Risk Factors Traced for Postpolypectomy Bleeding

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WASHINGTON — Large polyp size and the use of anticoagulants raised the risk of delayed postpolypectomy hemorrhage, but aspirin and a history of hypertension did not, according to a study presented at the annual Digestive Disease Week.

The results stand in contrast to studies finding that hypertension, polyp location, and sessile (as opposed to pedunculated) polyps were risk factors for delayed bleeding, wrote Dr. Nadim Salfiti and associates at the University of Minnesota, Minneapolis.

In the case-control, retrospective chart review, the researchers analyzed 41 cases of postpolypectomy bleeding and 132 control cases at the Minneapolis VA Medical Center in 1999–2006. Mean age of the 41 case patients was 64 years, all were male, and most were white. Inclusion criteria for cases were delayed hematochezia occurring 6 hours to 14 days after polyp resection, and one of the following: hospital admission, blood transfusion, drop in hemoglobin of more than 1 g/dL, or repeat colonoscopy.

The mean polyp size was 10.5 mm for cases and 6.7 mm for controls, a significant difference; 37% of cases and 11% of controls had a polyp size greater than 1 cm. Heparin or warfarin were used within 1 week after polypectomy in 34% of the patients with hemorrhage, a rate significantly higher than the 9% rate among controls.

At least one dose of aspirin was administered to roughly 40% of both cases and controls within the time period from 1 week before to 1 week after polypectomy, and slightly more than 60% of both cases and controls were hypertensive. Diabetes and lung disease were moderately significant risk factors, and coronary artery disease was present in 59% of cases and 32% of controls, a significant difference.

“This is the first study evaluating the risk of [using] anticoagulant medications after polypectomy,” Dr. Salfiti noted in an interview. “These results … provide some information that could facilitate the decision regarding the timing of resuming anticoagulation.”

Dr. Salfiti cautioned, however, that “each patient should be evaluated individually, and the risks of postpolypectomy bleeding versus the risk of some form of thromboembolic event in the short-term need to be assessed to decide how long anticoagulation should be delayed, if at all.”

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WASHINGTON — Large polyp size and the use of anticoagulants raised the risk of delayed postpolypectomy hemorrhage, but aspirin and a history of hypertension did not, according to a study presented at the annual Digestive Disease Week.

The results stand in contrast to studies finding that hypertension, polyp location, and sessile (as opposed to pedunculated) polyps were risk factors for delayed bleeding, wrote Dr. Nadim Salfiti and associates at the University of Minnesota, Minneapolis.

In the case-control, retrospective chart review, the researchers analyzed 41 cases of postpolypectomy bleeding and 132 control cases at the Minneapolis VA Medical Center in 1999–2006. Mean age of the 41 case patients was 64 years, all were male, and most were white. Inclusion criteria for cases were delayed hematochezia occurring 6 hours to 14 days after polyp resection, and one of the following: hospital admission, blood transfusion, drop in hemoglobin of more than 1 g/dL, or repeat colonoscopy.

The mean polyp size was 10.5 mm for cases and 6.7 mm for controls, a significant difference; 37% of cases and 11% of controls had a polyp size greater than 1 cm. Heparin or warfarin were used within 1 week after polypectomy in 34% of the patients with hemorrhage, a rate significantly higher than the 9% rate among controls.

At least one dose of aspirin was administered to roughly 40% of both cases and controls within the time period from 1 week before to 1 week after polypectomy, and slightly more than 60% of both cases and controls were hypertensive. Diabetes and lung disease were moderately significant risk factors, and coronary artery disease was present in 59% of cases and 32% of controls, a significant difference.

“This is the first study evaluating the risk of [using] anticoagulant medications after polypectomy,” Dr. Salfiti noted in an interview. “These results … provide some information that could facilitate the decision regarding the timing of resuming anticoagulation.”

Dr. Salfiti cautioned, however, that “each patient should be evaluated individually, and the risks of postpolypectomy bleeding versus the risk of some form of thromboembolic event in the short-term need to be assessed to decide how long anticoagulation should be delayed, if at all.”

WASHINGTON — Large polyp size and the use of anticoagulants raised the risk of delayed postpolypectomy hemorrhage, but aspirin and a history of hypertension did not, according to a study presented at the annual Digestive Disease Week.

The results stand in contrast to studies finding that hypertension, polyp location, and sessile (as opposed to pedunculated) polyps were risk factors for delayed bleeding, wrote Dr. Nadim Salfiti and associates at the University of Minnesota, Minneapolis.

In the case-control, retrospective chart review, the researchers analyzed 41 cases of postpolypectomy bleeding and 132 control cases at the Minneapolis VA Medical Center in 1999–2006. Mean age of the 41 case patients was 64 years, all were male, and most were white. Inclusion criteria for cases were delayed hematochezia occurring 6 hours to 14 days after polyp resection, and one of the following: hospital admission, blood transfusion, drop in hemoglobin of more than 1 g/dL, or repeat colonoscopy.

The mean polyp size was 10.5 mm for cases and 6.7 mm for controls, a significant difference; 37% of cases and 11% of controls had a polyp size greater than 1 cm. Heparin or warfarin were used within 1 week after polypectomy in 34% of the patients with hemorrhage, a rate significantly higher than the 9% rate among controls.

At least one dose of aspirin was administered to roughly 40% of both cases and controls within the time period from 1 week before to 1 week after polypectomy, and slightly more than 60% of both cases and controls were hypertensive. Diabetes and lung disease were moderately significant risk factors, and coronary artery disease was present in 59% of cases and 32% of controls, a significant difference.

“This is the first study evaluating the risk of [using] anticoagulant medications after polypectomy,” Dr. Salfiti noted in an interview. “These results … provide some information that could facilitate the decision regarding the timing of resuming anticoagulation.”

Dr. Salfiti cautioned, however, that “each patient should be evaluated individually, and the risks of postpolypectomy bleeding versus the risk of some form of thromboembolic event in the short-term need to be assessed to decide how long anticoagulation should be delayed, if at all.”

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Fear of Loss of Control Drives Patients to Resist New Therapies

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Professed patient satisfaction with their current rheumatoid arthritis therapy had less to do with actual therapeutic success than the fact that their disease did not worsen while on a given treatment, according to the findings of a large survey.

In their survey of 6,135 rheumatoid arthritis (RA) patients in the United States, Dr. Frederick Wolfe and Kaleb Michaud, Ph.D., both of the National Data Bank for Rheumatic Disease, in Wichita, Kan., found that overall, 66% of patients did not think there was a better treatment than what they were currently receiving; of those patients not receiving biologic agents (part of the recommended aggressive multidrug therapy for optimal RA treatment), the number was 58%.

The survey, conducted in January 2006, involved a 28-page questionnaire that assessed sociodemographic data as well as disease severity, disease duration, and past and present RA treatment. Median participant age was 62.7 years; median RA duration was 15 years. Nearly 80% were female.

Overall, roughly 64% said they would not want to change therapy unless their condition worsened. Of those, 87% cited a fear of side effects as a reason why they wouldn't switch therapies; fear of losing control if the new treatments didn't work was cited by 81%; and the belief that there were no better drugs for their disease was given by 76% of patients. The roughly two-thirds of patients who reported side effects to an arthritis drug at some point in their lifetime were least likely to be willing to change therapy (OR 1.8) and most likely to be concerned about the risk of side effects with a therapy switch (OR 1.2).

Despite patients' professed unwillingness to switch, 71% of patients who said they were satisfied with their treatment had moderate or greater arthritis activity on the Patient Activity Score, and 47% had Health Assessment Questionnaire scores greater than 1.0, which correlates with a severe disease rating, they reported (Arthritis Rheum. 2007;56:2135-42).

“Given relatively stable RA and prior experience with RA treatments, maintenance of current status [not getting worse] appears to be given high priority by patients,” wrote the investigators. They added that although cost of new drugs, inconvenience, and potential administrative hassles with their insurance carrier also contributed to patients' unwillingness to try potentially better, new therapies, “they played a small role in thinking about therapies,” compared with fear of side effects and fear of losing control, which led patients with even severe disease to resist switching therapies. “Patients' reluctance [to change therapy] may contain wisdom about homeostasis that goes beyond the experimentation of clinical trials and that is based on experience and preferences for the future. The idea of 'not getting worse' may be an important outcome that has not been considered sufficiently in therapeutic decision making.”

Dr. Wolfe acknowledged that the National Data Bank, a nonprofit research data bank, has received pharmaceutical support in the past, but the current study was independent.

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Professed patient satisfaction with their current rheumatoid arthritis therapy had less to do with actual therapeutic success than the fact that their disease did not worsen while on a given treatment, according to the findings of a large survey.

In their survey of 6,135 rheumatoid arthritis (RA) patients in the United States, Dr. Frederick Wolfe and Kaleb Michaud, Ph.D., both of the National Data Bank for Rheumatic Disease, in Wichita, Kan., found that overall, 66% of patients did not think there was a better treatment than what they were currently receiving; of those patients not receiving biologic agents (part of the recommended aggressive multidrug therapy for optimal RA treatment), the number was 58%.

The survey, conducted in January 2006, involved a 28-page questionnaire that assessed sociodemographic data as well as disease severity, disease duration, and past and present RA treatment. Median participant age was 62.7 years; median RA duration was 15 years. Nearly 80% were female.

Overall, roughly 64% said they would not want to change therapy unless their condition worsened. Of those, 87% cited a fear of side effects as a reason why they wouldn't switch therapies; fear of losing control if the new treatments didn't work was cited by 81%; and the belief that there were no better drugs for their disease was given by 76% of patients. The roughly two-thirds of patients who reported side effects to an arthritis drug at some point in their lifetime were least likely to be willing to change therapy (OR 1.8) and most likely to be concerned about the risk of side effects with a therapy switch (OR 1.2).

Despite patients' professed unwillingness to switch, 71% of patients who said they were satisfied with their treatment had moderate or greater arthritis activity on the Patient Activity Score, and 47% had Health Assessment Questionnaire scores greater than 1.0, which correlates with a severe disease rating, they reported (Arthritis Rheum. 2007;56:2135-42).

“Given relatively stable RA and prior experience with RA treatments, maintenance of current status [not getting worse] appears to be given high priority by patients,” wrote the investigators. They added that although cost of new drugs, inconvenience, and potential administrative hassles with their insurance carrier also contributed to patients' unwillingness to try potentially better, new therapies, “they played a small role in thinking about therapies,” compared with fear of side effects and fear of losing control, which led patients with even severe disease to resist switching therapies. “Patients' reluctance [to change therapy] may contain wisdom about homeostasis that goes beyond the experimentation of clinical trials and that is based on experience and preferences for the future. The idea of 'not getting worse' may be an important outcome that has not been considered sufficiently in therapeutic decision making.”

Dr. Wolfe acknowledged that the National Data Bank, a nonprofit research data bank, has received pharmaceutical support in the past, but the current study was independent.

Professed patient satisfaction with their current rheumatoid arthritis therapy had less to do with actual therapeutic success than the fact that their disease did not worsen while on a given treatment, according to the findings of a large survey.

In their survey of 6,135 rheumatoid arthritis (RA) patients in the United States, Dr. Frederick Wolfe and Kaleb Michaud, Ph.D., both of the National Data Bank for Rheumatic Disease, in Wichita, Kan., found that overall, 66% of patients did not think there was a better treatment than what they were currently receiving; of those patients not receiving biologic agents (part of the recommended aggressive multidrug therapy for optimal RA treatment), the number was 58%.

The survey, conducted in January 2006, involved a 28-page questionnaire that assessed sociodemographic data as well as disease severity, disease duration, and past and present RA treatment. Median participant age was 62.7 years; median RA duration was 15 years. Nearly 80% were female.

Overall, roughly 64% said they would not want to change therapy unless their condition worsened. Of those, 87% cited a fear of side effects as a reason why they wouldn't switch therapies; fear of losing control if the new treatments didn't work was cited by 81%; and the belief that there were no better drugs for their disease was given by 76% of patients. The roughly two-thirds of patients who reported side effects to an arthritis drug at some point in their lifetime were least likely to be willing to change therapy (OR 1.8) and most likely to be concerned about the risk of side effects with a therapy switch (OR 1.2).

Despite patients' professed unwillingness to switch, 71% of patients who said they were satisfied with their treatment had moderate or greater arthritis activity on the Patient Activity Score, and 47% had Health Assessment Questionnaire scores greater than 1.0, which correlates with a severe disease rating, they reported (Arthritis Rheum. 2007;56:2135-42).

“Given relatively stable RA and prior experience with RA treatments, maintenance of current status [not getting worse] appears to be given high priority by patients,” wrote the investigators. They added that although cost of new drugs, inconvenience, and potential administrative hassles with their insurance carrier also contributed to patients' unwillingness to try potentially better, new therapies, “they played a small role in thinking about therapies,” compared with fear of side effects and fear of losing control, which led patients with even severe disease to resist switching therapies. “Patients' reluctance [to change therapy] may contain wisdom about homeostasis that goes beyond the experimentation of clinical trials and that is based on experience and preferences for the future. The idea of 'not getting worse' may be an important outcome that has not been considered sufficiently in therapeutic decision making.”

Dr. Wolfe acknowledged that the National Data Bank, a nonprofit research data bank, has received pharmaceutical support in the past, but the current study was independent.

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Gout Treatment Patterns Vary Widely From Best Practices

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Just 25% of suspected gout patients had arthrocentesis for crystal analysis, despite the fact that the procedure remains the “gold standard” for diagnosis of the disease, according to a report by Dr. Danielle Petersel and Dr. Naomi Schlesinger.

Furthermore, of the 184 patients diagnosed with gout in one 400-bed hospital over a 2-year period from 2002 to 2004, only 38% received a rheumatology consultation, reported Dr. Petersel and Dr. Schlesinger, of the Robert Wood Johnson Medical School at New Brunswick, N.J. “The diagnostician was likely to be the admitting physician for these patients,” they wrote.

Of the 184 patients, the average age was 71 years (with a range from 40 to 96 years). All were male.

Another important finding was that a combination of anti-inflammatory agents was taken by 52% of patients, despite a lack of evidence in the literature supporting the use of combination therapy.

In fact, wrote the authors, “Combination therapy potentially puts the patient at risk of increased morbidity/mortality due to the combined effects upon the kidney.” Indeed, renal failure was present in 65% of patients with acute gout. Nevertheless, prednisone and colchicine were given in 23% of cases; nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine were given in 16%; and a steroid with an NSAID was administered in 13% of patients. Indomethacin was the most commonly prescribed NSAID (J. Rheumatol. 2007;34:1566-8).

Additionally, despite evidence that using the urate-lowering drug allopurinol to cut serum urate levels to less than 6 mg/dL is beneficial and leads to the dissolution of urate crystals and regression of tophi, only 27% were treated with the drug. “Even when it was taken, [serum urate] was not lowered to [an] SU goal of 6 mg/dL,” reported the researchers.

Rather, in 60% of patients treated with allopurinol, SU level was greater than 6 mg/dL.

“Practice patterns vary widely and support the need for education of health care professionals taking care of patients with gout,” concluded the authors.

“In our study, all patients were male, which may suggest that the cohort was somewhat biased. Long-term prospective, placebo-controlled studies are needed to establish guidelines for the diagnosis and treatment of gout,” they added.

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Just 25% of suspected gout patients had arthrocentesis for crystal analysis, despite the fact that the procedure remains the “gold standard” for diagnosis of the disease, according to a report by Dr. Danielle Petersel and Dr. Naomi Schlesinger.

Furthermore, of the 184 patients diagnosed with gout in one 400-bed hospital over a 2-year period from 2002 to 2004, only 38% received a rheumatology consultation, reported Dr. Petersel and Dr. Schlesinger, of the Robert Wood Johnson Medical School at New Brunswick, N.J. “The diagnostician was likely to be the admitting physician for these patients,” they wrote.

Of the 184 patients, the average age was 71 years (with a range from 40 to 96 years). All were male.

Another important finding was that a combination of anti-inflammatory agents was taken by 52% of patients, despite a lack of evidence in the literature supporting the use of combination therapy.

In fact, wrote the authors, “Combination therapy potentially puts the patient at risk of increased morbidity/mortality due to the combined effects upon the kidney.” Indeed, renal failure was present in 65% of patients with acute gout. Nevertheless, prednisone and colchicine were given in 23% of cases; nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine were given in 16%; and a steroid with an NSAID was administered in 13% of patients. Indomethacin was the most commonly prescribed NSAID (J. Rheumatol. 2007;34:1566-8).

Additionally, despite evidence that using the urate-lowering drug allopurinol to cut serum urate levels to less than 6 mg/dL is beneficial and leads to the dissolution of urate crystals and regression of tophi, only 27% were treated with the drug. “Even when it was taken, [serum urate] was not lowered to [an] SU goal of 6 mg/dL,” reported the researchers.

Rather, in 60% of patients treated with allopurinol, SU level was greater than 6 mg/dL.

“Practice patterns vary widely and support the need for education of health care professionals taking care of patients with gout,” concluded the authors.

“In our study, all patients were male, which may suggest that the cohort was somewhat biased. Long-term prospective, placebo-controlled studies are needed to establish guidelines for the diagnosis and treatment of gout,” they added.

Just 25% of suspected gout patients had arthrocentesis for crystal analysis, despite the fact that the procedure remains the “gold standard” for diagnosis of the disease, according to a report by Dr. Danielle Petersel and Dr. Naomi Schlesinger.

Furthermore, of the 184 patients diagnosed with gout in one 400-bed hospital over a 2-year period from 2002 to 2004, only 38% received a rheumatology consultation, reported Dr. Petersel and Dr. Schlesinger, of the Robert Wood Johnson Medical School at New Brunswick, N.J. “The diagnostician was likely to be the admitting physician for these patients,” they wrote.

Of the 184 patients, the average age was 71 years (with a range from 40 to 96 years). All were male.

Another important finding was that a combination of anti-inflammatory agents was taken by 52% of patients, despite a lack of evidence in the literature supporting the use of combination therapy.

In fact, wrote the authors, “Combination therapy potentially puts the patient at risk of increased morbidity/mortality due to the combined effects upon the kidney.” Indeed, renal failure was present in 65% of patients with acute gout. Nevertheless, prednisone and colchicine were given in 23% of cases; nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine were given in 16%; and a steroid with an NSAID was administered in 13% of patients. Indomethacin was the most commonly prescribed NSAID (J. Rheumatol. 2007;34:1566-8).

Additionally, despite evidence that using the urate-lowering drug allopurinol to cut serum urate levels to less than 6 mg/dL is beneficial and leads to the dissolution of urate crystals and regression of tophi, only 27% were treated with the drug. “Even when it was taken, [serum urate] was not lowered to [an] SU goal of 6 mg/dL,” reported the researchers.

Rather, in 60% of patients treated with allopurinol, SU level was greater than 6 mg/dL.

“Practice patterns vary widely and support the need for education of health care professionals taking care of patients with gout,” concluded the authors.

“In our study, all patients were male, which may suggest that the cohort was somewhat biased. Long-term prospective, placebo-controlled studies are needed to establish guidelines for the diagnosis and treatment of gout,” they added.

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Anti-TNF-α Efficacy in Trials Not Achieved in Real-World Scenarios

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Good clinical response and rheumatoid arthritis remission following treatment with tumor necrosis factor-α blockers is much rarer on the community level than results from randomized clinical trials, with their many exclusion criteria, would seem to indicate, according to results from an Italian group of researchers.

The Gruppo Italiano per lo Studio delle Early Arthritis study (GISEA) enrolled 1,257 patients who had longstanding rheumatoid arthritis (RA) and who started therapy with tumor necrosis factor-α (TNF-α) blockers. The original aim of the study was to pinpoint predictors of remission in longstanding arthritis patients treated with TNF-α blockers.

However, in the process, the researchers uncovered an unexpected finding: only 682 (54%) of patients experienced even the minimally acceptable improvement in their symptoms after 6 months of treatment with a TNF-α blocking agent. Specifically, these 682 patients were the only ones to experience at least a 0.25 improvement in their Health Assessment Questionnaire score (HAQ), which is considered the cutoff point for a clinically meaningful response.

Of the patients who dropped out, 32% cited inefficacy and 14% cited adverse events, including skin reactions, infusion reactions, and gastrointestinal problems.

Even at the outpatient clinics, only half of the patients reached a clinically meaningful result as defined by an HAQ improvement of 0.25, wrote the researchers.

“Therefore, patients in clinical practice are not representative of those recruited in clinical trials, and certainly do not reach the outcomes that have been provided in [randomized controlled clinical trials]. Among these, remission was observed in a small percentage of patients with a long disease duration,” they added.

The most likely interpretation for this discrepancy—randomized trials' extensive exclusion criteria—could “seriously influence not only the safety issue in general, but also the final clinical outcomes in aggressive and severe disease at the community level,” the study investigators noted (J. Rheumatol. 2007;34:1670-3).

Of the 682 patients who were studied further, only 591 (47% of the whole cohort) had both a 0.25 improvement in HAQ scores and underwent regular bimonthly assessments of clinical and laboratory measures.

In this cohort of 591 patients, 404 (68%) were women, and the mean age was 53 years.

Overall, 32% of the men and 24% of the women achieved remission, a difference that was statistically significant and which prompted the authors to speculate that “male patients with RA seem to benefit more from anti-TNF-α strategies than do female patients.”

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Good clinical response and rheumatoid arthritis remission following treatment with tumor necrosis factor-α blockers is much rarer on the community level than results from randomized clinical trials, with their many exclusion criteria, would seem to indicate, according to results from an Italian group of researchers.

The Gruppo Italiano per lo Studio delle Early Arthritis study (GISEA) enrolled 1,257 patients who had longstanding rheumatoid arthritis (RA) and who started therapy with tumor necrosis factor-α (TNF-α) blockers. The original aim of the study was to pinpoint predictors of remission in longstanding arthritis patients treated with TNF-α blockers.

However, in the process, the researchers uncovered an unexpected finding: only 682 (54%) of patients experienced even the minimally acceptable improvement in their symptoms after 6 months of treatment with a TNF-α blocking agent. Specifically, these 682 patients were the only ones to experience at least a 0.25 improvement in their Health Assessment Questionnaire score (HAQ), which is considered the cutoff point for a clinically meaningful response.

Of the patients who dropped out, 32% cited inefficacy and 14% cited adverse events, including skin reactions, infusion reactions, and gastrointestinal problems.

Even at the outpatient clinics, only half of the patients reached a clinically meaningful result as defined by an HAQ improvement of 0.25, wrote the researchers.

“Therefore, patients in clinical practice are not representative of those recruited in clinical trials, and certainly do not reach the outcomes that have been provided in [randomized controlled clinical trials]. Among these, remission was observed in a small percentage of patients with a long disease duration,” they added.

The most likely interpretation for this discrepancy—randomized trials' extensive exclusion criteria—could “seriously influence not only the safety issue in general, but also the final clinical outcomes in aggressive and severe disease at the community level,” the study investigators noted (J. Rheumatol. 2007;34:1670-3).

Of the 682 patients who were studied further, only 591 (47% of the whole cohort) had both a 0.25 improvement in HAQ scores and underwent regular bimonthly assessments of clinical and laboratory measures.

In this cohort of 591 patients, 404 (68%) were women, and the mean age was 53 years.

Overall, 32% of the men and 24% of the women achieved remission, a difference that was statistically significant and which prompted the authors to speculate that “male patients with RA seem to benefit more from anti-TNF-α strategies than do female patients.”

Good clinical response and rheumatoid arthritis remission following treatment with tumor necrosis factor-α blockers is much rarer on the community level than results from randomized clinical trials, with their many exclusion criteria, would seem to indicate, according to results from an Italian group of researchers.

The Gruppo Italiano per lo Studio delle Early Arthritis study (GISEA) enrolled 1,257 patients who had longstanding rheumatoid arthritis (RA) and who started therapy with tumor necrosis factor-α (TNF-α) blockers. The original aim of the study was to pinpoint predictors of remission in longstanding arthritis patients treated with TNF-α blockers.

However, in the process, the researchers uncovered an unexpected finding: only 682 (54%) of patients experienced even the minimally acceptable improvement in their symptoms after 6 months of treatment with a TNF-α blocking agent. Specifically, these 682 patients were the only ones to experience at least a 0.25 improvement in their Health Assessment Questionnaire score (HAQ), which is considered the cutoff point for a clinically meaningful response.

Of the patients who dropped out, 32% cited inefficacy and 14% cited adverse events, including skin reactions, infusion reactions, and gastrointestinal problems.

Even at the outpatient clinics, only half of the patients reached a clinically meaningful result as defined by an HAQ improvement of 0.25, wrote the researchers.

“Therefore, patients in clinical practice are not representative of those recruited in clinical trials, and certainly do not reach the outcomes that have been provided in [randomized controlled clinical trials]. Among these, remission was observed in a small percentage of patients with a long disease duration,” they added.

The most likely interpretation for this discrepancy—randomized trials' extensive exclusion criteria—could “seriously influence not only the safety issue in general, but also the final clinical outcomes in aggressive and severe disease at the community level,” the study investigators noted (J. Rheumatol. 2007;34:1670-3).

Of the 682 patients who were studied further, only 591 (47% of the whole cohort) had both a 0.25 improvement in HAQ scores and underwent regular bimonthly assessments of clinical and laboratory measures.

In this cohort of 591 patients, 404 (68%) were women, and the mean age was 53 years.

Overall, 32% of the men and 24% of the women achieved remission, a difference that was statistically significant and which prompted the authors to speculate that “male patients with RA seem to benefit more from anti-TNF-α strategies than do female patients.”

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Lupus Guidelines Focus on 12 Recommendations

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The first attempt to develop "comprehensive management guidelines" for systemic lupus erythematosus resulted in 12 recommendations—some potentially controversial—from a European task force.

A European League Against Rheumatism (EULAR) task force composed of 19 rheumatology specialists and one clinical epidemiologist based the guidelines on its review of over 8,000 articles. "These recommendations should facilitate the medical care of lupus patients without restricting the autonomy of the provider physicians," wrote the authors, adding the "remarkable heterogeneity" of lupus makes it especially challenging to cover all aspects of the disease.

As such, the authors did not cover some systemic lupus erythematosus (SLE) diagnostic criteria, such as the potential usefulness of the American College of Rheumatology 1999 classification criteria for diagnosing SLE at early stages. Nor did they delve into detailed management guidelines for cutaneous lupus. "These issues will be addressed in future sessions," they wrote.

Dr. Virginia D. Steen, professor of rheumatology at Georgetown University, Washington, noted the lack of differential diagnostic criteria in the guidelines. "Some of the biggest problems in lupus are things like separating infection from active lupus, determining whether 'CNS' disease is actually a manifestation of lupus … distinguishing drug toxicity from disease manifestations. These may not be things that are apropos to these types of guidelines, but they would be more helpful."

The members of the EULAR task force noted that in selecting studies to consider, "Retrieved items from electronic searches were screened for eligibility based on their title, abstract, and/or full content. Animal studies, narrative review articles, commentaries, conference abstracts or statements, expert opinion statements, and guidelines were excluded."

In assessing the prognosis, diagnosis, etiology, or comorbidities associated with SLE, studies were eligible if they had at least 50 patients. Randomized studies of therapy that included at least five patients were also included (Ann. Rheum. Dis. 2007 July 5 [Epub doi: 10.1136/ard.2007.070367

"For nontherapy questions of specific organ manifestations (e.g., nephritis, neuropsychiatric lupus), or specific problems (pregnancy, APS [antiphospholipid syndrome]), studies were eligible if they had studied at least 20 SLE patients with the relevant manifestation," the authors wrote.

Dr. Robert Lahita, who helped compile the ACR's SLE classification criteria in 1999, noted that some of the recommendations touch on divisive issues, such as the contention that "pregnancy may increase lupus disease activity, but these flares are usually mild."

"A lot of people say pregnancy makes lupus worse," said Dr. Lahita, a professor at Mount Sinai School of Medicine, New York, and chairman of medicine at Jersey City (N.J.) Medical Center.

Another controversial aspect of the EULAR guidelines is the task force's recommendation that "in patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss."

The recommendations of the EULAR task force include the following:

Prognosis. In SLE patients, new clinical signs (e.g., rashes, arthritis, serositis); routine laboratory tests (CBC, serum creatinine, proteinuria, and urinary sediment); and immunologic tests (e.g., serum C3, anti-ds DNA) may offer information about the outcome in general and in potential organ involvement. Confirmation by imaging (brain MRI) and pathology (renal biopsy) may add to this in selected patients.

Monitoring. New manifestations such as number and type of skin lesions, neurologic manifestations (seizures/psychosis), and validated global activity indices may be used to monitor lupus patients.

Comorbidities. SLE patients are at high risk for infections (urinary tract infections, among others), atherosclerosis, hypertension, dyslipidemias, diabetes, osteoporosis, avascular necrosis, and malignancies (especially non-Hodgkin's lymphoma). Minimize additional risk factors, harbor a high index of suspicion, and practice prompt evaluation and follow-up.

Treatment of nonmajor organ involvement. In SLE without major organ involvement, antimalarials and/or glucocorticoids may be used. NSAIDs may be used judiciously in patients at low risk for complications. In nonresponsive patients or patients unable to cut steroid doses to levels acceptable for chronic use, immunosuppressives (azathioprine, mycophenolate mofetil, methotrexate) may be considered.

Adjunctive therapy. Photoprotection should be considered in patients with skin manifestations. Lifestyle modifications (smoking cessation, weight control, exercise) should be encouraged. On a case-by-case basis, low-dose aspirin, calcium/vitamin D, bisphosphonates, statins, and antihypertensives, including angiotensin-converting enzyme inhibitors, may be considered. Estrogens may be used, but risks must be assessed.

Diagnosis of neuropsychiatric lupus. The diagnostic work-up (clinical, laboratory, neuropsychological, and imaging tests) of neuropsychiatric manifestations should be similar to that of a work-up for someone in the general population presenting with the same symptoms.

Treatment of severe, inflammatory neuropsychiatric lupus. Patients with major neuropsychiatric manifestations of inflammatory origin (optic neuritis, acute confusional state/coma, cranial or peripheral neuropathy, psychosis, and transverse myelitis/myelopathy) may benefit from immunosuppressives.

 

 

Pregnancy in lupus. There is no significant difference in fertility in lupus patients. Pregnancy may increase disease activity, but flares are usually mild. Lupus nephritis patients and patients with antiphospholipid antibodies are at increased risk of developing preeclampsia. SLE may affect the fetus, especially if the mother has a history of lupus nephritis and antiphospholipid, anti-Ro, and/or anti-La antibodies. These conditions are associated with an increased risk of miscarriage, stillbirth, premature delivery, intrauterine growth restriction, and fetal heart block. Prednisolone, azathioprine, hydroxychloroquine, and low-dose aspirin may be used in lupus pregnancies. Mycophenolate mofetil, cyclophosphamide, and methotrexate must all be avoided.

Antiphospholipid syndrome in lupus. In patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss. Other risk factors should be assessed; estrogen-containing drugs raise thrombosis risk. In nonpregnant patients with SLE and APS-associated thrombosis, long-term anticoagulation with oral anticoagulants is effective for secondary thrombosis prevention. In pregnant patients with SLE and antiphospholipid syndrome, combined unfractionated or low molecular weight heparin and aspirin cut pregnancy loss and thrombosis.

Lupus nephritis: diagnosis and disease monitoring. Renal biopsy, urine sediment analysis, proteinuria, and kidney function may have independent predictive ability for clinical outcome in therapy of lupus nephritis but need to be interpreted in conjunction with each other. Changes in immunologic tests (anti-ds DNA, serum C3) have only a limited ability to predict patient response to treatment and should be used only supplementally.

Lupus nephritis: treatment. In patients with proliferative lupus nephritis, glucocorticoids plus immunosuppressive agents are effective against progression to end-stage renal disease. Long-term efficacy has been demonstrated only for cyclophosphamide-based regimens, which have considerable adverse effects. In short- and medium-term trials, mycophenolate mofetil has demonstrated at least similar efficacy, compared with pulse cyclophosphamide, and has a more favorable toxicity profile. Failure to respond by 6 months should evoke discussions for intensification of therapy. Flares following remission are not uncommon and require diligent follow-up.

End-stage renal disease. Dialysis and transplantation in SLE have comparable rates for long-term patient and graft survival as those observed in nondiabetic non-SLE patients.

Despite the many manifestations of lupus, the new guidelines lack differential diagnostic criteria. DR. STEEN

Additional Lupus Research Is Needed

The EULAR task force that authored the new SLE guidelines has proposed a research agenda to correct for the current dearth of randomized controlled trials establishing optimal management of lupus. Areas that the task force highlighted for future investigation included:

▸ The validity of renal biopsy, urinary sediment analysis, tests for proteinuria, and immunologic tests as surrogate markers in the treatment of lupus nephritis.

▸ The relative impact on disease susceptibility and severity of environmental factors like sun exposure, smoking, diet, and genetics.

▸ Mechanisms by which to identify patients at higher risk for SLE.

▸ Diagnostic criteria with improved sensitivity and specificity as well as criteria to identify distinct SLE subpopulations.

▸ Reliable diagnostic algorithms for neuropsychiatric lupus.

▸ The indications and optimal targets for autologous stem cell therapy in SLE, as well as the major indications for biologic therapies like B-cell depletion, inhibition of B-cell differentiation, costimulation blockade, and toleragens.

▸ Treatment options for resistant disease that involve major and nonmajor organs.

▸ The mechanisms of a lupus flare, along with the best way to manage flares.

▸ The epidemiology, management, and long-term outcome of geriatric, pediatric, and adolescent SLE.

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The first attempt to develop "comprehensive management guidelines" for systemic lupus erythematosus resulted in 12 recommendations—some potentially controversial—from a European task force.

A European League Against Rheumatism (EULAR) task force composed of 19 rheumatology specialists and one clinical epidemiologist based the guidelines on its review of over 8,000 articles. "These recommendations should facilitate the medical care of lupus patients without restricting the autonomy of the provider physicians," wrote the authors, adding the "remarkable heterogeneity" of lupus makes it especially challenging to cover all aspects of the disease.

As such, the authors did not cover some systemic lupus erythematosus (SLE) diagnostic criteria, such as the potential usefulness of the American College of Rheumatology 1999 classification criteria for diagnosing SLE at early stages. Nor did they delve into detailed management guidelines for cutaneous lupus. "These issues will be addressed in future sessions," they wrote.

Dr. Virginia D. Steen, professor of rheumatology at Georgetown University, Washington, noted the lack of differential diagnostic criteria in the guidelines. "Some of the biggest problems in lupus are things like separating infection from active lupus, determining whether 'CNS' disease is actually a manifestation of lupus … distinguishing drug toxicity from disease manifestations. These may not be things that are apropos to these types of guidelines, but they would be more helpful."

The members of the EULAR task force noted that in selecting studies to consider, "Retrieved items from electronic searches were screened for eligibility based on their title, abstract, and/or full content. Animal studies, narrative review articles, commentaries, conference abstracts or statements, expert opinion statements, and guidelines were excluded."

In assessing the prognosis, diagnosis, etiology, or comorbidities associated with SLE, studies were eligible if they had at least 50 patients. Randomized studies of therapy that included at least five patients were also included (Ann. Rheum. Dis. 2007 July 5 [Epub doi: 10.1136/ard.2007.070367

"For nontherapy questions of specific organ manifestations (e.g., nephritis, neuropsychiatric lupus), or specific problems (pregnancy, APS [antiphospholipid syndrome]), studies were eligible if they had studied at least 20 SLE patients with the relevant manifestation," the authors wrote.

Dr. Robert Lahita, who helped compile the ACR's SLE classification criteria in 1999, noted that some of the recommendations touch on divisive issues, such as the contention that "pregnancy may increase lupus disease activity, but these flares are usually mild."

"A lot of people say pregnancy makes lupus worse," said Dr. Lahita, a professor at Mount Sinai School of Medicine, New York, and chairman of medicine at Jersey City (N.J.) Medical Center.

Another controversial aspect of the EULAR guidelines is the task force's recommendation that "in patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss."

The recommendations of the EULAR task force include the following:

Prognosis. In SLE patients, new clinical signs (e.g., rashes, arthritis, serositis); routine laboratory tests (CBC, serum creatinine, proteinuria, and urinary sediment); and immunologic tests (e.g., serum C3, anti-ds DNA) may offer information about the outcome in general and in potential organ involvement. Confirmation by imaging (brain MRI) and pathology (renal biopsy) may add to this in selected patients.

Monitoring. New manifestations such as number and type of skin lesions, neurologic manifestations (seizures/psychosis), and validated global activity indices may be used to monitor lupus patients.

Comorbidities. SLE patients are at high risk for infections (urinary tract infections, among others), atherosclerosis, hypertension, dyslipidemias, diabetes, osteoporosis, avascular necrosis, and malignancies (especially non-Hodgkin's lymphoma). Minimize additional risk factors, harbor a high index of suspicion, and practice prompt evaluation and follow-up.

Treatment of nonmajor organ involvement. In SLE without major organ involvement, antimalarials and/or glucocorticoids may be used. NSAIDs may be used judiciously in patients at low risk for complications. In nonresponsive patients or patients unable to cut steroid doses to levels acceptable for chronic use, immunosuppressives (azathioprine, mycophenolate mofetil, methotrexate) may be considered.

Adjunctive therapy. Photoprotection should be considered in patients with skin manifestations. Lifestyle modifications (smoking cessation, weight control, exercise) should be encouraged. On a case-by-case basis, low-dose aspirin, calcium/vitamin D, bisphosphonates, statins, and antihypertensives, including angiotensin-converting enzyme inhibitors, may be considered. Estrogens may be used, but risks must be assessed.

Diagnosis of neuropsychiatric lupus. The diagnostic work-up (clinical, laboratory, neuropsychological, and imaging tests) of neuropsychiatric manifestations should be similar to that of a work-up for someone in the general population presenting with the same symptoms.

Treatment of severe, inflammatory neuropsychiatric lupus. Patients with major neuropsychiatric manifestations of inflammatory origin (optic neuritis, acute confusional state/coma, cranial or peripheral neuropathy, psychosis, and transverse myelitis/myelopathy) may benefit from immunosuppressives.

 

 

Pregnancy in lupus. There is no significant difference in fertility in lupus patients. Pregnancy may increase disease activity, but flares are usually mild. Lupus nephritis patients and patients with antiphospholipid antibodies are at increased risk of developing preeclampsia. SLE may affect the fetus, especially if the mother has a history of lupus nephritis and antiphospholipid, anti-Ro, and/or anti-La antibodies. These conditions are associated with an increased risk of miscarriage, stillbirth, premature delivery, intrauterine growth restriction, and fetal heart block. Prednisolone, azathioprine, hydroxychloroquine, and low-dose aspirin may be used in lupus pregnancies. Mycophenolate mofetil, cyclophosphamide, and methotrexate must all be avoided.

Antiphospholipid syndrome in lupus. In patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss. Other risk factors should be assessed; estrogen-containing drugs raise thrombosis risk. In nonpregnant patients with SLE and APS-associated thrombosis, long-term anticoagulation with oral anticoagulants is effective for secondary thrombosis prevention. In pregnant patients with SLE and antiphospholipid syndrome, combined unfractionated or low molecular weight heparin and aspirin cut pregnancy loss and thrombosis.

Lupus nephritis: diagnosis and disease monitoring. Renal biopsy, urine sediment analysis, proteinuria, and kidney function may have independent predictive ability for clinical outcome in therapy of lupus nephritis but need to be interpreted in conjunction with each other. Changes in immunologic tests (anti-ds DNA, serum C3) have only a limited ability to predict patient response to treatment and should be used only supplementally.

Lupus nephritis: treatment. In patients with proliferative lupus nephritis, glucocorticoids plus immunosuppressive agents are effective against progression to end-stage renal disease. Long-term efficacy has been demonstrated only for cyclophosphamide-based regimens, which have considerable adverse effects. In short- and medium-term trials, mycophenolate mofetil has demonstrated at least similar efficacy, compared with pulse cyclophosphamide, and has a more favorable toxicity profile. Failure to respond by 6 months should evoke discussions for intensification of therapy. Flares following remission are not uncommon and require diligent follow-up.

End-stage renal disease. Dialysis and transplantation in SLE have comparable rates for long-term patient and graft survival as those observed in nondiabetic non-SLE patients.

Despite the many manifestations of lupus, the new guidelines lack differential diagnostic criteria. DR. STEEN

Additional Lupus Research Is Needed

The EULAR task force that authored the new SLE guidelines has proposed a research agenda to correct for the current dearth of randomized controlled trials establishing optimal management of lupus. Areas that the task force highlighted for future investigation included:

▸ The validity of renal biopsy, urinary sediment analysis, tests for proteinuria, and immunologic tests as surrogate markers in the treatment of lupus nephritis.

▸ The relative impact on disease susceptibility and severity of environmental factors like sun exposure, smoking, diet, and genetics.

▸ Mechanisms by which to identify patients at higher risk for SLE.

▸ Diagnostic criteria with improved sensitivity and specificity as well as criteria to identify distinct SLE subpopulations.

▸ Reliable diagnostic algorithms for neuropsychiatric lupus.

▸ The indications and optimal targets for autologous stem cell therapy in SLE, as well as the major indications for biologic therapies like B-cell depletion, inhibition of B-cell differentiation, costimulation blockade, and toleragens.

▸ Treatment options for resistant disease that involve major and nonmajor organs.

▸ The mechanisms of a lupus flare, along with the best way to manage flares.

▸ The epidemiology, management, and long-term outcome of geriatric, pediatric, and adolescent SLE.

The first attempt to develop "comprehensive management guidelines" for systemic lupus erythematosus resulted in 12 recommendations—some potentially controversial—from a European task force.

A European League Against Rheumatism (EULAR) task force composed of 19 rheumatology specialists and one clinical epidemiologist based the guidelines on its review of over 8,000 articles. "These recommendations should facilitate the medical care of lupus patients without restricting the autonomy of the provider physicians," wrote the authors, adding the "remarkable heterogeneity" of lupus makes it especially challenging to cover all aspects of the disease.

As such, the authors did not cover some systemic lupus erythematosus (SLE) diagnostic criteria, such as the potential usefulness of the American College of Rheumatology 1999 classification criteria for diagnosing SLE at early stages. Nor did they delve into detailed management guidelines for cutaneous lupus. "These issues will be addressed in future sessions," they wrote.

Dr. Virginia D. Steen, professor of rheumatology at Georgetown University, Washington, noted the lack of differential diagnostic criteria in the guidelines. "Some of the biggest problems in lupus are things like separating infection from active lupus, determining whether 'CNS' disease is actually a manifestation of lupus … distinguishing drug toxicity from disease manifestations. These may not be things that are apropos to these types of guidelines, but they would be more helpful."

The members of the EULAR task force noted that in selecting studies to consider, "Retrieved items from electronic searches were screened for eligibility based on their title, abstract, and/or full content. Animal studies, narrative review articles, commentaries, conference abstracts or statements, expert opinion statements, and guidelines were excluded."

In assessing the prognosis, diagnosis, etiology, or comorbidities associated with SLE, studies were eligible if they had at least 50 patients. Randomized studies of therapy that included at least five patients were also included (Ann. Rheum. Dis. 2007 July 5 [Epub doi: 10.1136/ard.2007.070367

"For nontherapy questions of specific organ manifestations (e.g., nephritis, neuropsychiatric lupus), or specific problems (pregnancy, APS [antiphospholipid syndrome]), studies were eligible if they had studied at least 20 SLE patients with the relevant manifestation," the authors wrote.

Dr. Robert Lahita, who helped compile the ACR's SLE classification criteria in 1999, noted that some of the recommendations touch on divisive issues, such as the contention that "pregnancy may increase lupus disease activity, but these flares are usually mild."

"A lot of people say pregnancy makes lupus worse," said Dr. Lahita, a professor at Mount Sinai School of Medicine, New York, and chairman of medicine at Jersey City (N.J.) Medical Center.

Another controversial aspect of the EULAR guidelines is the task force's recommendation that "in patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss."

The recommendations of the EULAR task force include the following:

Prognosis. In SLE patients, new clinical signs (e.g., rashes, arthritis, serositis); routine laboratory tests (CBC, serum creatinine, proteinuria, and urinary sediment); and immunologic tests (e.g., serum C3, anti-ds DNA) may offer information about the outcome in general and in potential organ involvement. Confirmation by imaging (brain MRI) and pathology (renal biopsy) may add to this in selected patients.

Monitoring. New manifestations such as number and type of skin lesions, neurologic manifestations (seizures/psychosis), and validated global activity indices may be used to monitor lupus patients.

Comorbidities. SLE patients are at high risk for infections (urinary tract infections, among others), atherosclerosis, hypertension, dyslipidemias, diabetes, osteoporosis, avascular necrosis, and malignancies (especially non-Hodgkin's lymphoma). Minimize additional risk factors, harbor a high index of suspicion, and practice prompt evaluation and follow-up.

Treatment of nonmajor organ involvement. In SLE without major organ involvement, antimalarials and/or glucocorticoids may be used. NSAIDs may be used judiciously in patients at low risk for complications. In nonresponsive patients or patients unable to cut steroid doses to levels acceptable for chronic use, immunosuppressives (azathioprine, mycophenolate mofetil, methotrexate) may be considered.

Adjunctive therapy. Photoprotection should be considered in patients with skin manifestations. Lifestyle modifications (smoking cessation, weight control, exercise) should be encouraged. On a case-by-case basis, low-dose aspirin, calcium/vitamin D, bisphosphonates, statins, and antihypertensives, including angiotensin-converting enzyme inhibitors, may be considered. Estrogens may be used, but risks must be assessed.

Diagnosis of neuropsychiatric lupus. The diagnostic work-up (clinical, laboratory, neuropsychological, and imaging tests) of neuropsychiatric manifestations should be similar to that of a work-up for someone in the general population presenting with the same symptoms.

Treatment of severe, inflammatory neuropsychiatric lupus. Patients with major neuropsychiatric manifestations of inflammatory origin (optic neuritis, acute confusional state/coma, cranial or peripheral neuropathy, psychosis, and transverse myelitis/myelopathy) may benefit from immunosuppressives.

 

 

Pregnancy in lupus. There is no significant difference in fertility in lupus patients. Pregnancy may increase disease activity, but flares are usually mild. Lupus nephritis patients and patients with antiphospholipid antibodies are at increased risk of developing preeclampsia. SLE may affect the fetus, especially if the mother has a history of lupus nephritis and antiphospholipid, anti-Ro, and/or anti-La antibodies. These conditions are associated with an increased risk of miscarriage, stillbirth, premature delivery, intrauterine growth restriction, and fetal heart block. Prednisolone, azathioprine, hydroxychloroquine, and low-dose aspirin may be used in lupus pregnancies. Mycophenolate mofetil, cyclophosphamide, and methotrexate must all be avoided.

Antiphospholipid syndrome in lupus. In patients with SLE and antiphospholipid antibodies, low-dose aspirin may be considered for primary prevention of thrombosis and pregnancy loss. Other risk factors should be assessed; estrogen-containing drugs raise thrombosis risk. In nonpregnant patients with SLE and APS-associated thrombosis, long-term anticoagulation with oral anticoagulants is effective for secondary thrombosis prevention. In pregnant patients with SLE and antiphospholipid syndrome, combined unfractionated or low molecular weight heparin and aspirin cut pregnancy loss and thrombosis.

Lupus nephritis: diagnosis and disease monitoring. Renal biopsy, urine sediment analysis, proteinuria, and kidney function may have independent predictive ability for clinical outcome in therapy of lupus nephritis but need to be interpreted in conjunction with each other. Changes in immunologic tests (anti-ds DNA, serum C3) have only a limited ability to predict patient response to treatment and should be used only supplementally.

Lupus nephritis: treatment. In patients with proliferative lupus nephritis, glucocorticoids plus immunosuppressive agents are effective against progression to end-stage renal disease. Long-term efficacy has been demonstrated only for cyclophosphamide-based regimens, which have considerable adverse effects. In short- and medium-term trials, mycophenolate mofetil has demonstrated at least similar efficacy, compared with pulse cyclophosphamide, and has a more favorable toxicity profile. Failure to respond by 6 months should evoke discussions for intensification of therapy. Flares following remission are not uncommon and require diligent follow-up.

End-stage renal disease. Dialysis and transplantation in SLE have comparable rates for long-term patient and graft survival as those observed in nondiabetic non-SLE patients.

Despite the many manifestations of lupus, the new guidelines lack differential diagnostic criteria. DR. STEEN

Additional Lupus Research Is Needed

The EULAR task force that authored the new SLE guidelines has proposed a research agenda to correct for the current dearth of randomized controlled trials establishing optimal management of lupus. Areas that the task force highlighted for future investigation included:

▸ The validity of renal biopsy, urinary sediment analysis, tests for proteinuria, and immunologic tests as surrogate markers in the treatment of lupus nephritis.

▸ The relative impact on disease susceptibility and severity of environmental factors like sun exposure, smoking, diet, and genetics.

▸ Mechanisms by which to identify patients at higher risk for SLE.

▸ Diagnostic criteria with improved sensitivity and specificity as well as criteria to identify distinct SLE subpopulations.

▸ Reliable diagnostic algorithms for neuropsychiatric lupus.

▸ The indications and optimal targets for autologous stem cell therapy in SLE, as well as the major indications for biologic therapies like B-cell depletion, inhibition of B-cell differentiation, costimulation blockade, and toleragens.

▸ Treatment options for resistant disease that involve major and nonmajor organs.

▸ The mechanisms of a lupus flare, along with the best way to manage flares.

▸ The epidemiology, management, and long-term outcome of geriatric, pediatric, and adolescent SLE.

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Dental Clinic Gives Options to Medicaid Patients

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For families on Medicaid, getting an appointment for a dental checkup can be a daunting task, but a chain of clinics is looking to change that.

Small Smiles of Washington is one of 52 clinics of the same name in 17 states that only accept Medicaid-qualified patients. That makes it the largest provider of Medicaid dental services in the country, according to Dr. Aldred Williams, the Washington clinic's lead dentist.

Many dentists don't take Medicaid at all because of poor reimbursement rates. Often, the only dental clinics that do accept Medicaid patients are few and far between, or perform a limited range of services, and patients can expect long wait times for an appointment.

On the inside, Small Smiles looks like any of its counterparts in one of the surrounding, affluent D.C. suburbs. There is a spacious waiting room filled with toys and decorated with colorful, professional murals, plus a television. The examination rooms are also bright and inviting, and there are plenty of them—nine treatment rooms, plus separate consultation rooms, hygiene rooms, x-ray rooms, and doctor offices. They, too, are outfitted with high-tech, top-of-the-line equipment.

Paradoxically, it is from an outside view that Small Smiles—run by FORBA (an acronym that means For Better Access), a management company based in Pueblo, Colo.—reveals itself. The building resides in a converted nightclub that used to be called “The Black Hole.” Dollar stores and pawn shops abound up and down the stretch of Georgia Avenue where the clinic is located. A security guard, employed by the clinic, circles the block.

But this is a perfect location for Small Smiles. Its patients, after all, aren't coming from the wealthy suburbs. This is their neighborhood dentist.

Small Smiles is one of the few clinics in the area to accept Medicaid. The clinic pays the bills despite Medicaid's poor reimbursement because of its location in an area with a high concentration of Medicaid-qualified patients. Sheer volume—anywhere from 60 to 90 visits per day (150 appointments, 40% of which are cancelled or result in no-shows, for which Small Smiles charges no punitive fee)—keeps the practice financially afloat.

The place is busy, but not overwhelmed. Five front office personnel, five dentists, 12 assistants, and three hygienists keep the clinic running smoothly. The average wait for an appointment at Small Smiles is just 2 weeks, and the practice accepts walk-ins and emergency cases. Its staff—although not necessarily trained as pediatric dentists—is qualified and able to perform complicated pediatric procedures as well as routine cleanings.

Dr. Williams said in an interview that they are paid a competitive wage, and although turnover is high, advantages like regular working hours and FORBA's handling of reimbursement and human resources lure new graduates and former retirees, like himself, to the clinic.

Often, area clinics send their developmentally disabled or autistic patients to Small Smiles, which is trained and equipped to treat these special needs children.

Todd Cruse, vice president of development and government affairs for FORBA, said in an interview that last year there were 697,000 patient visits at Small Smiles clinics around the country. (For a list of locations, visit www.smallsmilesusa.com

In areas without a clinic like Small Smiles, “It is difficult for many low-income families to find or afford a dentist,” said Dr. David Krol, chair of the department of pediatrics at the University of Toledo who listed multiple problems that can arise following lax dental care. “Imagine trying to concentrate in school with a toothache, or trying to eat when it hurts to chew. If a child isn't eating, think of how hard it is to get the calories needed to grow.”

“In older children, especially older adolescents, I sometimes see periodontal [gum] disease. We are learning that gum disease may have effects on diabetes, heart disease, and preterm birth,” he said.

The cheery interior of the Small Smiles Dental Clinic in Washington features state-of-the-art equipment. Denise Napoli/Elsevier Global Medical News

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For families on Medicaid, getting an appointment for a dental checkup can be a daunting task, but a chain of clinics is looking to change that.

Small Smiles of Washington is one of 52 clinics of the same name in 17 states that only accept Medicaid-qualified patients. That makes it the largest provider of Medicaid dental services in the country, according to Dr. Aldred Williams, the Washington clinic's lead dentist.

Many dentists don't take Medicaid at all because of poor reimbursement rates. Often, the only dental clinics that do accept Medicaid patients are few and far between, or perform a limited range of services, and patients can expect long wait times for an appointment.

On the inside, Small Smiles looks like any of its counterparts in one of the surrounding, affluent D.C. suburbs. There is a spacious waiting room filled with toys and decorated with colorful, professional murals, plus a television. The examination rooms are also bright and inviting, and there are plenty of them—nine treatment rooms, plus separate consultation rooms, hygiene rooms, x-ray rooms, and doctor offices. They, too, are outfitted with high-tech, top-of-the-line equipment.

Paradoxically, it is from an outside view that Small Smiles—run by FORBA (an acronym that means For Better Access), a management company based in Pueblo, Colo.—reveals itself. The building resides in a converted nightclub that used to be called “The Black Hole.” Dollar stores and pawn shops abound up and down the stretch of Georgia Avenue where the clinic is located. A security guard, employed by the clinic, circles the block.

But this is a perfect location for Small Smiles. Its patients, after all, aren't coming from the wealthy suburbs. This is their neighborhood dentist.

Small Smiles is one of the few clinics in the area to accept Medicaid. The clinic pays the bills despite Medicaid's poor reimbursement because of its location in an area with a high concentration of Medicaid-qualified patients. Sheer volume—anywhere from 60 to 90 visits per day (150 appointments, 40% of which are cancelled or result in no-shows, for which Small Smiles charges no punitive fee)—keeps the practice financially afloat.

The place is busy, but not overwhelmed. Five front office personnel, five dentists, 12 assistants, and three hygienists keep the clinic running smoothly. The average wait for an appointment at Small Smiles is just 2 weeks, and the practice accepts walk-ins and emergency cases. Its staff—although not necessarily trained as pediatric dentists—is qualified and able to perform complicated pediatric procedures as well as routine cleanings.

Dr. Williams said in an interview that they are paid a competitive wage, and although turnover is high, advantages like regular working hours and FORBA's handling of reimbursement and human resources lure new graduates and former retirees, like himself, to the clinic.

Often, area clinics send their developmentally disabled or autistic patients to Small Smiles, which is trained and equipped to treat these special needs children.

Todd Cruse, vice president of development and government affairs for FORBA, said in an interview that last year there were 697,000 patient visits at Small Smiles clinics around the country. (For a list of locations, visit www.smallsmilesusa.com

In areas without a clinic like Small Smiles, “It is difficult for many low-income families to find or afford a dentist,” said Dr. David Krol, chair of the department of pediatrics at the University of Toledo who listed multiple problems that can arise following lax dental care. “Imagine trying to concentrate in school with a toothache, or trying to eat when it hurts to chew. If a child isn't eating, think of how hard it is to get the calories needed to grow.”

“In older children, especially older adolescents, I sometimes see periodontal [gum] disease. We are learning that gum disease may have effects on diabetes, heart disease, and preterm birth,” he said.

The cheery interior of the Small Smiles Dental Clinic in Washington features state-of-the-art equipment. Denise Napoli/Elsevier Global Medical News

For families on Medicaid, getting an appointment for a dental checkup can be a daunting task, but a chain of clinics is looking to change that.

Small Smiles of Washington is one of 52 clinics of the same name in 17 states that only accept Medicaid-qualified patients. That makes it the largest provider of Medicaid dental services in the country, according to Dr. Aldred Williams, the Washington clinic's lead dentist.

Many dentists don't take Medicaid at all because of poor reimbursement rates. Often, the only dental clinics that do accept Medicaid patients are few and far between, or perform a limited range of services, and patients can expect long wait times for an appointment.

On the inside, Small Smiles looks like any of its counterparts in one of the surrounding, affluent D.C. suburbs. There is a spacious waiting room filled with toys and decorated with colorful, professional murals, plus a television. The examination rooms are also bright and inviting, and there are plenty of them—nine treatment rooms, plus separate consultation rooms, hygiene rooms, x-ray rooms, and doctor offices. They, too, are outfitted with high-tech, top-of-the-line equipment.

Paradoxically, it is from an outside view that Small Smiles—run by FORBA (an acronym that means For Better Access), a management company based in Pueblo, Colo.—reveals itself. The building resides in a converted nightclub that used to be called “The Black Hole.” Dollar stores and pawn shops abound up and down the stretch of Georgia Avenue where the clinic is located. A security guard, employed by the clinic, circles the block.

But this is a perfect location for Small Smiles. Its patients, after all, aren't coming from the wealthy suburbs. This is their neighborhood dentist.

Small Smiles is one of the few clinics in the area to accept Medicaid. The clinic pays the bills despite Medicaid's poor reimbursement because of its location in an area with a high concentration of Medicaid-qualified patients. Sheer volume—anywhere from 60 to 90 visits per day (150 appointments, 40% of which are cancelled or result in no-shows, for which Small Smiles charges no punitive fee)—keeps the practice financially afloat.

The place is busy, but not overwhelmed. Five front office personnel, five dentists, 12 assistants, and three hygienists keep the clinic running smoothly. The average wait for an appointment at Small Smiles is just 2 weeks, and the practice accepts walk-ins and emergency cases. Its staff—although not necessarily trained as pediatric dentists—is qualified and able to perform complicated pediatric procedures as well as routine cleanings.

Dr. Williams said in an interview that they are paid a competitive wage, and although turnover is high, advantages like regular working hours and FORBA's handling of reimbursement and human resources lure new graduates and former retirees, like himself, to the clinic.

Often, area clinics send their developmentally disabled or autistic patients to Small Smiles, which is trained and equipped to treat these special needs children.

Todd Cruse, vice president of development and government affairs for FORBA, said in an interview that last year there were 697,000 patient visits at Small Smiles clinics around the country. (For a list of locations, visit www.smallsmilesusa.com

In areas without a clinic like Small Smiles, “It is difficult for many low-income families to find or afford a dentist,” said Dr. David Krol, chair of the department of pediatrics at the University of Toledo who listed multiple problems that can arise following lax dental care. “Imagine trying to concentrate in school with a toothache, or trying to eat when it hurts to chew. If a child isn't eating, think of how hard it is to get the calories needed to grow.”

“In older children, especially older adolescents, I sometimes see periodontal [gum] disease. We are learning that gum disease may have effects on diabetes, heart disease, and preterm birth,” he said.

The cheery interior of the Small Smiles Dental Clinic in Washington features state-of-the-art equipment. Denise Napoli/Elsevier Global Medical News

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Postpolypectomy Surveillance Intervals May Be Narrowed

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WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD). Patients under 40 years of age and those with a history of colon cancer were excluded.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were excluded.

Most of the patients in all three groups were male and white, and had a mean age of 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for [physicians] to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

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WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD). Patients under 40 years of age and those with a history of colon cancer were excluded.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were excluded.

Most of the patients in all three groups were male and white, and had a mean age of 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for [physicians] to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD). Patients under 40 years of age and those with a history of colon cancer were excluded.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were excluded.

Most of the patients in all three groups were male and white, and had a mean age of 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for [physicians] to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

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Surveillance Intervals After Polypectomy Should Be Narrowed

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WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD).

Patients under 40 years of age and those with a history of colon cancer were excluded from the study.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were therefore excluded.

Most of the patients in all three groups were male and white, and the mean age was 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for clinicians to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

“Our data demonstrate [that] this group likely has a high rate of synchronous advanced polyps, and an early 'second look' procedure may be necessary to achieve optimal prevention of colorectal cancer.”

Dr. Rudraraju conceded that the study had limitations, such as the fact that the researchers did not know their patients' family histories of colorectal cancer, and that pathology specimens were unavailable for review, since it was a retrospective study.

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WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD).

Patients under 40 years of age and those with a history of colon cancer were excluded from the study.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were therefore excluded.

Most of the patients in all three groups were male and white, and the mean age was 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for clinicians to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

“Our data demonstrate [that] this group likely has a high rate of synchronous advanced polyps, and an early 'second look' procedure may be necessary to achieve optimal prevention of colorectal cancer.”

Dr. Rudraraju conceded that the study had limitations, such as the fact that the researchers did not know their patients' family histories of colorectal cancer, and that pathology specimens were unavailable for review, since it was a retrospective study.

WASHINGTON — Postpolypectomy surveillance should follow surgery far sooner than current guidelines recommend, according to a study presented at the annual Digestive Disease Week.

In a retrospective cohort study, Dr. Madhavi Rudraraju of the University of Oklahoma, Oklahoma City, and her colleagues including Dr. William Tierney found that the recurrence rate for advanced adenomas following polypectomy was 25.8%, and the time to recurrence was 6.4 months—much sooner than the 3-year follow-up surveillance period recommended by current guidelines (Gastroenterology 2006;130:1872–85).

The researchers analyzed medical records at the VA Medical Center in Oklahoma City from Jan. 1, 1990, to Dec. 31, 2002. The patients had had at least one surveillance colonoscopy following removal of a polyp with high-grade dysplasia (HGD).

Patients under 40 years of age and those with a history of colon cancer were excluded from the study.

There were two control groups: patients with tubular adenomatous polyps, who were matched for polyp size and had at least one surveillance colonoscopy; and those with normal colonoscopy findings who had undergone at least one subsequent colonoscopy. Both groups were also matched for age, gender, race, and year of index colonoscopy.

Polyps with advanced features (adenoma greater than 1 cm; villous histology; HGD; colon cancer) were counted as outcomes of interest. Polyps found in the same region of the colon within 6 months or after documented incomplete polypectomy were counted as residual, rather than incident, lesions, and were therefore excluded.

Most of the patients in all three groups were male and white, and the mean age was 66 years. A total of 89 patients met the study criteria for having HGD.

In the HGD group, the mean polyp size was 1 cm, the mean number of polyps was 4.1, all had complete resection, and 73% were sessile. Polyp characteristics for the tubular adenoma group were similar—mean size was also 1 cm, mean number was 4.4, 79.8% were sessile, and, as in the HGD group, 100% were completely resected.

“At the Oklahoma VA Medical Center, surveillance is performed at the least at 3 and 12 months, but most patients had it at 3 months, 6 months, 9 months, and 12 months,” said Dr. Rudraraju. This practice of aggressive surveillance has continued at this facility despite the recent guidelines.

The study found that in the HGD group, 25.8% (23 of 89 patients) went on to develop advanced polyp recurrence, and among those 23 patients, the median time to recurrence was 6.4 months. In contrast, 16.8% (15 of 89) of the tubular adenoma group developed recurring advanced polyps at a median time of 36.6 months after initial polypectomy. In the group with no polyps on initial colonoscopy, 5.6% (5 of 89) developed advanced polyps at a median of 34.8 months later.

The range of advanced polyp development in the HGD group was 2.6–101 months. Overall, 5.6% (5 of 89) developed colon cancer at a median of 6 months after initial polypectomy.

“Until we have further prospective evidence about this group of patients with high-grade dysplasia, it would be very reasonable for clinicians to consider intense early surveillance, given [that] this represents the largest study to date looking at this particular group of patients,” said Dr. Rudraraju in an interview.

“Our data demonstrate [that] this group likely has a high rate of synchronous advanced polyps, and an early 'second look' procedure may be necessary to achieve optimal prevention of colorectal cancer.”

Dr. Rudraraju conceded that the study had limitations, such as the fact that the researchers did not know their patients' family histories of colorectal cancer, and that pathology specimens were unavailable for review, since it was a retrospective study.

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Most Well-Child Visits Skip Obesity Prevention

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WASHINGTON — Even as pediatric obesity is on the rise, fewer than a third of nonobese children in the United States are likely to be receiving obesity prevention counseling at well-child visits, based on a representative sample presented in a poster by Dr. Chris Branner at the annual Digestive Disease Week.

Ethnicity plays a role in whether children get the information they need about preventing overweight and obesity: Just 15% of Hispanic pediatric patients received counseling, versus 25% of whites and 27% of blacks. Region and pay type also affected whether patients received counseling.

Dr. Branner, of Vanderbilt University Medical Center, Nashville, Tenn., and colleagues, analyzed results from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) during the period 2001–2004 for patients aged 4–18 years. Obesity prevention counseling was defined as the combined delivery of diet and nutrition and exercise counseling.

Of more than 55.6 million well-child visits of patients aged 4–18 years tallied in the two surveys, just over 13.5 million visits (24%) included obesity prevention counseling (OPC). Overall, 91% were recorded as part of the NAMCS, and while 26% involved counseling, just 12% of those visits in a hospital setting and recorded in the NHAMCS involved preventive counseling.

Region of the United States affected whether children received OPC, with 30% of visits in the Northeast including counseling versus 13% in the West, 20% in the East, and 30% in the South.

Twenty-seven percent of visits covered by private insurers involved OPC, compared with 19% of Medicaid-insured visits, and just 15% of self-pay visits; 6% were listed as “other” in terms of type of payer, 14% of which had OPC.

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WASHINGTON — Even as pediatric obesity is on the rise, fewer than a third of nonobese children in the United States are likely to be receiving obesity prevention counseling at well-child visits, based on a representative sample presented in a poster by Dr. Chris Branner at the annual Digestive Disease Week.

Ethnicity plays a role in whether children get the information they need about preventing overweight and obesity: Just 15% of Hispanic pediatric patients received counseling, versus 25% of whites and 27% of blacks. Region and pay type also affected whether patients received counseling.

Dr. Branner, of Vanderbilt University Medical Center, Nashville, Tenn., and colleagues, analyzed results from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) during the period 2001–2004 for patients aged 4–18 years. Obesity prevention counseling was defined as the combined delivery of diet and nutrition and exercise counseling.

Of more than 55.6 million well-child visits of patients aged 4–18 years tallied in the two surveys, just over 13.5 million visits (24%) included obesity prevention counseling (OPC). Overall, 91% were recorded as part of the NAMCS, and while 26% involved counseling, just 12% of those visits in a hospital setting and recorded in the NHAMCS involved preventive counseling.

Region of the United States affected whether children received OPC, with 30% of visits in the Northeast including counseling versus 13% in the West, 20% in the East, and 30% in the South.

Twenty-seven percent of visits covered by private insurers involved OPC, compared with 19% of Medicaid-insured visits, and just 15% of self-pay visits; 6% were listed as “other” in terms of type of payer, 14% of which had OPC.

WASHINGTON — Even as pediatric obesity is on the rise, fewer than a third of nonobese children in the United States are likely to be receiving obesity prevention counseling at well-child visits, based on a representative sample presented in a poster by Dr. Chris Branner at the annual Digestive Disease Week.

Ethnicity plays a role in whether children get the information they need about preventing overweight and obesity: Just 15% of Hispanic pediatric patients received counseling, versus 25% of whites and 27% of blacks. Region and pay type also affected whether patients received counseling.

Dr. Branner, of Vanderbilt University Medical Center, Nashville, Tenn., and colleagues, analyzed results from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) during the period 2001–2004 for patients aged 4–18 years. Obesity prevention counseling was defined as the combined delivery of diet and nutrition and exercise counseling.

Of more than 55.6 million well-child visits of patients aged 4–18 years tallied in the two surveys, just over 13.5 million visits (24%) included obesity prevention counseling (OPC). Overall, 91% were recorded as part of the NAMCS, and while 26% involved counseling, just 12% of those visits in a hospital setting and recorded in the NHAMCS involved preventive counseling.

Region of the United States affected whether children received OPC, with 30% of visits in the Northeast including counseling versus 13% in the West, 20% in the East, and 30% in the South.

Twenty-seven percent of visits covered by private insurers involved OPC, compared with 19% of Medicaid-insured visits, and just 15% of self-pay visits; 6% were listed as “other” in terms of type of payer, 14% of which had OPC.

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Regional Networks to Form the Basis of New Quality Push

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WASHINGTON — The Bush administration aims to move forward on its goal of health care price and quality transparency through its new Value-Driven Health Care Initiative.

The initiative, which will certify and support regional collaboratives of health care payers, providers, and purchasers, was announced by Health and Human Services Secretary Mike Leavitt at a press briefing sponsored by the journal Health Affairs.

Participants in the program's collaborative groups, called Value Exchanges, will be able to share practices for increasing quality with fellow members through a federally funded learning network, for which $4 million has been earmarked in the proposed 2008 federal budget. Providers who can demonstrate improved transparency and quality are also likely to reap rewards from payers.

Mr. Leavitt gave as an example one private insurer affiliated with a pilot Value Exchange in California that paid out as much as $50 million to physicians who had met certain standards of quality care. “[Insurers] rewarded the quality practice. But if you don't have a standard way of measuring [quality], then those [bonuses] are not able to be developed or executed,” he said.

Dr. John Tooker, executive vice president and chief executive officer of the American College of Physicians (ACP), said that it is too soon to determine the success of the pilot programs.

“I think the [level of physician] engagement in the program will determine how much value is to be derived from the program,” he said.

However, “You've got to start somewhere. The ACP and many other medical societies have been supportive of moving the evidence-based performance measures into meaningful field testing. … These Value Exchanges provide an opportunity to test these measures.”

Quality standards by which care will be measured are being formulated by physician groups.

Leadership from groups such as the ACP, the Society for Thoracic Surgery, and the American Academy of Family Physicians, as well as the American Medical Association's Physician Consortium for Performance Improvement, will provide the basis, said Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality. “This is what the profession believes is the best science,” said Dr. Clancy at the meeting. Though the program will use national measures of quality, it will be governed locally.

Local control is important for two reasons, Mr. Leavitt said. The first deals with the initial collection of medical records with which the program would develop comparisons between providers. “Until we have a robust system of electronic health records, the [process of acquiring] this information is essentially going in and looking at medical records—most of the time, paper records—to determine what quality is and when it occurs. That, by its very nature, is local.”

The second reason why local facilitation is important has to do with trust, he said. “This is a very significant change and it requires people to work together collaboratively in order to be comfortable. [Doctors] will be much less likely to work with Washington, where they can't affect the process, [rather than local networks].”

To become a Value Exchange, a collaborative group must submit an application to the Department of Health and Human Services detailing its adherence to four “cornerstones” of the program. In addition to the adoption of an electronic medical records system, these cornerstones include public reporting of performance; public reporting of price; and the support of incentives rewarding quality and value.

Mr. Leavitt sketched a rough timeline for widespread adoption of the program.

“Five years from now, the word 'value' will be a regular part of the medical lexicon,” he said. “Ten years from now, this network will have matured into a national network.”

Electronic medical records have to be the backbone of this system, he said.

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WASHINGTON — The Bush administration aims to move forward on its goal of health care price and quality transparency through its new Value-Driven Health Care Initiative.

The initiative, which will certify and support regional collaboratives of health care payers, providers, and purchasers, was announced by Health and Human Services Secretary Mike Leavitt at a press briefing sponsored by the journal Health Affairs.

Participants in the program's collaborative groups, called Value Exchanges, will be able to share practices for increasing quality with fellow members through a federally funded learning network, for which $4 million has been earmarked in the proposed 2008 federal budget. Providers who can demonstrate improved transparency and quality are also likely to reap rewards from payers.

Mr. Leavitt gave as an example one private insurer affiliated with a pilot Value Exchange in California that paid out as much as $50 million to physicians who had met certain standards of quality care. “[Insurers] rewarded the quality practice. But if you don't have a standard way of measuring [quality], then those [bonuses] are not able to be developed or executed,” he said.

Dr. John Tooker, executive vice president and chief executive officer of the American College of Physicians (ACP), said that it is too soon to determine the success of the pilot programs.

“I think the [level of physician] engagement in the program will determine how much value is to be derived from the program,” he said.

However, “You've got to start somewhere. The ACP and many other medical societies have been supportive of moving the evidence-based performance measures into meaningful field testing. … These Value Exchanges provide an opportunity to test these measures.”

Quality standards by which care will be measured are being formulated by physician groups.

Leadership from groups such as the ACP, the Society for Thoracic Surgery, and the American Academy of Family Physicians, as well as the American Medical Association's Physician Consortium for Performance Improvement, will provide the basis, said Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality. “This is what the profession believes is the best science,” said Dr. Clancy at the meeting. Though the program will use national measures of quality, it will be governed locally.

Local control is important for two reasons, Mr. Leavitt said. The first deals with the initial collection of medical records with which the program would develop comparisons between providers. “Until we have a robust system of electronic health records, the [process of acquiring] this information is essentially going in and looking at medical records—most of the time, paper records—to determine what quality is and when it occurs. That, by its very nature, is local.”

The second reason why local facilitation is important has to do with trust, he said. “This is a very significant change and it requires people to work together collaboratively in order to be comfortable. [Doctors] will be much less likely to work with Washington, where they can't affect the process, [rather than local networks].”

To become a Value Exchange, a collaborative group must submit an application to the Department of Health and Human Services detailing its adherence to four “cornerstones” of the program. In addition to the adoption of an electronic medical records system, these cornerstones include public reporting of performance; public reporting of price; and the support of incentives rewarding quality and value.

Mr. Leavitt sketched a rough timeline for widespread adoption of the program.

“Five years from now, the word 'value' will be a regular part of the medical lexicon,” he said. “Ten years from now, this network will have matured into a national network.”

Electronic medical records have to be the backbone of this system, he said.

WASHINGTON — The Bush administration aims to move forward on its goal of health care price and quality transparency through its new Value-Driven Health Care Initiative.

The initiative, which will certify and support regional collaboratives of health care payers, providers, and purchasers, was announced by Health and Human Services Secretary Mike Leavitt at a press briefing sponsored by the journal Health Affairs.

Participants in the program's collaborative groups, called Value Exchanges, will be able to share practices for increasing quality with fellow members through a federally funded learning network, for which $4 million has been earmarked in the proposed 2008 federal budget. Providers who can demonstrate improved transparency and quality are also likely to reap rewards from payers.

Mr. Leavitt gave as an example one private insurer affiliated with a pilot Value Exchange in California that paid out as much as $50 million to physicians who had met certain standards of quality care. “[Insurers] rewarded the quality practice. But if you don't have a standard way of measuring [quality], then those [bonuses] are not able to be developed or executed,” he said.

Dr. John Tooker, executive vice president and chief executive officer of the American College of Physicians (ACP), said that it is too soon to determine the success of the pilot programs.

“I think the [level of physician] engagement in the program will determine how much value is to be derived from the program,” he said.

However, “You've got to start somewhere. The ACP and many other medical societies have been supportive of moving the evidence-based performance measures into meaningful field testing. … These Value Exchanges provide an opportunity to test these measures.”

Quality standards by which care will be measured are being formulated by physician groups.

Leadership from groups such as the ACP, the Society for Thoracic Surgery, and the American Academy of Family Physicians, as well as the American Medical Association's Physician Consortium for Performance Improvement, will provide the basis, said Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality. “This is what the profession believes is the best science,” said Dr. Clancy at the meeting. Though the program will use national measures of quality, it will be governed locally.

Local control is important for two reasons, Mr. Leavitt said. The first deals with the initial collection of medical records with which the program would develop comparisons between providers. “Until we have a robust system of electronic health records, the [process of acquiring] this information is essentially going in and looking at medical records—most of the time, paper records—to determine what quality is and when it occurs. That, by its very nature, is local.”

The second reason why local facilitation is important has to do with trust, he said. “This is a very significant change and it requires people to work together collaboratively in order to be comfortable. [Doctors] will be much less likely to work with Washington, where they can't affect the process, [rather than local networks].”

To become a Value Exchange, a collaborative group must submit an application to the Department of Health and Human Services detailing its adherence to four “cornerstones” of the program. In addition to the adoption of an electronic medical records system, these cornerstones include public reporting of performance; public reporting of price; and the support of incentives rewarding quality and value.

Mr. Leavitt sketched a rough timeline for widespread adoption of the program.

“Five years from now, the word 'value' will be a regular part of the medical lexicon,” he said. “Ten years from now, this network will have matured into a national network.”

Electronic medical records have to be the backbone of this system, he said.

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Regional Networks to Form the Basis of New Quality Push
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