Digestive Disease Week (DDW 2011)

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.

CHICAGO – The risk of gallbladder disease was more than twice as high in pregnant women in the top quartile of carbohydrate consumption, compared with those in the bottom quartile, based on data from a prospective study of 3,070 pregnant women.

Female sex is a risk factor for gallstones, and pregnancy is an especially high-risk time for gallstone development, Dr. Alexander Wong of the University of Washington, Seattle, said at a press conference at the annual Digestive Disease Week.

"Gallbladder disease is the most common nonobstetrical cause of maternal rehospitalization the first 60 days after delivery," said Dr. Wong. "Carbohydrate intake has been linked to increased risk of cholecystectomy in women. However, the effect of carbohydrate intake on gallbladder disease during pregnancy is unclear."

To determine the effect of diet during pregnancy on gallstone formation, Dr. Wong and his colleagues performed ultrasounds on pregnant women during each trimester and at 4-6 weeks post partum. The average age of the women was 25 years, and each had at least two interpretable ultrasounds. Women who had gallstones at the first ultrasound and those with a history of gallstones were excluded.

Overall, the cumulative incidence of new gallstones or biliary sludge indicative of gallbladder disease was 10%. In addition, women in the highest quartile of starch consumption were 80% more likely than those in the lowest quartile to show signs of gallbladder disease. In addition, those in the highest quartile of fructose consumption had double the risk, compared with the lowest quartile, of showing signs of gallbladder disease. Dietary factors were assessed using standard food composition data.

Women who formed sludge or stones were more likely to have a higher caffeine and alcohol intake, be of Hispanic origin, and gain less weight during pregnancy.

By contrast, the highest quartile of galactose intake was independently associated with a decreased risk of gallbladder disease, compared with the lowest quartile, noted coauthor Dr. Cynthia Ko, also of the university, who presented the study results at a press conference. The results held after control for variables including age, prepregnancy weight, ethnicity, smoking, diabetes, total calorie intake, alcohol intake, and weight gain during pregnancy.

"We believe that high carbohydrate intake during pregnancy may stimulate even more insulin release, therefore increasing the negative effects of hyperinsulinemia on bile composition," Dr. Wong said.

"The fructose finding is fairly novel," added Dr. Ko. "We hypothesize that fructose is metabolized differently than many other carbohydrates." High fructose intake can cause insulin resistance, which can predispose individuals to gallstone formation, she noted.

"The galactose finding is quite novel, and we don’t have a good scientific explanation for why we found that," she added. "This is a very preliminary finding that needs further confirmation and explanation."

The results suggest that cutting down on refined, processed carbohydrates during pregnancy might reduce a woman’s risk of gallstones, Dr. Ko noted.

Dr. Ko said she had no relevant financial disclosures.

CHICAGO – The risk of gallbladder disease was more than twice as high in pregnant women in the top quartile of carbohydrate consumption, compared with those in the bottom quartile, based on data from a prospective study of 3,070 pregnant women.

Female sex is a risk factor for gallstones, and pregnancy is an especially high-risk time for gallstone development, Dr. Alexander Wong of the University of Washington, Seattle, said at a press conference at the annual Digestive Disease Week.

"Gallbladder disease is the most common nonobstetrical cause of maternal rehospitalization the first 60 days after delivery," said Dr. Wong. "Carbohydrate intake has been linked to increased risk of cholecystectomy in women. However, the effect of carbohydrate intake on gallbladder disease during pregnancy is unclear."

To determine the effect of diet during pregnancy on gallstone formation, Dr. Wong and his colleagues performed ultrasounds on pregnant women during each trimester and at 4-6 weeks post partum. The average age of the women was 25 years, and each had at least two interpretable ultrasounds. Women who had gallstones at the first ultrasound and those with a history of gallstones were excluded.

Overall, the cumulative incidence of new gallstones or biliary sludge indicative of gallbladder disease was 10%. In addition, women in the highest quartile of starch consumption were 80% more likely than those in the lowest quartile to show signs of gallbladder disease. In addition, those in the highest quartile of fructose consumption had double the risk, compared with the lowest quartile, of showing signs of gallbladder disease. Dietary factors were assessed using standard food composition data.

Women who formed sludge or stones were more likely to have a higher caffeine and alcohol intake, be of Hispanic origin, and gain less weight during pregnancy.

By contrast, the highest quartile of galactose intake was independently associated with a decreased risk of gallbladder disease, compared with the lowest quartile, noted coauthor Dr. Cynthia Ko, also of the university, who presented the study results at a press conference. The results held after control for variables including age, prepregnancy weight, ethnicity, smoking, diabetes, total calorie intake, alcohol intake, and weight gain during pregnancy.

"We believe that high carbohydrate intake during pregnancy may stimulate even more insulin release, therefore increasing the negative effects of hyperinsulinemia on bile composition," Dr. Wong said.

"The fructose finding is fairly novel," added Dr. Ko. "We hypothesize that fructose is metabolized differently than many other carbohydrates." High fructose intake can cause insulin resistance, which can predispose individuals to gallstone formation, she noted.

"The galactose finding is quite novel, and we don’t have a good scientific explanation for why we found that," she added. "This is a very preliminary finding that needs further confirmation and explanation."

The results suggest that cutting down on refined, processed carbohydrates during pregnancy might reduce a woman’s risk of gallstones, Dr. Ko noted.

Dr. Ko said she had no relevant financial disclosures.

CHICAGO – The risk of gallbladder disease was more than twice as high in pregnant women in the top quartile of carbohydrate consumption, compared with those in the bottom quartile, based on data from a prospective study of 3,070 pregnant women.

Female sex is a risk factor for gallstones, and pregnancy is an especially high-risk time for gallstone development, Dr. Alexander Wong of the University of Washington, Seattle, said at a press conference at the annual Digestive Disease Week.

"Gallbladder disease is the most common nonobstetrical cause of maternal rehospitalization the first 60 days after delivery," said Dr. Wong. "Carbohydrate intake has been linked to increased risk of cholecystectomy in women. However, the effect of carbohydrate intake on gallbladder disease during pregnancy is unclear."

To determine the effect of diet during pregnancy on gallstone formation, Dr. Wong and his colleagues performed ultrasounds on pregnant women during each trimester and at 4-6 weeks post partum. The average age of the women was 25 years, and each had at least two interpretable ultrasounds. Women who had gallstones at the first ultrasound and those with a history of gallstones were excluded.

Overall, the cumulative incidence of new gallstones or biliary sludge indicative of gallbladder disease was 10%. In addition, women in the highest quartile of starch consumption were 80% more likely than those in the lowest quartile to show signs of gallbladder disease. In addition, those in the highest quartile of fructose consumption had double the risk, compared with the lowest quartile, of showing signs of gallbladder disease. Dietary factors were assessed using standard food composition data.

Women who formed sludge or stones were more likely to have a higher caffeine and alcohol intake, be of Hispanic origin, and gain less weight during pregnancy.

By contrast, the highest quartile of galactose intake was independently associated with a decreased risk of gallbladder disease, compared with the lowest quartile, noted coauthor Dr. Cynthia Ko, also of the university, who presented the study results at a press conference. The results held after control for variables including age, prepregnancy weight, ethnicity, smoking, diabetes, total calorie intake, alcohol intake, and weight gain during pregnancy.

"We believe that high carbohydrate intake during pregnancy may stimulate even more insulin release, therefore increasing the negative effects of hyperinsulinemia on bile composition," Dr. Wong said.

"The fructose finding is fairly novel," added Dr. Ko. "We hypothesize that fructose is metabolized differently than many other carbohydrates." High fructose intake can cause insulin resistance, which can predispose individuals to gallstone formation, she noted.

"The galactose finding is quite novel, and we don’t have a good scientific explanation for why we found that," she added. "This is a very preliminary finding that needs further confirmation and explanation."

The results suggest that cutting down on refined, processed carbohydrates during pregnancy might reduce a woman’s risk of gallstones, Dr. Ko noted.

Dr. Ko said she had no relevant financial disclosures.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – Water infusion during the insertion phase of colonoscopy improved overall and proximal-colon adenoma-detection rates by 11% over standard air insufflation in a prospective randomized trial involving 368 patients.

After controlling for age, body mass index, smoking, alcohol consumption, withdrawal time, and the quality of bowel preparation, researchers found 81% higher odds of detecting an adenoma using the water-method group than in the air-method patients (odds ratio 1.81), Dr. Felix Leung reported at the annual Digestive Disease Week.

A prospective randomized trial in 82 veterans reported last year by Dr. Leung as a proof of principle of water insufflation in unsedated colonoscopy demonstrated improved patient comfort and cecal intubation with that method (Gastrointest Endosc. 2010;72:693-700).

The use of water to aid colonoscope insertion avoids colon elongation, minimizes angulations, helps identify the lumen, and provides a clear view of the colon, explained Dr. Leung, who is with the Veterans Affairs Greater Los Angeles Healthcare System in North Hills, Calif.

Water had been used before in colonoscopy, but the method proved cumbersome because multiple syringes were required to deliver the liquid. In the current study, doctors delivered room temperature water via pedal pump and a tube connected to the base of the colonoscope, with its air feature turned off. Roughly 100 ccs of water were used if the bowel was fairly clean, and 1-1.5 liters if fairly dirty, Dr. Leung said.

In the other group, air insufflation was performed as usual. Doctors used air during the withdrawal of colonoscopes from the patients in both groups. All procedures were performed using high-definition adult colonoscopes (Olympus 180-H series).

The overall adenoma-detection rate was 46% among the patients that were treated with air during insertion and 57% among patients treated with water, a significant difference (P = .04), according to Dr. Leung and his coauthor Dr. Francisco C. Ramirez of the University of Arizona, Phoenix.

Patients in whom colonoscopy detected at least one proximal adenoma were more likely to be in the water than the air group (46% vs. 35%, P = .03). This advantage held for adenomas less than 10 mm in size (42% vs. 31%, P = .04) but not for those 10 mm or larger (9% vs. 10%).

The mean time to the cecum was longer during colonoscopy initiated with water than with air, but only by 1.6 minutes (6.9 minutes vs. 5.3 minutes, P < .0001), Dr. Leung said.

Colonoscopy was accomplished in the water group with lower mean doses of fentanyl (68.8 mcg vs. 76.5 mcg, P = .0006) and midazolam (2.8 mg vs. 3.1 mg, P = .0007), and fewer patients in the water group received additional sedation (17.5% vs. 27%, P = .03).

The use of external pressure was also lower with water vs. air (12% vs. 28%, P < .0001).

Limitations of the study include a mostly male population (96%) and that a single endoscopist with a relatively high baseline adenoma-detection rate (46%) performed the procedures.

Good and excellent bowel preparation was reported in 79% of the 191 air-method patients and in 84% of the 177 water-method patients. Cecal intubation rates were similar at 100% in the air group and 92% in the water group. One adverse event was reported in each group.

Dr. Leung said the next randomized trial should compare the use of water for insertion and carbon dioxide for withdrawal – with polypectomy allowed at physician discretion – vs. a traditional air technique. He speculated that the water–carbon dioxide method would reduce pain during and after colonoscopy, salvage the procedure in patients with suboptimal bowel prep, and perhaps increase adenoma detection.

"This will impact post-colonoscopy pain-related [emergency room] visits and hospitalization, and because of the reduction in pain, perhaps colleagues will consider minimizing sedation and therefore decrease the overall patient burden," he said.

Also presented during the session were preliminary results from 313 patients in a randomized trial of unsedated colonoscopy comparing carbon dioxide insufflation during both colonoscope insertion and withdrawal , warm water infusion (98.6º F) during insertion and air insufflation during withdrawal, and standard air insufflation during both phases.

The proportion of patients requesting sedation or analgesia, the study’s primary end point, was 15.5% in the carbon dioxide group, 13.2% in the water-air group, and 25.6% in the all-air group, lead author Dr. Arnaldo Amato said. These differences were statistically significant for carbon dioxide vs. all air (P = .04) and for water-air vs. all-air (P = .03).

Median pain scores assessed by a visual analogue scale were 30 for the carbon dioxide group, 28 for the water-air group, and 46 for the all-air group. The differences were significant between the carbon dioxide and all-air groups and between the water-air and all-air groups (both at P less than .001).

Dr. Amato noted that 93% of the patients treated with carbon dioxide were willing to repeat the procedure vs. 90% of water-air patients and 80% of all-air patients. The differences were significant for carbon dioxide vs. all-air (P = .03) and for water-air vs. all-air (P = .02), said Dr. Amato, who practices at Valduce Hospital in Como, Italy.

Adenoma detection rates for the three groups were similar at 30.4%, 39%, and 37%.

As for how often American clinicians are using water during colonoscopies, session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., said in an interview, "I suspect it’s increasing." He estimated that only 10% of colonoscopists use water throughout a procedure.

Dr. Coyle said his use of water has steadily increased and that his hybrid technique incorporates large amounts of water during insertion, then switches to a combination of air and water when the colonoscope approaches the transverse and ascending colon.

Dr. Leung cautioned during his presentation, however, that switching from water to air during a procedure can simplify the identification of the lumen but leave behind dirty water that can impair the view during withdrawal.

Dr. Coyle said this has not been a problem, citing a detection rate of 60%.

Dr. Leung and his coauthor Dr. Francisco C. Ramirez and Dr. Amato and his coauthors reported no conflict of interest. Dr. Coyle reported a financial relationship with Takeda Pharmaceutical.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – A novel quality indicator called Adenomas Under the Curve might have important advantages over the established metric, the Adenoma Detection Rate, for evaluation of endoscopists’ performance, said Dr. Hank S. Wang at the annual Digestive Disease Week.

The adenoma detection rate (ADR) was developed by the U.S. Multisociety Task Force on Colorectal Cancer and is widely used. However, while it may have strengths, it also has glaring weaknesses – most notably the lack of distinction between detection of one adenoma, and detection of more than one, in a given patient, Dr. Wang said.

"An endoscopist who consistently finds one adenoma per case receives the same credit towards ADR as somebody who consistently finds more than one," said Dr. Wang, a gastroenterology fellow in the division of digestive diseases, University of California, Los Angeles, Training Program.

"Clearly these [two] endoscopists are performing differently, and over a large enough case series, they may even be providing different rates of protection against colorectal cancer. Yet by ADR, they would appear to be identical," he explained.

Use of ADR as a quality measure might actually discourage the search for additional adenomas, said Dr. Wang, or even promote "gaming the quality indicator" to maximize efficiency while still ensuring that credit is received for ADR. Some endoscopists may become less vigilant once they have found the first adenoma, and thus the use of ADR may create a subtle disincentive, he said.

The new metric developed by Dr. Wang and his colleagues, Adenomas Under the Curve (AUC), incorporates ADR data and provides additional quality data on the total number of adenomas detected. Thus AUC extends ADR by capturing data on incremental adenomas beyond the first one detected, said Dr. Wang.

The abstract presented by Dr. Wang compared ADR to AUC in two groups of physicians – academic and community – who were providing screening services for the same pool of patients. Screening colonoscopies were performed over a 4-year period (2005-2009) by two types of practices: a Veterans Affairs teaching hospital endoscopy unit, and a group of three nonteaching, fee-for-service facilities, all serving same population of veterans. The choice of facility was made by the veterans, and the analysis was adjusted for selection bias.

ADR was calculated by dividing the number of cases with one or more adenoma(s) by the total number of cases performed.

In contrast, calculating the AUC involved plotting a histogram showing the frequency of cases and the number of adenomas detected by case. To account for weighting, case frequency was multiplied by the number of adenomas detected per case. When these data were combined, they yielded the measure Adenomas Under the Curve.

A bivariate analysis was performed to evaluate comparability between the two groups of patients. ADR was compared between groups using bivariate and multivariable logistic regression. Relative difference in ADR vs. AUC, and between the two cohorts, was also calculated.

Of the total population of 3,302 patients, 1,216 patients presented to the teaching facility (there were 6 academic gastroenterologists) and 2,086 presented to the nonteaching facilities (12 community-based gastroenterologists). Patients at the nonteaching facilities were on average 1 year younger, and the endoscopists there were slightly more experienced. All patients in both arms presented for screening, and none had a known history of polyps.

The mean ADR at the teaching site was 28.9%, compared with 25.9% at the nonteaching sites, a small difference that did not reach statistical significance (P = .056). However, when the model was adjusted for differences such as age, sedation, furthest point seen, bowel prep type and quality, experience, and the presence of a fellow, the odds of adenoma detection were 43% higher at the teaching facility, a difference that was highly statistically significant (adjusted odds ratio, 1.43 [1.1-1.8], P = .003).

A plot of the AUC for the teaching site superimposed on the AUC for the nonteaching sites clearly showed that, after detection of the first adenoma at the nonteaching facilities, there was a steep drop-off in the number of cases in which two, three, or four adenomas were detected.

"The difference in AUC between the two sites is largely driven by this difference in the frequency of cases where two, three, and four adenomas are detected per case. We calculated AUC of our teaching facility; it was 56.4 units, compared to 42.7 units at the nonteaching site. This difference was highly statistically significant," (P less than .001), said Dr. Wang. The relative difference in ADR was 10.6%, but the relative AUC difference was 25%.

"As we move toward an era of greater accountability in medicine, our performance measures must become more, and not less, accurate. And I believe the AUC is a step in that direction," said Dr. Wang.

The study was sponsored by an NIH GI Training Grant and CURE: Digestive Diseases Research Center.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, VA. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, VA. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, VA. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.

CHICAGO – Adding the protease inhibitor telaprevir to the standard combination therapy of pegylated interferon alfa-2a and ribavirin significantly improved outcomes in three categories of genotype 1 hepatitis C patients who had failed standard treatment, according to final results from the phase III REALIZE trial.

Approximately 60% of genotype 1 hepatitis C patients treated with standard therapy do not respond, said Dr. Zobair M. Younossi of Inova Fairfax Hospital in Falls Church, Va. "Re-treating these patients will be very difficult if you want to treat them with the currently available double-combination therapy," said Dr. Younossi, who presented the study findings in a press conference at the annual Digestive Disease Week.

The researchers, led by Dr. Paul Pockros of the Scripps Translational Science Institute in La Jolla, Calif., conducted an international, multicenter, double-blind, randomized placebo-controlled trial – the REALIZE trial – to assess the safety and tolerability of adding 750 mg of telaprevir every 8 hours to the standard therapy of 180 mcg/week of pegylated interferon alfa-2a and 1000-1200 mg/day of ribavirin. The control group received the standard therapy plus a placebo.

The treatment arms were as follows: telaprevir plus standard therapy for 12 weeks followed by standard therapy for 36 weeks; standard therapy for 4 weeks followed by telaprevir plus standard therapy for 12 weeks and then standard therapy for 32 weeks; and standard therapy for 48 weeks.

Approximately 70% of the 662 treated patients were male, and 93% were white. About one-quarter (26%) had cirrhosis, and 89% had a baseline HCV RNA level of at least 800,000 IU/mL. They were divided into three groups: those who had relapsed after standard treatment, those who had a partial response to standard treatment, and those who had no response to standard treatment.

Among the prior relapsers, the response rate in the telaprevir patients was 83%-88%, compared with 23% in the placebo group. Among the prior partial responders, the response rate in the telaprevir patients ranged from 54% to 59%, compared with 23% of the placebo patients. And among the prior nonresponders, the response rate was 29% to 33% in the telaprevir group and 5% in the placebo group. The differences between telaprevir and placebo were significant in all three patient categories – prior partial responders, prior nonresponders, and prior relapsers.

The main goal of the study was to assess whether telaprevir together with standard therapy had superior efficacy for prior relapsers and prior nonresponders, compared with standard therapy alone.

"Another important part of the study was that the lead-in phase did not add to the efficacy and the sustained virologic response in these patients," Dr. Younossi noted.

The safety and tolerability data for telaprevir were similar to results from previous studies, Dr. Younossi said. The most frequently reported adverse events included fatigue, pruritus, rash, nausea, flulike symptoms, anemia, and diarrhea. Rash (4%) and anemia (3%) were the most common reasons given for treatment discontinuation.

"We are on the verge of the next wave of treatment for hepatitis C," said the moderator of the press conference, Dr. Adrian M. Di Bisceglie, codirector of the liver center and chief of hepatology, St. Louis University. Both telaprevir and boceprevir (which was not evaluated in the REALIZE trial) are protease inhibitors; they are direct-acting antivirals that have been tested in phase III trials with pegylated interferon and ribavirin, he said.

On April 27, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of boceprevir and, on April 28, unanimously voted to recommend approval of telaprevir, both for use in combination with pegylated interferon and ribavirin as a treatment for genotype 1 chronic hepatitis C. At press time, neither drug had been approved, but approval was considered imminent for both drugs.

Dr. Younossi has served on advisory committees or review boards for multiple pharmaceutical companies, including study sponsor Vertex Pharmaceuticals.