Mitchel L. Zoler, PhD

BERLIN – Treatment with a drug that blocked the action of tumor necrosis factor led to a significant reduction of cardiovascular events in patients with rheumatoid arthritis, compared with treatment with methotrexate or other nonbiologic disease modifying antirheumatic drugs, in a review of more than 100,000 patients treated during routine practice, according to Dr. Michael T. Nurmohamed.

Although this finding adds to the accumulating circumstantial evidence that treating patients with rheumatoid arthritis (RA) with a drug that blocks tumor necrosis factor (TNF) reduces their cardiovascular disease risk better than does treatment with disease-modifying antirheumatic drugs (DMARDs), current evidence does not yet clearly support an early start to anti-TNF treatment to maximize cardiovascular risk reduction, Dr. Nurmohamed said in an interview at the annual European Congress of Rheumatology.

"However, the literature does indicate that effective inflammatory suppression is essential [for patients with RA], and that if this is not achieved within a reasonable time frame with high-dose methotrexate or another DMARD then treatment with a biological, anti-TNF drug should be considered," he noted.

"The rheumatologic aim of treatment should be minimal RA disease activity and preferably remission. An additional aim of treatment might be cardiovascular risk reduction. If anti-TNF treatment stops when an RA patient achieves disease remission, we need to know whether the arterial inflammatory process also stays in remission. Investigations of this are now underway, and these studies may reveal new biomarkers of cardiovascular risk in RA patients. Until these results are available, cardiovascular risk management in patients with RA should follow EULAR recommendations (Ann. Rheum. Dis. 2010;69:325-31)," said Dr. Nurmohamed, a rheumatologist at VU University Medical Centre in Amsterdam.

"It appears that in patients with RA, atherosclerotic plaques rupture earlier," he said in an interview. "We know that inflammation is very important in that process. It might be that when you treat patients with an anti-TNF drug or other anti-inflammatory, you reduce the inflammatory content of the plaque. Therefore the plaque ruptures later. That may be the way that anti-TNF drugs lower myocardial infarctions," according to Dr. Nurmohamed.

The new results he reported came from a review of 109,462 United States patients diagnosed with RA who had filled at least one prescription for an anti-TNF drug, methotrexate, or another DMARD, and were included in a database maintained by Thomson Reuters MarketScan The researchers reviewed the patient records following the date when they filled their index prescription until they developed a cardiovascular event, ended their enrollment in their health plan, or until 6 months after they stopped taking their index drug, whichever came first. The review included 48,210 patient-years of follow-up while on treatment with an anti-TNF drug, 13,540 patient-years of treatment with methotrexate, and 7,320 patient-years of treatment with another nonbiologic DMARD. The database included more than 75,000 patient-years of follow-up when patients received monotherapy with one of these three treatments, according to Dr. Nurmohamed.

During follow-up, 1,743 patients (1.6%) had a cardiovascular event, a myocardial infarction (MI), unstable angina, heart failure, or stroke. Events primarily occurred as MI, unstable angina, or heart failure. Dr. Nurmohamed said that he and his associates then ran a series of Cox proportional hazard models that assessed the outcomes from cumulative exposure to the various treatments and controlled for patient demographics, use of cardiovascular medications, smoking, comorbidities, hypertension, diabetes, history of cardiovascular events, and medical-resource use.

The analyses showed that for every 6 months of treatment with an anti-TNF drug, the rate of all cardiovascular events fell by 13%, compared with patients not treated with an anti-TNF drug. Six months of anti-TNF-drug treatment cut the rate of MIs specifically by 20%, compared with nonuse of an anti-TNF drug. Both effects were statistically significant.

The analyses also showed that the cardiovascular-event effect of anti-TNF drugs was cumulative. A year of use cut the cardiovascular event rate by 24%, 2 years cut the rate by 42%, and 3 years cut the rate by 56%, compared with patients who did not receive an anti-TNF drug, Dr. Nurmohamed reported. This cumulative effect was not surprising because "prolonged inflammatory suppression will lead to more pronounced risk reduction," he said.

The analyses also showed that the cardiovascular-risk reduction of treatment with an anti-TNF drug, compared with patients who did not get this drug class, was a statistically significant 14% in patients who were at least 50 years old, and a significant 15% in patients with no prior exposure to methotrexate. The analyses failed to find a significant impact on cardiovascular disease from treatment with methotrexate or other nonbiologic DMARDs.

Dr. Nurmohamed said that he had no relevant disclosures.

BERLIN – Treatment with a drug that blocked the action of tumor necrosis factor led to a significant reduction of cardiovascular events in patients with rheumatoid arthritis, compared with treatment with methotrexate or other nonbiologic disease modifying antirheumatic drugs, in a review of more than 100,000 patients treated during routine practice, according to Dr. Michael T. Nurmohamed.

Although this finding adds to the accumulating circumstantial evidence that treating patients with rheumatoid arthritis (RA) with a drug that blocks tumor necrosis factor (TNF) reduces their cardiovascular disease risk better than does treatment with disease-modifying antirheumatic drugs (DMARDs), current evidence does not yet clearly support an early start to anti-TNF treatment to maximize cardiovascular risk reduction, Dr. Nurmohamed said in an interview at the annual European Congress of Rheumatology.

"However, the literature does indicate that effective inflammatory suppression is essential [for patients with RA], and that if this is not achieved within a reasonable time frame with high-dose methotrexate or another DMARD then treatment with a biological, anti-TNF drug should be considered," he noted.

"The rheumatologic aim of treatment should be minimal RA disease activity and preferably remission. An additional aim of treatment might be cardiovascular risk reduction. If anti-TNF treatment stops when an RA patient achieves disease remission, we need to know whether the arterial inflammatory process also stays in remission. Investigations of this are now underway, and these studies may reveal new biomarkers of cardiovascular risk in RA patients. Until these results are available, cardiovascular risk management in patients with RA should follow EULAR recommendations (Ann. Rheum. Dis. 2010;69:325-31)," said Dr. Nurmohamed, a rheumatologist at VU University Medical Centre in Amsterdam.

"It appears that in patients with RA, atherosclerotic plaques rupture earlier," he said in an interview. "We know that inflammation is very important in that process. It might be that when you treat patients with an anti-TNF drug or other anti-inflammatory, you reduce the inflammatory content of the plaque. Therefore the plaque ruptures later. That may be the way that anti-TNF drugs lower myocardial infarctions," according to Dr. Nurmohamed.

The new results he reported came from a review of 109,462 United States patients diagnosed with RA who had filled at least one prescription for an anti-TNF drug, methotrexate, or another DMARD, and were included in a database maintained by Thomson Reuters MarketScan The researchers reviewed the patient records following the date when they filled their index prescription until they developed a cardiovascular event, ended their enrollment in their health plan, or until 6 months after they stopped taking their index drug, whichever came first. The review included 48,210 patient-years of follow-up while on treatment with an anti-TNF drug, 13,540 patient-years of treatment with methotrexate, and 7,320 patient-years of treatment with another nonbiologic DMARD. The database included more than 75,000 patient-years of follow-up when patients received monotherapy with one of these three treatments, according to Dr. Nurmohamed.

During follow-up, 1,743 patients (1.6%) had a cardiovascular event, a myocardial infarction (MI), unstable angina, heart failure, or stroke. Events primarily occurred as MI, unstable angina, or heart failure. Dr. Nurmohamed said that he and his associates then ran a series of Cox proportional hazard models that assessed the outcomes from cumulative exposure to the various treatments and controlled for patient demographics, use of cardiovascular medications, smoking, comorbidities, hypertension, diabetes, history of cardiovascular events, and medical-resource use.

The analyses showed that for every 6 months of treatment with an anti-TNF drug, the rate of all cardiovascular events fell by 13%, compared with patients not treated with an anti-TNF drug. Six months of anti-TNF-drug treatment cut the rate of MIs specifically by 20%, compared with nonuse of an anti-TNF drug. Both effects were statistically significant.

The analyses also showed that the cardiovascular-event effect of anti-TNF drugs was cumulative. A year of use cut the cardiovascular event rate by 24%, 2 years cut the rate by 42%, and 3 years cut the rate by 56%, compared with patients who did not receive an anti-TNF drug, Dr. Nurmohamed reported. This cumulative effect was not surprising because "prolonged inflammatory suppression will lead to more pronounced risk reduction," he said.

The analyses also showed that the cardiovascular-risk reduction of treatment with an anti-TNF drug, compared with patients who did not get this drug class, was a statistically significant 14% in patients who were at least 50 years old, and a significant 15% in patients with no prior exposure to methotrexate. The analyses failed to find a significant impact on cardiovascular disease from treatment with methotrexate or other nonbiologic DMARDs.

Dr. Nurmohamed said that he had no relevant disclosures.

BERLIN – Treatment with a drug that blocked the action of tumor necrosis factor led to a significant reduction of cardiovascular events in patients with rheumatoid arthritis, compared with treatment with methotrexate or other nonbiologic disease modifying antirheumatic drugs, in a review of more than 100,000 patients treated during routine practice, according to Dr. Michael T. Nurmohamed.

Although this finding adds to the accumulating circumstantial evidence that treating patients with rheumatoid arthritis (RA) with a drug that blocks tumor necrosis factor (TNF) reduces their cardiovascular disease risk better than does treatment with disease-modifying antirheumatic drugs (DMARDs), current evidence does not yet clearly support an early start to anti-TNF treatment to maximize cardiovascular risk reduction, Dr. Nurmohamed said in an interview at the annual European Congress of Rheumatology.

"However, the literature does indicate that effective inflammatory suppression is essential [for patients with RA], and that if this is not achieved within a reasonable time frame with high-dose methotrexate or another DMARD then treatment with a biological, anti-TNF drug should be considered," he noted.

"The rheumatologic aim of treatment should be minimal RA disease activity and preferably remission. An additional aim of treatment might be cardiovascular risk reduction. If anti-TNF treatment stops when an RA patient achieves disease remission, we need to know whether the arterial inflammatory process also stays in remission. Investigations of this are now underway, and these studies may reveal new biomarkers of cardiovascular risk in RA patients. Until these results are available, cardiovascular risk management in patients with RA should follow EULAR recommendations (Ann. Rheum. Dis. 2010;69:325-31)," said Dr. Nurmohamed, a rheumatologist at VU University Medical Centre in Amsterdam.

"It appears that in patients with RA, atherosclerotic plaques rupture earlier," he said in an interview. "We know that inflammation is very important in that process. It might be that when you treat patients with an anti-TNF drug or other anti-inflammatory, you reduce the inflammatory content of the plaque. Therefore the plaque ruptures later. That may be the way that anti-TNF drugs lower myocardial infarctions," according to Dr. Nurmohamed.

The new results he reported came from a review of 109,462 United States patients diagnosed with RA who had filled at least one prescription for an anti-TNF drug, methotrexate, or another DMARD, and were included in a database maintained by Thomson Reuters MarketScan The researchers reviewed the patient records following the date when they filled their index prescription until they developed a cardiovascular event, ended their enrollment in their health plan, or until 6 months after they stopped taking their index drug, whichever came first. The review included 48,210 patient-years of follow-up while on treatment with an anti-TNF drug, 13,540 patient-years of treatment with methotrexate, and 7,320 patient-years of treatment with another nonbiologic DMARD. The database included more than 75,000 patient-years of follow-up when patients received monotherapy with one of these three treatments, according to Dr. Nurmohamed.

During follow-up, 1,743 patients (1.6%) had a cardiovascular event, a myocardial infarction (MI), unstable angina, heart failure, or stroke. Events primarily occurred as MI, unstable angina, or heart failure. Dr. Nurmohamed said that he and his associates then ran a series of Cox proportional hazard models that assessed the outcomes from cumulative exposure to the various treatments and controlled for patient demographics, use of cardiovascular medications, smoking, comorbidities, hypertension, diabetes, history of cardiovascular events, and medical-resource use.

The analyses showed that for every 6 months of treatment with an anti-TNF drug, the rate of all cardiovascular events fell by 13%, compared with patients not treated with an anti-TNF drug. Six months of anti-TNF-drug treatment cut the rate of MIs specifically by 20%, compared with nonuse of an anti-TNF drug. Both effects were statistically significant.

The analyses also showed that the cardiovascular-event effect of anti-TNF drugs was cumulative. A year of use cut the cardiovascular event rate by 24%, 2 years cut the rate by 42%, and 3 years cut the rate by 56%, compared with patients who did not receive an anti-TNF drug, Dr. Nurmohamed reported. This cumulative effect was not surprising because "prolonged inflammatory suppression will lead to more pronounced risk reduction," he said.

The analyses also showed that the cardiovascular-risk reduction of treatment with an anti-TNF drug, compared with patients who did not get this drug class, was a statistically significant 14% in patients who were at least 50 years old, and a significant 15% in patients with no prior exposure to methotrexate. The analyses failed to find a significant impact on cardiovascular disease from treatment with methotrexate or other nonbiologic DMARDs.

Dr. Nurmohamed said that he had no relevant disclosures.

SAN DIEGO – Elderly patients who never previously underwent screening colonoscopy have a high prevalence of colorectal cancer and could benefit from screening if they are healthy and functional and have a life expectancy of at least about 7 years, based on a review of colonoscopies done on people aged 76-85 at one U.S. center.

The results also showed a reasonable detection rate for colorectal cancers in the same age group when their prior colonoscopy had last been done 10 or more years before, Dr. Therese G. Kerwel said at the annual Digestive Disease Week meeting.

"The U.S. Preventive Services Task Force says that you don’t see benefit [from screening colonoscopy] until about 7 years so that’s the benchmark. If you think the person will live for another 7 or more years, then screen. If not, then it’s not worth the resources," said Dr. Kerwel, a surgeon at Spectrum Health in Grand Rapids, Mich.

"The headline from the U.S. Preventive Services Task Force is to stop screening at age 75; that’s what everyone knows. A lot of people don’t read the fine print, the loophole that you can screen elderly people if they are healthy and functional," Dr. Kerwel said in an interview.

Another reason to strongly consider screening elderly patients who are healthy enough to potentially benefit is that if they develop colorectal cancer, they have an increased risk for an emergency presentation compared with younger adults, with the potential to develop bleeding, obstruction, or perforation, she said.

"It’s always a balance of risk and benefit, but there is definitely a subset of the elderly who need to be focused on a little more."

The review also showed a sizeable percent of elderly people underwent colonoscopy at Spectrum Health roughly 5 years following a prior procedure, with no cases of colorectal cancer detected, indicating that a significant number of elderly people had been subjected to overly aggressive colonoscopy, Dr. Kerwel said.

She and her associates reviewed 903 people, aged 76-85 years, who underwent colonoscopy at Spectrum Health during January 2009 to December 2010. The colonoscopy occurred purely for screening in 19%, for surveillance in 42%, for symptoms in 35%, and for other reasons in 4%.

Fifty-three of the people had never previously undergone colonoscopy (in this subgroup roughly half the procedures were for screening and half were for symptoms). Colonoscopy identified colorectal carcinoma in 9%. An additional 56 people from the study group had not had a prior colonoscopy for at least 10 years; in this group the new procedure detected carcinoma in 5%.

The remaining 88% of the procedures reviewed occurred within 9 years or less of prior colonoscopy. The largest subgroup was 247 people (27% of the study group) examined 4-5 years after a prior colonoscopy. In this subgroup the procedure identified no carcinomas, and in everyone else examined 9 or fewer years after their prior examination, about 3% had cancers identified.

These results suggest that repeat colonoscopies at intervals shorter than 10 years may have questionable utility in the elderly, Dr. Kerwel said.

She said that she had no relevant financial disclosures.

SAN DIEGO – Elderly patients who never previously underwent screening colonoscopy have a high prevalence of colorectal cancer and could benefit from screening if they are healthy and functional and have a life expectancy of at least about 7 years, based on a review of colonoscopies done on people aged 76-85 at one U.S. center.

The results also showed a reasonable detection rate for colorectal cancers in the same age group when their prior colonoscopy had last been done 10 or more years before, Dr. Therese G. Kerwel said at the annual Digestive Disease Week meeting.

"The U.S. Preventive Services Task Force says that you don’t see benefit [from screening colonoscopy] until about 7 years so that’s the benchmark. If you think the person will live for another 7 or more years, then screen. If not, then it’s not worth the resources," said Dr. Kerwel, a surgeon at Spectrum Health in Grand Rapids, Mich.

"The headline from the U.S. Preventive Services Task Force is to stop screening at age 75; that’s what everyone knows. A lot of people don’t read the fine print, the loophole that you can screen elderly people if they are healthy and functional," Dr. Kerwel said in an interview.

Another reason to strongly consider screening elderly patients who are healthy enough to potentially benefit is that if they develop colorectal cancer, they have an increased risk for an emergency presentation compared with younger adults, with the potential to develop bleeding, obstruction, or perforation, she said.

"It’s always a balance of risk and benefit, but there is definitely a subset of the elderly who need to be focused on a little more."

The review also showed a sizeable percent of elderly people underwent colonoscopy at Spectrum Health roughly 5 years following a prior procedure, with no cases of colorectal cancer detected, indicating that a significant number of elderly people had been subjected to overly aggressive colonoscopy, Dr. Kerwel said.

She and her associates reviewed 903 people, aged 76-85 years, who underwent colonoscopy at Spectrum Health during January 2009 to December 2010. The colonoscopy occurred purely for screening in 19%, for surveillance in 42%, for symptoms in 35%, and for other reasons in 4%.

Fifty-three of the people had never previously undergone colonoscopy (in this subgroup roughly half the procedures were for screening and half were for symptoms). Colonoscopy identified colorectal carcinoma in 9%. An additional 56 people from the study group had not had a prior colonoscopy for at least 10 years; in this group the new procedure detected carcinoma in 5%.

The remaining 88% of the procedures reviewed occurred within 9 years or less of prior colonoscopy. The largest subgroup was 247 people (27% of the study group) examined 4-5 years after a prior colonoscopy. In this subgroup the procedure identified no carcinomas, and in everyone else examined 9 or fewer years after their prior examination, about 3% had cancers identified.

These results suggest that repeat colonoscopies at intervals shorter than 10 years may have questionable utility in the elderly, Dr. Kerwel said.

She said that she had no relevant financial disclosures.

SAN DIEGO – Elderly patients who never previously underwent screening colonoscopy have a high prevalence of colorectal cancer and could benefit from screening if they are healthy and functional and have a life expectancy of at least about 7 years, based on a review of colonoscopies done on people aged 76-85 at one U.S. center.

The results also showed a reasonable detection rate for colorectal cancers in the same age group when their prior colonoscopy had last been done 10 or more years before, Dr. Therese G. Kerwel said at the annual Digestive Disease Week meeting.

"The U.S. Preventive Services Task Force says that you don’t see benefit [from screening colonoscopy] until about 7 years so that’s the benchmark. If you think the person will live for another 7 or more years, then screen. If not, then it’s not worth the resources," said Dr. Kerwel, a surgeon at Spectrum Health in Grand Rapids, Mich.

"The headline from the U.S. Preventive Services Task Force is to stop screening at age 75; that’s what everyone knows. A lot of people don’t read the fine print, the loophole that you can screen elderly people if they are healthy and functional," Dr. Kerwel said in an interview.

Another reason to strongly consider screening elderly patients who are healthy enough to potentially benefit is that if they develop colorectal cancer, they have an increased risk for an emergency presentation compared with younger adults, with the potential to develop bleeding, obstruction, or perforation, she said.

"It’s always a balance of risk and benefit, but there is definitely a subset of the elderly who need to be focused on a little more."

The review also showed a sizeable percent of elderly people underwent colonoscopy at Spectrum Health roughly 5 years following a prior procedure, with no cases of colorectal cancer detected, indicating that a significant number of elderly people had been subjected to overly aggressive colonoscopy, Dr. Kerwel said.

She and her associates reviewed 903 people, aged 76-85 years, who underwent colonoscopy at Spectrum Health during January 2009 to December 2010. The colonoscopy occurred purely for screening in 19%, for surveillance in 42%, for symptoms in 35%, and for other reasons in 4%.

Fifty-three of the people had never previously undergone colonoscopy (in this subgroup roughly half the procedures were for screening and half were for symptoms). Colonoscopy identified colorectal carcinoma in 9%. An additional 56 people from the study group had not had a prior colonoscopy for at least 10 years; in this group the new procedure detected carcinoma in 5%.

The remaining 88% of the procedures reviewed occurred within 9 years or less of prior colonoscopy. The largest subgroup was 247 people (27% of the study group) examined 4-5 years after a prior colonoscopy. In this subgroup the procedure identified no carcinomas, and in everyone else examined 9 or fewer years after their prior examination, about 3% had cancers identified.

These results suggest that repeat colonoscopies at intervals shorter than 10 years may have questionable utility in the elderly, Dr. Kerwel said.

She said that she had no relevant financial disclosures.

SAN DIEGO – Researchers have taken a major step toward eliminating the need for routine pathology on every polyp removed during colonoscopy.

Use of a high-definition, dual-focus colonoscope allowed endoscopists to perform "significantly more accurate, high-confidence endoscopic diagnosis of diminutive polyps," Dr. Tonya Kaltenbach said at the annual Digestive Disease Week.

"In many hospitals, about 20%-25% of all pathology samples are small colon polyps, almost all of which are benign. This is a lot of money that can be saved," said Dr. Kaltenbach in a written statement. About 80% of all polyps found during screening colonoscopy are diminutive, 5 mm in diameter or less, and the current standard of care is to do a pathology analysis on each of these polyps.

As used by five gastroenterologists who participated in the study at three U.S. centers to assess 530 polyps in 277 people, the high-definition scope produced a 95.9% agreement in polyp assignment for follow-up surveillance, compared with pathology-laboratory analysis of the same polyps, and a 96.4% negative predictive value for adenomas, said Dr. Kaltenbach, a gastroenterologist at the VA Medical Center in Palo Alto, Calif.

These performance levels surpassed the greater than 90% targets for colonoscopic assessment of diminutive polyps set last year by a committee organized by the American Society of Gastrointestinal Endoscopy (Gastrointest. Endosc. 2011;73:419-22). Notably, the 90% threshold for assignment of postpolypectomy surveillance accuracy and negative predictive value was set by the ASGE committee before dual-focus colonoscopies like the one used in the current study were in widespread use, said Dr. Roy Soetikno, chief of endoscopy at the Palo Alto VA and senior investigator on the study.

Today, some of the scopes used in routine U.S. practice have the high-definition, dual focus features of the one used in the study, and within the next 5 years essentially all U.S. colonoscopies will have these performance characteristics, he said in an interview.

Although the new study results showed that endoscopists can surpass the thresholds set by the ASGE for visual assessment, widespread use of the method will require further validation, Dr. Soetikno said. "We need to develop programs to teach gastroenterologists and incorporate them into fellowship programs. We also need a way to store the images so that people can document their diagnoses. But [our study] is the beginning," he said.

Dr. Soetikno also noted that the idea of visual assessment of potentially cancerous or precancerous lesions is not new, as the same approach is routinely used in dermatology. With new technologies, gastroenterologists "may be able to do the same thing. We can save our resources, and not spend money on evaluating polyps of no consequence."

Dr. Soetikno, Dr. Kaltenbach, and their associates designed the Veterans Affairs Colorectal Lesion Interpretation and Diagnosis (VALID) study to test the hypothesis that colonoscopy using a high-definition, narrow-band imaging, dual focus colonoscope could increase the rate of accurate, high-confidence histology predictions of diminutive polyps. Five endoscopists working at three VA Medical Centers randomized 558 patients scheduled to undergo routine colonoscopy. The patients averaged 63 years old, 95% were men, and about 80% were white. Roughly 38% underwent colonoscopy for screening, 44% for surveillance following a history of polyps, and for 19% the examination was symptom driven (total is 101% due to rounding).

The protocol randomized 277 people to high-definition colonoscopy with an Olympus model CF-HQ190, and 281 people to examination with an older model without dual-focus capability, the Olympus CF-H180. Examination of the people in the dual-focus group found 710 polyps, including 530 diminutive lesions; the control group had 599 polyps, including 445 that were 5 mm or less.

The endoscopists made accurate, high-confidence endoscopic predictions on 75% of the diminutive polyps that they saw using the dual-focus device, compared with a 63% when they used the less advanced endoscope, a statistically significant difference. When compared with the pathologic assessments, 95.9% of the high-confidence, dual-focus diagnoses produced correct surveillance-interval recommendations, compared with a 95.2% rate using the standard-focus device. Negative predictive value was 96.4% using the dual-focus scope and 92.0% for the more conventional scope. In addition, the dual-focus scope produced no misdiagnoses of advanced histology as non-neoplasia, and use of this scope did not result in any meaningful increase in examination time, nor did it produce any bleeding or perforation.

The VALID study received partial funding from Olympus America, the company that markets the dual-focus, high-definition colonoscope tested. Dr. Soetikno said that he has been a consultant to Olympus. Dr. Kaltenbach and Dr. Kochman said they had no disclosures.

SAN DIEGO – Researchers have taken a major step toward eliminating the need for routine pathology on every polyp removed during colonoscopy.

Use of a high-definition, dual-focus colonoscope allowed endoscopists to perform "significantly more accurate, high-confidence endoscopic diagnosis of diminutive polyps," Dr. Tonya Kaltenbach said at the annual Digestive Disease Week.

"In many hospitals, about 20%-25% of all pathology samples are small colon polyps, almost all of which are benign. This is a lot of money that can be saved," said Dr. Kaltenbach in a written statement. About 80% of all polyps found during screening colonoscopy are diminutive, 5 mm in diameter or less, and the current standard of care is to do a pathology analysis on each of these polyps.

As used by five gastroenterologists who participated in the study at three U.S. centers to assess 530 polyps in 277 people, the high-definition scope produced a 95.9% agreement in polyp assignment for follow-up surveillance, compared with pathology-laboratory analysis of the same polyps, and a 96.4% negative predictive value for adenomas, said Dr. Kaltenbach, a gastroenterologist at the VA Medical Center in Palo Alto, Calif.

These performance levels surpassed the greater than 90% targets for colonoscopic assessment of diminutive polyps set last year by a committee organized by the American Society of Gastrointestinal Endoscopy (Gastrointest. Endosc. 2011;73:419-22). Notably, the 90% threshold for assignment of postpolypectomy surveillance accuracy and negative predictive value was set by the ASGE committee before dual-focus colonoscopies like the one used in the current study were in widespread use, said Dr. Roy Soetikno, chief of endoscopy at the Palo Alto VA and senior investigator on the study.

Today, some of the scopes used in routine U.S. practice have the high-definition, dual focus features of the one used in the study, and within the next 5 years essentially all U.S. colonoscopies will have these performance characteristics, he said in an interview.

Although the new study results showed that endoscopists can surpass the thresholds set by the ASGE for visual assessment, widespread use of the method will require further validation, Dr. Soetikno said. "We need to develop programs to teach gastroenterologists and incorporate them into fellowship programs. We also need a way to store the images so that people can document their diagnoses. But [our study] is the beginning," he said.

Dr. Soetikno also noted that the idea of visual assessment of potentially cancerous or precancerous lesions is not new, as the same approach is routinely used in dermatology. With new technologies, gastroenterologists "may be able to do the same thing. We can save our resources, and not spend money on evaluating polyps of no consequence."

Dr. Soetikno, Dr. Kaltenbach, and their associates designed the Veterans Affairs Colorectal Lesion Interpretation and Diagnosis (VALID) study to test the hypothesis that colonoscopy using a high-definition, narrow-band imaging, dual focus colonoscope could increase the rate of accurate, high-confidence histology predictions of diminutive polyps. Five endoscopists working at three VA Medical Centers randomized 558 patients scheduled to undergo routine colonoscopy. The patients averaged 63 years old, 95% were men, and about 80% were white. Roughly 38% underwent colonoscopy for screening, 44% for surveillance following a history of polyps, and for 19% the examination was symptom driven (total is 101% due to rounding).

The protocol randomized 277 people to high-definition colonoscopy with an Olympus model CF-HQ190, and 281 people to examination with an older model without dual-focus capability, the Olympus CF-H180. Examination of the people in the dual-focus group found 710 polyps, including 530 diminutive lesions; the control group had 599 polyps, including 445 that were 5 mm or less.

The endoscopists made accurate, high-confidence endoscopic predictions on 75% of the diminutive polyps that they saw using the dual-focus device, compared with a 63% when they used the less advanced endoscope, a statistically significant difference. When compared with the pathologic assessments, 95.9% of the high-confidence, dual-focus diagnoses produced correct surveillance-interval recommendations, compared with a 95.2% rate using the standard-focus device. Negative predictive value was 96.4% using the dual-focus scope and 92.0% for the more conventional scope. In addition, the dual-focus scope produced no misdiagnoses of advanced histology as non-neoplasia, and use of this scope did not result in any meaningful increase in examination time, nor did it produce any bleeding or perforation.

The VALID study received partial funding from Olympus America, the company that markets the dual-focus, high-definition colonoscope tested. Dr. Soetikno said that he has been a consultant to Olympus. Dr. Kaltenbach and Dr. Kochman said they had no disclosures.

SAN DIEGO – Researchers have taken a major step toward eliminating the need for routine pathology on every polyp removed during colonoscopy.

Use of a high-definition, dual-focus colonoscope allowed endoscopists to perform "significantly more accurate, high-confidence endoscopic diagnosis of diminutive polyps," Dr. Tonya Kaltenbach said at the annual Digestive Disease Week.

"In many hospitals, about 20%-25% of all pathology samples are small colon polyps, almost all of which are benign. This is a lot of money that can be saved," said Dr. Kaltenbach in a written statement. About 80% of all polyps found during screening colonoscopy are diminutive, 5 mm in diameter or less, and the current standard of care is to do a pathology analysis on each of these polyps.

As used by five gastroenterologists who participated in the study at three U.S. centers to assess 530 polyps in 277 people, the high-definition scope produced a 95.9% agreement in polyp assignment for follow-up surveillance, compared with pathology-laboratory analysis of the same polyps, and a 96.4% negative predictive value for adenomas, said Dr. Kaltenbach, a gastroenterologist at the VA Medical Center in Palo Alto, Calif.

These performance levels surpassed the greater than 90% targets for colonoscopic assessment of diminutive polyps set last year by a committee organized by the American Society of Gastrointestinal Endoscopy (Gastrointest. Endosc. 2011;73:419-22). Notably, the 90% threshold for assignment of postpolypectomy surveillance accuracy and negative predictive value was set by the ASGE committee before dual-focus colonoscopies like the one used in the current study were in widespread use, said Dr. Roy Soetikno, chief of endoscopy at the Palo Alto VA and senior investigator on the study.

Today, some of the scopes used in routine U.S. practice have the high-definition, dual focus features of the one used in the study, and within the next 5 years essentially all U.S. colonoscopies will have these performance characteristics, he said in an interview.

Although the new study results showed that endoscopists can surpass the thresholds set by the ASGE for visual assessment, widespread use of the method will require further validation, Dr. Soetikno said. "We need to develop programs to teach gastroenterologists and incorporate them into fellowship programs. We also need a way to store the images so that people can document their diagnoses. But [our study] is the beginning," he said.

Dr. Soetikno also noted that the idea of visual assessment of potentially cancerous or precancerous lesions is not new, as the same approach is routinely used in dermatology. With new technologies, gastroenterologists "may be able to do the same thing. We can save our resources, and not spend money on evaluating polyps of no consequence."

Dr. Soetikno, Dr. Kaltenbach, and their associates designed the Veterans Affairs Colorectal Lesion Interpretation and Diagnosis (VALID) study to test the hypothesis that colonoscopy using a high-definition, narrow-band imaging, dual focus colonoscope could increase the rate of accurate, high-confidence histology predictions of diminutive polyps. Five endoscopists working at three VA Medical Centers randomized 558 patients scheduled to undergo routine colonoscopy. The patients averaged 63 years old, 95% were men, and about 80% were white. Roughly 38% underwent colonoscopy for screening, 44% for surveillance following a history of polyps, and for 19% the examination was symptom driven (total is 101% due to rounding).

The protocol randomized 277 people to high-definition colonoscopy with an Olympus model CF-HQ190, and 281 people to examination with an older model without dual-focus capability, the Olympus CF-H180. Examination of the people in the dual-focus group found 710 polyps, including 530 diminutive lesions; the control group had 599 polyps, including 445 that were 5 mm or less.

The endoscopists made accurate, high-confidence endoscopic predictions on 75% of the diminutive polyps that they saw using the dual-focus device, compared with a 63% when they used the less advanced endoscope, a statistically significant difference. When compared with the pathologic assessments, 95.9% of the high-confidence, dual-focus diagnoses produced correct surveillance-interval recommendations, compared with a 95.2% rate using the standard-focus device. Negative predictive value was 96.4% using the dual-focus scope and 92.0% for the more conventional scope. In addition, the dual-focus scope produced no misdiagnoses of advanced histology as non-neoplasia, and use of this scope did not result in any meaningful increase in examination time, nor did it produce any bleeding or perforation.

The VALID study received partial funding from Olympus America, the company that markets the dual-focus, high-definition colonoscope tested. Dr. Soetikno said that he has been a consultant to Olympus. Dr. Kaltenbach and Dr. Kochman said they had no disclosures.

PHILADELPHIA – An investigational, four-coil device for transcranial magnetic stimulation deep in the brain produced some striking cases of sustained pain relief when it was tested on five fibromyalgia patients in a pilot study.

Based on these promising early results, the next step will be a larger, controlled study, involving about 40 fibromyalgia patients, Dr. M. Bret Schneider said at the annual meeting of the American Psychiatric Association.

Mitchel L. Zoler/IMNG Medical Media

The new device for repetitive transcranial magnetic stimulation (rTMS) builds on the premise of a TMS device marketed by NeuroStar and approved by the Food and Drug Administration for treating depression. Instead of the single coil used in the NeuroStar device to create a pulsating magnetic field and produce an electrical current within a patient’s prefrontal cortex, Dr. Schneider and his associates designed a four-coil device to target a deeper brain region, much like a Gamma Knife used for radiosurgery. Their target was the dorsal anterior cingulate, a region of the brain linked with chronic pain. The concept was to stimulate the cingulate to produce a noninvasive cingulotomy, a surgical procedure occasionally performed to sever white-matter connections to the cingulate and provide pain relief to patients with intractable, chronic pain.

Dr. Schneider cofounded a company (Cervel Neurotech) to develop this device. The first step was to test several different four-coil arrays on healthy volunteers to identify the orientation that appeared to produce the greatest effect within the dorsal anterior cingulate, based on the treatment’s impact on cingulate metabolism measured with oxygen-15 PET scanning.

The developers next took the most promising orientation and applied it using two different treatment modes in a study that included a total of 45 fibromyalgia patients with chronic, intractable pain. Some patients in the study received treatments with a different coil orientation, or sham treatments.

The best results occurred in five patients who received the highest frequency of magnetic pulses, 10 Hz in the best-performing coil orientation. These patients had a treatment course that involved 10 pulses per second for 4 seconds, followed by a 26-second pause, and then a repeat. Each daily treatment session included 75 of these repeated courses (a total treatment time of 37.5 minutes). Patients received this daily session 5 days a week for 4 weeks, and then their residual pain levels off treatment were measured using the BPI (Brief Pain Inventory) 3 days after their last session, and then 4 weeks after their last treatment session. The researchers also performed BPI measures on each patient at baseline, and on each of the 20 days when each patient underwent treatment.

Courtesy Cervel Neurotech

The results showed that all five patients averaged a steady drop in their pain levels over the course of the 4-week treatment, and that their pain fell even further when measured after their treatment finished. Their lowest pain level occurred at the 4-week follow-up, when they showed an overall average 45% drop in their pain scores, compared with baseline. Individually, "some of the patients had complete pain relief, while others less so," said Dr. Schneider, who is also a psychiatrist and neurosurgeon at Stanford (Calif.) University.

The treatment appeared safe, with fewer adverse effects reported by patients who received any of the active treatments, compared with those who received sham treatments. The most common, treatment-associated adverse effects were mild episodes of headache, nausea, and scalp pain, he said.

The presumed mechanism of action is that the sessions of rTMS produce long-term potentiation in the cingulate, Dr. Schneider said in an interview. During rTMS treatment, neurons in the cingulate rapidly fire, but once treatment stops, the activity in the cingulate appears to fall below the basal level. The researchers documented this with their ¹⁵O PET studies, which showed that following rTMS, the dorsal anterior cingulate has reduced blood flow and metabolic activity. This reduced cingulate activity might explain the pain relief that patients reported, Dr. Schneider said.

The study was funded by Cervel Neurotech, the company developing this new device. Dr. Schneider is a founder, employee, and stockholder of the company.

PHILADELPHIA – An investigational, four-coil device for transcranial magnetic stimulation deep in the brain produced some striking cases of sustained pain relief when it was tested on five fibromyalgia patients in a pilot study.

Based on these promising early results, the next step will be a larger, controlled study, involving about 40 fibromyalgia patients, Dr. M. Bret Schneider said at the annual meeting of the American Psychiatric Association.

Mitchel L. Zoler/IMNG Medical Media

The new device for repetitive transcranial magnetic stimulation (rTMS) builds on the premise of a TMS device marketed by NeuroStar and approved by the Food and Drug Administration for treating depression. Instead of the single coil used in the NeuroStar device to create a pulsating magnetic field and produce an electrical current within a patient’s prefrontal cortex, Dr. Schneider and his associates designed a four-coil device to target a deeper brain region, much like a Gamma Knife used for radiosurgery. Their target was the dorsal anterior cingulate, a region of the brain linked with chronic pain. The concept was to stimulate the cingulate to produce a noninvasive cingulotomy, a surgical procedure occasionally performed to sever white-matter connections to the cingulate and provide pain relief to patients with intractable, chronic pain.

Dr. Schneider cofounded a company (Cervel Neurotech) to develop this device. The first step was to test several different four-coil arrays on healthy volunteers to identify the orientation that appeared to produce the greatest effect within the dorsal anterior cingulate, based on the treatment’s impact on cingulate metabolism measured with oxygen-15 PET scanning.

The developers next took the most promising orientation and applied it using two different treatment modes in a study that included a total of 45 fibromyalgia patients with chronic, intractable pain. Some patients in the study received treatments with a different coil orientation, or sham treatments.

The best results occurred in five patients who received the highest frequency of magnetic pulses, 10 Hz in the best-performing coil orientation. These patients had a treatment course that involved 10 pulses per second for 4 seconds, followed by a 26-second pause, and then a repeat. Each daily treatment session included 75 of these repeated courses (a total treatment time of 37.5 minutes). Patients received this daily session 5 days a week for 4 weeks, and then their residual pain levels off treatment were measured using the BPI (Brief Pain Inventory) 3 days after their last session, and then 4 weeks after their last treatment session. The researchers also performed BPI measures on each patient at baseline, and on each of the 20 days when each patient underwent treatment.

Courtesy Cervel Neurotech

The results showed that all five patients averaged a steady drop in their pain levels over the course of the 4-week treatment, and that their pain fell even further when measured after their treatment finished. Their lowest pain level occurred at the 4-week follow-up, when they showed an overall average 45% drop in their pain scores, compared with baseline. Individually, "some of the patients had complete pain relief, while others less so," said Dr. Schneider, who is also a psychiatrist and neurosurgeon at Stanford (Calif.) University.

The treatment appeared safe, with fewer adverse effects reported by patients who received any of the active treatments, compared with those who received sham treatments. The most common, treatment-associated adverse effects were mild episodes of headache, nausea, and scalp pain, he said.

The presumed mechanism of action is that the sessions of rTMS produce long-term potentiation in the cingulate, Dr. Schneider said in an interview. During rTMS treatment, neurons in the cingulate rapidly fire, but once treatment stops, the activity in the cingulate appears to fall below the basal level. The researchers documented this with their ¹⁵O PET studies, which showed that following rTMS, the dorsal anterior cingulate has reduced blood flow and metabolic activity. This reduced cingulate activity might explain the pain relief that patients reported, Dr. Schneider said.

The study was funded by Cervel Neurotech, the company developing this new device. Dr. Schneider is a founder, employee, and stockholder of the company.

PHILADELPHIA – An investigational, four-coil device for transcranial magnetic stimulation deep in the brain produced some striking cases of sustained pain relief when it was tested on five fibromyalgia patients in a pilot study.

Based on these promising early results, the next step will be a larger, controlled study, involving about 40 fibromyalgia patients, Dr. M. Bret Schneider said at the annual meeting of the American Psychiatric Association.

Mitchel L. Zoler/IMNG Medical Media

The new device for repetitive transcranial magnetic stimulation (rTMS) builds on the premise of a TMS device marketed by NeuroStar and approved by the Food and Drug Administration for treating depression. Instead of the single coil used in the NeuroStar device to create a pulsating magnetic field and produce an electrical current within a patient’s prefrontal cortex, Dr. Schneider and his associates designed a four-coil device to target a deeper brain region, much like a Gamma Knife used for radiosurgery. Their target was the dorsal anterior cingulate, a region of the brain linked with chronic pain. The concept was to stimulate the cingulate to produce a noninvasive cingulotomy, a surgical procedure occasionally performed to sever white-matter connections to the cingulate and provide pain relief to patients with intractable, chronic pain.

Dr. Schneider cofounded a company (Cervel Neurotech) to develop this device. The first step was to test several different four-coil arrays on healthy volunteers to identify the orientation that appeared to produce the greatest effect within the dorsal anterior cingulate, based on the treatment’s impact on cingulate metabolism measured with oxygen-15 PET scanning.

The developers next took the most promising orientation and applied it using two different treatment modes in a study that included a total of 45 fibromyalgia patients with chronic, intractable pain. Some patients in the study received treatments with a different coil orientation, or sham treatments.

The best results occurred in five patients who received the highest frequency of magnetic pulses, 10 Hz in the best-performing coil orientation. These patients had a treatment course that involved 10 pulses per second for 4 seconds, followed by a 26-second pause, and then a repeat. Each daily treatment session included 75 of these repeated courses (a total treatment time of 37.5 minutes). Patients received this daily session 5 days a week for 4 weeks, and then their residual pain levels off treatment were measured using the BPI (Brief Pain Inventory) 3 days after their last session, and then 4 weeks after their last treatment session. The researchers also performed BPI measures on each patient at baseline, and on each of the 20 days when each patient underwent treatment.

Courtesy Cervel Neurotech

The results showed that all five patients averaged a steady drop in their pain levels over the course of the 4-week treatment, and that their pain fell even further when measured after their treatment finished. Their lowest pain level occurred at the 4-week follow-up, when they showed an overall average 45% drop in their pain scores, compared with baseline. Individually, "some of the patients had complete pain relief, while others less so," said Dr. Schneider, who is also a psychiatrist and neurosurgeon at Stanford (Calif.) University.

The treatment appeared safe, with fewer adverse effects reported by patients who received any of the active treatments, compared with those who received sham treatments. The most common, treatment-associated adverse effects were mild episodes of headache, nausea, and scalp pain, he said.

The presumed mechanism of action is that the sessions of rTMS produce long-term potentiation in the cingulate, Dr. Schneider said in an interview. During rTMS treatment, neurons in the cingulate rapidly fire, but once treatment stops, the activity in the cingulate appears to fall below the basal level. The researchers documented this with their ¹⁵O PET studies, which showed that following rTMS, the dorsal anterior cingulate has reduced blood flow and metabolic activity. This reduced cingulate activity might explain the pain relief that patients reported, Dr. Schneider said.

The study was funded by Cervel Neurotech, the company developing this new device. Dr. Schneider is a founder, employee, and stockholder of the company.

PHILADELPHIA – Switching physician coverage in a hospital’s acute-care psychiatric ward from 13 consultant psychiatrists to a single, full-time hospitalist psychiatrist led to significant care improvements and reduced costs.

Perhaps the most striking benefit from the staffing switch was in average patient length of stay, which dropped by about half, Dr. Julian Beezhold said at the meeting. Average length of stay fell from nearly 22 days before the staffing change to about 11 days. "The reduced length of stay made a huge impact on cost savings." In addition, "the evidence is overwhelming that patient outcomes were better" following the change, said Dr. Beezhold, chief of psychiatry at Norfolk and Waveney Mental Health in Norwich, U.K.

Mitchel L. Zoler/IMNG Medical Media

Taking into account all the outcome changes produced by the switch to hospitalist-based psychiatric care, the study provides "overwhelming, robust evidence showing clear benefit from a hospitalist model of care," Dr. Beezhold concluded.

The Psychiatric Hospitalist Network Evaluation Study included 5,019 patients admitted to the hospital for an acute psychiatric condition in 2002-2010, during the 42 months before and 42 months after Norfolk and Waveney switched from relying on 13 consultant psychiatrists to having one hospitalist psychiatrist who either directly administered or supervised all psychiatric admissions and in-hospital management. As a control, the study used data collected from a second psychiatric ward at the hospital that treated similar patients from a different geographic region. The control ward remained on the hospitalist model for psychiatric care throughout the study period.

The patients averaged about 40 years old, and slightly more than half were men. The most common psychiatric diagnosis was psychosis, in a quarter to a third of the admitted patients, followed by bipolar disorder and depression.

To analyze outcomes, Dr. Beezhold and his associates compared outcome rates before and after the model change in the study ward, and compared the extent of change with what occurred in the control ward, which did not change its staffing model. For 15 of the 20 outcomes assessed, the test ward that switched from a consultant model to a hospitalist model had significantly better changes compared with the control ward.

The staffing change led to reductions in deaths, violent episodes, deliberate self-harm, staff accidents, and patient accidents, while the ward that had no change showed similar rates, smaller decreases, or even increases from the before to after periods. For example, the rate of all incidents per admission fell by a statistically significant 48% from the before to after period in the ward that switched to hospitalist care, which the same measure had a statistically not-significant, 4% rise from before to after in the control ward. The rate of deliberate self-harm per admission fell by a statistically significant 76% from before to after in the ward that switched to hospitalist care, while the same measure showed a statistically non-significant decline in the control ward.

The results are likely widely generalizable since they came from an observational study of routine, community practice that had no patient exclusions, Dr. Beezhold said.

Dr. Beezhold said he had no disclosures.

PHILADELPHIA – Switching physician coverage in a hospital’s acute-care psychiatric ward from 13 consultant psychiatrists to a single, full-time hospitalist psychiatrist led to significant care improvements and reduced costs.

Perhaps the most striking benefit from the staffing switch was in average patient length of stay, which dropped by about half, Dr. Julian Beezhold said at the meeting. Average length of stay fell from nearly 22 days before the staffing change to about 11 days. "The reduced length of stay made a huge impact on cost savings." In addition, "the evidence is overwhelming that patient outcomes were better" following the change, said Dr. Beezhold, chief of psychiatry at Norfolk and Waveney Mental Health in Norwich, U.K.

Mitchel L. Zoler/IMNG Medical Media

Taking into account all the outcome changes produced by the switch to hospitalist-based psychiatric care, the study provides "overwhelming, robust evidence showing clear benefit from a hospitalist model of care," Dr. Beezhold concluded.

The Psychiatric Hospitalist Network Evaluation Study included 5,019 patients admitted to the hospital for an acute psychiatric condition in 2002-2010, during the 42 months before and 42 months after Norfolk and Waveney switched from relying on 13 consultant psychiatrists to having one hospitalist psychiatrist who either directly administered or supervised all psychiatric admissions and in-hospital management. As a control, the study used data collected from a second psychiatric ward at the hospital that treated similar patients from a different geographic region. The control ward remained on the hospitalist model for psychiatric care throughout the study period.

The patients averaged about 40 years old, and slightly more than half were men. The most common psychiatric diagnosis was psychosis, in a quarter to a third of the admitted patients, followed by bipolar disorder and depression.

To analyze outcomes, Dr. Beezhold and his associates compared outcome rates before and after the model change in the study ward, and compared the extent of change with what occurred in the control ward, which did not change its staffing model. For 15 of the 20 outcomes assessed, the test ward that switched from a consultant model to a hospitalist model had significantly better changes compared with the control ward.

The staffing change led to reductions in deaths, violent episodes, deliberate self-harm, staff accidents, and patient accidents, while the ward that had no change showed similar rates, smaller decreases, or even increases from the before to after periods. For example, the rate of all incidents per admission fell by a statistically significant 48% from the before to after period in the ward that switched to hospitalist care, which the same measure had a statistically not-significant, 4% rise from before to after in the control ward. The rate of deliberate self-harm per admission fell by a statistically significant 76% from before to after in the ward that switched to hospitalist care, while the same measure showed a statistically non-significant decline in the control ward.

The results are likely widely generalizable since they came from an observational study of routine, community practice that had no patient exclusions, Dr. Beezhold said.

Dr. Beezhold said he had no disclosures.

PHILADELPHIA – Switching physician coverage in a hospital’s acute-care psychiatric ward from 13 consultant psychiatrists to a single, full-time hospitalist psychiatrist led to significant care improvements and reduced costs.

Perhaps the most striking benefit from the staffing switch was in average patient length of stay, which dropped by about half, Dr. Julian Beezhold said at the meeting. Average length of stay fell from nearly 22 days before the staffing change to about 11 days. "The reduced length of stay made a huge impact on cost savings." In addition, "the evidence is overwhelming that patient outcomes were better" following the change, said Dr. Beezhold, chief of psychiatry at Norfolk and Waveney Mental Health in Norwich, U.K.

Mitchel L. Zoler/IMNG Medical Media

Taking into account all the outcome changes produced by the switch to hospitalist-based psychiatric care, the study provides "overwhelming, robust evidence showing clear benefit from a hospitalist model of care," Dr. Beezhold concluded.

The Psychiatric Hospitalist Network Evaluation Study included 5,019 patients admitted to the hospital for an acute psychiatric condition in 2002-2010, during the 42 months before and 42 months after Norfolk and Waveney switched from relying on 13 consultant psychiatrists to having one hospitalist psychiatrist who either directly administered or supervised all psychiatric admissions and in-hospital management. As a control, the study used data collected from a second psychiatric ward at the hospital that treated similar patients from a different geographic region. The control ward remained on the hospitalist model for psychiatric care throughout the study period.

The patients averaged about 40 years old, and slightly more than half were men. The most common psychiatric diagnosis was psychosis, in a quarter to a third of the admitted patients, followed by bipolar disorder and depression.

To analyze outcomes, Dr. Beezhold and his associates compared outcome rates before and after the model change in the study ward, and compared the extent of change with what occurred in the control ward, which did not change its staffing model. For 15 of the 20 outcomes assessed, the test ward that switched from a consultant model to a hospitalist model had significantly better changes compared with the control ward.

The staffing change led to reductions in deaths, violent episodes, deliberate self-harm, staff accidents, and patient accidents, while the ward that had no change showed similar rates, smaller decreases, or even increases from the before to after periods. For example, the rate of all incidents per admission fell by a statistically significant 48% from the before to after period in the ward that switched to hospitalist care, which the same measure had a statistically not-significant, 4% rise from before to after in the control ward. The rate of deliberate self-harm per admission fell by a statistically significant 76% from before to after in the ward that switched to hospitalist care, while the same measure showed a statistically non-significant decline in the control ward.

The results are likely widely generalizable since they came from an observational study of routine, community practice that had no patient exclusions, Dr. Beezhold said.

Dr. Beezhold said he had no disclosures.

PHILADELPHIA – Long-acting, injectable formulations of antipsychotic drugs significantly boosted treatment compliance in patients with schizophrenia in a review of reimbursement records for more than 3,600 patients.

The increased compliance achieved with depot administration of antipsychotic medications makes it an attractive alternative to oral administration of antipsychotic drugs to patients with schizophrenia, Dr. Bruce J. Wong said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

Greater use of depot medications could improve the management of patients with schizophrenia because treatment compliance is a major determinant of the ongoing health of schizophrenia patients, said Dr. Wong, a consultant clinical epidemiologist in Wayne, Pa.

"Lack of patient adherence to psychotropic medications is the single largest factor contributing to the ongoing morbidity of schizophrenia today. Even short gaps in antipsychotic usage increase the risk of rehospitalization" of patients, said Dr. Wong, also of the department of biostatistics and epidemiology at the University of Pennsylvania, Philadelphia.

"In practice today, depot, injected antipsychotic medications are secondary treatments, used almost like punishment when patients are noncompliant with oral drugs but should be viewed more like a reward," he said. The same drugs are formulated into oral and injectable preparations, so depot versions are not less effective or less safe than oral forms. Instead, a series of social factors relegate injectable formulations to second-line status: needle phobia in patients, a modest amount of pain that can occur when antipsychotic drugs are injected into muscle, the lack of comfort that psychiatrists often have with performing injections, and the need for a psychiatrist to obtain and have the drug on hand as opposed to the convenience of writing a prescription for the patient to get the oral form.

None of these alone is a major barrier, but together they seem to create enough of a roadblock to make injections less favored, Dr. Wong said in an interview.

To better document how the two delivery options relate to compliance, Dr. Wong and his associates used data collected on 3,004 commercially insured patients with schizophrenia in the MarketScan database of Thompson Reuters, and on 665 Medicare patients collected by the Center for Medicare and Medicaid Services during January 2005 to September 2010. The analysis focused on patients who began treatment with either an oral or a long-acting injected formulation of an antipsychotic drug, and who had at least 12 months of continuous health coverage prior to the index prescription.

In the commercial group, 13% of patients received an incident prescription for an injectable formulation, and 87% received an incident prescription for an oral antipsychotic. In the Medicare group, 22% filled a first-time prescription for a depot, injected formulation, and 78% fell into the oral group.

During follow-up, the researchers measured compliance by the average level of patients’ medication possession ratio. For patients taking an oral drug, this was determined by how many days during follow-up patients had their prescribed medication based on their history of filling their prescription. For patients receiving an injected drug, Dr. Wong and his associates calculated a medication possession ratio based on the frequency at which a patient’s records documented receiving an injection, and the number of days the injection covered during follow-up.

Among commercially insured patients, those who received injections had an average 67% medication possession ratio, compared with a 56% rate among patients taking an oral drug. In the Medicare group, injected patients had a 68% possession ratio, compared with 59% in those on an oral drug. In both subgroups the difference in ratios between the two types of treatment were statistically significant.

The analyses also identified other differences between the two treatment groups. Among the commercially insured, injected drugs were significantly more common than oral drugs in patients treated in comprehensive health plans, while injected drugs were used significantly less often than oral drugs in health maintenance organization settings.

Among commercially insured patients, those who received long-acting injections averaged 42 years old, significantly older than those who received oral drugs, who averaged 37 years old. Dr. Wong attributed this age difference to patients typically starting on an oral formulation and only switching to an injected formulation a few years later, once they showed that they were not reliable oral users. Medicare patients also showed a significant age difference, but the relationship flipped in this older age group. The mean age of the patients on injected antipsychotics was 67, while those on an oral drug averaged 73 years old. Dr. Wong said he did not have an explanation for this pattern among Medicare patients.

In the commercial group, patients on injected drugs were also significantly sicker, with an average Charlson comorbidity index of 0.58, compared with an average of 0.47 in the orally treated patients. Again, this pattern was reversed in Medicare patients, where the injected patients had an average Charlson comorbidity index score of 1.24, significantly less than the 1.83 average among patients on an oral drug.

The analysis also showed regional differences in the use of the two treatment options, with injections exceeding oral drug use in the North-Central U.S. region, while oral drugs were substantially more popular than injected drugs in the Western half of the United States. In other U.S. regions, the use of the two treatment routes was generally more balanced.

The study was sponsored by Otsuka, which markets the antipsychotic drug aripiprazole. Dr. Wong said he has been a consultant to Otsuka.

PHILADELPHIA – Long-acting, injectable formulations of antipsychotic drugs significantly boosted treatment compliance in patients with schizophrenia in a review of reimbursement records for more than 3,600 patients.

The increased compliance achieved with depot administration of antipsychotic medications makes it an attractive alternative to oral administration of antipsychotic drugs to patients with schizophrenia, Dr. Bruce J. Wong said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

Greater use of depot medications could improve the management of patients with schizophrenia because treatment compliance is a major determinant of the ongoing health of schizophrenia patients, said Dr. Wong, a consultant clinical epidemiologist in Wayne, Pa.

"Lack of patient adherence to psychotropic medications is the single largest factor contributing to the ongoing morbidity of schizophrenia today. Even short gaps in antipsychotic usage increase the risk of rehospitalization" of patients, said Dr. Wong, also of the department of biostatistics and epidemiology at the University of Pennsylvania, Philadelphia.

"In practice today, depot, injected antipsychotic medications are secondary treatments, used almost like punishment when patients are noncompliant with oral drugs but should be viewed more like a reward," he said. The same drugs are formulated into oral and injectable preparations, so depot versions are not less effective or less safe than oral forms. Instead, a series of social factors relegate injectable formulations to second-line status: needle phobia in patients, a modest amount of pain that can occur when antipsychotic drugs are injected into muscle, the lack of comfort that psychiatrists often have with performing injections, and the need for a psychiatrist to obtain and have the drug on hand as opposed to the convenience of writing a prescription for the patient to get the oral form.

None of these alone is a major barrier, but together they seem to create enough of a roadblock to make injections less favored, Dr. Wong said in an interview.

To better document how the two delivery options relate to compliance, Dr. Wong and his associates used data collected on 3,004 commercially insured patients with schizophrenia in the MarketScan database of Thompson Reuters, and on 665 Medicare patients collected by the Center for Medicare and Medicaid Services during January 2005 to September 2010. The analysis focused on patients who began treatment with either an oral or a long-acting injected formulation of an antipsychotic drug, and who had at least 12 months of continuous health coverage prior to the index prescription.

In the commercial group, 13% of patients received an incident prescription for an injectable formulation, and 87% received an incident prescription for an oral antipsychotic. In the Medicare group, 22% filled a first-time prescription for a depot, injected formulation, and 78% fell into the oral group.

During follow-up, the researchers measured compliance by the average level of patients’ medication possession ratio. For patients taking an oral drug, this was determined by how many days during follow-up patients had their prescribed medication based on their history of filling their prescription. For patients receiving an injected drug, Dr. Wong and his associates calculated a medication possession ratio based on the frequency at which a patient’s records documented receiving an injection, and the number of days the injection covered during follow-up.

Among commercially insured patients, those who received injections had an average 67% medication possession ratio, compared with a 56% rate among patients taking an oral drug. In the Medicare group, injected patients had a 68% possession ratio, compared with 59% in those on an oral drug. In both subgroups the difference in ratios between the two types of treatment were statistically significant.

The analyses also identified other differences between the two treatment groups. Among the commercially insured, injected drugs were significantly more common than oral drugs in patients treated in comprehensive health plans, while injected drugs were used significantly less often than oral drugs in health maintenance organization settings.

Among commercially insured patients, those who received long-acting injections averaged 42 years old, significantly older than those who received oral drugs, who averaged 37 years old. Dr. Wong attributed this age difference to patients typically starting on an oral formulation and only switching to an injected formulation a few years later, once they showed that they were not reliable oral users. Medicare patients also showed a significant age difference, but the relationship flipped in this older age group. The mean age of the patients on injected antipsychotics was 67, while those on an oral drug averaged 73 years old. Dr. Wong said he did not have an explanation for this pattern among Medicare patients.

In the commercial group, patients on injected drugs were also significantly sicker, with an average Charlson comorbidity index of 0.58, compared with an average of 0.47 in the orally treated patients. Again, this pattern was reversed in Medicare patients, where the injected patients had an average Charlson comorbidity index score of 1.24, significantly less than the 1.83 average among patients on an oral drug.

The analysis also showed regional differences in the use of the two treatment options, with injections exceeding oral drug use in the North-Central U.S. region, while oral drugs were substantially more popular than injected drugs in the Western half of the United States. In other U.S. regions, the use of the two treatment routes was generally more balanced.

The study was sponsored by Otsuka, which markets the antipsychotic drug aripiprazole. Dr. Wong said he has been a consultant to Otsuka.

PHILADELPHIA – Long-acting, injectable formulations of antipsychotic drugs significantly boosted treatment compliance in patients with schizophrenia in a review of reimbursement records for more than 3,600 patients.

The increased compliance achieved with depot administration of antipsychotic medications makes it an attractive alternative to oral administration of antipsychotic drugs to patients with schizophrenia, Dr. Bruce J. Wong said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

Greater use of depot medications could improve the management of patients with schizophrenia because treatment compliance is a major determinant of the ongoing health of schizophrenia patients, said Dr. Wong, a consultant clinical epidemiologist in Wayne, Pa.

"Lack of patient adherence to psychotropic medications is the single largest factor contributing to the ongoing morbidity of schizophrenia today. Even short gaps in antipsychotic usage increase the risk of rehospitalization" of patients, said Dr. Wong, also of the department of biostatistics and epidemiology at the University of Pennsylvania, Philadelphia.

"In practice today, depot, injected antipsychotic medications are secondary treatments, used almost like punishment when patients are noncompliant with oral drugs but should be viewed more like a reward," he said. The same drugs are formulated into oral and injectable preparations, so depot versions are not less effective or less safe than oral forms. Instead, a series of social factors relegate injectable formulations to second-line status: needle phobia in patients, a modest amount of pain that can occur when antipsychotic drugs are injected into muscle, the lack of comfort that psychiatrists often have with performing injections, and the need for a psychiatrist to obtain and have the drug on hand as opposed to the convenience of writing a prescription for the patient to get the oral form.

None of these alone is a major barrier, but together they seem to create enough of a roadblock to make injections less favored, Dr. Wong said in an interview.

To better document how the two delivery options relate to compliance, Dr. Wong and his associates used data collected on 3,004 commercially insured patients with schizophrenia in the MarketScan database of Thompson Reuters, and on 665 Medicare patients collected by the Center for Medicare and Medicaid Services during January 2005 to September 2010. The analysis focused on patients who began treatment with either an oral or a long-acting injected formulation of an antipsychotic drug, and who had at least 12 months of continuous health coverage prior to the index prescription.

In the commercial group, 13% of patients received an incident prescription for an injectable formulation, and 87% received an incident prescription for an oral antipsychotic. In the Medicare group, 22% filled a first-time prescription for a depot, injected formulation, and 78% fell into the oral group.

During follow-up, the researchers measured compliance by the average level of patients’ medication possession ratio. For patients taking an oral drug, this was determined by how many days during follow-up patients had their prescribed medication based on their history of filling their prescription. For patients receiving an injected drug, Dr. Wong and his associates calculated a medication possession ratio based on the frequency at which a patient’s records documented receiving an injection, and the number of days the injection covered during follow-up.

Among commercially insured patients, those who received injections had an average 67% medication possession ratio, compared with a 56% rate among patients taking an oral drug. In the Medicare group, injected patients had a 68% possession ratio, compared with 59% in those on an oral drug. In both subgroups the difference in ratios between the two types of treatment were statistically significant.

The analyses also identified other differences between the two treatment groups. Among the commercially insured, injected drugs were significantly more common than oral drugs in patients treated in comprehensive health plans, while injected drugs were used significantly less often than oral drugs in health maintenance organization settings.

Among commercially insured patients, those who received long-acting injections averaged 42 years old, significantly older than those who received oral drugs, who averaged 37 years old. Dr. Wong attributed this age difference to patients typically starting on an oral formulation and only switching to an injected formulation a few years later, once they showed that they were not reliable oral users. Medicare patients also showed a significant age difference, but the relationship flipped in this older age group. The mean age of the patients on injected antipsychotics was 67, while those on an oral drug averaged 73 years old. Dr. Wong said he did not have an explanation for this pattern among Medicare patients.

In the commercial group, patients on injected drugs were also significantly sicker, with an average Charlson comorbidity index of 0.58, compared with an average of 0.47 in the orally treated patients. Again, this pattern was reversed in Medicare patients, where the injected patients had an average Charlson comorbidity index score of 1.24, significantly less than the 1.83 average among patients on an oral drug.

The analysis also showed regional differences in the use of the two treatment options, with injections exceeding oral drug use in the North-Central U.S. region, while oral drugs were substantially more popular than injected drugs in the Western half of the United States. In other U.S. regions, the use of the two treatment routes was generally more balanced.

The study was sponsored by Otsuka, which markets the antipsychotic drug aripiprazole. Dr. Wong said he has been a consultant to Otsuka.

SAN DIEGO – A new study has found that people with diverticulosis actually have a low risk of progression to diverticulitis – far lower than the rates of 10%-25% commonly cited in the medical literature.

The actual rate seems to be at most six cases of progression from diverticulosis to diverticulitis for each 1,000 person years of follow-up. And if a stricter definition of diverticulitis is used, the rate for progression is even lower, 1.5 episodes for every 1,000 person-years, Dr. Kamyar Shahedi said at the meeting.

The newly derived rate came from a careful review of more than 2,000 people who were identified with diverticulosis in the VA Greater Los Angeles Healthcare System and followed for as long as 16 years.

The analysis also showed that the risk for developing diverticulitis subsequent to diagnosis of diverticulosis fell markedly with age, dropping by an average of 24% for each added decade of life from the time diverticulosis was first identified, said Dr. Shahedi, a gastroenterologist at the University of California, Los Angeles.

The highest cumulative hazard that people in the study faced for developing diverticulitis was if their diverticulosis was identified when they were in their 40s. The next highest rate of progression occurred among people first identified with diverticulosis in their 50s, and so on, with the lowest risk faced by people first found to have diverticulosis in their 70s.

Dr. Shahedi and his associates suspected that the age-related dimension to the risk for progression may have stemmed from a bias linked to the indication for the colonoscopy that found the diverticulosis, but after adjustment for the colonoscopy indication, younger age remained a significant, independent risk factor for more rapid progression. "Future research should try to explain how and why age affects risk," he said.

Diverticulosis is the most common finding during colonoscopy. Results from a recent review of U.S. adults who underwent colonoscopy during 2001-2005 showed that the procedures identified about 45% with diverticulosis (Gastroenterology 2009;136:741-54).

Citations for a 10%-25% rate of progression of diverticulosis to diverticulitis appear widely in the literature, such as in 1999 diverticulitis guidelines published by the American College of Gastroenterology (Am. J. Gastroenterol. 1999;94:3110-21).

But in the 1999 ACG guidelines, the citation for the 10%-25% rate is a 1975 textbook, and when Dr. Shahedi checked the book he found that the original data behind this rate came out in the 1930s, 1940s, and 1950s. "Few recent studies" have calculated a more contemporary progression rate, and the studies that have been done were small, Dr. Shahedi said.

His study involved a manual chart review of all people in the VA Greater Los Angeles Health Care system identified with diverticulosis during 1996-2011. This system includes 14 community clinics and 1 inpatient medical center and serves about 3 million people.

The manual review excluded people with a prior diagnosis of diverticulosis, and identified 2,222 newly diagnosed cases. The records for these incident diverticulosis cases then underwent further careful review to flag the people who subsequently developed diverticulitis.

The researchers used four different criteria for identifying progression to diverticulitis: a chart diagnosis that included no objective evidence of progression, a diagnosis supported by objective data but without radiographic documentation, a diagnosis supported by imaging, and a diagnosis supported by a surgical specimen.

The review identified 95 of the 2,222 people (4.3%) who progressed to diverticulitis by any of these four criteria, and 23 people (1% of the 2,222) among these 95 whose progression to diverticulitis included documentation by at least one of the two strictest criteria, either radiographic or surgical evidence. The median time to progression to diverticulitis documented by any of the four criteria was 7.1 years.

The 2,222 people with diverticulosis were all veterans, their average age was 67 years, about 98% were men, and their average body mass index was 28.5 kg/m². About 40% of the group was white, 10% African American, 8% Hispanic, and the rest were of other ethnic groups. Dr. Shahedi noted that the study was limited by examining a VA population that largely included men, it was a retrospective study, and all the people included came from a single health care system.

Dr. Shahedi said that he had no disclosures.

SAN DIEGO – A new study has found that people with diverticulosis actually have a low risk of progression to diverticulitis – far lower than the rates of 10%-25% commonly cited in the medical literature.

The actual rate seems to be at most six cases of progression from diverticulosis to diverticulitis for each 1,000 person years of follow-up. And if a stricter definition of diverticulitis is used, the rate for progression is even lower, 1.5 episodes for every 1,000 person-years, Dr. Kamyar Shahedi said at the meeting.

The newly derived rate came from a careful review of more than 2,000 people who were identified with diverticulosis in the VA Greater Los Angeles Healthcare System and followed for as long as 16 years.

The analysis also showed that the risk for developing diverticulitis subsequent to diagnosis of diverticulosis fell markedly with age, dropping by an average of 24% for each added decade of life from the time diverticulosis was first identified, said Dr. Shahedi, a gastroenterologist at the University of California, Los Angeles.

The highest cumulative hazard that people in the study faced for developing diverticulitis was if their diverticulosis was identified when they were in their 40s. The next highest rate of progression occurred among people first identified with diverticulosis in their 50s, and so on, with the lowest risk faced by people first found to have diverticulosis in their 70s.

Dr. Shahedi and his associates suspected that the age-related dimension to the risk for progression may have stemmed from a bias linked to the indication for the colonoscopy that found the diverticulosis, but after adjustment for the colonoscopy indication, younger age remained a significant, independent risk factor for more rapid progression. "Future research should try to explain how and why age affects risk," he said.

Diverticulosis is the most common finding during colonoscopy. Results from a recent review of U.S. adults who underwent colonoscopy during 2001-2005 showed that the procedures identified about 45% with diverticulosis (Gastroenterology 2009;136:741-54).

Citations for a 10%-25% rate of progression of diverticulosis to diverticulitis appear widely in the literature, such as in 1999 diverticulitis guidelines published by the American College of Gastroenterology (Am. J. Gastroenterol. 1999;94:3110-21).

But in the 1999 ACG guidelines, the citation for the 10%-25% rate is a 1975 textbook, and when Dr. Shahedi checked the book he found that the original data behind this rate came out in the 1930s, 1940s, and 1950s. "Few recent studies" have calculated a more contemporary progression rate, and the studies that have been done were small, Dr. Shahedi said.

His study involved a manual chart review of all people in the VA Greater Los Angeles Health Care system identified with diverticulosis during 1996-2011. This system includes 14 community clinics and 1 inpatient medical center and serves about 3 million people.

The manual review excluded people with a prior diagnosis of diverticulosis, and identified 2,222 newly diagnosed cases. The records for these incident diverticulosis cases then underwent further careful review to flag the people who subsequently developed diverticulitis.

The researchers used four different criteria for identifying progression to diverticulitis: a chart diagnosis that included no objective evidence of progression, a diagnosis supported by objective data but without radiographic documentation, a diagnosis supported by imaging, and a diagnosis supported by a surgical specimen.

The review identified 95 of the 2,222 people (4.3%) who progressed to diverticulitis by any of these four criteria, and 23 people (1% of the 2,222) among these 95 whose progression to diverticulitis included documentation by at least one of the two strictest criteria, either radiographic or surgical evidence. The median time to progression to diverticulitis documented by any of the four criteria was 7.1 years.

The 2,222 people with diverticulosis were all veterans, their average age was 67 years, about 98% were men, and their average body mass index was 28.5 kg/m². About 40% of the group was white, 10% African American, 8% Hispanic, and the rest were of other ethnic groups. Dr. Shahedi noted that the study was limited by examining a VA population that largely included men, it was a retrospective study, and all the people included came from a single health care system.

Dr. Shahedi said that he had no disclosures.

SAN DIEGO – A new study has found that people with diverticulosis actually have a low risk of progression to diverticulitis – far lower than the rates of 10%-25% commonly cited in the medical literature.

The actual rate seems to be at most six cases of progression from diverticulosis to diverticulitis for each 1,000 person years of follow-up. And if a stricter definition of diverticulitis is used, the rate for progression is even lower, 1.5 episodes for every 1,000 person-years, Dr. Kamyar Shahedi said at the meeting.

The newly derived rate came from a careful review of more than 2,000 people who were identified with diverticulosis in the VA Greater Los Angeles Healthcare System and followed for as long as 16 years.

The analysis also showed that the risk for developing diverticulitis subsequent to diagnosis of diverticulosis fell markedly with age, dropping by an average of 24% for each added decade of life from the time diverticulosis was first identified, said Dr. Shahedi, a gastroenterologist at the University of California, Los Angeles.

The highest cumulative hazard that people in the study faced for developing diverticulitis was if their diverticulosis was identified when they were in their 40s. The next highest rate of progression occurred among people first identified with diverticulosis in their 50s, and so on, with the lowest risk faced by people first found to have diverticulosis in their 70s.

Dr. Shahedi and his associates suspected that the age-related dimension to the risk for progression may have stemmed from a bias linked to the indication for the colonoscopy that found the diverticulosis, but after adjustment for the colonoscopy indication, younger age remained a significant, independent risk factor for more rapid progression. "Future research should try to explain how and why age affects risk," he said.

Diverticulosis is the most common finding during colonoscopy. Results from a recent review of U.S. adults who underwent colonoscopy during 2001-2005 showed that the procedures identified about 45% with diverticulosis (Gastroenterology 2009;136:741-54).

Citations for a 10%-25% rate of progression of diverticulosis to diverticulitis appear widely in the literature, such as in 1999 diverticulitis guidelines published by the American College of Gastroenterology (Am. J. Gastroenterol. 1999;94:3110-21).

But in the 1999 ACG guidelines, the citation for the 10%-25% rate is a 1975 textbook, and when Dr. Shahedi checked the book he found that the original data behind this rate came out in the 1930s, 1940s, and 1950s. "Few recent studies" have calculated a more contemporary progression rate, and the studies that have been done were small, Dr. Shahedi said.

His study involved a manual chart review of all people in the VA Greater Los Angeles Health Care system identified with diverticulosis during 1996-2011. This system includes 14 community clinics and 1 inpatient medical center and serves about 3 million people.

The manual review excluded people with a prior diagnosis of diverticulosis, and identified 2,222 newly diagnosed cases. The records for these incident diverticulosis cases then underwent further careful review to flag the people who subsequently developed diverticulitis.

The researchers used four different criteria for identifying progression to diverticulitis: a chart diagnosis that included no objective evidence of progression, a diagnosis supported by objective data but without radiographic documentation, a diagnosis supported by imaging, and a diagnosis supported by a surgical specimen.

The review identified 95 of the 2,222 people (4.3%) who progressed to diverticulitis by any of these four criteria, and 23 people (1% of the 2,222) among these 95 whose progression to diverticulitis included documentation by at least one of the two strictest criteria, either radiographic or surgical evidence. The median time to progression to diverticulitis documented by any of the four criteria was 7.1 years.

The 2,222 people with diverticulosis were all veterans, their average age was 67 years, about 98% were men, and their average body mass index was 28.5 kg/m². About 40% of the group was white, 10% African American, 8% Hispanic, and the rest were of other ethnic groups. Dr. Shahedi noted that the study was limited by examining a VA population that largely included men, it was a retrospective study, and all the people included came from a single health care system.

Dr. Shahedi said that he had no disclosures.

SAN DIEGO – Screening colonoscopy showed its efficacy for preventing incident cases of colorectal cancer in prospectively collected data during follow-up of up to 24 years in about 170,000 average-risk Americans.

The finding adds prospectively collected data from a large database of average-risk Americans to the evidence supporting routine colonoscopy screening for colorectal cancer. In contrast, data from the influential National Polyp Study assessed screening colonoscopy in high-risk patients who first underwent polypectomy (N. Engl. J. Med. 2012;366:687-96), Dr. Paul Lochhead said at the annual Digestive Disease Week.

In general, the new findings support current public health recommendations for screening colonoscopy every 10 years in adults aged 50-75 years, but with a few caveats.

The new results showed that screening colonoscopy can significantly cut the risk for new-onset colorectal cancer by 51%, that the benefit from a single colonoscopy screen extended beyond 7 years, and that colonoscopy worked better than screening sigmoidoscopy. The findings also highlighted that colonoscopy was much better at preventing new distal cancers compared with its efficacy for stopping incident proximal tumors, and that when people had two, three, or more screening colonoscopies over time their risk of incident colorectal cancer fell further than after a single screening, said Dr. Lochhead, a gastroenterologist at the University of Aberdeen (Scotland).

"Although a single negative colonoscopy is associated with risk reduction, continued screening may be associated with greater benefit," undercutting the notion that average-risk middle-aged adults should undergo just a single screening colonoscopy with no follow-up screening if the first proves negative, he said.

In addition, "efforts to improve prevention [resulting from] proximal screening are warranted," he added.

"For distal cancers, we saw benefit beyond 10 years, but for proximal cancers we’re less certain about the duration of benefit. It appears there was a pattern of additional risk reduction with multiple screens regardless of whether the cancers were proximal or distal. That is something to bear in mind before we say that once is enough," he said in an interview.

The study used data from two large, prospective, U.S. observational studies: the Nurses’ Health Study, which began in 1976 and initially included 121,700 U.S. women, and the Health Professionals Follow-Up Study, which began in 1986 and included 51,529 men.

In the Nurses’ Health Study, data became available on screening endoscopy starting in 1984, so the data that Dr. Lochhead and his associates used through 2008 included up to 24 years of follow-up. The Health Professionals Follow-Up Study started tracking screening endoscopy in 1988, which gave as many as 20 years of follow-up data through 2008.

For this analysis, the researchers excluded participants in the two studies who had a lower endoscopy prior to the index procedures included in the two databases, those who had prior polyps or any cancer other than nonmelanoma skin cancer before they had their index endoscopy, and participants with inflammatory bowel disease. They calculated multivariate Cox proportional hazard models on the follow-up data that controlled for age, body mass index, smoking, family history of colorectal cancer, regular aspirin use, physical activity, diet, and multivitamin use.

The database included more than 2 million person-years of follow-up from both studies, and during follow-up 2,198 participants developed new-onset colorectal cancer. The majority of participants, constituting nearly 1.4 million person-years of follow-up, underwent no screening endoscopy during the years studied. About 424,000 person years of follow-up came after screening sigmoidoscopy, nearly 300,000 person years of follow-up came following screening colonoscopy, and over 65,000 person-years of follow-up came after polypectomy.

In the multivariate model, compared with no endoscopy, a negative colonoscopy result cut the rate of colorectal cancer by a statistically significant 51%, while negative sigmoidoscopy and polypectomy each cut the subsequent cancer rates by a statistically significant 37%, Dr. Lochhead reported.

When broken down by cancer site – proximal or distal – a negative colonoscopy was the only procedure to cut the risk for incident proximal cancers significantly, reducing the rate by 26% compared with no endoscopy. For distal cancers, colonoscopy cut the rate by 71%, compared with no screening, while sigmoidoscopy and polypectomy each cut the rate by 53%; all these risk reductions for distal cancers were statistically significant.

In the analysis that assessed the durability of protection, screening colonoscopy cut the risk for new colorectal cancers by a statistically significant 34%, compared with no screening, even when incident cancers were tallied more than 7 years following the index colonoscopy procedure. When cancers were divided by location, however, colonoscopy only provided significant protection for the first 3 years, with a risk reduction of 41% compared with no screening. Beyond that, colonoscopy did not produce a statistically significant reduction in incident cancers compared with no screening.

In contrast, for distal cancers the protective benefit of colonoscopy extended beyond 7 years: Screening colonoscopy provided a significant 42% cancer-rate reduction, compared with no screening, more than 7 years out.

The analysis also showed that the statistically significant protective benefit from polypectomy lasted for just 3 years for all cancer locations, with a 52% protection rate compared with no screening. For distal cancers a significant protective effect lasted for 5 years, but for proximal cancers polypectomy did not provide significant protection, even during the first 3 years after the procedure.

An additional multivariate analysis showed cumulative protection from multiple colonoscopies. A single screening colonoscopy cut the rate of incident cancers, both proximal and distal, by a statistically significant 47%, but two colonoscopies cut the risk by 59% and three or more colonoscopies cut the risk by 64%.

Dr. Lochhead said that he had no disclosures.

SAN DIEGO – Screening colonoscopy showed its efficacy for preventing incident cases of colorectal cancer in prospectively collected data during follow-up of up to 24 years in about 170,000 average-risk Americans.

The finding adds prospectively collected data from a large database of average-risk Americans to the evidence supporting routine colonoscopy screening for colorectal cancer. In contrast, data from the influential National Polyp Study assessed screening colonoscopy in high-risk patients who first underwent polypectomy (N. Engl. J. Med. 2012;366:687-96), Dr. Paul Lochhead said at the annual Digestive Disease Week.

In general, the new findings support current public health recommendations for screening colonoscopy every 10 years in adults aged 50-75 years, but with a few caveats.

The new results showed that screening colonoscopy can significantly cut the risk for new-onset colorectal cancer by 51%, that the benefit from a single colonoscopy screen extended beyond 7 years, and that colonoscopy worked better than screening sigmoidoscopy. The findings also highlighted that colonoscopy was much better at preventing new distal cancers compared with its efficacy for stopping incident proximal tumors, and that when people had two, three, or more screening colonoscopies over time their risk of incident colorectal cancer fell further than after a single screening, said Dr. Lochhead, a gastroenterologist at the University of Aberdeen (Scotland).

"Although a single negative colonoscopy is associated with risk reduction, continued screening may be associated with greater benefit," undercutting the notion that average-risk middle-aged adults should undergo just a single screening colonoscopy with no follow-up screening if the first proves negative, he said.

In addition, "efforts to improve prevention [resulting from] proximal screening are warranted," he added.

"For distal cancers, we saw benefit beyond 10 years, but for proximal cancers we’re less certain about the duration of benefit. It appears there was a pattern of additional risk reduction with multiple screens regardless of whether the cancers were proximal or distal. That is something to bear in mind before we say that once is enough," he said in an interview.

The study used data from two large, prospective, U.S. observational studies: the Nurses’ Health Study, which began in 1976 and initially included 121,700 U.S. women, and the Health Professionals Follow-Up Study, which began in 1986 and included 51,529 men.

In the Nurses’ Health Study, data became available on screening endoscopy starting in 1984, so the data that Dr. Lochhead and his associates used through 2008 included up to 24 years of follow-up. The Health Professionals Follow-Up Study started tracking screening endoscopy in 1988, which gave as many as 20 years of follow-up data through 2008.

For this analysis, the researchers excluded participants in the two studies who had a lower endoscopy prior to the index procedures included in the two databases, those who had prior polyps or any cancer other than nonmelanoma skin cancer before they had their index endoscopy, and participants with inflammatory bowel disease. They calculated multivariate Cox proportional hazard models on the follow-up data that controlled for age, body mass index, smoking, family history of colorectal cancer, regular aspirin use, physical activity, diet, and multivitamin use.

The database included more than 2 million person-years of follow-up from both studies, and during follow-up 2,198 participants developed new-onset colorectal cancer. The majority of participants, constituting nearly 1.4 million person-years of follow-up, underwent no screening endoscopy during the years studied. About 424,000 person years of follow-up came after screening sigmoidoscopy, nearly 300,000 person years of follow-up came following screening colonoscopy, and over 65,000 person-years of follow-up came after polypectomy.

In the multivariate model, compared with no endoscopy, a negative colonoscopy result cut the rate of colorectal cancer by a statistically significant 51%, while negative sigmoidoscopy and polypectomy each cut the subsequent cancer rates by a statistically significant 37%, Dr. Lochhead reported.

When broken down by cancer site – proximal or distal – a negative colonoscopy was the only procedure to cut the risk for incident proximal cancers significantly, reducing the rate by 26% compared with no endoscopy. For distal cancers, colonoscopy cut the rate by 71%, compared with no screening, while sigmoidoscopy and polypectomy each cut the rate by 53%; all these risk reductions for distal cancers were statistically significant.

In the analysis that assessed the durability of protection, screening colonoscopy cut the risk for new colorectal cancers by a statistically significant 34%, compared with no screening, even when incident cancers were tallied more than 7 years following the index colonoscopy procedure. When cancers were divided by location, however, colonoscopy only provided significant protection for the first 3 years, with a risk reduction of 41% compared with no screening. Beyond that, colonoscopy did not produce a statistically significant reduction in incident cancers compared with no screening.

In contrast, for distal cancers the protective benefit of colonoscopy extended beyond 7 years: Screening colonoscopy provided a significant 42% cancer-rate reduction, compared with no screening, more than 7 years out.

The analysis also showed that the statistically significant protective benefit from polypectomy lasted for just 3 years for all cancer locations, with a 52% protection rate compared with no screening. For distal cancers a significant protective effect lasted for 5 years, but for proximal cancers polypectomy did not provide significant protection, even during the first 3 years after the procedure.

An additional multivariate analysis showed cumulative protection from multiple colonoscopies. A single screening colonoscopy cut the rate of incident cancers, both proximal and distal, by a statistically significant 47%, but two colonoscopies cut the risk by 59% and three or more colonoscopies cut the risk by 64%.

Dr. Lochhead said that he had no disclosures.

SAN DIEGO – Screening colonoscopy showed its efficacy for preventing incident cases of colorectal cancer in prospectively collected data during follow-up of up to 24 years in about 170,000 average-risk Americans.

The finding adds prospectively collected data from a large database of average-risk Americans to the evidence supporting routine colonoscopy screening for colorectal cancer. In contrast, data from the influential National Polyp Study assessed screening colonoscopy in high-risk patients who first underwent polypectomy (N. Engl. J. Med. 2012;366:687-96), Dr. Paul Lochhead said at the annual Digestive Disease Week.

In general, the new findings support current public health recommendations for screening colonoscopy every 10 years in adults aged 50-75 years, but with a few caveats.

The new results showed that screening colonoscopy can significantly cut the risk for new-onset colorectal cancer by 51%, that the benefit from a single colonoscopy screen extended beyond 7 years, and that colonoscopy worked better than screening sigmoidoscopy. The findings also highlighted that colonoscopy was much better at preventing new distal cancers compared with its efficacy for stopping incident proximal tumors, and that when people had two, three, or more screening colonoscopies over time their risk of incident colorectal cancer fell further than after a single screening, said Dr. Lochhead, a gastroenterologist at the University of Aberdeen (Scotland).

"Although a single negative colonoscopy is associated with risk reduction, continued screening may be associated with greater benefit," undercutting the notion that average-risk middle-aged adults should undergo just a single screening colonoscopy with no follow-up screening if the first proves negative, he said.

In addition, "efforts to improve prevention [resulting from] proximal screening are warranted," he added.

"For distal cancers, we saw benefit beyond 10 years, but for proximal cancers we’re less certain about the duration of benefit. It appears there was a pattern of additional risk reduction with multiple screens regardless of whether the cancers were proximal or distal. That is something to bear in mind before we say that once is enough," he said in an interview.

The study used data from two large, prospective, U.S. observational studies: the Nurses’ Health Study, which began in 1976 and initially included 121,700 U.S. women, and the Health Professionals Follow-Up Study, which began in 1986 and included 51,529 men.

In the Nurses’ Health Study, data became available on screening endoscopy starting in 1984, so the data that Dr. Lochhead and his associates used through 2008 included up to 24 years of follow-up. The Health Professionals Follow-Up Study started tracking screening endoscopy in 1988, which gave as many as 20 years of follow-up data through 2008.

For this analysis, the researchers excluded participants in the two studies who had a lower endoscopy prior to the index procedures included in the two databases, those who had prior polyps or any cancer other than nonmelanoma skin cancer before they had their index endoscopy, and participants with inflammatory bowel disease. They calculated multivariate Cox proportional hazard models on the follow-up data that controlled for age, body mass index, smoking, family history of colorectal cancer, regular aspirin use, physical activity, diet, and multivitamin use.

The database included more than 2 million person-years of follow-up from both studies, and during follow-up 2,198 participants developed new-onset colorectal cancer. The majority of participants, constituting nearly 1.4 million person-years of follow-up, underwent no screening endoscopy during the years studied. About 424,000 person years of follow-up came after screening sigmoidoscopy, nearly 300,000 person years of follow-up came following screening colonoscopy, and over 65,000 person-years of follow-up came after polypectomy.

In the multivariate model, compared with no endoscopy, a negative colonoscopy result cut the rate of colorectal cancer by a statistically significant 51%, while negative sigmoidoscopy and polypectomy each cut the subsequent cancer rates by a statistically significant 37%, Dr. Lochhead reported.

When broken down by cancer site – proximal or distal – a negative colonoscopy was the only procedure to cut the risk for incident proximal cancers significantly, reducing the rate by 26% compared with no endoscopy. For distal cancers, colonoscopy cut the rate by 71%, compared with no screening, while sigmoidoscopy and polypectomy each cut the rate by 53%; all these risk reductions for distal cancers were statistically significant.

In the analysis that assessed the durability of protection, screening colonoscopy cut the risk for new colorectal cancers by a statistically significant 34%, compared with no screening, even when incident cancers were tallied more than 7 years following the index colonoscopy procedure. When cancers were divided by location, however, colonoscopy only provided significant protection for the first 3 years, with a risk reduction of 41% compared with no screening. Beyond that, colonoscopy did not produce a statistically significant reduction in incident cancers compared with no screening.

In contrast, for distal cancers the protective benefit of colonoscopy extended beyond 7 years: Screening colonoscopy provided a significant 42% cancer-rate reduction, compared with no screening, more than 7 years out.

The analysis also showed that the statistically significant protective benefit from polypectomy lasted for just 3 years for all cancer locations, with a 52% protection rate compared with no screening. For distal cancers a significant protective effect lasted for 5 years, but for proximal cancers polypectomy did not provide significant protection, even during the first 3 years after the procedure.

An additional multivariate analysis showed cumulative protection from multiple colonoscopies. A single screening colonoscopy cut the rate of incident cancers, both proximal and distal, by a statistically significant 47%, but two colonoscopies cut the risk by 59% and three or more colonoscopies cut the risk by 64%.

Dr. Lochhead said that he had no disclosures.