority. Another big problem is endpoints – we need clinically meaningful, primary endpoints, not secondary or tertiary endpoints. We look for input from specialty societies, such as AGA.

When we are looking at journal articles by impartial experts, we are influenced by their concluding remarks, especially if they recommend further study. If the experts don’t think it’s ready for prime time, then we don’t either.

We also like to see a wider patient population. Very few studies deal with people older than 65, so we don’t know how effective or harmful your device would be to the Medicare population, people who are older, or medically fragile.

Dr. Fox

Those who design studies need to design them around a clinically meaningful primary endpoint, and physicians will have to decide what that is. We can’t just have a statistically significant endpoint. It has to mean something to patients. We want evidence of outcomes that show this device is making a difference in patients’ lives – not just in patient scores. Do they feel better? Does it cut down on the need for additional procedures or treatments? Is there evidence that it’s a good alternative to a more expensive therapy? Does it produce a better outcome with a lower cost? How are physicians going to use the device, and how will it change their management of patients?

If you can’t come to the table with information like that, I’ll be playing defense against something that isn’t really helping patients and may be costing them more.

2) What do you look for in terms of durability of effect?

Dr. Yao

We want to see technology that can be replicated consistently in a real-world practice setting, not just in the ideal setting of a clinical trial or in tertiary care centers with strict protocols and ideal patient populations.

As far as long-term safety, we get a lot of requests from device manufacturers who have 6-month data. With a brand new innovation, we feel 6 months is not long enough. We would like to see at least 1-2 year follow-up data with good results and no adverse events. For example, there was a very highly anticipated implant for postprostatectomy urinary incontinence where the data initially looked very good. But as longer-term data became available, the reimplantation rate was about 25%, and this turned out to be a very invasive procedure. You don’t get this with only 6 months of observation.

[email protected]

SAN FRANCISCO – Colonoscopy may be the most commonly used technique to screen for colorectal cancer in the United States, but it’s far from perfect, according to Dr. David A. Lieberman.

For one thing, serious complications occur in 3-5 per 1,000 procedures at 30 days of follow-up, “and if you look at individuals over 65, the rates almost double in terms of serious complications,” Dr. Lieberman, chief of the division of gastroenterology and hepatology at Oregon Health and Science University, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology. “The rate of perforation over age 65 is about 1 per 1,000,” he said.

Colonoscopy is invasive, “and it would never be conceived of as the ideal test for population-based screening,” he added. “It’s expensive, and [clinicians] in many countries simply do not have the resources and expertise to do it.”

Compared with current screening rates in the United States for cervical and breast cancer, a “screening gap” exists in the percentage of adults who are up to date in tests for colorectal cancer, he said. “If you look at what’s been accomplished with cervical cancer screening and mammography, we see that there’s a ways to go for colonoscopy,” he said.

The ideal screening test for colorectal cancer would accurately identify individuals at risk for colon cancer at an early, preventable stage, Dr. Lieberman said. That prevention element “really averts the downstream colon cancer care costs, which would be very attractive in a single-payer health care system,” he said. “If we had a system that took care of us for life, that system would be very invested in trying to prevent colon cancer, because [it would] be worried about those downstream costs.”

One potential alternative to colonoscopy is fecal immunochemical testing (FIT). A recent meta-analysis suggested that FIT detected cancer with a 79% sensitivity (Ann. Intern. Med. 2014;160:171-81), and a separate, recent prospective study found a 74% sensitivity rate in detecting cancer, but a 24% sensitivity rate in detecting advanced adenoma (N. Engl. J. Med. 2014;370:1287-97). “So in terms of early detection, FIT is pretty good,” Dr. Lieberman said. “In terms of cancer prevention? Maybe not so good. There are also issues around the testing program, which requires adherence to both positive and negative tests. Some of these behavioral factors play a major role in the actual effectiveness. So you can have a great test, but if it’s not getting done properly then there’s going to be an issue. There is some potential for CRC prevention, but it’s going to be less than for some others.”

What about stool DNA? A landmark study found that stool DNA detected cancer with a sensitivity of 92%, compared with FIT at 74% (N. Engl. J Med. 2014;370:1287-97). However, the sensitivity for detecting adenomas was relatively low for both methods (42% for stool DNA, compared with 24% for FIT). Stool DNA testing “appears to be an effective screening test [but] the appropriate interval for testing is still uncertain,” Dr. Lieberman said. “The recommendation is a 3-year interval.”

He characterized serum testing as the “holy grail” of screening for colorectal cancer, “because it would be ideal to have a noninvasive test. You’d come in, get a blood draw, and get risk stratified. There are a number of different possible pathways, one looking at specific genetic markers, others looking at genetic fingerprinting: in other words, seeing a pattern of genes that are associated with colon cancer versus patients who do not have colon cancer. Proteomics is another fingerprinting technique, as is metabolomics: looking at a variety of metabolites that may be altered by the presence of having neoplasia. This is an intriguing area but so far there hasn’t been a lot of data.”

To date, the most progress involved in this area involves molecular tests of DNA or proteins. “These studies are all relatively small and somewhat promising in terms of cancer sensitivity, but not so great for adenoma sensitivity,” he said. “It’s fair to say that this is still a work in progress.”

Dr. Lieberman reported having served on the scientific advisory board of Exact Sciences.

In a separate presentation, Dr. Uri Ladabaum updated attendees on the status of PillCam, also known as colon capsule endoscopy (CCE), for detecting colon cancer. The PillCam is cleared by the Food and Drug Administration for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, or if a complete evaluation of the colon was not technically possible. In a large meta-analysis, the first-generation PillCam achieved a sensitivity of 71% and a specificity of 75% in detecting polyps of any size and a sensitivity of 68% and a specificity of 82% in detecting polyps 6 mm in size or larger (Clin. Gastroenterol. Hepatol. 2010;8:515-22). “The results were somewhat disappointing for a test like this, not hitting the bar that we would want,” said Dr. Ladabaum, professor of medicine in the division of gastroenterology and hepatology at Stanford (Calif.) University.

The second generation PillCam features an improved angle of the imagers, from 156 degrees to 172 degrees, “so you get a bigger view all the way around,” he said. Another new feature is an adaptive imaging rate. The first-generation device captured 4 images per second regardless of where the capsule was moving. The new system “goes at 4 images per second when stationary, goes as fast as 35 imagers per second while moving, and 14 images per second before it reaches the small bowel,” Dr. Ladabaum said.

In an early study of the second-generation system, the device achieved a sensitivity of 89% and a specificity of 76% in detecting polyps of 6 mm in size or larger and a sensitivity of 88% and a specificity of 89% in detecting polyps 10 mm in size or larger (Endoscopy 2009;41:1026-31).

More recently, researchers examined consecutive patients who had incomplete colonoscopy and compared a follow-up with either second-generation CCE or CT colonography (Gut 2015;64:272-81). The diagnostic yield of CCE and CT colonography was 25% and 12%, respectively, for polyps 6 mm or larger and 5% vs. 3% for polyps 10 mm or larger.

In a larger, multisite study, researchers examined the efficacy of the second-generation PillCam as a primary screening tool (Gastroenterology 2015 [doi:10.1053/j.gastro.2015.01.025). Of 884 subjects enrolled, 85 were excluded from the analysis for a variety of reasons. Of these, 12 were excluded because the capsule did not reach the colon within 12 hours and 8 were excluded because the capsule did not pass the cecum within 12 hours. “So if used in practice, we’ll see this – [incomplete capsule studies],” Dr. Ladabaum said.

In addition, 77 were excluded for inadequate cleansing and capsule transit time through the colon in less than 40 minutes. “Maybe that’s due to the booster regimen,” he said. “There are still some things to work out in the bowel prep. Overall, there were a good number of people [in this study] who didn’t really have the exam [completed as intended]. Is that going to pan out as a big problem in clinical practice? That remains to be seen.”

The study found that the second-generation PillCam achieved a sensitivity of 87% and a specificity of 94% in detecting polyps 6 mm or larger and a sensitivity of 85% and a specificity of 97% in detecting polyps 10 mm in size or larger. “Is this good enough for this kind of technology?” Dr. Ladabaum asked. “There’s lots of room for debate here. Interestingly, the numbers for sessile serrated polyps didn’t look that good” (a sensitivity of 29% for polyps 6 mm in size or greater and 33% for polyps 10 mm in size or greater).

Dr. Ladabaum disclosed that he has served as a consultant for Given Imaging and Exact Sciences. He has also served on the advisory board for Mauna Kea Technologies.

In conclusion, according to Dr. Lieberman, there are several feasible alternatives to colonoscopy for primary colon cancer screening in average-risk individuals. Each has advantages and limitations and offers a less invasive approach to screening. The bar for screening has been raised from early cancer detection alone to both early detection and prevention. These less invasive tests will be expected to achieve accurate detection of individuals with early stage colon cancer and those at risk for colon cancer.

[email protected]

SAN FRANCISCO – Colonoscopy may be the most commonly used technique to screen for colorectal cancer in the United States, but it’s far from perfect, according to Dr. David A. Lieberman.

For one thing, serious complications occur in 3-5 per 1,000 procedures at 30 days of follow-up, “and if you look at individuals over 65, the rates almost double in terms of serious complications,” Dr. Lieberman, chief of the division of gastroenterology and hepatology at Oregon Health and Science University, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology. “The rate of perforation over age 65 is about 1 per 1,000,” he said.

Colonoscopy is invasive, “and it would never be conceived of as the ideal test for population-based screening,” he added. “It’s expensive, and [clinicians] in many countries simply do not have the resources and expertise to do it.”

Compared with current screening rates in the United States for cervical and breast cancer, a “screening gap” exists in the percentage of adults who are up to date in tests for colorectal cancer, he said. “If you look at what’s been accomplished with cervical cancer screening and mammography, we see that there’s a ways to go for colonoscopy,” he said.

The ideal screening test for colorectal cancer would accurately identify individuals at risk for colon cancer at an early, preventable stage, Dr. Lieberman said. That prevention element “really averts the downstream colon cancer care costs, which would be very attractive in a single-payer health care system,” he said. “If we had a system that took care of us for life, that system would be very invested in trying to prevent colon cancer, because [it would] be worried about those downstream costs.”

One potential alternative to colonoscopy is fecal immunochemical testing (FIT). A recent meta-analysis suggested that FIT detected cancer with a 79% sensitivity (Ann. Intern. Med. 2014;160:171-81), and a separate, recent prospective study found a 74% sensitivity rate in detecting cancer, but a 24% sensitivity rate in detecting advanced adenoma (N. Engl. J. Med. 2014;370:1287-97). “So in terms of early detection, FIT is pretty good,” Dr. Lieberman said. “In terms of cancer prevention? Maybe not so good. There are also issues around the testing program, which requires adherence to both positive and negative tests. Some of these behavioral factors play a major role in the actual effectiveness. So you can have a great test, but if it’s not getting done properly then there’s going to be an issue. There is some potential for CRC prevention, but it’s going to be less than for some others.”

What about stool DNA? A landmark study found that stool DNA detected cancer with a sensitivity of 92%, compared with FIT at 74% (N. Engl. J Med. 2014;370:1287-97). However, the sensitivity for detecting adenomas was relatively low for both methods (42% for stool DNA, compared with 24% for FIT). Stool DNA testing “appears to be an effective screening test [but] the appropriate interval for testing is still uncertain,” Dr. Lieberman said. “The recommendation is a 3-year interval.”

He characterized serum testing as the “holy grail” of screening for colorectal cancer, “because it would be ideal to have a noninvasive test. You’d come in, get a blood draw, and get risk stratified. There are a number of different possible pathways, one looking at specific genetic markers, others looking at genetic fingerprinting: in other words, seeing a pattern of genes that are associated with colon cancer versus patients who do not have colon cancer. Proteomics is another fingerprinting technique, as is metabolomics: looking at a variety of metabolites that may be altered by the presence of having neoplasia. This is an intriguing area but so far there hasn’t been a lot of data.”

To date, the most progress involved in this area involves molecular tests of DNA or proteins. “These studies are all relatively small and somewhat promising in terms of cancer sensitivity, but not so great for adenoma sensitivity,” he said. “It’s fair to say that this is still a work in progress.”

Dr. Lieberman reported having served on the scientific advisory board of Exact Sciences.

In a separate presentation, Dr. Uri Ladabaum updated attendees on the status of PillCam, also known as colon capsule endoscopy (CCE), for detecting colon cancer. The PillCam is cleared by the Food and Drug Administration for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, or if a complete evaluation of the colon was not technically possible. In a large meta-analysis, the first-generation PillCam achieved a sensitivity of 71% and a specificity of 75% in detecting polyps of any size and a sensitivity of 68% and a specificity of 82% in detecting polyps 6 mm in size or larger (Clin. Gastroenterol. Hepatol. 2010;8:515-22). “The results were somewhat disappointing for a test like this, not hitting the bar that we would want,” said Dr. Ladabaum, professor of medicine in the division of gastroenterology and hepatology at Stanford (Calif.) University.

The second generation PillCam features an improved angle of the imagers, from 156 degrees to 172 degrees, “so you get a bigger view all the way around,” he said. Another new feature is an adaptive imaging rate. The first-generation device captured 4 images per second regardless of where the capsule was moving. The new system “goes at 4 images per second when stationary, goes as fast as 35 imagers per second while moving, and 14 images per second before it reaches the small bowel,” Dr. Ladabaum said.

In an early study of the second-generation system, the device achieved a sensitivity of 89% and a specificity of 76% in detecting polyps of 6 mm in size or larger and a sensitivity of 88% and a specificity of 89% in detecting polyps 10 mm in size or larger (Endoscopy 2009;41:1026-31).

More recently, researchers examined consecutive patients who had incomplete colonoscopy and compared a follow-up with either second-generation CCE or CT colonography (Gut 2015;64:272-81). The diagnostic yield of CCE and CT colonography was 25% and 12%, respectively, for polyps 6 mm or larger and 5% vs. 3% for polyps 10 mm or larger.

In a larger, multisite study, researchers examined the efficacy of the second-generation PillCam as a primary screening tool (Gastroenterology 2015 [doi:10.1053/j.gastro.2015.01.025). Of 884 subjects enrolled, 85 were excluded from the analysis for a variety of reasons. Of these, 12 were excluded because the capsule did not reach the colon within 12 hours and 8 were excluded because the capsule did not pass the cecum within 12 hours. “So if used in practice, we’ll see this – [incomplete capsule studies],” Dr. Ladabaum said.

In addition, 77 were excluded for inadequate cleansing and capsule transit time through the colon in less than 40 minutes. “Maybe that’s due to the booster regimen,” he said. “There are still some things to work out in the bowel prep. Overall, there were a good number of people [in this study] who didn’t really have the exam [completed as intended]. Is that going to pan out as a big problem in clinical practice? That remains to be seen.”

The study found that the second-generation PillCam achieved a sensitivity of 87% and a specificity of 94% in detecting polyps 6 mm or larger and a sensitivity of 85% and a specificity of 97% in detecting polyps 10 mm in size or larger. “Is this good enough for this kind of technology?” Dr. Ladabaum asked. “There’s lots of room for debate here. Interestingly, the numbers for sessile serrated polyps didn’t look that good” (a sensitivity of 29% for polyps 6 mm in size or greater and 33% for polyps 10 mm in size or greater).

Dr. Ladabaum disclosed that he has served as a consultant for Given Imaging and Exact Sciences. He has also served on the advisory board for Mauna Kea Technologies.

In conclusion, according to Dr. Lieberman, there are several feasible alternatives to colonoscopy for primary colon cancer screening in average-risk individuals. Each has advantages and limitations and offers a less invasive approach to screening. The bar for screening has been raised from early cancer detection alone to both early detection and prevention. These less invasive tests will be expected to achieve accurate detection of individuals with early stage colon cancer and those at risk for colon cancer.

[email protected]

SAN FRANCISCO – Colonoscopy may be the most commonly used technique to screen for colorectal cancer in the United States, but it’s far from perfect, according to Dr. David A. Lieberman.

For one thing, serious complications occur in 3-5 per 1,000 procedures at 30 days of follow-up, “and if you look at individuals over 65, the rates almost double in terms of serious complications,” Dr. Lieberman, chief of the division of gastroenterology and hepatology at Oregon Health and Science University, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology. “The rate of perforation over age 65 is about 1 per 1,000,” he said.

Colonoscopy is invasive, “and it would never be conceived of as the ideal test for population-based screening,” he added. “It’s expensive, and [clinicians] in many countries simply do not have the resources and expertise to do it.”

Compared with current screening rates in the United States for cervical and breast cancer, a “screening gap” exists in the percentage of adults who are up to date in tests for colorectal cancer, he said. “If you look at what’s been accomplished with cervical cancer screening and mammography, we see that there’s a ways to go for colonoscopy,” he said.

The ideal screening test for colorectal cancer would accurately identify individuals at risk for colon cancer at an early, preventable stage, Dr. Lieberman said. That prevention element “really averts the downstream colon cancer care costs, which would be very attractive in a single-payer health care system,” he said. “If we had a system that took care of us for life, that system would be very invested in trying to prevent colon cancer, because [it would] be worried about those downstream costs.”

One potential alternative to colonoscopy is fecal immunochemical testing (FIT). A recent meta-analysis suggested that FIT detected cancer with a 79% sensitivity (Ann. Intern. Med. 2014;160:171-81), and a separate, recent prospective study found a 74% sensitivity rate in detecting cancer, but a 24% sensitivity rate in detecting advanced adenoma (N. Engl. J. Med. 2014;370:1287-97). “So in terms of early detection, FIT is pretty good,” Dr. Lieberman said. “In terms of cancer prevention? Maybe not so good. There are also issues around the testing program, which requires adherence to both positive and negative tests. Some of these behavioral factors play a major role in the actual effectiveness. So you can have a great test, but if it’s not getting done properly then there’s going to be an issue. There is some potential for CRC prevention, but it’s going to be less than for some others.”

What about stool DNA? A landmark study found that stool DNA detected cancer with a sensitivity of 92%, compared with FIT at 74% (N. Engl. J Med. 2014;370:1287-97). However, the sensitivity for detecting adenomas was relatively low for both methods (42% for stool DNA, compared with 24% for FIT). Stool DNA testing “appears to be an effective screening test [but] the appropriate interval for testing is still uncertain,” Dr. Lieberman said. “The recommendation is a 3-year interval.”

He characterized serum testing as the “holy grail” of screening for colorectal cancer, “because it would be ideal to have a noninvasive test. You’d come in, get a blood draw, and get risk stratified. There are a number of different possible pathways, one looking at specific genetic markers, others looking at genetic fingerprinting: in other words, seeing a pattern of genes that are associated with colon cancer versus patients who do not have colon cancer. Proteomics is another fingerprinting technique, as is metabolomics: looking at a variety of metabolites that may be altered by the presence of having neoplasia. This is an intriguing area but so far there hasn’t been a lot of data.”

To date, the most progress involved in this area involves molecular tests of DNA or proteins. “These studies are all relatively small and somewhat promising in terms of cancer sensitivity, but not so great for adenoma sensitivity,” he said. “It’s fair to say that this is still a work in progress.”

Dr. Lieberman reported having served on the scientific advisory board of Exact Sciences.

In a separate presentation, Dr. Uri Ladabaum updated attendees on the status of PillCam, also known as colon capsule endoscopy (CCE), for detecting colon cancer. The PillCam is cleared by the Food and Drug Administration for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, or if a complete evaluation of the colon was not technically possible. In a large meta-analysis, the first-generation PillCam achieved a sensitivity of 71% and a specificity of 75% in detecting polyps of any size and a sensitivity of 68% and a specificity of 82% in detecting polyps 6 mm in size or larger (Clin. Gastroenterol. Hepatol. 2010;8:515-22). “The results were somewhat disappointing for a test like this, not hitting the bar that we would want,” said Dr. Ladabaum, professor of medicine in the division of gastroenterology and hepatology at Stanford (Calif.) University.

The second generation PillCam features an improved angle of the imagers, from 156 degrees to 172 degrees, “so you get a bigger view all the way around,” he said. Another new feature is an adaptive imaging rate. The first-generation device captured 4 images per second regardless of where the capsule was moving. The new system “goes at 4 images per second when stationary, goes as fast as 35 imagers per second while moving, and 14 images per second before it reaches the small bowel,” Dr. Ladabaum said.

In an early study of the second-generation system, the device achieved a sensitivity of 89% and a specificity of 76% in detecting polyps of 6 mm in size or larger and a sensitivity of 88% and a specificity of 89% in detecting polyps 10 mm in size or larger (Endoscopy 2009;41:1026-31).

More recently, researchers examined consecutive patients who had incomplete colonoscopy and compared a follow-up with either second-generation CCE or CT colonography (Gut 2015;64:272-81). The diagnostic yield of CCE and CT colonography was 25% and 12%, respectively, for polyps 6 mm or larger and 5% vs. 3% for polyps 10 mm or larger.

In a larger, multisite study, researchers examined the efficacy of the second-generation PillCam as a primary screening tool (Gastroenterology 2015 [doi:10.1053/j.gastro.2015.01.025). Of 884 subjects enrolled, 85 were excluded from the analysis for a variety of reasons. Of these, 12 were excluded because the capsule did not reach the colon within 12 hours and 8 were excluded because the capsule did not pass the cecum within 12 hours. “So if used in practice, we’ll see this – [incomplete capsule studies],” Dr. Ladabaum said.

In addition, 77 were excluded for inadequate cleansing and capsule transit time through the colon in less than 40 minutes. “Maybe that’s due to the booster regimen,” he said. “There are still some things to work out in the bowel prep. Overall, there were a good number of people [in this study] who didn’t really have the exam [completed as intended]. Is that going to pan out as a big problem in clinical practice? That remains to be seen.”

The study found that the second-generation PillCam achieved a sensitivity of 87% and a specificity of 94% in detecting polyps 6 mm or larger and a sensitivity of 85% and a specificity of 97% in detecting polyps 10 mm in size or larger. “Is this good enough for this kind of technology?” Dr. Ladabaum asked. “There’s lots of room for debate here. Interestingly, the numbers for sessile serrated polyps didn’t look that good” (a sensitivity of 29% for polyps 6 mm in size or greater and 33% for polyps 10 mm in size or greater).

Dr. Ladabaum disclosed that he has served as a consultant for Given Imaging and Exact Sciences. He has also served on the advisory board for Mauna Kea Technologies.

In conclusion, according to Dr. Lieberman, there are several feasible alternatives to colonoscopy for primary colon cancer screening in average-risk individuals. Each has advantages and limitations and offers a less invasive approach to screening. The bar for screening has been raised from early cancer detection alone to both early detection and prevention. These less invasive tests will be expected to achieve accurate detection of individuals with early stage colon cancer and those at risk for colon cancer.

[email protected]

A successful medical device needs to bat two out of three requirements: fulfill an unmet need, be an effective treatment, and be a simple solution.

But not all of those criteria may be completely determined before the product launch, according to speakers at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Nick Piegari/Frontline Medical News

Poor marketing strategy to clinicians and payers combined with 12-month follow-up data sank an apparently promising endoscopic treatment for gastroesophageal reflux disease (the ENTERYX procedure). It was effective but technically difficult, and it was intended for patients who were already responding to medical therapy.

Aortic valve replacement, however – seemingly a much more complicated procedure requiring cardiac bypass and tiny stitches – has not only survived but also thrived, with demonstrable success and constantly evolving iterations.

Why the disparity?

Learning from failure

The ENTERYX procedure involved the circumferential injection of polymer just above the pyloric sphincter – a permanent solution for thousands of GERD patients taking proton pump inhibitors. The polymer induced inflammation and encapsulation, effectively narrowing the gastroesophageal junction and preventing reflex.

“Our preclinical studies looked great,” said Rich Cohen, who handled the project for the Boston Scientific Corporation at the time. “We were approved by the Food and Drug Administration as a Class III medical device. Our pivotal randomized trial, conducted after approval, was very good; 70% of patients were able to get off their medication.”

ENTERYX was launched in 2003, said Mr. Cohen, who is now global director of market development for the endoscopy division of Boston Scientific. Almost 4,000 patients underwent the procedure, most with very good, very stable results.

But injection precision was critical; the polymer had to be deposited intramurally. Fluoroscopy was necessary to provide real-time feedback of the deposition location. Unfortunately, this safeguard didn’t work every time, he said.

“We had good results in the hands of experts, but it never translated down, despite our required training program,” Mr. Cohen said. There were reports of chest pain and dysphagia in treated patients, another patient experienced a partial reduction in renal function due to partial embolization. Two patients died (0.05%), both due to complications from aortoenteric fistula.

In 2005, FDA issued an advisory about the procedure, and Boston Scientific voluntarily recalled it, ending its use.

Such rare complications might possibly have been acceptable for a procedure that was successful for a hard-to-treat disorder with no alternative treatment, but patients who qualified for ENTERYX were already being treated successfully with PPIs, Mr. Cohen said.

“Any time you are treating something invasively that already has a successful alternative, it’s very difficult to sell. And when you do sell it, the bar for adverse events is very, very low.”

Even before the clinical events, ENTERYX was a marketing problem child. The first stumbling block was actually a sales issue, Mr. Cohen said. Because patients were already being medically managed, most primary care providers felt there was no need for surgical or endoscopic referral, at least partially damming the flow of interest.

Reimbursement was also an issue. “Our clinical data supporting safety and efficacy were not enough to sway decision makers. We ended up having to do a randomized controlled trial after we launched. If we had to do it over again, we would tie our approval trials to [Centers for Medicare & Medicaid Services] for coding, because without that you are really facing an uphill battle for something that treats a quality-of-life disease,” Mr. Cohen said.¹

Getting premarket support from specialists is crucial. “We should have talked to physician societies before launching. Without that, it’s like pushing a boulder uphill and the minute you stop, you get run over. Even if you’ve got the best product in the world, it’s useless if patients never get treated.”

A look at success

Aortic valve replacement, on the other hand, is a perfect solution to a perfect market and clinical confluence.

Initiated in 1960, it’s grown exponentially to serve a huge global market, said Dr. Stanley Chetcuti, director of cardiac catheterization at the University of Michigan Hospital and Health System, Ann Arbor.

“The numbers with aortic stenosis are similar to the numbers with coronary artery disease – about 1.5 million in the U.S. Of these 25% are operable, meaning about 300,000 patients eligible for replacement each year. Unfortunately only about 80,000 get that surgery, but even with that small number, it’s an enormous need.”

And an enormous market as well.

Aortic stenosis is far from a quality-of-life disease. In fact, the prognosis without surgery is dismal, with less than a 30% 5-year survival if the stenosis is symptomatic. There’s no real alternative management, either.

“The indications for surgery are well defined, the surgery is straightforward, many people need it, and the outcomes are usually quite good,” said Dr. Chetcuti.

Still, the operation carries a perioperative mortality rate of up to 10% and usually a need for lifelong anticoagulant therapy. Despite all of that, aortic valve replacement has been widely adopted and continues to evolve. The latest iteration uses a built-in filter to catch any liberated emboli.

Teamwork has also greatly enhanced the technical success and evolution of heart valve surgery, Dr. Chetcuti said. “The new paradigm, and the reason this has truly become a technical success, is the combined heart team. It’s a really robust team effort that crosses borders – it includes the cardiologist, the interventionalist, the primary care physician, and the anesthesiologist. And it has to include the hospital administrator, especially when you’re implementing a new technology with no set plan for reimbursement. You need a support team to grab this thing and make it work.”

[email protected]@alz_gal

^1.This is where the AGA Center for GI Innovation and Technology comes in. The center helps companies develop their early studies in a way that captures the data needed by other regulatory groups, such as CMS and private payers, who need different data than the FDA to cover and pay for technology. Learn more about the center by visiting www.gastro.org.

A successful medical device needs to bat two out of three requirements: fulfill an unmet need, be an effective treatment, and be a simple solution.

But not all of those criteria may be completely determined before the product launch, according to speakers at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Nick Piegari/Frontline Medical News

Poor marketing strategy to clinicians and payers combined with 12-month follow-up data sank an apparently promising endoscopic treatment for gastroesophageal reflux disease (the ENTERYX procedure). It was effective but technically difficult, and it was intended for patients who were already responding to medical therapy.

Aortic valve replacement, however – seemingly a much more complicated procedure requiring cardiac bypass and tiny stitches – has not only survived but also thrived, with demonstrable success and constantly evolving iterations.

Why the disparity?

Learning from failure

The ENTERYX procedure involved the circumferential injection of polymer just above the pyloric sphincter – a permanent solution for thousands of GERD patients taking proton pump inhibitors. The polymer induced inflammation and encapsulation, effectively narrowing the gastroesophageal junction and preventing reflex.

“Our preclinical studies looked great,” said Rich Cohen, who handled the project for the Boston Scientific Corporation at the time. “We were approved by the Food and Drug Administration as a Class III medical device. Our pivotal randomized trial, conducted after approval, was very good; 70% of patients were able to get off their medication.”

ENTERYX was launched in 2003, said Mr. Cohen, who is now global director of market development for the endoscopy division of Boston Scientific. Almost 4,000 patients underwent the procedure, most with very good, very stable results.

But injection precision was critical; the polymer had to be deposited intramurally. Fluoroscopy was necessary to provide real-time feedback of the deposition location. Unfortunately, this safeguard didn’t work every time, he said.

“We had good results in the hands of experts, but it never translated down, despite our required training program,” Mr. Cohen said. There were reports of chest pain and dysphagia in treated patients, another patient experienced a partial reduction in renal function due to partial embolization. Two patients died (0.05%), both due to complications from aortoenteric fistula.

In 2005, FDA issued an advisory about the procedure, and Boston Scientific voluntarily recalled it, ending its use.

Such rare complications might possibly have been acceptable for a procedure that was successful for a hard-to-treat disorder with no alternative treatment, but patients who qualified for ENTERYX were already being treated successfully with PPIs, Mr. Cohen said.

“Any time you are treating something invasively that already has a successful alternative, it’s very difficult to sell. And when you do sell it, the bar for adverse events is very, very low.”

Even before the clinical events, ENTERYX was a marketing problem child. The first stumbling block was actually a sales issue, Mr. Cohen said. Because patients were already being medically managed, most primary care providers felt there was no need for surgical or endoscopic referral, at least partially damming the flow of interest.

Reimbursement was also an issue. “Our clinical data supporting safety and efficacy were not enough to sway decision makers. We ended up having to do a randomized controlled trial after we launched. If we had to do it over again, we would tie our approval trials to [Centers for Medicare & Medicaid Services] for coding, because without that you are really facing an uphill battle for something that treats a quality-of-life disease,” Mr. Cohen said.¹

Getting premarket support from specialists is crucial. “We should have talked to physician societies before launching. Without that, it’s like pushing a boulder uphill and the minute you stop, you get run over. Even if you’ve got the best product in the world, it’s useless if patients never get treated.”

A look at success

Aortic valve replacement, on the other hand, is a perfect solution to a perfect market and clinical confluence.

Initiated in 1960, it’s grown exponentially to serve a huge global market, said Dr. Stanley Chetcuti, director of cardiac catheterization at the University of Michigan Hospital and Health System, Ann Arbor.

“The numbers with aortic stenosis are similar to the numbers with coronary artery disease – about 1.5 million in the U.S. Of these 25% are operable, meaning about 300,000 patients eligible for replacement each year. Unfortunately only about 80,000 get that surgery, but even with that small number, it’s an enormous need.”

And an enormous market as well.

Aortic stenosis is far from a quality-of-life disease. In fact, the prognosis without surgery is dismal, with less than a 30% 5-year survival if the stenosis is symptomatic. There’s no real alternative management, either.

“The indications for surgery are well defined, the surgery is straightforward, many people need it, and the outcomes are usually quite good,” said Dr. Chetcuti.

Still, the operation carries a perioperative mortality rate of up to 10% and usually a need for lifelong anticoagulant therapy. Despite all of that, aortic valve replacement has been widely adopted and continues to evolve. The latest iteration uses a built-in filter to catch any liberated emboli.

Teamwork has also greatly enhanced the technical success and evolution of heart valve surgery, Dr. Chetcuti said. “The new paradigm, and the reason this has truly become a technical success, is the combined heart team. It’s a really robust team effort that crosses borders – it includes the cardiologist, the interventionalist, the primary care physician, and the anesthesiologist. And it has to include the hospital administrator, especially when you’re implementing a new technology with no set plan for reimbursement. You need a support team to grab this thing and make it work.”

[email protected]@alz_gal

^1.This is where the AGA Center for GI Innovation and Technology comes in. The center helps companies develop their early studies in a way that captures the data needed by other regulatory groups, such as CMS and private payers, who need different data than the FDA to cover and pay for technology. Learn more about the center by visiting www.gastro.org.

A successful medical device needs to bat two out of three requirements: fulfill an unmet need, be an effective treatment, and be a simple solution.

But not all of those criteria may be completely determined before the product launch, according to speakers at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Nick Piegari/Frontline Medical News

Poor marketing strategy to clinicians and payers combined with 12-month follow-up data sank an apparently promising endoscopic treatment for gastroesophageal reflux disease (the ENTERYX procedure). It was effective but technically difficult, and it was intended for patients who were already responding to medical therapy.

Aortic valve replacement, however – seemingly a much more complicated procedure requiring cardiac bypass and tiny stitches – has not only survived but also thrived, with demonstrable success and constantly evolving iterations.

Why the disparity?

Learning from failure

The ENTERYX procedure involved the circumferential injection of polymer just above the pyloric sphincter – a permanent solution for thousands of GERD patients taking proton pump inhibitors. The polymer induced inflammation and encapsulation, effectively narrowing the gastroesophageal junction and preventing reflex.

“Our preclinical studies looked great,” said Rich Cohen, who handled the project for the Boston Scientific Corporation at the time. “We were approved by the Food and Drug Administration as a Class III medical device. Our pivotal randomized trial, conducted after approval, was very good; 70% of patients were able to get off their medication.”

ENTERYX was launched in 2003, said Mr. Cohen, who is now global director of market development for the endoscopy division of Boston Scientific. Almost 4,000 patients underwent the procedure, most with very good, very stable results.

But injection precision was critical; the polymer had to be deposited intramurally. Fluoroscopy was necessary to provide real-time feedback of the deposition location. Unfortunately, this safeguard didn’t work every time, he said.

“We had good results in the hands of experts, but it never translated down, despite our required training program,” Mr. Cohen said. There were reports of chest pain and dysphagia in treated patients, another patient experienced a partial reduction in renal function due to partial embolization. Two patients died (0.05%), both due to complications from aortoenteric fistula.

In 2005, FDA issued an advisory about the procedure, and Boston Scientific voluntarily recalled it, ending its use.

Such rare complications might possibly have been acceptable for a procedure that was successful for a hard-to-treat disorder with no alternative treatment, but patients who qualified for ENTERYX were already being treated successfully with PPIs, Mr. Cohen said.

“Any time you are treating something invasively that already has a successful alternative, it’s very difficult to sell. And when you do sell it, the bar for adverse events is very, very low.”

Even before the clinical events, ENTERYX was a marketing problem child. The first stumbling block was actually a sales issue, Mr. Cohen said. Because patients were already being medically managed, most primary care providers felt there was no need for surgical or endoscopic referral, at least partially damming the flow of interest.

Reimbursement was also an issue. “Our clinical data supporting safety and efficacy were not enough to sway decision makers. We ended up having to do a randomized controlled trial after we launched. If we had to do it over again, we would tie our approval trials to [Centers for Medicare & Medicaid Services] for coding, because without that you are really facing an uphill battle for something that treats a quality-of-life disease,” Mr. Cohen said.¹

Getting premarket support from specialists is crucial. “We should have talked to physician societies before launching. Without that, it’s like pushing a boulder uphill and the minute you stop, you get run over. Even if you’ve got the best product in the world, it’s useless if patients never get treated.”

A look at success

Aortic valve replacement, on the other hand, is a perfect solution to a perfect market and clinical confluence.

Initiated in 1960, it’s grown exponentially to serve a huge global market, said Dr. Stanley Chetcuti, director of cardiac catheterization at the University of Michigan Hospital and Health System, Ann Arbor.

“The numbers with aortic stenosis are similar to the numbers with coronary artery disease – about 1.5 million in the U.S. Of these 25% are operable, meaning about 300,000 patients eligible for replacement each year. Unfortunately only about 80,000 get that surgery, but even with that small number, it’s an enormous need.”

And an enormous market as well.

Aortic stenosis is far from a quality-of-life disease. In fact, the prognosis without surgery is dismal, with less than a 30% 5-year survival if the stenosis is symptomatic. There’s no real alternative management, either.

“The indications for surgery are well defined, the surgery is straightforward, many people need it, and the outcomes are usually quite good,” said Dr. Chetcuti.

Still, the operation carries a perioperative mortality rate of up to 10% and usually a need for lifelong anticoagulant therapy. Despite all of that, aortic valve replacement has been widely adopted and continues to evolve. The latest iteration uses a built-in filter to catch any liberated emboli.

Teamwork has also greatly enhanced the technical success and evolution of heart valve surgery, Dr. Chetcuti said. “The new paradigm, and the reason this has truly become a technical success, is the combined heart team. It’s a really robust team effort that crosses borders – it includes the cardiologist, the interventionalist, the primary care physician, and the anesthesiologist. And it has to include the hospital administrator, especially when you’re implementing a new technology with no set plan for reimbursement. You need a support team to grab this thing and make it work.”

[email protected]@alz_gal

^1.This is where the AGA Center for GI Innovation and Technology comes in. The center helps companies develop their early studies in a way that captures the data needed by other regulatory groups, such as CMS and private payers, who need different data than the FDA to cover and pay for technology. Learn more about the center by visiting www.gastro.org.

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, two researchers provided attendees with an update on their innovative research projects made possible thanks to grants from the AGA Research Foundation.

First, Dr. Richard Kwon updated attendees on the status of his research supported by the inaugural AGA–Covidien Research & Development Pilot Award in Technology. Announced in the fall of 2014, this award is supported by a generous grant from Covidien, a leading global provider of health care products. With this grant, Dr. Kwon and his associates at the University of Michigan are investigating how an image processing and analysis method known as analytic morphomics can be used to improve the care of patients with pancreatic cysts. To date, the inability to accurately distinguish the cyst types has led to a significant amount of unnecessary surgeries and surveillance.

AGA Institute

“Nonmucinous cysts generally are comprised of serous cystadenomas as well as inflammatory cells and a small handful of zebra cysts,” explained Dr. Kwon, a gastroenterologist at the university. “These are generally considered benign and do not require follow-up. In contrast, mucinous cysts are made of mucinous cystic neoplasms, which are characterized by a variant stroma and IPMN [intraductal papillary mucinous neoplasm]. This is important because these are the cysts that have malignant potential and therefore require some sort of follow-up and/or surgery.”

He described analytic morphomics as “a novel method to quantitatively analyze structural data such as shape and surface contour (which are otherwise descriptive) from CT scans in order to predict disease states. In our minds, the benefit is that it overcomes some of the shortcomings of imaging curvilinear organs. It has the potential to overcome qualitative descriptions and the limitations of characterizing these cysts based on one cut or one slice of imaging. Hopefully, it will allow us to establish quantifiable criteria, it can be performed on existing studies so you don’t need a new CT scan, and there’s no specialized laboratory or equipment that you need other than a high-powered computer.”

Dr. Kwon presented results from 81 cystic lesions processed with the method. Analytic morphomics yielded a sensitivity of 78% in predicting serous cystadenomas (SCA), a specificity of 90%, a positive predictive value of 73%, and negative predictive value of 88%. The accuracy was 84%. He and his associates are in the process of validating the findings and are in the planning stages of a prospective study comparing morphomics and cyst fluid analysis. “The accuracy of the SCA prediction model appears equal to cyst fluid carcinoembryonic antigen testing, suggesting morphomic data have the potential to replace endoscopic ultrasound/fine needle aspiration in certain scenarios,” he said.

During a separate presentation, Dr. Ashish Nimgaonkar updated attendees on the status of his research, supported by the inaugural AGA–Boston Scientific Career Development Technology & Innovation Award. Bestowed in the fall of 2014, this award is supported by a grant from Boston Scientific, a leading innovator of medical solutions. Dr. Nimgaonkar’s research focuses on developing technology to manage patients with refractory ascites – a condition in which fluid builds up in the abdomen. This fluid accumulation eventually becomes resistant to medical therapy and the only definitive treatment at this stage is liver transplantation, which is limited by organ availability. The only option for them is removal of this fluid every few weeks in a hospital or clinical setting. “When we started to look at this problem, the biggest driving factor for a [solution] was a way to keep these patients out of the hospital and to be able to do this at home,” said Dr. Nimgaonkar, associate medical director at the Center for Bioengineering Innovation and Design in the department of biomedical engineering at Johns Hopkins University, Baltimore.

He and his colleagues have developed a wireless implantable shunt technology to pull the fluid from the peritoneal space into the stomach. With this approach, patients can manage their fluid drainage needs at home – significantly improving their quality of life, as well as reducing the cost of care associated with frequent hospital visits. “You can think of it as a combination of a peritoneal drain and a percutaneous gastrostomy tube, which is a feeding tube hooked but completely implanted in the subcutaneous space,” he said of the technology, which is currently being refined and tested in animal models. “It can be done under conscious sedation. The current design we are working on is a simple, nonelectromechanical solution – silicone-based – which uses the diaphragmatic movements of the patient to drive the fluid. It turns out that the pressure differential between the peritoneal space and the intragastric cavity is minimal, so you need some kind of actuation mechanism.”

Dr. Nimgaonkar and his colleagues hope to study the technology in humans “in the next year or so.”

[email protected]

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, two researchers provided attendees with an update on their innovative research projects made possible thanks to grants from the AGA Research Foundation.

First, Dr. Richard Kwon updated attendees on the status of his research supported by the inaugural AGA–Covidien Research & Development Pilot Award in Technology. Announced in the fall of 2014, this award is supported by a generous grant from Covidien, a leading global provider of health care products. With this grant, Dr. Kwon and his associates at the University of Michigan are investigating how an image processing and analysis method known as analytic morphomics can be used to improve the care of patients with pancreatic cysts. To date, the inability to accurately distinguish the cyst types has led to a significant amount of unnecessary surgeries and surveillance.

AGA Institute

“Nonmucinous cysts generally are comprised of serous cystadenomas as well as inflammatory cells and a small handful of zebra cysts,” explained Dr. Kwon, a gastroenterologist at the university. “These are generally considered benign and do not require follow-up. In contrast, mucinous cysts are made of mucinous cystic neoplasms, which are characterized by a variant stroma and IPMN [intraductal papillary mucinous neoplasm]. This is important because these are the cysts that have malignant potential and therefore require some sort of follow-up and/or surgery.”

He described analytic morphomics as “a novel method to quantitatively analyze structural data such as shape and surface contour (which are otherwise descriptive) from CT scans in order to predict disease states. In our minds, the benefit is that it overcomes some of the shortcomings of imaging curvilinear organs. It has the potential to overcome qualitative descriptions and the limitations of characterizing these cysts based on one cut or one slice of imaging. Hopefully, it will allow us to establish quantifiable criteria, it can be performed on existing studies so you don’t need a new CT scan, and there’s no specialized laboratory or equipment that you need other than a high-powered computer.”

Dr. Kwon presented results from 81 cystic lesions processed with the method. Analytic morphomics yielded a sensitivity of 78% in predicting serous cystadenomas (SCA), a specificity of 90%, a positive predictive value of 73%, and negative predictive value of 88%. The accuracy was 84%. He and his associates are in the process of validating the findings and are in the planning stages of a prospective study comparing morphomics and cyst fluid analysis. “The accuracy of the SCA prediction model appears equal to cyst fluid carcinoembryonic antigen testing, suggesting morphomic data have the potential to replace endoscopic ultrasound/fine needle aspiration in certain scenarios,” he said.

During a separate presentation, Dr. Ashish Nimgaonkar updated attendees on the status of his research, supported by the inaugural AGA–Boston Scientific Career Development Technology & Innovation Award. Bestowed in the fall of 2014, this award is supported by a grant from Boston Scientific, a leading innovator of medical solutions. Dr. Nimgaonkar’s research focuses on developing technology to manage patients with refractory ascites – a condition in which fluid builds up in the abdomen. This fluid accumulation eventually becomes resistant to medical therapy and the only definitive treatment at this stage is liver transplantation, which is limited by organ availability. The only option for them is removal of this fluid every few weeks in a hospital or clinical setting. “When we started to look at this problem, the biggest driving factor for a [solution] was a way to keep these patients out of the hospital and to be able to do this at home,” said Dr. Nimgaonkar, associate medical director at the Center for Bioengineering Innovation and Design in the department of biomedical engineering at Johns Hopkins University, Baltimore.

He and his colleagues have developed a wireless implantable shunt technology to pull the fluid from the peritoneal space into the stomach. With this approach, patients can manage their fluid drainage needs at home – significantly improving their quality of life, as well as reducing the cost of care associated with frequent hospital visits. “You can think of it as a combination of a peritoneal drain and a percutaneous gastrostomy tube, which is a feeding tube hooked but completely implanted in the subcutaneous space,” he said of the technology, which is currently being refined and tested in animal models. “It can be done under conscious sedation. The current design we are working on is a simple, nonelectromechanical solution – silicone-based – which uses the diaphragmatic movements of the patient to drive the fluid. It turns out that the pressure differential between the peritoneal space and the intragastric cavity is minimal, so you need some kind of actuation mechanism.”

Dr. Nimgaonkar and his colleagues hope to study the technology in humans “in the next year or so.”

[email protected]

SAN FRANCISCO – At the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology, two researchers provided attendees with an update on their innovative research projects made possible thanks to grants from the AGA Research Foundation.

First, Dr. Richard Kwon updated attendees on the status of his research supported by the inaugural AGA–Covidien Research & Development Pilot Award in Technology. Announced in the fall of 2014, this award is supported by a generous grant from Covidien, a leading global provider of health care products. With this grant, Dr. Kwon and his associates at the University of Michigan are investigating how an image processing and analysis method known as analytic morphomics can be used to improve the care of patients with pancreatic cysts. To date, the inability to accurately distinguish the cyst types has led to a significant amount of unnecessary surgeries and surveillance.

AGA Institute

“Nonmucinous cysts generally are comprised of serous cystadenomas as well as inflammatory cells and a small handful of zebra cysts,” explained Dr. Kwon, a gastroenterologist at the university. “These are generally considered benign and do not require follow-up. In contrast, mucinous cysts are made of mucinous cystic neoplasms, which are characterized by a variant stroma and IPMN [intraductal papillary mucinous neoplasm]. This is important because these are the cysts that have malignant potential and therefore require some sort of follow-up and/or surgery.”

He described analytic morphomics as “a novel method to quantitatively analyze structural data such as shape and surface contour (which are otherwise descriptive) from CT scans in order to predict disease states. In our minds, the benefit is that it overcomes some of the shortcomings of imaging curvilinear organs. It has the potential to overcome qualitative descriptions and the limitations of characterizing these cysts based on one cut or one slice of imaging. Hopefully, it will allow us to establish quantifiable criteria, it can be performed on existing studies so you don’t need a new CT scan, and there’s no specialized laboratory or equipment that you need other than a high-powered computer.”

Dr. Kwon presented results from 81 cystic lesions processed with the method. Analytic morphomics yielded a sensitivity of 78% in predicting serous cystadenomas (SCA), a specificity of 90%, a positive predictive value of 73%, and negative predictive value of 88%. The accuracy was 84%. He and his associates are in the process of validating the findings and are in the planning stages of a prospective study comparing morphomics and cyst fluid analysis. “The accuracy of the SCA prediction model appears equal to cyst fluid carcinoembryonic antigen testing, suggesting morphomic data have the potential to replace endoscopic ultrasound/fine needle aspiration in certain scenarios,” he said.

During a separate presentation, Dr. Ashish Nimgaonkar updated attendees on the status of his research, supported by the inaugural AGA–Boston Scientific Career Development Technology & Innovation Award. Bestowed in the fall of 2014, this award is supported by a grant from Boston Scientific, a leading innovator of medical solutions. Dr. Nimgaonkar’s research focuses on developing technology to manage patients with refractory ascites – a condition in which fluid builds up in the abdomen. This fluid accumulation eventually becomes resistant to medical therapy and the only definitive treatment at this stage is liver transplantation, which is limited by organ availability. The only option for them is removal of this fluid every few weeks in a hospital or clinical setting. “When we started to look at this problem, the biggest driving factor for a [solution] was a way to keep these patients out of the hospital and to be able to do this at home,” said Dr. Nimgaonkar, associate medical director at the Center for Bioengineering Innovation and Design in the department of biomedical engineering at Johns Hopkins University, Baltimore.

He and his colleagues have developed a wireless implantable shunt technology to pull the fluid from the peritoneal space into the stomach. With this approach, patients can manage their fluid drainage needs at home – significantly improving their quality of life, as well as reducing the cost of care associated with frequent hospital visits. “You can think of it as a combination of a peritoneal drain and a percutaneous gastrostomy tube, which is a feeding tube hooked but completely implanted in the subcutaneous space,” he said of the technology, which is currently being refined and tested in animal models. “It can be done under conscious sedation. The current design we are working on is a simple, nonelectromechanical solution – silicone-based – which uses the diaphragmatic movements of the patient to drive the fluid. It turns out that the pressure differential between the peritoneal space and the intragastric cavity is minimal, so you need some kind of actuation mechanism.”

Dr. Nimgaonkar and his colleagues hope to study the technology in humans “in the next year or so.”

[email protected]

SAN FRANCISCO – Adopting a new GI device means getting it passed through a supply chain at a clinic or a hospital committee. With increasing health care consolidation, it has become harder for new technology to get a foothold. The AGA Center for GI Innovation and Technology can work with manufacturers, physicians, or a facility to help manage the process of pushing a new product along the supply chain. Dr. Joel V. Brill, who serves on the executive committee for the center, explains in this video interview. 

SAN FRANCISCO – Adopting a new GI device means getting it passed through a supply chain at a clinic or a hospital committee. With increasing health care consolidation, it has become harder for new technology to get a foothold. The AGA Center for GI Innovation and Technology can work with manufacturers, physicians, or a facility to help manage the process of pushing a new product along the supply chain. Dr. Joel V. Brill, who serves on the executive committee for the center, explains in this video interview. 

SAN FRANCISCO – Adopting a new GI device means getting it passed through a supply chain at a clinic or a hospital committee. With increasing health care consolidation, it has become harder for new technology to get a foothold. The AGA Center for GI Innovation and Technology can work with manufacturers, physicians, or a facility to help manage the process of pushing a new product along the supply chain. Dr. Joel V. Brill, who serves on the executive committee for the center, explains in this video interview. 

SAN FRANCISCO–The way Dr. Amanda Christini sees it, universities and academic medical centers should care about commercialization of innovation, because it creates new opportunities to impact patient care.

“As academicians, we need to engage in cultural change from the ground up in order to be good at effective innovation and in order to contribute in a meaningful way,” Dr. Christini, director of strategic initiatives for the Penn Medicine Center for Health Care Innovation, Philadelphia, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Traditionally, the “value” of commercialization from a university or academic medical standpoint has been defined by royalties from product sales. “But it turns out there are different kinds of value,” Dr. Christini said. “Value is created when we have an impact on patient care. Value is created when we disseminate something we do that has impact, and it’s adopted broadly within your own institution or by other centers.”

The current health care “ecosystem” consists of many stakeholders, including patients, academic medical centers, the government, payers, large industry partners, investors, and start-ups, she continued. Current options for commercializing a product include licensing a product or device to an industry partner, creating a broad partnership with an industry partner, “where they fund your research and invest in core infrastructure such as manufacturing,” or creating a new company altogether. Embarking on such endeavors at today’s universities and academic medical centers is challenging because “the historic focus on therapeutics is slow to change,” Dr. Christini explained. “It’s very product oriented. What winds up happening is, instead of asking ‘what is possible,’ [decision-makers at] universities and academic medical centers will often say ‘No, we don’t do that.’ There is a fundamental culture shift that has to happen in order to allow this to be successful.”

Stanford (Calif.) University and the Massachusetts Institute of Technology, Cambridge, have been especially successful in fostering collaboration among stakeholders in the health care ecosystem, Dr. Christini said. In fact, Stanford alumni have launched 40,000 companies resulting in $2.7 trillion in annual revenue, while MIT grads have launched 25,800 companies resulting in $2.2 trillion in annual revenue. Strong leadership skills form the backbone of such success. “And it’s not just leadership that gets up and says the word ‘innovation’ over and over again,” she said. “It’s leadership that actually changes what happens inside the institution. One way to do that is to create metrics that measure what you actually care about – not just royalty stream. [You want to measure things] like how long does it take to get a transaction done? Is the faculty happy? Is the faculty satisfied? Do they feel like they are being served by these [shareholder] groups? How many start-ups with funding above a certain number have been created as a result of the work that’s done? These kinds of things can have a dramatic impact on how successful you are.”

[email protected]

SAN FRANCISCO–The way Dr. Amanda Christini sees it, universities and academic medical centers should care about commercialization of innovation, because it creates new opportunities to impact patient care.

“As academicians, we need to engage in cultural change from the ground up in order to be good at effective innovation and in order to contribute in a meaningful way,” Dr. Christini, director of strategic initiatives for the Penn Medicine Center for Health Care Innovation, Philadelphia, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Traditionally, the “value” of commercialization from a university or academic medical standpoint has been defined by royalties from product sales. “But it turns out there are different kinds of value,” Dr. Christini said. “Value is created when we have an impact on patient care. Value is created when we disseminate something we do that has impact, and it’s adopted broadly within your own institution or by other centers.”

The current health care “ecosystem” consists of many stakeholders, including patients, academic medical centers, the government, payers, large industry partners, investors, and start-ups, she continued. Current options for commercializing a product include licensing a product or device to an industry partner, creating a broad partnership with an industry partner, “where they fund your research and invest in core infrastructure such as manufacturing,” or creating a new company altogether. Embarking on such endeavors at today’s universities and academic medical centers is challenging because “the historic focus on therapeutics is slow to change,” Dr. Christini explained. “It’s very product oriented. What winds up happening is, instead of asking ‘what is possible,’ [decision-makers at] universities and academic medical centers will often say ‘No, we don’t do that.’ There is a fundamental culture shift that has to happen in order to allow this to be successful.”

Stanford (Calif.) University and the Massachusetts Institute of Technology, Cambridge, have been especially successful in fostering collaboration among stakeholders in the health care ecosystem, Dr. Christini said. In fact, Stanford alumni have launched 40,000 companies resulting in $2.7 trillion in annual revenue, while MIT grads have launched 25,800 companies resulting in $2.2 trillion in annual revenue. Strong leadership skills form the backbone of such success. “And it’s not just leadership that gets up and says the word ‘innovation’ over and over again,” she said. “It’s leadership that actually changes what happens inside the institution. One way to do that is to create metrics that measure what you actually care about – not just royalty stream. [You want to measure things] like how long does it take to get a transaction done? Is the faculty happy? Is the faculty satisfied? Do they feel like they are being served by these [shareholder] groups? How many start-ups with funding above a certain number have been created as a result of the work that’s done? These kinds of things can have a dramatic impact on how successful you are.”

[email protected]

SAN FRANCISCO–The way Dr. Amanda Christini sees it, universities and academic medical centers should care about commercialization of innovation, because it creates new opportunities to impact patient care.

“As academicians, we need to engage in cultural change from the ground up in order to be good at effective innovation and in order to contribute in a meaningful way,” Dr. Christini, director of strategic initiatives for the Penn Medicine Center for Health Care Innovation, Philadelphia, said at the 2015 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.

Traditionally, the “value” of commercialization from a university or academic medical standpoint has been defined by royalties from product sales. “But it turns out there are different kinds of value,” Dr. Christini said. “Value is created when we have an impact on patient care. Value is created when we disseminate something we do that has impact, and it’s adopted broadly within your own institution or by other centers.”

The current health care “ecosystem” consists of many stakeholders, including patients, academic medical centers, the government, payers, large industry partners, investors, and start-ups, she continued. Current options for commercializing a product include licensing a product or device to an industry partner, creating a broad partnership with an industry partner, “where they fund your research and invest in core infrastructure such as manufacturing,” or creating a new company altogether. Embarking on such endeavors at today’s universities and academic medical centers is challenging because “the historic focus on therapeutics is slow to change,” Dr. Christini explained. “It’s very product oriented. What winds up happening is, instead of asking ‘what is possible,’ [decision-makers at] universities and academic medical centers will often say ‘No, we don’t do that.’ There is a fundamental culture shift that has to happen in order to allow this to be successful.”

Stanford (Calif.) University and the Massachusetts Institute of Technology, Cambridge, have been especially successful in fostering collaboration among stakeholders in the health care ecosystem, Dr. Christini said. In fact, Stanford alumni have launched 40,000 companies resulting in $2.7 trillion in annual revenue, while MIT grads have launched 25,800 companies resulting in $2.2 trillion in annual revenue. Strong leadership skills form the backbone of such success. “And it’s not just leadership that gets up and says the word ‘innovation’ over and over again,” she said. “It’s leadership that actually changes what happens inside the institution. One way to do that is to create metrics that measure what you actually care about – not just royalty stream. [You want to measure things] like how long does it take to get a transaction done? Is the faculty happy? Is the faculty satisfied? Do they feel like they are being served by these [shareholder] groups? How many start-ups with funding above a certain number have been created as a result of the work that’s done? These kinds of things can have a dramatic impact on how successful you are.”

[email protected]

SAN FRANCISCO – In the best of all possible worlds, patient care wouldn’t stop outside the four walls of the treatment or exam room. It would eliminate post-treatment problems by effective follow-up. It would encourage compliance by understanding a patient’s “real life.” It would involve primary care in a collegial, collaborative relationship, and bring in the family when appropriate.

We might not live in the best of all possible worlds. But we do live in an increasingly connected world, where technology can bridge the space between “would” and “will,” Dr. Ashish Atreja said at the 2015 AGA Tech Summit.

“The time is ripe” to put smartphone apps, social media, and teleconferencing to work to improve patient outcomes, Dr. Atreja of Mt. Sinai Hospital, New York, said at the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Not only can these connections improve doctor-patient relationships and clinical outcomes, they stand ready to harness the research power of real-time data.

“We can merge clinical data from the electronic medical record and link to a registry. We can mine data for safety and efficacy. We can even use it to enroll patients in clinical trials that might otherwise take years to build a meaningful cohort.”

When Dr. Atreja says “The future is now,” he means it. Just days ago, Apple launched its new iPhone program, ResearchKit. The app allows users to become part of enormous potential research pools. Within just 36 hours of launch, thousands of users had signed up.

They can enter all kinds of baseline health data – for example, blood pressure, body mass index, and chronic illnesses. They can also complete user-interface activities like finger-tapping the screen, speaking into the phone, and walking with it – all of which can flag potential disease-specific symptoms.

Researchers looking for study subjects can comb through the data and identify subjects who might be interested in participating, then reach out to them.

Digital communication also makes extending care beyond clinic a reality, said Dr. Brennan Spiegel, director of Health Services Research at Cedars-Sinai Hospital, Los Angeles.

“Our patients don’t just exist in the clinic. They are at senior centers. They are at home, at work, at play in parks. These are the places where they experience the psychomedical effects of their illness. And we need to find a way to get to them.”

Patients are not always completely reliable, or even open, during a clinic visit. The physician, therefore, can be working off incomplete information even before embarking on a complex 20-minute interview.

“We need to get a history, do an exam, think about tests, try and understand the emotional context of the illness, assess the patient’s motivation, educate and counsel, and develop a targeted treatment plan. All from behind the laptop that separates us from the patient.”

The patient often leaves with unanswered questions, or simply overwhelmed with information. “But she has a computer. She has smartphone. And so do we. . . so we can still exchange information.”

Is it practical, though, for the physician who already has too few hours in any day to stay glued to a cellphone or laptop for this kind of continuous interaction? The answer is a most decided “No.”

Instead, Dr. Spiegel said, interactive algorithms can be employed to gather real-time patient metrics through voluntary input or automatic monitoring programs, and send what amounts to personally dictated notes to providers through the patients’ electronic medical record.

My GI Health, which Dr. Spiegel co-created, is a good example of this technology.

Patients can access a secure portal and answers basic questions about GI symptoms and medical history. The program translates this into something very much akin to a provider-generated history and presentation document. This can be reviewed before an appointment to facilitate communication. And because the initial information is shared privately, Dr. Spiegel said patients may be more forthcoming than discussing what they perceive as embarrassing topics face-to-face.

The computer-generated notes are impressively accurate. A study published in the American Journal of Gastroenterology in January showed just how impressive.

Blinded physician reviewers compared both computer- and physician-generated histories for 75 GI patients. The reviewers found the computer-created histories consistently superior, even after adjusting for physician and visit type, location, mode of transcription, and demographics. They said the computer histories were more complete, more useful, better organized, more succinct and more comprehensible. All of the computer histories could have been billed at the highest level, compared to 84% of those written by humans.

“That doesn’t mean computers are better than doctors,” Dr. Spiegel said. “We still need ‘us’ … to look at patients face-to-face, to understand the deep, nuanced complexity of their lives and illnesses. But computers are excellent at collecting information and putting that into meaningful context. And we can use this to benefit everyone.”

[email protected]

SAN FRANCISCO – In the best of all possible worlds, patient care wouldn’t stop outside the four walls of the treatment or exam room. It would eliminate post-treatment problems by effective follow-up. It would encourage compliance by understanding a patient’s “real life.” It would involve primary care in a collegial, collaborative relationship, and bring in the family when appropriate.

We might not live in the best of all possible worlds. But we do live in an increasingly connected world, where technology can bridge the space between “would” and “will,” Dr. Ashish Atreja said at the 2015 AGA Tech Summit.

“The time is ripe” to put smartphone apps, social media, and teleconferencing to work to improve patient outcomes, Dr. Atreja of Mt. Sinai Hospital, New York, said at the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Not only can these connections improve doctor-patient relationships and clinical outcomes, they stand ready to harness the research power of real-time data.

“We can merge clinical data from the electronic medical record and link to a registry. We can mine data for safety and efficacy. We can even use it to enroll patients in clinical trials that might otherwise take years to build a meaningful cohort.”

When Dr. Atreja says “The future is now,” he means it. Just days ago, Apple launched its new iPhone program, ResearchKit. The app allows users to become part of enormous potential research pools. Within just 36 hours of launch, thousands of users had signed up.

They can enter all kinds of baseline health data – for example, blood pressure, body mass index, and chronic illnesses. They can also complete user-interface activities like finger-tapping the screen, speaking into the phone, and walking with it – all of which can flag potential disease-specific symptoms.

Researchers looking for study subjects can comb through the data and identify subjects who might be interested in participating, then reach out to them.

Digital communication also makes extending care beyond clinic a reality, said Dr. Brennan Spiegel, director of Health Services Research at Cedars-Sinai Hospital, Los Angeles.

“Our patients don’t just exist in the clinic. They are at senior centers. They are at home, at work, at play in parks. These are the places where they experience the psychomedical effects of their illness. And we need to find a way to get to them.”

Patients are not always completely reliable, or even open, during a clinic visit. The physician, therefore, can be working off incomplete information even before embarking on a complex 20-minute interview.

“We need to get a history, do an exam, think about tests, try and understand the emotional context of the illness, assess the patient’s motivation, educate and counsel, and develop a targeted treatment plan. All from behind the laptop that separates us from the patient.”

The patient often leaves with unanswered questions, or simply overwhelmed with information. “But she has a computer. She has smartphone. And so do we. . . so we can still exchange information.”

Is it practical, though, for the physician who already has too few hours in any day to stay glued to a cellphone or laptop for this kind of continuous interaction? The answer is a most decided “No.”

Instead, Dr. Spiegel said, interactive algorithms can be employed to gather real-time patient metrics through voluntary input or automatic monitoring programs, and send what amounts to personally dictated notes to providers through the patients’ electronic medical record.

My GI Health, which Dr. Spiegel co-created, is a good example of this technology.

Patients can access a secure portal and answers basic questions about GI symptoms and medical history. The program translates this into something very much akin to a provider-generated history and presentation document. This can be reviewed before an appointment to facilitate communication. And because the initial information is shared privately, Dr. Spiegel said patients may be more forthcoming than discussing what they perceive as embarrassing topics face-to-face.

The computer-generated notes are impressively accurate. A study published in the American Journal of Gastroenterology in January showed just how impressive.

Blinded physician reviewers compared both computer- and physician-generated histories for 75 GI patients. The reviewers found the computer-created histories consistently superior, even after adjusting for physician and visit type, location, mode of transcription, and demographics. They said the computer histories were more complete, more useful, better organized, more succinct and more comprehensible. All of the computer histories could have been billed at the highest level, compared to 84% of those written by humans.

“That doesn’t mean computers are better than doctors,” Dr. Spiegel said. “We still need ‘us’ … to look at patients face-to-face, to understand the deep, nuanced complexity of their lives and illnesses. But computers are excellent at collecting information and putting that into meaningful context. And we can use this to benefit everyone.”

[email protected]

SAN FRANCISCO – In the best of all possible worlds, patient care wouldn’t stop outside the four walls of the treatment or exam room. It would eliminate post-treatment problems by effective follow-up. It would encourage compliance by understanding a patient’s “real life.” It would involve primary care in a collegial, collaborative relationship, and bring in the family when appropriate.

We might not live in the best of all possible worlds. But we do live in an increasingly connected world, where technology can bridge the space between “would” and “will,” Dr. Ashish Atreja said at the 2015 AGA Tech Summit.

“The time is ripe” to put smartphone apps, social media, and teleconferencing to work to improve patient outcomes, Dr. Atreja of Mt. Sinai Hospital, New York, said at the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Not only can these connections improve doctor-patient relationships and clinical outcomes, they stand ready to harness the research power of real-time data.

“We can merge clinical data from the electronic medical record and link to a registry. We can mine data for safety and efficacy. We can even use it to enroll patients in clinical trials that might otherwise take years to build a meaningful cohort.”

When Dr. Atreja says “The future is now,” he means it. Just days ago, Apple launched its new iPhone program, ResearchKit. The app allows users to become part of enormous potential research pools. Within just 36 hours of launch, thousands of users had signed up.

They can enter all kinds of baseline health data – for example, blood pressure, body mass index, and chronic illnesses. They can also complete user-interface activities like finger-tapping the screen, speaking into the phone, and walking with it – all of which can flag potential disease-specific symptoms.

Researchers looking for study subjects can comb through the data and identify subjects who might be interested in participating, then reach out to them.

Digital communication also makes extending care beyond clinic a reality, said Dr. Brennan Spiegel, director of Health Services Research at Cedars-Sinai Hospital, Los Angeles.

“Our patients don’t just exist in the clinic. They are at senior centers. They are at home, at work, at play in parks. These are the places where they experience the psychomedical effects of their illness. And we need to find a way to get to them.”

Patients are not always completely reliable, or even open, during a clinic visit. The physician, therefore, can be working off incomplete information even before embarking on a complex 20-minute interview.

“We need to get a history, do an exam, think about tests, try and understand the emotional context of the illness, assess the patient’s motivation, educate and counsel, and develop a targeted treatment plan. All from behind the laptop that separates us from the patient.”

The patient often leaves with unanswered questions, or simply overwhelmed with information. “But she has a computer. She has smartphone. And so do we. . . so we can still exchange information.”

Is it practical, though, for the physician who already has too few hours in any day to stay glued to a cellphone or laptop for this kind of continuous interaction? The answer is a most decided “No.”

Instead, Dr. Spiegel said, interactive algorithms can be employed to gather real-time patient metrics through voluntary input or automatic monitoring programs, and send what amounts to personally dictated notes to providers through the patients’ electronic medical record.

My GI Health, which Dr. Spiegel co-created, is a good example of this technology.

Patients can access a secure portal and answers basic questions about GI symptoms and medical history. The program translates this into something very much akin to a provider-generated history and presentation document. This can be reviewed before an appointment to facilitate communication. And because the initial information is shared privately, Dr. Spiegel said patients may be more forthcoming than discussing what they perceive as embarrassing topics face-to-face.

The computer-generated notes are impressively accurate. A study published in the American Journal of Gastroenterology in January showed just how impressive.

Blinded physician reviewers compared both computer- and physician-generated histories for 75 GI patients. The reviewers found the computer-created histories consistently superior, even after adjusting for physician and visit type, location, mode of transcription, and demographics. They said the computer histories were more complete, more useful, better organized, more succinct and more comprehensible. All of the computer histories could have been billed at the highest level, compared to 84% of those written by humans.

“That doesn’t mean computers are better than doctors,” Dr. Spiegel said. “We still need ‘us’ … to look at patients face-to-face, to understand the deep, nuanced complexity of their lives and illnesses. But computers are excellent at collecting information and putting that into meaningful context. And we can use this to benefit everyone.”

[email protected]

SAN FRANCISCO – AGA President-Elect Michael Camilleri discusses how innovation is an integral part of AGA’s strategic plan during the 2015 AGA Tech Summit. Technologies are beginning to address the unmet needs of patients with gastrointestinal and metabolic diseases, and AGA will keep its physician members well-informed on how these new innovations will transform patient care.

SAN FRANCISCO – AGA President-Elect Michael Camilleri discusses how innovation is an integral part of AGA’s strategic plan during the 2015 AGA Tech Summit. Technologies are beginning to address the unmet needs of patients with gastrointestinal and metabolic diseases, and AGA will keep its physician members well-informed on how these new innovations will transform patient care.

SAN FRANCISCO – AGA President-Elect Michael Camilleri discusses how innovation is an integral part of AGA’s strategic plan during the 2015 AGA Tech Summit. Technologies are beginning to address the unmet needs of patients with gastrointestinal and metabolic diseases, and AGA will keep its physician members well-informed on how these new innovations will transform patient care.

SAN FRANCISCO – A wide range of individual patient factors can influence the development of obesity, said AGA President-Elect Michael Camilleri in a video interview at the AGA Tech Summit. To effectively help obese patients, physicians need to be able to determine the individual factors driving the obesity and be able to draw on technologies that are personalized to the needs of each individual.

SAN FRANCISCO – A wide range of individual patient factors can influence the development of obesity, said AGA President-Elect Michael Camilleri in a video interview at the AGA Tech Summit. To effectively help obese patients, physicians need to be able to determine the individual factors driving the obesity and be able to draw on technologies that are personalized to the needs of each individual.

SAN FRANCISCO – A wide range of individual patient factors can influence the development of obesity, said AGA President-Elect Michael Camilleri in a video interview at the AGA Tech Summit. To effectively help obese patients, physicians need to be able to determine the individual factors driving the obesity and be able to draw on technologies that are personalized to the needs of each individual.

SAN FRANCISCO – Taking a device from inception through the Food and Drug Administration approval process, CPT coding, payer coverage, and adoption by physicians can take 10 years or more and millions of dollars. Working with the AGA Center for GI Innovation and Technology to develop a registry and trial design can assist in speeding this process. At the 2015 AGA Tech Summit in San Francisco, Dr. Ashish Atreja, director of medical informatics at the Mount Sinai School of Medicine, New York, and chair of the AGA Registry Oversight Committee, discusses how the AGA can provide full-service device registry support. He also discusses the goals of AGA’s STAR registry and provides a look ahead at upcoming registry initiatives.

[email protected]

SAN FRANCISCO – Taking a device from inception through the Food and Drug Administration approval process, CPT coding, payer coverage, and adoption by physicians can take 10 years or more and millions of dollars. Working with the AGA Center for GI Innovation and Technology to develop a registry and trial design can assist in speeding this process. At the 2015 AGA Tech Summit in San Francisco, Dr. Ashish Atreja, director of medical informatics at the Mount Sinai School of Medicine, New York, and chair of the AGA Registry Oversight Committee, discusses how the AGA can provide full-service device registry support. He also discusses the goals of AGA’s STAR registry and provides a look ahead at upcoming registry initiatives.

[email protected]

SAN FRANCISCO – Taking a device from inception through the Food and Drug Administration approval process, CPT coding, payer coverage, and adoption by physicians can take 10 years or more and millions of dollars. Working with the AGA Center for GI Innovation and Technology to develop a registry and trial design can assist in speeding this process. At the 2015 AGA Tech Summit in San Francisco, Dr. Ashish Atreja, director of medical informatics at the Mount Sinai School of Medicine, New York, and chair of the AGA Registry Oversight Committee, discusses how the AGA can provide full-service device registry support. He also discusses the goals of AGA’s STAR registry and provides a look ahead at upcoming registry initiatives.

[email protected]