DDW 2013

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.

Early referral for 24-hour esophageal pH monitoring in patients with suspected gastroesophageal reflux disease who fail to respond to proton pump inhibitor therapy can lead to substantial health care cost savings, according to findings from a retrospective study.

Although most guidelines recommend an empiric 8-week trial of PPIs in symptomatic patients, many remain on treatment for much longer than that, Dr. David Kleiman explained at a press briefing held in advance of the annual Digestive Disease Week, where the findings will be presented.

In fact, in 100 patients who underwent 24-hour pH monitoring, 21,411 weeks of PPI therapy were prescribed beyond the recommended 8-week trial, and nearly a third (32%) of those were in patients who had a negative 24-hour pH monitoring study, said Dr. Kleiman of New York Presbyterian Hospital–Weill Cornell Medical College, New York.

Based on a cost model created from a third-party payer perspective over a 10-year period, that equals excess costs of between $1,966 and $7,825 per patient, assuming 100% sensitivity of pH monitoring. The range represents costs from low-dose generic PPIs to high-dose name-brand PPIs.

Based on the average wholesale unit prices of PPIs as reported in the 2012 Micromedex Redbook, and the cost of 24-hour pH monitoring and manometry (which was used to determine esophageal function and for appropriate positioning of the pH probe) as determined by 2012 Medicare fees, the weekly cost of PPIs ranged from $29.06 to $107.70 and the cost of monitoring was $690, Dr. Kleiman said.

Depending on the PPI regimen used, the costs of PPI therapy and the costs of monitoring equalized between 6.4 and 23.7 weeks; Patients with esophageal GERD symptoms reported a median of 208 weeks of therapy prior to referral for 24-hour pH monitoring; those with extraesophageal GERD symptoms reported a median of 52 weeks of PPI use before referral.

Sensitivity of 24-hour pH monitoring ranges from 30% to 96%, according to a review of the literature. As long as the sensitivity of pH monitoring is above 35%, the strategy of prompt referral after an 8-week PPI trial will be cost-effective, Dr. Kleiman said.

These findings demonstrate "surprisingly convincing" benefits of performing pH monitoring.

"By utilizing pH monitoring we were able to identify a large percentage of patients who were taking PPIs without having any signs of GERD," he said.

Given that an estimated 25%-40% of Americans experience daily heartburn – which may or may not be associated with GERD – the findings have important implications for patient management, he said, noting that the overuse of PPIs in the general population has been garnering increasing attention in recent years.

A "shocking"$9.4 billion is spent on PPIs just in the United States each year, he said.

"And these numbers, every time they come out, keep increasing. More and more papers are acknowledging that there is a great deal of inappropriate use of PPIs in patients that really do not need to be taking them. I think raising the awareness of this issue is really critical to optimizing the care that we provide for our patients," he said.

As for which patients should undergo pH testing, the best scenario has yet to be identified, and while it is clear that not every single person who experiences reflux occasionally – or even more than occasionally – needs to undergo pH monitoring, the available data suggest that those who continue to experience symptoms after an 8-week PPI trial most likely have another disorder that is being overlooked, Dr. Kleiman said.

"I think those patients, certainly, should be considered to have this testing sooner than they would have previously," he said.

Dr. Kleiman has no financial conflicts relevant to this study.*

*Correction 05/20/2013: An earlier version of this story misstated Dr. Kleiman's financial declaration.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.