Denise Napoli

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in patients who take anti–tumor necrosis factor therapies, and should prompt physicians to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for rheumatoid arthritis (RA) and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

According to Dr. Ranganathan, among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported.

Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks anti-TNFs are still a good choice for patients who've failed other treatments. “People with risk factors should be watched more closely and maybe have periodic skin exams,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial conflicts relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in patients who take anti–tumor necrosis factor therapies, and should prompt physicians to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for rheumatoid arthritis (RA) and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

According to Dr. Ranganathan, among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported.

Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks anti-TNFs are still a good choice for patients who've failed other treatments. “People with risk factors should be watched more closely and maybe have periodic skin exams,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial conflicts relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in patients who take anti–tumor necrosis factor therapies, and should prompt physicians to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for rheumatoid arthritis (RA) and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

According to Dr. Ranganathan, among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported.

Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks anti-TNFs are still a good choice for patients who've failed other treatments. “People with risk factors should be watched more closely and maybe have periodic skin exams,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial conflicts relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt rheumatologists to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan, who presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998 and Sept. 30, 2006, she said. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk. The melanoma incidence was increased as well, with 3.7 cases per 1,000 patient-years seen in the anti-TNF–treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. The differences were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported, pointing out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks—including being male and older, and having a history of skin cancer—anti-TNFs are still a good choice for patients who've failed other treatments.

While patients at risk may need periodic skin exams, “I don't think [having risk factors] would be an absolute contraindication,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial disclosures relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt rheumatologists to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan, who presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998 and Sept. 30, 2006, she said. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk. The melanoma incidence was increased as well, with 3.7 cases per 1,000 patient-years seen in the anti-TNF–treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. The differences were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported, pointing out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks—including being male and older, and having a history of skin cancer—anti-TNFs are still a good choice for patients who've failed other treatments.

While patients at risk may need periodic skin exams, “I don't think [having risk factors] would be an absolute contraindication,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial disclosures relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt rheumatologists to evaluate the use of these drugs in patients who are at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, according to Dr. Prahba Ranganathan, who presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNFs at the VA between Oct. 1, 1998 and Sept. 30, 2006, she said. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk. The melanoma incidence was increased as well, with 3.7 cases per 1,000 patient-years seen in the anti-TNF–treated group, vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. The differences were significant.

A second study presented at the press conference confirmed these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNFs.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNFs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4.

That was a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported, pointing out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even in patients with multiple skin cancer risks—including being male and older, and having a history of skin cancer—anti-TNFs are still a good choice for patients who've failed other treatments.

While patients at risk may need periodic skin exams, “I don't think [having risk factors] would be an absolute contraindication,” she said.

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not report having any financial disclosures relative to their studies.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt evaluation of the use of these drugs in patients at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, Dr. Prahba Ranganathan said.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNF drugs at VA medical centers between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference mirrored these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNF agents.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNF drugs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4, for a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported. Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even for patients who have multiple skin cancer risks, anti-TNF agents are still a good choice for patients who have failed other treatments.

“People with risk factors should be watched more closely and maybe have periodic skin exams,” she said, adding, “I don't think [having risk factors] would be an absolute contraindication.”

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not have any financial disclosures.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt evaluation of the use of these drugs in patients at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, Dr. Prahba Ranganathan said.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNF drugs at VA medical centers between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference mirrored these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNF agents.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNF drugs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4, for a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported. Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even for patients who have multiple skin cancer risks, anti-TNF agents are still a good choice for patients who have failed other treatments.

“People with risk factors should be watched more closely and maybe have periodic skin exams,” she said, adding, “I don't think [having risk factors] would be an absolute contraindication.”

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not have any financial disclosures.

PHILADELPHIA — Two studies showed an increased risk for nonmelanoma skin cancer in rheumatoid arthritis patients who take anti–tumor necrosis factor therapies, and should prompt evaluation of the use of these drugs in patients at risk for skin cancer, according to the researchers.

Previous studies have been too small to show a definitive link between biologic therapy for RA and skin malignancy, although RA previously has been well established as a risk factor for skin cancer, Dr. Prahba Ranganathan said.

She presented the results of her retrospective cohort study of RA patients in the Department of Veterans Affairs national database at the annual meeting of the American College of Rheumatology.

Among 16,829 patients with RA, 3,096 were treated with anti-TNF drugs at VA medical centers between Oct. 1, 1998, and Sept. 30, 2006. The incidence of nonmelanoma skin cancer was 25.9 per 1,000 patient-years in this cohort, compared with 19.6 per 1,000 patient-years in the biologic-naive cohort, a 34% increased risk.

The incidence of melanoma also was increased by about 50%, with about 3.7 cases per 1,000 patient-years seen in the anti-TNF-treated group vs. 2.6 cases per 1,000 patient-years in the biologic-naive cohort. Both results were significant.

A second study presented at the press conference mirrored these findings. Dr. Kimme Hyrich of the University of Manchester (England) looked at RA patients from the British Society for Rheumatology's biologics register, a prospective cohort study begun in 2001 to monitor the long-term safety of anti-TNF agents.

Dr. Hyrich found that among 11,598 RA patients who were treated with anti-TNF drugs and had no prior nonmelanoma skin cancer, the incidence of a malignancy was 3.5 per 1,000 patient-years. In contrast, among 8,975 similar patients who were treated with nonbiologic therapies, the incidence of new nonmelanoma skin cancers was 2.4, for a 70% increased risk for the anti-TNF–treated patients, although the data were not significant, Dr. Hyrich reported. Dr. Hyrich pointed out that patients treated with anti-TNF drugs typically have more contact with their physicians, which could have introduced a surveillance bias.

Dr. Ranganathan cautioned that even for patients who have multiple skin cancer risks, anti-TNF agents are still a good choice for patients who have failed other treatments.

“People with risk factors should be watched more closely and maybe have periodic skin exams,” she said, adding, “I don't think [having risk factors] would be an absolute contraindication.”

Dr. Ranganathan, Dr. Hyrich, and their respective research teams did not have any financial disclosures.

PHILADELPHIA — Septic arthritis was twice as likely to occur in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do patients who take these agents in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose.

A comparison group of 3,515 patients with active RA who were taking only DMARDs was also followed.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1-3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

The investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” Dr. Symmons said.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab.

Staphylococcus bacteria caused half of the infections in the DMARD group and 75% of infections in the anti-TNF group.

Dr. Symmons, along with one other researcher on the study, reported affiliation with the British Society for Rheumatology, on whose registry data the study was based. The researchers wrote that they had no other conflicts to disclose.

Compared with controls, patients on anti-TNF agents had a 2.0 hazard ratio for contracting septic arthritis.

Source DR. SYMMONS

PHILADELPHIA — Septic arthritis was twice as likely to occur in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do patients who take these agents in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose.

A comparison group of 3,515 patients with active RA who were taking only DMARDs was also followed.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1-3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

The investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” Dr. Symmons said.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab.

Staphylococcus bacteria caused half of the infections in the DMARD group and 75% of infections in the anti-TNF group.

Dr. Symmons, along with one other researcher on the study, reported affiliation with the British Society for Rheumatology, on whose registry data the study was based. The researchers wrote that they had no other conflicts to disclose.

Compared with controls, patients on anti-TNF agents had a 2.0 hazard ratio for contracting septic arthritis.

Source DR. SYMMONS

PHILADELPHIA — Septic arthritis was twice as likely to occur in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do patients who take these agents in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose.

A comparison group of 3,515 patients with active RA who were taking only DMARDs was also followed.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1-3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

The investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” Dr. Symmons said.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab.

Staphylococcus bacteria caused half of the infections in the DMARD group and 75% of infections in the anti-TNF group.

Dr. Symmons, along with one other researcher on the study, reported affiliation with the British Society for Rheumatology, on whose registry data the study was based. The researchers wrote that they had no other conflicts to disclose.

Compared with controls, patients on anti-TNF agents had a 2.0 hazard ratio for contracting septic arthritis.

Source DR. SYMMONS

A follow-up to a landmark diabetes study confirms that even after 10 years, intensive lifestyle modification can prevent or delay development of the disease among high-risk adults.

Furthermore, although physical activity and lifestyle change remain the surest way to prevent type 2 diabetes, when metformin was combined with some lifestyle intervention strategies, it performed as well as did intensive lifestyle interventions alone in reducing diabetes mellitus incidence.

The new study, the Diabetes Prevention Program Outcomes Study (DPPOS) is a follow-up to the 2002 Diabetes Prevention Program (DPP) trial. That study randomized adults at high risk for diabetes to an intensive lifestyle intervention, to 850 mg of metformin twice daily, or to placebo. High risk was indicated by raised fasting plasma glucose levels, impaired glucose tolerance, or a high body mass index (24 kg/m

After nearly 3 years, the incidence of diabetes was found to be 4.8 cases per 100 person-years in the lifestyle group and 7.8 cases in the metformin group, compared with 11.0 cases per 100 person-years among the controls.

The current study, led by Dr. William C. Knowler of the National Institute of Diabetes and Digestive and Kidney Diseases, followed up on 2,766 of these patients from the original 3,150 DPP participants for an additional 7 years, with about 900 patients coming from each of the three original cohorts.

This time, all three groups were offered lifestyle intervention, which encouraged 150 minutes of moderate-intensity activity per week and offered behavior reinforcement counseling sessions every 3 months. Patients who were in the lifestyle group in the original study also received two extra group classes “to reinvigorate their self-management behaviors for weight loss,” the authors wrote, and patients who were originally in the metformin-only group continued on their dose of 850 mg twice daily in addition to the lifestyle intervention.

The primary outcome—just as in the original study—was a fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or higher, measured every 6 months, or a 2-hour plasma glucose level of 11.1 mmol/L (about 200 mg/dL) or higher after a 75-g oral glucose load, measured yearly.

At the current study's end, roughly 10 years from patients' randomization into the original DPP, the combined incidence of diabetes (throughout both the original and current study periods) was 4.9 per 100 person-years for patients who received metformin plus lifestyle intervention, and 5.6 per 100 person-years among patients who had originally received only placebo but now received lifestyle intervention. The incidence of diabetes was 5.9 cases per 100 person-years among those who continued on the lifestyle-only intervention to which they had originally been assigned (Lancet 2009 Oct. 29 [doi:10.1016/S0140-6736(09)61457-4]).

“These results clearly advance our reasons to make lifestyle intervention a high priority for people who are at high risk for type 2 diabetes,” said Dr. R. Paul Robertson, the American Diabetes Association's president of medicine and science.

“It is our hope that health care professionals will translate the findings of this study to further motivate patients to make changes in their diet and physical activity to lower their risk,” he added.

A second phase of the follow-up, scheduled to be completed in 2014, will examine longer-term outcomes such as mortality.

Dr. Knowler and coauthors in the DPP research group declared that they had no conflicts of interest related to this study, which was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The ADA provided research funding support to the DPP and DPPOS.

The incidence of diabetes was 5.9 cases per 100 person-years in those who stayed on the lifestyle-only intervention.

Source Dr. Knowler

A follow-up to a landmark diabetes study confirms that even after 10 years, intensive lifestyle modification can prevent or delay development of the disease among high-risk adults.

Furthermore, although physical activity and lifestyle change remain the surest way to prevent type 2 diabetes, when metformin was combined with some lifestyle intervention strategies, it performed as well as did intensive lifestyle interventions alone in reducing diabetes mellitus incidence.

The new study, the Diabetes Prevention Program Outcomes Study (DPPOS) is a follow-up to the 2002 Diabetes Prevention Program (DPP) trial. That study randomized adults at high risk for diabetes to an intensive lifestyle intervention, to 850 mg of metformin twice daily, or to placebo. High risk was indicated by raised fasting plasma glucose levels, impaired glucose tolerance, or a high body mass index (24 kg/m

After nearly 3 years, the incidence of diabetes was found to be 4.8 cases per 100 person-years in the lifestyle group and 7.8 cases in the metformin group, compared with 11.0 cases per 100 person-years among the controls.

The current study, led by Dr. William C. Knowler of the National Institute of Diabetes and Digestive and Kidney Diseases, followed up on 2,766 of these patients from the original 3,150 DPP participants for an additional 7 years, with about 900 patients coming from each of the three original cohorts.

This time, all three groups were offered lifestyle intervention, which encouraged 150 minutes of moderate-intensity activity per week and offered behavior reinforcement counseling sessions every 3 months. Patients who were in the lifestyle group in the original study also received two extra group classes “to reinvigorate their self-management behaviors for weight loss,” the authors wrote, and patients who were originally in the metformin-only group continued on their dose of 850 mg twice daily in addition to the lifestyle intervention.

The primary outcome—just as in the original study—was a fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or higher, measured every 6 months, or a 2-hour plasma glucose level of 11.1 mmol/L (about 200 mg/dL) or higher after a 75-g oral glucose load, measured yearly.

At the current study's end, roughly 10 years from patients' randomization into the original DPP, the combined incidence of diabetes (throughout both the original and current study periods) was 4.9 per 100 person-years for patients who received metformin plus lifestyle intervention, and 5.6 per 100 person-years among patients who had originally received only placebo but now received lifestyle intervention. The incidence of diabetes was 5.9 cases per 100 person-years among those who continued on the lifestyle-only intervention to which they had originally been assigned (Lancet 2009 Oct. 29 [doi:10.1016/S0140-6736(09)61457-4]).

“These results clearly advance our reasons to make lifestyle intervention a high priority for people who are at high risk for type 2 diabetes,” said Dr. R. Paul Robertson, the American Diabetes Association's president of medicine and science.

“It is our hope that health care professionals will translate the findings of this study to further motivate patients to make changes in their diet and physical activity to lower their risk,” he added.

A second phase of the follow-up, scheduled to be completed in 2014, will examine longer-term outcomes such as mortality.

Dr. Knowler and coauthors in the DPP research group declared that they had no conflicts of interest related to this study, which was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The ADA provided research funding support to the DPP and DPPOS.

The incidence of diabetes was 5.9 cases per 100 person-years in those who stayed on the lifestyle-only intervention.

Source Dr. Knowler

A follow-up to a landmark diabetes study confirms that even after 10 years, intensive lifestyle modification can prevent or delay development of the disease among high-risk adults.

Furthermore, although physical activity and lifestyle change remain the surest way to prevent type 2 diabetes, when metformin was combined with some lifestyle intervention strategies, it performed as well as did intensive lifestyle interventions alone in reducing diabetes mellitus incidence.

The new study, the Diabetes Prevention Program Outcomes Study (DPPOS) is a follow-up to the 2002 Diabetes Prevention Program (DPP) trial. That study randomized adults at high risk for diabetes to an intensive lifestyle intervention, to 850 mg of metformin twice daily, or to placebo. High risk was indicated by raised fasting plasma glucose levels, impaired glucose tolerance, or a high body mass index (24 kg/m

After nearly 3 years, the incidence of diabetes was found to be 4.8 cases per 100 person-years in the lifestyle group and 7.8 cases in the metformin group, compared with 11.0 cases per 100 person-years among the controls.

The current study, led by Dr. William C. Knowler of the National Institute of Diabetes and Digestive and Kidney Diseases, followed up on 2,766 of these patients from the original 3,150 DPP participants for an additional 7 years, with about 900 patients coming from each of the three original cohorts.

This time, all three groups were offered lifestyle intervention, which encouraged 150 minutes of moderate-intensity activity per week and offered behavior reinforcement counseling sessions every 3 months. Patients who were in the lifestyle group in the original study also received two extra group classes “to reinvigorate their self-management behaviors for weight loss,” the authors wrote, and patients who were originally in the metformin-only group continued on their dose of 850 mg twice daily in addition to the lifestyle intervention.

The primary outcome—just as in the original study—was a fasting plasma glucose level of 7.0 mmol/L (126 mg/dL) or higher, measured every 6 months, or a 2-hour plasma glucose level of 11.1 mmol/L (about 200 mg/dL) or higher after a 75-g oral glucose load, measured yearly.

At the current study's end, roughly 10 years from patients' randomization into the original DPP, the combined incidence of diabetes (throughout both the original and current study periods) was 4.9 per 100 person-years for patients who received metformin plus lifestyle intervention, and 5.6 per 100 person-years among patients who had originally received only placebo but now received lifestyle intervention. The incidence of diabetes was 5.9 cases per 100 person-years among those who continued on the lifestyle-only intervention to which they had originally been assigned (Lancet 2009 Oct. 29 [doi:10.1016/S0140-6736(09)61457-4]).

“These results clearly advance our reasons to make lifestyle intervention a high priority for people who are at high risk for type 2 diabetes,” said Dr. R. Paul Robertson, the American Diabetes Association's president of medicine and science.

“It is our hope that health care professionals will translate the findings of this study to further motivate patients to make changes in their diet and physical activity to lower their risk,” he added.

A second phase of the follow-up, scheduled to be completed in 2014, will examine longer-term outcomes such as mortality.

Dr. Knowler and coauthors in the DPP research group declared that they had no conflicts of interest related to this study, which was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The ADA provided research funding support to the DPP and DPPOS.

The incidence of diabetes was 5.9 cases per 100 person-years in those who stayed on the lifestyle-only intervention.

Source Dr. Knowler

PHILADELPHIA — Septic arthritis was twice as common in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do those in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose. The control group was 3,515 patients with active RA who were taking only DMARDs.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1–3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

Additionally, the investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” said Dr. Symmons.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab. Staphylococcus bacteria made up 50% of infection in the DMARD group, and fully 75% of infections in the anti-TNF group.

Dr. Symmons reported affiliation with the British Society for Rheumatology. The researchers wrote that they had no other conflicts to disclose.

Use of an anti-TNF agent did not increase the risk of septic arthritis more than did having a prosthetic knee.

Source DR. SYMMONS

PHILADELPHIA — Septic arthritis was twice as common in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do those in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose. The control group was 3,515 patients with active RA who were taking only DMARDs.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1–3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

Additionally, the investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” said Dr. Symmons.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab. Staphylococcus bacteria made up 50% of infection in the DMARD group, and fully 75% of infections in the anti-TNF group.

Dr. Symmons reported affiliation with the British Society for Rheumatology. The researchers wrote that they had no other conflicts to disclose.

Use of an anti-TNF agent did not increase the risk of septic arthritis more than did having a prosthetic knee.

Source DR. SYMMONS

PHILADELPHIA — Septic arthritis was twice as common in patients taking anti–tumor necrosis factor drugs for rheumatoid arthritis as in patients with the disease who did not take anti-TNFs.

However, the results may not be fully translatable to a U.S. population of RA patients, according to Dr. Deborah P. Symmons, who presented the findings during a press briefing at the annual meeting of the American College of Rheumatology.

In the United Kingdom, she explained, patients must have failed two disease-modifying antirheumatic drugs and have a high disease activity score in order to be eligible for treatment with TNF blockers. “Those people may have more serious disease” than do those in the United States, said Dr. Symmons, professor of rheumatology and musculoskeletal epidemiology at the University of Manchester (England).

Dr. Symmons and her associates studied the records of 11,757 RA patients from the British Society for Rheumatology Biologics Register who received anti-TNF drugs from October 2001 through May 2008. Patients were followed for 6 months or until death. Septic arthritis was counted in all patients who received that diagnosis either while taking anti-TNFs or within 90 days of their last dose. The control group was 3,515 patients with active RA who were taking only DMARDs.

According to Dr. Symmons, 179 cases of septic arthritis that met study criteria occurred during the study period, for an incident rate of 1 per 200 patients (5 cases per 1,000 patient-years). In contrast, among the DMARD-only control group, there were 17 cases of septic arthritis, for an incidence of 1.9 cases per 1,000 patient-years.

That amounted to a hazard ratio for contracting septic arthritis of 2.0 for the anti-TNF patients, compared with controls (95% confidence interval, 1.1–3.5) after adjustment for age, sex, disease severity, prior joint replacement, comorbidity, and steroid use.

Additionally, the investigators reported that 51% of septic arthritis cases occurred in patients' “native” joints (that is, not prosthetic joints), which are generally considered to have a higher risk of septic arthritis. However, “in both groups, having a replaced joint increased the patient's risk for an infection, but that risk was not further increased by use of an anti-TNF drug,” said Dr. Symmons.

The risk was highest with the use of etanercept, compared with infliximab and adalimumab. Staphylococcus bacteria made up 50% of infection in the DMARD group, and fully 75% of infections in the anti-TNF group.

Dr. Symmons reported affiliation with the British Society for Rheumatology. The researchers wrote that they had no other conflicts to disclose.

Use of an anti-TNF agent did not increase the risk of septic arthritis more than did having a prosthetic knee.

Source DR. SYMMONS

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroup,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported.

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

Currently, the Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs which were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote. Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker. And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors. While the CDR and PBAC denied coverage, NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision-making. Given that the number of expensive, targeted pharmaceuticals for cancer and other chronic conditions is increasing, pharmaceutical reimbursement will continue to be a key challenge to formularies in all countries.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health. No individual financial disclosures were reported.

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroup,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported.

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

Currently, the Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs which were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote. Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker. And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors. While the CDR and PBAC denied coverage, NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision-making. Given that the number of expensive, targeted pharmaceuticals for cancer and other chronic conditions is increasing, pharmaceutical reimbursement will continue to be a key challenge to formularies in all countries.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health. No individual financial disclosures were reported.

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroup,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported.

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

Currently, the Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs which were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote. Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker. And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors. While the CDR and PBAC denied coverage, NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision-making. Given that the number of expensive, targeted pharmaceuticals for cancer and other chronic conditions is increasing, pharmaceutical reimbursement will continue to be a key challenge to formularies in all countries.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health. No individual financial disclosures were reported.

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost-effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroups,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported (JAMA 2009;302:1437-43).

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

The Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs that were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote.

Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker.

And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors.

The CDR and PBAC denied coverage, but NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost-effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision making.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health.

No individual financial disclosures were reported.

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost-effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroups,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported (JAMA 2009;302:1437-43).

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

The Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs that were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote.

Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker.

And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors.

The CDR and PBAC denied coverage, but NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost-effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision making.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health.

No individual financial disclosures were reported.

As debate continues over whether to enact a public health plan in the United States, researchers from Canada and Australia assert that “the use of cost-effectiveness in coverage decisions need not be an undue barrier to drug funding” by a national plan.

That goes “even for expensive medications, when there is robust evidence of effectiveness, at least in some patient subgroups,” Fiona M. Clement, Ph.D., of the University of Calgary (Alta.) and her colleagues reported (JAMA 2009;302:1437-43).

Comparative effectiveness and cost-effectiveness research need not result in only either-or decisions, according to Dr. Clement and her colleagues. “Medications can be reimbursed in specific subgroups where they are felt to be cost effective or can be listed with a higher co-payment if choice and access to therapy are valued highly.”

The Food and Drug Administration does not take cost-effectiveness into consideration when approving medications, nor does Medicare when making coverage decisions.

The investigators looked at a total of 602 decisions by governmental agencies tasked with determining whether new drugs should be listed in public formularies in their respective countries: the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the Common Drug Review (CDR) in Canada.

The investigators made case studies of three high-cost drugs that were considered by all three agencies: ranibizumab (marketed as Lucentis in the United States); insulin glargine (Lantus), and teriparatide (Forteo).

Ranibizumab, which clinical studies showed to be highly effective for wet age-related macular degeneration, was approved by all three agencies, despite a high cost per monthly injection.

In the case of insulin glargine, which is three times more expensive than the already approved intermediate-acting insulin NPH, “although each of the committees agreed that insulin glargine offered small incremental benefits over insulin NPH, all felt that unrestricted use at the price submitted was not cost-effective,” the authors wrote.

Nevertheless, out of the three agencies studied, only Canada's CDR denied coverage of the drug. Australia's PBAC negotiated an unrestricted benefit for Lantus in that country at a “confidential,” cheaper price after five resubmissions by the maker.

And in the United Kingdom, the drug was still recommended for all type 1 diabetes patients, as well as for a subset of type 2 patients without restriction.

When it came to teriparatide, “each of the committees agreed that [the drug] had been shown to reduce the incidence of vertebral and nonvertebral fractures in comparison with placebo, but felt that bisphosphonates would have been a more appropriate comparator within randomized trials,” wrote the authors.

The CDR and PBAC denied coverage, but NICE “felt that the use of this agent might be cost-effective in a small subgroup of patients with severe osteoporosis for whom bisphosphonates had failed, and listed it for this small subset of patients.”

The investigators concluded that “perhaps the main lesson from the experience of the three countries is that systematic, durable, and widely accepted decisions can be made using comparative effectiveness and cost-effectiveness, although it is evident that other information beyond these two criteria can be incorporated into decision making.”

The study was funded by a grant from the Canadian Agency for Drugs and Technologies in Health.

No individual financial disclosures were reported.

WASHINGTON — Physicians and other providers in certain states are beginning to receive demand letters from Medicare Recovery Audit Contractors, Dr. Thomas Valuck said at a meeting of the Practicing Physicians Advisory Council.

Officials from the Centers for Medicare and Medicaid Services will begin to roll out the program to the rest of the country later this summer, with demand letters reaching providers in August or early September, according to Dr. Valuck, medical officer and senior adviser at the Center for Medicare Management.

The Recovery Audit Contractor (RAC) program is designed to identify and correct past improper Medicare payments, including underpayments. It began as a demonstration project in three states in 2005, and was made permanent and nationwide in 2006 by the Tax Relief and Healthcare Act. It is administered by private contractors who collect a fee based on the errors they detect.

The RACs—which have access to Medicare fee-for-service claims data—use software to analyze claims for inaccuracies regarding coding, billing, and payment. Beginning in September, the RACs will also conduct computer-facilitated “complex reviews” on diagnosis-related group (DRG) coding errors, according to Cmdr. Marie Casey, USPHS, CMS deputy director of recovery audit operations. And by 2010, the RACs will also review the medical necessity of certain claims, relying on the expert medical opinion of physicians and other medical professionals who work for the RACs.

Cmdr. Casey added that the RACs can audit any Medicare fee-for-service claims up to 3 years from the payment date, but for now will review only claims made on or after Oct. 1, 2007.

Cmdr. Casey and her colleague, Lt. Terrance Lew, USPHS, a health insurance specialist at the division of recovery audit operations at the CMS, offered advice for preparing for an RAC review:

▸ Know where previous improper payments have been found so that you can avoid making the same mistakes. This information is available at www.cms.hhs.gov/RAC/Downloads/RAC%20Evaluation%20Report.pdf

▸ “Keep a clean shop,” Lt. Lew advised. “Make sure that you're in compliance with all the applicable Medicare policies, coverage determinations, coding directives, requirements for documentation.”

▸ Develop processes for tracking and responding to RAC requests and demand letters. “There are timelines attached to demand letters,” Lt. Lew said. “You're going to want to have a system for tracking those timelines, and knowing if you have X days to come up with a record for such-and-such a claim, or Y days to file an appeal, if that's your decision.”

▸ Appeal when necessary. “If you make a business decision that an appeal is warranted, we would certainly encourage you to appeal,” Lt. Lew said.

▸ Identify key RAC contacts. Each region has its own RAC. (See box.)

Outreach designed to educate providers about the RAC program and what to expect is still being conducted in Regions B and D, and the CMS soon will begin outreach in Region A. The updated provider outreach schedule can be found at www.cms.hhs.gov/rac

Provider outreach must occur in each state before an RAC is authorized to send any correspondence to a provider, such as a demand letter for recoupment or a request for additional documentation.

The RACs will begin with basic “black and white” reviews, Cmdr. Casey said, adding that these reviews will be performed on an automated basis (no medical records are required). Starting in September, the RACs may begin reviewing coding issues and diagnosis-related group validations, which will require the review of additional documentation.

Once the RAC has been established in the region, the RAC may begin to review claims for medical necessity. The RACs may be contacted at:

▸ Region A: Diversified Collection Services (DCS), 866–201-0580; www.dcsrac.com

▸ Region B: CGI, 877-316-7222; http://racb.cgi.com[email protected]

▸ Region C: Connolly Consulting Inc., 866-360-2507; www.connollyhealthcare.com/RAC[email protected]

▸ Region D: HealthDataInsights Inc., 866-590-5598 (Part A); 866-376-2319 (Part B); [email protected]

Source ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — Physicians and other providers in certain states are beginning to receive demand letters from Medicare Recovery Audit Contractors, Dr. Thomas Valuck said at a meeting of the Practicing Physicians Advisory Council.

Officials from the Centers for Medicare and Medicaid Services will begin to roll out the program to the rest of the country later this summer, with demand letters reaching providers in August or early September, according to Dr. Valuck, medical officer and senior adviser at the Center for Medicare Management.

The Recovery Audit Contractor (RAC) program is designed to identify and correct past improper Medicare payments, including underpayments. It began as a demonstration project in three states in 2005, and was made permanent and nationwide in 2006 by the Tax Relief and Healthcare Act. It is administered by private contractors who collect a fee based on the errors they detect.

The RACs—which have access to Medicare fee-for-service claims data—use software to analyze claims for inaccuracies regarding coding, billing, and payment. Beginning in September, the RACs will also conduct computer-facilitated “complex reviews” on diagnosis-related group (DRG) coding errors, according to Cmdr. Marie Casey, USPHS, CMS deputy director of recovery audit operations. And by 2010, the RACs will also review the medical necessity of certain claims, relying on the expert medical opinion of physicians and other medical professionals who work for the RACs.

Cmdr. Casey added that the RACs can audit any Medicare fee-for-service claims up to 3 years from the payment date, but for now will review only claims made on or after Oct. 1, 2007.

Cmdr. Casey and her colleague, Lt. Terrance Lew, USPHS, a health insurance specialist at the division of recovery audit operations at the CMS, offered advice for preparing for an RAC review:

▸ Know where previous improper payments have been found so that you can avoid making the same mistakes. This information is available at www.cms.hhs.gov/RAC/Downloads/RAC%20Evaluation%20Report.pdf

▸ “Keep a clean shop,” Lt. Lew advised. “Make sure that you're in compliance with all the applicable Medicare policies, coverage determinations, coding directives, requirements for documentation.”

▸ Develop processes for tracking and responding to RAC requests and demand letters. “There are timelines attached to demand letters,” Lt. Lew said. “You're going to want to have a system for tracking those timelines, and knowing if you have X days to come up with a record for such-and-such a claim, or Y days to file an appeal, if that's your decision.”

▸ Appeal when necessary. “If you make a business decision that an appeal is warranted, we would certainly encourage you to appeal,” Lt. Lew said.

▸ Identify key RAC contacts. Each region has its own RAC. (See box.)

Outreach designed to educate providers about the RAC program and what to expect is still being conducted in Regions B and D, and the CMS soon will begin outreach in Region A. The updated provider outreach schedule can be found at www.cms.hhs.gov/rac

Provider outreach must occur in each state before an RAC is authorized to send any correspondence to a provider, such as a demand letter for recoupment or a request for additional documentation.

The RACs will begin with basic “black and white” reviews, Cmdr. Casey said, adding that these reviews will be performed on an automated basis (no medical records are required). Starting in September, the RACs may begin reviewing coding issues and diagnosis-related group validations, which will require the review of additional documentation.

Once the RAC has been established in the region, the RAC may begin to review claims for medical necessity. The RACs may be contacted at:

▸ Region A: Diversified Collection Services (DCS), 866–201-0580; www.dcsrac.com

▸ Region B: CGI, 877-316-7222; http://racb.cgi.com[email protected]

▸ Region C: Connolly Consulting Inc., 866-360-2507; www.connollyhealthcare.com/RAC[email protected]

▸ Region D: HealthDataInsights Inc., 866-590-5598 (Part A); 866-376-2319 (Part B); [email protected]

Source ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — Physicians and other providers in certain states are beginning to receive demand letters from Medicare Recovery Audit Contractors, Dr. Thomas Valuck said at a meeting of the Practicing Physicians Advisory Council.

Officials from the Centers for Medicare and Medicaid Services will begin to roll out the program to the rest of the country later this summer, with demand letters reaching providers in August or early September, according to Dr. Valuck, medical officer and senior adviser at the Center for Medicare Management.

The Recovery Audit Contractor (RAC) program is designed to identify and correct past improper Medicare payments, including underpayments. It began as a demonstration project in three states in 2005, and was made permanent and nationwide in 2006 by the Tax Relief and Healthcare Act. It is administered by private contractors who collect a fee based on the errors they detect.

The RACs—which have access to Medicare fee-for-service claims data—use software to analyze claims for inaccuracies regarding coding, billing, and payment. Beginning in September, the RACs will also conduct computer-facilitated “complex reviews” on diagnosis-related group (DRG) coding errors, according to Cmdr. Marie Casey, USPHS, CMS deputy director of recovery audit operations. And by 2010, the RACs will also review the medical necessity of certain claims, relying on the expert medical opinion of physicians and other medical professionals who work for the RACs.

Cmdr. Casey added that the RACs can audit any Medicare fee-for-service claims up to 3 years from the payment date, but for now will review only claims made on or after Oct. 1, 2007.

Cmdr. Casey and her colleague, Lt. Terrance Lew, USPHS, a health insurance specialist at the division of recovery audit operations at the CMS, offered advice for preparing for an RAC review:

▸ Know where previous improper payments have been found so that you can avoid making the same mistakes. This information is available at www.cms.hhs.gov/RAC/Downloads/RAC%20Evaluation%20Report.pdf

▸ “Keep a clean shop,” Lt. Lew advised. “Make sure that you're in compliance with all the applicable Medicare policies, coverage determinations, coding directives, requirements for documentation.”

▸ Develop processes for tracking and responding to RAC requests and demand letters. “There are timelines attached to demand letters,” Lt. Lew said. “You're going to want to have a system for tracking those timelines, and knowing if you have X days to come up with a record for such-and-such a claim, or Y days to file an appeal, if that's your decision.”

▸ Appeal when necessary. “If you make a business decision that an appeal is warranted, we would certainly encourage you to appeal,” Lt. Lew said.

▸ Identify key RAC contacts. Each region has its own RAC. (See box.)

Outreach designed to educate providers about the RAC program and what to expect is still being conducted in Regions B and D, and the CMS soon will begin outreach in Region A. The updated provider outreach schedule can be found at www.cms.hhs.gov/rac

Provider outreach must occur in each state before an RAC is authorized to send any correspondence to a provider, such as a demand letter for recoupment or a request for additional documentation.

The RACs will begin with basic “black and white” reviews, Cmdr. Casey said, adding that these reviews will be performed on an automated basis (no medical records are required). Starting in September, the RACs may begin reviewing coding issues and diagnosis-related group validations, which will require the review of additional documentation.

Once the RAC has been established in the region, the RAC may begin to review claims for medical necessity. The RACs may be contacted at:

▸ Region A: Diversified Collection Services (DCS), 866–201-0580; www.dcsrac.com

▸ Region B: CGI, 877-316-7222; http://racb.cgi.com[email protected]

▸ Region C: Connolly Consulting Inc., 866-360-2507; www.connollyhealthcare.com/RAC[email protected]

▸ Region D: HealthDataInsights Inc., 866-590-5598 (Part A); 866-376-2319 (Part B); [email protected]

Source ELSEVIER GLOBAL MEDICAL NEWS

A project aimed at improving catheter line maintenance reduced the overall rate of catheter-associated bloodstream infections to 1.2 per 1,000 line-days at the critical care unit at Children's National Medical Center in Washington.

Compared with the national 2006 pooled mean of 5.3 infections per 1,000 central line-days, “that's pretty good,” Dr. Heidi Dalton said. She formerly headed the unit, which recently went 197 days without any patients developing catheter-associated bloodstream infections, and now is chief of critical care at Phoenix Children's Hospital.

The secret of the unit's success, according to Dr. Marlene Miller, is an approach that focuses on line maintenance rather than line insertion.

In adults, a catheter line is accessed relatively infrequently and infection rates are sharply reduced by relatively simple insertion standardization policies. But in children, catheter lines are accessed much more frequently—more than 30 times per day in some cases, said Dr. Miller, cochair of the Catheter-Associated Bloodstream Infections Project, run by the National Association of Children's Hospitals and Related Institutions (NACHRI).

“In children, we'll draw all our blood samples from the line so that the child doesn't have to have another painful needle stick. Every one of these 'creature comforts' to minimize the pain is extremely important” for pediatric patients, she said. Lines are difficult to insert in children, she added, and thus are often left in longer. “Although the child may look good today, tomorrow they might not look so good. Since it is very hard to put these types of lines in children, especially younger ones, we carefully consider when to remove the line.”

Another variable is the location of line placement. With young children, “we might be hesitant to put a line in the neck region where they can grab it,” said Dr. Miller, who is also vice chair of Quality and Safety at Johns Hopkins Children's Center in Baltimore.

The project has led to “a sustained improvement,” Dr. Heidi Dalton said.

Source Paula Darte/Children's National Medical Center

The frequency of access to pediatric lines and the duration of placement mean that best practices for line insertion aren't enough, she said. To lower the catheter-associated bloodstream infection (CA-BSI) rate, pediatric critical care teams must focus on line maintenance.

Children's National Medical Center succeeded in achieving reduced rates after becoming 1 of 27 hospitals around the country that enrolled in phase I of the NACHRI collaborative after it was initiated in October 2006. The collaborative was later expanded to include more than 60 pediatric intensive care units.

From the start of the project through October 2008, the 29 phase I teams at the 27 hospitals prevented an estimated 560 CA-BSIs and a possible 65 deaths. The group saved an anticipated $20 million in slightly over 2 years. Overall, the phase I participants achieved a sustained reduction in the CA-BSI rate from 5.9 per 1,000 line-days to 2.3 per 1,000 line-days, said Mitchell Harris, Ph.D., director of research and statistics at NACHRI.

The NACHRI program provides “bundles,” or prompts for intensive care unit staff to ask themselves each time a line is accessed. For example, one prompt asks whether any medications can be converted from venous to oral administration, Dr. Miller said. Another bundle offers evaluation tools and encourages critical care teams to frequently assess whether a line can be removed.

Nurses and other staff are also instructed about the cleaning and changing of the catheter line's cap (different protocols apply according to whether the line has most recently been used for feeding, medication, or blood drawing), the changing of the dressing at the insertion site, and the methods of clearly communicating the status of each aspect of central line care for each patient to the nurses in the next shift.

“It's a lot of work, but this is the only statistically significant predictor we have: If you do maintenance care better, you're significantly more likely to have a lower CA-BSI rate in pediatric patients,” Dr. Miller said.

Dr. Dalton said that the hospital's adoption of a minocycline/rifampin-impregnated line designed for children, the Cook Spectrum (Cook Medical), as well as a change to chlorhexadine skin scrub and the use of the Biopath (Johnson & Johnson Inc.), were completed during the study period. These factors may have played a role in the reduction of BSIs noted at Children's National Medical Center.

Just participating in the collaborative drives infection reductions, she added. “All the hospitals in that collaborative make their data transparent [to each other],” she said. “So you're not just 'unit 22.' Everyone knows [unit 22] is Children's National Medical Center data. The peer pressure of the network has really made a sustained improvement in our infection rate.”

Also, “every other month or every other quarter, [participants] have a Web call and talk about ideas. And then twice a year we get together as a group,” Dr. Dalton said. This open channel of communication has led to best practices in other areas. For example, “the last two bloodstream infections in our ICU have been in kids that had long-term percutaneous lines” as opposed to more common central lines. “So we just had a meeting with all our [percutaneous] line people.”

Phase II of the NACHRI program enrolled 25 additional hospitals, and phase III will start this fall.

Dr. Dalton declared that she has no conflicts of interest to disclose in relation to her use of the Cook Spectrum catheter, Biopatch, or chlorhexidine.

For more information about the NACHRI project, visit www.childrenshospitals.net

A project aimed at improving catheter line maintenance reduced the overall rate of catheter-associated bloodstream infections to 1.2 per 1,000 line-days at the critical care unit at Children's National Medical Center in Washington.

Compared with the national 2006 pooled mean of 5.3 infections per 1,000 central line-days, “that's pretty good,” Dr. Heidi Dalton said. She formerly headed the unit, which recently went 197 days without any patients developing catheter-associated bloodstream infections, and now is chief of critical care at Phoenix Children's Hospital.

The secret of the unit's success, according to Dr. Marlene Miller, is an approach that focuses on line maintenance rather than line insertion.

In adults, a catheter line is accessed relatively infrequently and infection rates are sharply reduced by relatively simple insertion standardization policies. But in children, catheter lines are accessed much more frequently—more than 30 times per day in some cases, said Dr. Miller, cochair of the Catheter-Associated Bloodstream Infections Project, run by the National Association of Children's Hospitals and Related Institutions (NACHRI).

“In children, we'll draw all our blood samples from the line so that the child doesn't have to have another painful needle stick. Every one of these 'creature comforts' to minimize the pain is extremely important” for pediatric patients, she said. Lines are difficult to insert in children, she added, and thus are often left in longer. “Although the child may look good today, tomorrow they might not look so good. Since it is very hard to put these types of lines in children, especially younger ones, we carefully consider when to remove the line.”

Another variable is the location of line placement. With young children, “we might be hesitant to put a line in the neck region where they can grab it,” said Dr. Miller, who is also vice chair of Quality and Safety at Johns Hopkins Children's Center in Baltimore.

The project has led to “a sustained improvement,” Dr. Heidi Dalton said.

Source Paula Darte/Children's National Medical Center

The frequency of access to pediatric lines and the duration of placement mean that best practices for line insertion aren't enough, she said. To lower the catheter-associated bloodstream infection (CA-BSI) rate, pediatric critical care teams must focus on line maintenance.

Children's National Medical Center succeeded in achieving reduced rates after becoming 1 of 27 hospitals around the country that enrolled in phase I of the NACHRI collaborative after it was initiated in October 2006. The collaborative was later expanded to include more than 60 pediatric intensive care units.

From the start of the project through October 2008, the 29 phase I teams at the 27 hospitals prevented an estimated 560 CA-BSIs and a possible 65 deaths. The group saved an anticipated $20 million in slightly over 2 years. Overall, the phase I participants achieved a sustained reduction in the CA-BSI rate from 5.9 per 1,000 line-days to 2.3 per 1,000 line-days, said Mitchell Harris, Ph.D., director of research and statistics at NACHRI.

The NACHRI program provides “bundles,” or prompts for intensive care unit staff to ask themselves each time a line is accessed. For example, one prompt asks whether any medications can be converted from venous to oral administration, Dr. Miller said. Another bundle offers evaluation tools and encourages critical care teams to frequently assess whether a line can be removed.

Nurses and other staff are also instructed about the cleaning and changing of the catheter line's cap (different protocols apply according to whether the line has most recently been used for feeding, medication, or blood drawing), the changing of the dressing at the insertion site, and the methods of clearly communicating the status of each aspect of central line care for each patient to the nurses in the next shift.

“It's a lot of work, but this is the only statistically significant predictor we have: If you do maintenance care better, you're significantly more likely to have a lower CA-BSI rate in pediatric patients,” Dr. Miller said.

Dr. Dalton said that the hospital's adoption of a minocycline/rifampin-impregnated line designed for children, the Cook Spectrum (Cook Medical), as well as a change to chlorhexadine skin scrub and the use of the Biopath (Johnson & Johnson Inc.), were completed during the study period. These factors may have played a role in the reduction of BSIs noted at Children's National Medical Center.

Just participating in the collaborative drives infection reductions, she added. “All the hospitals in that collaborative make their data transparent [to each other],” she said. “So you're not just 'unit 22.' Everyone knows [unit 22] is Children's National Medical Center data. The peer pressure of the network has really made a sustained improvement in our infection rate.”

Also, “every other month or every other quarter, [participants] have a Web call and talk about ideas. And then twice a year we get together as a group,” Dr. Dalton said. This open channel of communication has led to best practices in other areas. For example, “the last two bloodstream infections in our ICU have been in kids that had long-term percutaneous lines” as opposed to more common central lines. “So we just had a meeting with all our [percutaneous] line people.”

Phase II of the NACHRI program enrolled 25 additional hospitals, and phase III will start this fall.

Dr. Dalton declared that she has no conflicts of interest to disclose in relation to her use of the Cook Spectrum catheter, Biopatch, or chlorhexidine.

For more information about the NACHRI project, visit www.childrenshospitals.net

A project aimed at improving catheter line maintenance reduced the overall rate of catheter-associated bloodstream infections to 1.2 per 1,000 line-days at the critical care unit at Children's National Medical Center in Washington.

Compared with the national 2006 pooled mean of 5.3 infections per 1,000 central line-days, “that's pretty good,” Dr. Heidi Dalton said. She formerly headed the unit, which recently went 197 days without any patients developing catheter-associated bloodstream infections, and now is chief of critical care at Phoenix Children's Hospital.

The secret of the unit's success, according to Dr. Marlene Miller, is an approach that focuses on line maintenance rather than line insertion.

In adults, a catheter line is accessed relatively infrequently and infection rates are sharply reduced by relatively simple insertion standardization policies. But in children, catheter lines are accessed much more frequently—more than 30 times per day in some cases, said Dr. Miller, cochair of the Catheter-Associated Bloodstream Infections Project, run by the National Association of Children's Hospitals and Related Institutions (NACHRI).

“In children, we'll draw all our blood samples from the line so that the child doesn't have to have another painful needle stick. Every one of these 'creature comforts' to minimize the pain is extremely important” for pediatric patients, she said. Lines are difficult to insert in children, she added, and thus are often left in longer. “Although the child may look good today, tomorrow they might not look so good. Since it is very hard to put these types of lines in children, especially younger ones, we carefully consider when to remove the line.”

Another variable is the location of line placement. With young children, “we might be hesitant to put a line in the neck region where they can grab it,” said Dr. Miller, who is also vice chair of Quality and Safety at Johns Hopkins Children's Center in Baltimore.

The project has led to “a sustained improvement,” Dr. Heidi Dalton said.

Source Paula Darte/Children's National Medical Center

The frequency of access to pediatric lines and the duration of placement mean that best practices for line insertion aren't enough, she said. To lower the catheter-associated bloodstream infection (CA-BSI) rate, pediatric critical care teams must focus on line maintenance.

Children's National Medical Center succeeded in achieving reduced rates after becoming 1 of 27 hospitals around the country that enrolled in phase I of the NACHRI collaborative after it was initiated in October 2006. The collaborative was later expanded to include more than 60 pediatric intensive care units.

From the start of the project through October 2008, the 29 phase I teams at the 27 hospitals prevented an estimated 560 CA-BSIs and a possible 65 deaths. The group saved an anticipated $20 million in slightly over 2 years. Overall, the phase I participants achieved a sustained reduction in the CA-BSI rate from 5.9 per 1,000 line-days to 2.3 per 1,000 line-days, said Mitchell Harris, Ph.D., director of research and statistics at NACHRI.

The NACHRI program provides “bundles,” or prompts for intensive care unit staff to ask themselves each time a line is accessed. For example, one prompt asks whether any medications can be converted from venous to oral administration, Dr. Miller said. Another bundle offers evaluation tools and encourages critical care teams to frequently assess whether a line can be removed.

Nurses and other staff are also instructed about the cleaning and changing of the catheter line's cap (different protocols apply according to whether the line has most recently been used for feeding, medication, or blood drawing), the changing of the dressing at the insertion site, and the methods of clearly communicating the status of each aspect of central line care for each patient to the nurses in the next shift.

“It's a lot of work, but this is the only statistically significant predictor we have: If you do maintenance care better, you're significantly more likely to have a lower CA-BSI rate in pediatric patients,” Dr. Miller said.

Dr. Dalton said that the hospital's adoption of a minocycline/rifampin-impregnated line designed for children, the Cook Spectrum (Cook Medical), as well as a change to chlorhexadine skin scrub and the use of the Biopath (Johnson & Johnson Inc.), were completed during the study period. These factors may have played a role in the reduction of BSIs noted at Children's National Medical Center.

Just participating in the collaborative drives infection reductions, she added. “All the hospitals in that collaborative make their data transparent [to each other],” she said. “So you're not just 'unit 22.' Everyone knows [unit 22] is Children's National Medical Center data. The peer pressure of the network has really made a sustained improvement in our infection rate.”

Also, “every other month or every other quarter, [participants] have a Web call and talk about ideas. And then twice a year we get together as a group,” Dr. Dalton said. This open channel of communication has led to best practices in other areas. For example, “the last two bloodstream infections in our ICU have been in kids that had long-term percutaneous lines” as opposed to more common central lines. “So we just had a meeting with all our [percutaneous] line people.”

Phase II of the NACHRI program enrolled 25 additional hospitals, and phase III will start this fall.

Dr. Dalton declared that she has no conflicts of interest to disclose in relation to her use of the Cook Spectrum catheter, Biopatch, or chlorhexidine.

For more information about the NACHRI project, visit www.childrenshospitals.net