Sharon Worcester

CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m² of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m² of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

CHICAGO – Newly updated American College of Rheumatology guidelines for the screening and management of lupus nephritis in adults, which are expected to be published in early 2012, focus largely on induction therapy with mycophenolate mofetil or cyclophosphamide and on maintenance therapy with mycophenolate mofetil and azathioprine.

An algorithm for diffuse proliferative nephritis, for example, indicates that in patients with active class III and IV disease without cellular crescents, induction therapy should include mycophenolate mofetil (MMF) at 2-3 g/day for 6 months. Cyclophosphamide is an alternative option in these patients, according to the guidelines, which note that the literature suggests MMF is preferred for initial therapy in African Americans and Hispanics in North America and Latin America.

These recommendations are based on level A evidence from multiple randomized controlled trials or a meta-analysis, Dr. Bevra H. Hahn noted at the annual meeting of the American College of Rheumatology, where she presented the updated guidelines.

In patients who are given cyclophosphamide, the dose should be 500 mg intravenously every 2 weeks for 6 weeks, or 500-1,000 mg/m² of body surface area. This recommendation is based on level B evidence from a single randomized controlled trial or nonrandomized studies. The latter choice has been studied only in Caucasians of European descent, noted Dr. Hahn, a professor of medicine and chair of the rheumatology department at the University of California, Los Angeles, as well as a member of the core working group for the updated guidelines.

Also recommended for class III and IV patients without cellular crescents is a concomitant pulse of steroids for 3 days, then prednisone at a dose of 0.5-1.0 mg/kg to induce improvement, with tapering to the lowest effective dose after a few weeks. Data supporting a specific dose in this range are lacking, and this recommendation, which is based on level C evidence indicating the recommendation is derived from consensus, expert opinion, or a case series, also states that the prednisone should continue for 6 months.

The algorithm for patients with diffuse proliferative disease also addresses patients with cellular crescents. Such patients should receive the higher 1.0-mg/kg per day prednisone dose. Patients who do not respond to induction should be switched from their initial induction regimen, be it MMF or cyclophosphamide, to the other. Maintenance therapy for responders to either MMF or cyclophosphamide should include MMF at 1-2 g/day or azathioprine at 2 mg/kg per day plus low-dose daily glucocorticoids.

The updated guidelines also address renal biopsy, adjunctive treatments, patients with focal disease, patients with class V disease, lupus nephritis in pregnancy, and recommendations for monitoring.

Notably, the guidelines do not advocate use of belimumab, as it has not been studied in active lupus nephritis, Dr. Hahn said, noting that despite the expanded literature on lupus nephritis that led to development of these updated guidelines, there are a number of unmet needs.

Between 20% and 35% of patients do not respond at all to induction therapies, and in many the response is slow, taking up to 52 weeks to determine response. Furthermore, response rates remain low.

"So it takes a long time, and you certainly don’t get 100% response rates, she said.

The guidelines, developed by a core working group that conducted the literature reviews and wrote scenarios, and by a task force panel of international experts in rheumatology, nephrology, and pathology who voted on the scenarios, will be published in Arthritis Care & Research, most likely in the spring, Dr. Hahn said. Currently they are pending approval by the ACR Guidelines Subcommittee, Quality of Care Committee, and Board of Directors.

Dr. Hahn, however, is already looking forward to new advances in the treatment of lupus nephritis and to the next guidelines update.

"I can’t wait to have something that’s better, so in another decade when we write guidelines, we can talk to you about 80% to 100% response rates," she said.

The lupus nephritis guideline project was sponsored by the ACR via a competitive grant mechanism. Of the 39 working group and task force members, 16 declared potential conflicts of interest, including relationships with Aspreva, Bristol-Myers Squibb, Genentech, and Human Genome Sciences.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

CHICAGO – The addition of daily low-dose prednisone to a methotrexate-based tight control treatment strategy in patients with early rheumatoid arthritis reduced erosive joint damage, improved disease control, and reduced the need for biological therapy without increasing toxicity in a 2-year randomized controlled trial involving 236 patients.

Of 119 patients from the Computer Assisted Management of Early RA–II (CAMERA-II) trial who were randomized to receive methotrexate plus 10 mg/day of prednisone from the start of therapy, 78% were erosion free at 2 years, compared with 67% of 117 patients randomized to receive methotrexate plus placebo. The difference was statistically significant, Dr. Johannes W.G. Jacobs reported at the annual meeting of the American College of Rheumatology.

Also, reductions in disease activity scores (DAS28) occurred more quickly and were more pronounced in the patients in the prednisone group, said Dr. Jacobs of University Medical Center Utrecht (the Netherlands).

First remission was achieved at a mean of 6 months in the prednisone group, compared with 11 months in the placebo group, a significant difference. Although a greater proportion of patients in the prednisone group achieved sustained remission (72% vs. 61% in the placebo group), this difference did not reach statistical significance. However, a significantly lower proportion of the prednisone patients ultimately required biological therapy (14% vs. 36%), he said.

Adverse events occurred in 29% of patient in the prednisone group, and 35% of those in the placebo group. The only significant differences seen in regard to adverse events between the two groups were for nausea and elevated transaminases, both of which were more frequent in the placebo group. This could be explained by the fact that use of concomitant prednisone appeared to have a methotrexate-sparing effect; the mean methotrexate dose in the prednisone patients was significantly lower at 15.1 mg/week, compared with 19.2 mg/week in the placebo group, Dr. Jacobs said.

Participants in this double-blind, multicenter trial were disease-modifying antirheumatic drug– and glucocorticoid-naive adults aged 18 years and older with RA duration less than 1 year. They received individualized treatment with methotrexate, beginning at a dose of 10 mg/week with step up to no more than 30 mg/week. Dosing, tailored to the individual at monthly visits using computer-assisted step-up, was based on predefined response criteria with an aim of achieving remission as defined by a swollen-joint count of 0 (of 38 joints including feet) and two or more of either tender-joint count of 3 or less (of 38 joints), erythrocyte sedimentation rate of 20 mm/hr or less, and Visual Analog Scale (VAS) general well-being score of 20 mm or less.

Biological therapy was added to the regimen in patients who failed to achieve remission at the maximum tolerable dose of methotrexate.

The findings suggest that while tight control treatment strategies are highly effective both clinically and radiographically, they can be further improved with the addition of low-dose prednisone, Dr. Jacobs said, noting that although prednisone has been shown to inhibit the progression of erosive joint damage in early RA, it has not previously been studied as part of a tight control and treat-to-target strategy.

The CAMERA-II trial was funded by an unrestricted grant from the Dutch Catharijne Foundation. Dr. Jacobs and another study author, Dr. J.W. Bijlsma, disclosed that they are members of the speakers bureau of Multipharma.

A novel, less-intensive monitoring schedule for patients with localized primary cutaneous melanoma appears to reduce follow-up visits without affecting the rate of detection of new primary or recurrent melanomas, according to an analysis of data from an inception cohort of 3,081 patients.

Given that follow-up care for melanoma patients in the United States costs up to $500 million per year, the findings could have important implications for cost savings, according to Robin M. Turner, Ph.D., and colleagues.

Using data from the Melanoma Institute Australia on the inception cohort, which included consecutive patients with stage I or II melanoma first diagnosed between January 1985 and December 2009, the investigators modeled the delay in diagnosis of a new primary melanoma or recurrence with two different monitoring schedules.

Schedule one was based on 2008 Australian and New Zealand guidelines, which recommend follow-up every 6 months for 5 years, then annually for 5 years for patients with stage 1A and 1B disease, or every 3 months for 5 years, then annually for 5 years in patients with stages IIA, IIB, or IIC.

Schedule two, the novel monitoring arm, called for annual follow-up for 10 years for patients with stage I disease; every 6 months for 2 years, and then annually for 8 years, for patients with stage IIA disease; and every 4 months for 2 years, every 6 months in year 3, and then annually for 5 years, for patients with stages IIB and IIC disease.

Within 10 years, the total number of recurrences was 229 for every 1,000 patients, and the number of new primary melanomas was 61 for every 1,000 patients.

Compared with the 2008 Australia and New Zealand guidelines for monitoring, the novel schedule, which required almost 3,000 fewer visits per 1,000 patients (8,044 vs. 5,221 visits), resulted in a delay in the detection – by at least 2 months – of an additional 44.9 recurrences per 1,000 patients, and an additional 9.6 new primary melanomas, Robin M. Turner, Ph.D., of the School of Public Health at the University of Sydney, Australia, and colleagues reported online in the Journal of Clinical Oncology (2011 Nov. 7 [doi:10.1200/JCO.2010.34.2956]).

"If we assume self-detection rates based on published estimates [75% for recurrence and 50% for new primary], use of schedule two rather than schedule one results in only a small number of additional patients experiencing a delay in recurrence diagnosis (up to [a] maximum of 3 months; extra 11.3 patients per 1,000 with delay [greater than] 2 months) and even fewer experiencing a delay in new primary diagnosis (up to [a] maximum of 6 months; extra 4.9 per 1,000)," the investigators wrote.

Moreover, if there were no patients lost to follow-up and they attended all visits until diagnosis or 10 years, the total number of visits for schedule one would be 19,546, compared with 12,303 for schedule two.

"Not only would these fewer monitoring visits reduce the burden on patients in terms of time and expense in attendance and possible unnecessary anxiety, but they would also represent substantial savings for the health care system," the investigators wrote.

They also found that the risk of recurrence was greatest in the first year of follow-up; that the most important predictor of recurrence was American Joint Committee on Cancer substage (hazard ratios of 1, 1.12, 0.56, 0.70, and 0.95 for stages IA, IB, IIA, IIB, and IIC, respectively); and that the most important predictors of new primary melanomas were age and date of primary diagnosis after 1992 (hazard ratios of 1.29 and 2.21, respectively).

This study was supported by grants from the Australian National Health and Medical Research Council. The investigators said they had no relevant financial disclosures.

A novel, less-intensive monitoring schedule for patients with localized primary cutaneous melanoma appears to reduce follow-up visits without affecting the rate of detection of new primary or recurrent melanomas, according to an analysis of data from an inception cohort of 3,081 patients.

Given that follow-up care for melanoma patients in the United States costs up to $500 million per year, the findings could have important implications for cost savings, according to Robin M. Turner, Ph.D., and colleagues.

Using data from the Melanoma Institute Australia on the inception cohort, which included consecutive patients with stage I or II melanoma first diagnosed between January 1985 and December 2009, the investigators modeled the delay in diagnosis of a new primary melanoma or recurrence with two different monitoring schedules.

Schedule one was based on 2008 Australian and New Zealand guidelines, which recommend follow-up every 6 months for 5 years, then annually for 5 years for patients with stage 1A and 1B disease, or every 3 months for 5 years, then annually for 5 years in patients with stages IIA, IIB, or IIC.

Schedule two, the novel monitoring arm, called for annual follow-up for 10 years for patients with stage I disease; every 6 months for 2 years, and then annually for 8 years, for patients with stage IIA disease; and every 4 months for 2 years, every 6 months in year 3, and then annually for 5 years, for patients with stages IIB and IIC disease.

Within 10 years, the total number of recurrences was 229 for every 1,000 patients, and the number of new primary melanomas was 61 for every 1,000 patients.

Compared with the 2008 Australia and New Zealand guidelines for monitoring, the novel schedule, which required almost 3,000 fewer visits per 1,000 patients (8,044 vs. 5,221 visits), resulted in a delay in the detection – by at least 2 months – of an additional 44.9 recurrences per 1,000 patients, and an additional 9.6 new primary melanomas, Robin M. Turner, Ph.D., of the School of Public Health at the University of Sydney, Australia, and colleagues reported online in the Journal of Clinical Oncology (2011 Nov. 7 [doi:10.1200/JCO.2010.34.2956]).

"If we assume self-detection rates based on published estimates [75% for recurrence and 50% for new primary], use of schedule two rather than schedule one results in only a small number of additional patients experiencing a delay in recurrence diagnosis (up to [a] maximum of 3 months; extra 11.3 patients per 1,000 with delay [greater than] 2 months) and even fewer experiencing a delay in new primary diagnosis (up to [a] maximum of 6 months; extra 4.9 per 1,000)," the investigators wrote.

Moreover, if there were no patients lost to follow-up and they attended all visits until diagnosis or 10 years, the total number of visits for schedule one would be 19,546, compared with 12,303 for schedule two.

"Not only would these fewer monitoring visits reduce the burden on patients in terms of time and expense in attendance and possible unnecessary anxiety, but they would also represent substantial savings for the health care system," the investigators wrote.

They also found that the risk of recurrence was greatest in the first year of follow-up; that the most important predictor of recurrence was American Joint Committee on Cancer substage (hazard ratios of 1, 1.12, 0.56, 0.70, and 0.95 for stages IA, IB, IIA, IIB, and IIC, respectively); and that the most important predictors of new primary melanomas were age and date of primary diagnosis after 1992 (hazard ratios of 1.29 and 2.21, respectively).

This study was supported by grants from the Australian National Health and Medical Research Council. The investigators said they had no relevant financial disclosures.

A novel, less-intensive monitoring schedule for patients with localized primary cutaneous melanoma appears to reduce follow-up visits without affecting the rate of detection of new primary or recurrent melanomas, according to an analysis of data from an inception cohort of 3,081 patients.

Given that follow-up care for melanoma patients in the United States costs up to $500 million per year, the findings could have important implications for cost savings, according to Robin M. Turner, Ph.D., and colleagues.

Using data from the Melanoma Institute Australia on the inception cohort, which included consecutive patients with stage I or II melanoma first diagnosed between January 1985 and December 2009, the investigators modeled the delay in diagnosis of a new primary melanoma or recurrence with two different monitoring schedules.

Schedule one was based on 2008 Australian and New Zealand guidelines, which recommend follow-up every 6 months for 5 years, then annually for 5 years for patients with stage 1A and 1B disease, or every 3 months for 5 years, then annually for 5 years in patients with stages IIA, IIB, or IIC.

Schedule two, the novel monitoring arm, called for annual follow-up for 10 years for patients with stage I disease; every 6 months for 2 years, and then annually for 8 years, for patients with stage IIA disease; and every 4 months for 2 years, every 6 months in year 3, and then annually for 5 years, for patients with stages IIB and IIC disease.

Within 10 years, the total number of recurrences was 229 for every 1,000 patients, and the number of new primary melanomas was 61 for every 1,000 patients.

Compared with the 2008 Australia and New Zealand guidelines for monitoring, the novel schedule, which required almost 3,000 fewer visits per 1,000 patients (8,044 vs. 5,221 visits), resulted in a delay in the detection – by at least 2 months – of an additional 44.9 recurrences per 1,000 patients, and an additional 9.6 new primary melanomas, Robin M. Turner, Ph.D., of the School of Public Health at the University of Sydney, Australia, and colleagues reported online in the Journal of Clinical Oncology (2011 Nov. 7 [doi:10.1200/JCO.2010.34.2956]).

"If we assume self-detection rates based on published estimates [75% for recurrence and 50% for new primary], use of schedule two rather than schedule one results in only a small number of additional patients experiencing a delay in recurrence diagnosis (up to [a] maximum of 3 months; extra 11.3 patients per 1,000 with delay [greater than] 2 months) and even fewer experiencing a delay in new primary diagnosis (up to [a] maximum of 6 months; extra 4.9 per 1,000)," the investigators wrote.

Moreover, if there were no patients lost to follow-up and they attended all visits until diagnosis or 10 years, the total number of visits for schedule one would be 19,546, compared with 12,303 for schedule two.

"Not only would these fewer monitoring visits reduce the burden on patients in terms of time and expense in attendance and possible unnecessary anxiety, but they would also represent substantial savings for the health care system," the investigators wrote.

They also found that the risk of recurrence was greatest in the first year of follow-up; that the most important predictor of recurrence was American Joint Committee on Cancer substage (hazard ratios of 1, 1.12, 0.56, 0.70, and 0.95 for stages IA, IB, IIA, IIB, and IIC, respectively); and that the most important predictors of new primary melanomas were age and date of primary diagnosis after 1992 (hazard ratios of 1.29 and 2.21, respectively).

This study was supported by grants from the Australian National Health and Medical Research Council. The investigators said they had no relevant financial disclosures.

Breast cancer outcomes have improved over time, but more so in younger women than in those aged 75 years and older, according to findings from a review of data spanning nearly three decades.

The findings are concerning, because women aged 75 and older represent the fastest growing group of women affected by the disease, Dr. Benjamin D. Smith of the University of Texas M.D. Anderson Cancer Center, Houston, and his colleagues reported online in the Journal of Clinical Oncology.

According to data from National Vital Statistics Reports, breast cancer death rates began to decrease in 1990. Between that year and 2007, the breast cancer death rate in the general population declined by 2.5% per year among women aged 20-49 years, by 2.1% per year among those aged 50-64 years, and by 2.0% per year for those aged 65-74 years – but only by 1.1% per year for those aged 75 years and older.

Underlying factors that may account for the discrepancy include lower use of screening mammography in older women, lack of understanding regarding the optimal treatment for older women due to lack of representation of the older age group in clinical trials, conflicting evidence regarding the magnitude of benefit from adjuvant chemotherapy in different age groups, and a tendency to reduce chemotherapy dose intensity in older patients because of concern about increased risk of toxicity.

The "evolving disparity by age in breast cancer outcome" demonstrated by this study suggests research is needed "to understand preferences of older adults for screening and treatment and to identify optimal adjuvant therapy regimens that are both effective and tolerable in the setting of the functional status, comorbid illnesses, and social support of older women," the authors stated.

Based on data from 219,024 women diagnosed with breast cancer between 1980 and 1997 who were part of the Surveillance, Epidemiology, and End Results nine-registry cohort (SEER-9), the investigators reported that the risk of breast cancer death within 10 years decreased from 29.6% for those diagnosed in 1980-1984 to 20.1% for those diagnosed between 1995 and 1997, (J. Clin. Oncol. 2011 [doi:10.1200/JCO.2011.35.8408]).

"In multivariate analysis, the risk of breast cancer death decreased by a relative amount of 4.5% per diagnosis year after adjusting for age, race, and SEER registry," they said, adding that the 10-year absolute risk of breast cancer death from 1980 to 1997 decreased by 10.1% for women aged 20-49 years at diagnosis, by 15.3% for those aged 50-64 years at diagnosis, and by 12.5% for those aged 65-74 years at diagnosis – but only by 7.5% for those aged 75 years and older at diagnosis.

From 1980-1994, the older women experienced the lowest risk of 10-year breast cancer death at 24.8%, compared with rates ranging from 28.0% to 31.9% for the other age groups, but by 1995-1997 the older women experienced a higher risk of breast cancer death than other postmenopausal women (17.3% vs. 15.4%-16.6%), they said.

The findings demonstrate that both the rate of breast cancer death in the general population and the risk of breast cancer death in newly diagnosed patients decreased two to three times more rapidly for younger women, compared with women aged 75 and older, the investigators said, noting that it appears older women "may have missed out on advances in breast cancer diagnosis and treatment."

"Notably, approximately 40,000 women [aged 75 years or older] are diagnosed with breast cancer each year in the United States ... older women are the most rapidly growing cohort of patients with breast cancer, with 57% growth expected over the next 20 years as the US population ages," they wrote, adding: "Although our data provided reassurance that younger women have experienced substantial gains in breast cancer outcomes as a result of improvements in screening and treatment, these gains do not appear to have fully extended to the oldest 20% of patients with breast cancer."

Of note, the investigators also found race-based disparities in breast cancer outcomes. The findings indicate that, "black women are another sociodemographic group that has not fully reaped the benefits of improved breast cancer outcomes," they said, noting that the race-based gap emerged in the 1980s and continues to increase.

Dr. Smith reported receiving research funding from Varian Medical Systems. Another study author, Dr. Arti Huria, reported receiving research funding from Celgene, GlaxoSmithKline, and Abraxis BioScience, as well as serving as a consultant or in an advisory role for Genentech, Amgen, and GTx. The study was supported in part by a philanthropic gift from Ann Cazalot and Clarence Cazalot.

Breast cancer outcomes have improved over time, but more so in younger women than in those aged 75 years and older, according to findings from a review of data spanning nearly three decades.

The findings are concerning, because women aged 75 and older represent the fastest growing group of women affected by the disease, Dr. Benjamin D. Smith of the University of Texas M.D. Anderson Cancer Center, Houston, and his colleagues reported online in the Journal of Clinical Oncology.

According to data from National Vital Statistics Reports, breast cancer death rates began to decrease in 1990. Between that year and 2007, the breast cancer death rate in the general population declined by 2.5% per year among women aged 20-49 years, by 2.1% per year among those aged 50-64 years, and by 2.0% per year for those aged 65-74 years – but only by 1.1% per year for those aged 75 years and older.

Underlying factors that may account for the discrepancy include lower use of screening mammography in older women, lack of understanding regarding the optimal treatment for older women due to lack of representation of the older age group in clinical trials, conflicting evidence regarding the magnitude of benefit from adjuvant chemotherapy in different age groups, and a tendency to reduce chemotherapy dose intensity in older patients because of concern about increased risk of toxicity.

The "evolving disparity by age in breast cancer outcome" demonstrated by this study suggests research is needed "to understand preferences of older adults for screening and treatment and to identify optimal adjuvant therapy regimens that are both effective and tolerable in the setting of the functional status, comorbid illnesses, and social support of older women," the authors stated.

Based on data from 219,024 women diagnosed with breast cancer between 1980 and 1997 who were part of the Surveillance, Epidemiology, and End Results nine-registry cohort (SEER-9), the investigators reported that the risk of breast cancer death within 10 years decreased from 29.6% for those diagnosed in 1980-1984 to 20.1% for those diagnosed between 1995 and 1997, (J. Clin. Oncol. 2011 [doi:10.1200/JCO.2011.35.8408]).

"In multivariate analysis, the risk of breast cancer death decreased by a relative amount of 4.5% per diagnosis year after adjusting for age, race, and SEER registry," they said, adding that the 10-year absolute risk of breast cancer death from 1980 to 1997 decreased by 10.1% for women aged 20-49 years at diagnosis, by 15.3% for those aged 50-64 years at diagnosis, and by 12.5% for those aged 65-74 years at diagnosis – but only by 7.5% for those aged 75 years and older at diagnosis.

From 1980-1994, the older women experienced the lowest risk of 10-year breast cancer death at 24.8%, compared with rates ranging from 28.0% to 31.9% for the other age groups, but by 1995-1997 the older women experienced a higher risk of breast cancer death than other postmenopausal women (17.3% vs. 15.4%-16.6%), they said.

The findings demonstrate that both the rate of breast cancer death in the general population and the risk of breast cancer death in newly diagnosed patients decreased two to three times more rapidly for younger women, compared with women aged 75 and older, the investigators said, noting that it appears older women "may have missed out on advances in breast cancer diagnosis and treatment."

"Notably, approximately 40,000 women [aged 75 years or older] are diagnosed with breast cancer each year in the United States ... older women are the most rapidly growing cohort of patients with breast cancer, with 57% growth expected over the next 20 years as the US population ages," they wrote, adding: "Although our data provided reassurance that younger women have experienced substantial gains in breast cancer outcomes as a result of improvements in screening and treatment, these gains do not appear to have fully extended to the oldest 20% of patients with breast cancer."

Of note, the investigators also found race-based disparities in breast cancer outcomes. The findings indicate that, "black women are another sociodemographic group that has not fully reaped the benefits of improved breast cancer outcomes," they said, noting that the race-based gap emerged in the 1980s and continues to increase.

Dr. Smith reported receiving research funding from Varian Medical Systems. Another study author, Dr. Arti Huria, reported receiving research funding from Celgene, GlaxoSmithKline, and Abraxis BioScience, as well as serving as a consultant or in an advisory role for Genentech, Amgen, and GTx. The study was supported in part by a philanthropic gift from Ann Cazalot and Clarence Cazalot.

Breast cancer outcomes have improved over time, but more so in younger women than in those aged 75 years and older, according to findings from a review of data spanning nearly three decades.

The findings are concerning, because women aged 75 and older represent the fastest growing group of women affected by the disease, Dr. Benjamin D. Smith of the University of Texas M.D. Anderson Cancer Center, Houston, and his colleagues reported online in the Journal of Clinical Oncology.

According to data from National Vital Statistics Reports, breast cancer death rates began to decrease in 1990. Between that year and 2007, the breast cancer death rate in the general population declined by 2.5% per year among women aged 20-49 years, by 2.1% per year among those aged 50-64 years, and by 2.0% per year for those aged 65-74 years – but only by 1.1% per year for those aged 75 years and older.

Underlying factors that may account for the discrepancy include lower use of screening mammography in older women, lack of understanding regarding the optimal treatment for older women due to lack of representation of the older age group in clinical trials, conflicting evidence regarding the magnitude of benefit from adjuvant chemotherapy in different age groups, and a tendency to reduce chemotherapy dose intensity in older patients because of concern about increased risk of toxicity.

The "evolving disparity by age in breast cancer outcome" demonstrated by this study suggests research is needed "to understand preferences of older adults for screening and treatment and to identify optimal adjuvant therapy regimens that are both effective and tolerable in the setting of the functional status, comorbid illnesses, and social support of older women," the authors stated.

Based on data from 219,024 women diagnosed with breast cancer between 1980 and 1997 who were part of the Surveillance, Epidemiology, and End Results nine-registry cohort (SEER-9), the investigators reported that the risk of breast cancer death within 10 years decreased from 29.6% for those diagnosed in 1980-1984 to 20.1% for those diagnosed between 1995 and 1997, (J. Clin. Oncol. 2011 [doi:10.1200/JCO.2011.35.8408]).

"In multivariate analysis, the risk of breast cancer death decreased by a relative amount of 4.5% per diagnosis year after adjusting for age, race, and SEER registry," they said, adding that the 10-year absolute risk of breast cancer death from 1980 to 1997 decreased by 10.1% for women aged 20-49 years at diagnosis, by 15.3% for those aged 50-64 years at diagnosis, and by 12.5% for those aged 65-74 years at diagnosis – but only by 7.5% for those aged 75 years and older at diagnosis.

From 1980-1994, the older women experienced the lowest risk of 10-year breast cancer death at 24.8%, compared with rates ranging from 28.0% to 31.9% for the other age groups, but by 1995-1997 the older women experienced a higher risk of breast cancer death than other postmenopausal women (17.3% vs. 15.4%-16.6%), they said.

The findings demonstrate that both the rate of breast cancer death in the general population and the risk of breast cancer death in newly diagnosed patients decreased two to three times more rapidly for younger women, compared with women aged 75 and older, the investigators said, noting that it appears older women "may have missed out on advances in breast cancer diagnosis and treatment."

"Notably, approximately 40,000 women [aged 75 years or older] are diagnosed with breast cancer each year in the United States ... older women are the most rapidly growing cohort of patients with breast cancer, with 57% growth expected over the next 20 years as the US population ages," they wrote, adding: "Although our data provided reassurance that younger women have experienced substantial gains in breast cancer outcomes as a result of improvements in screening and treatment, these gains do not appear to have fully extended to the oldest 20% of patients with breast cancer."

Of note, the investigators also found race-based disparities in breast cancer outcomes. The findings indicate that, "black women are another sociodemographic group that has not fully reaped the benefits of improved breast cancer outcomes," they said, noting that the race-based gap emerged in the 1980s and continues to increase.

Dr. Smith reported receiving research funding from Varian Medical Systems. Another study author, Dr. Arti Huria, reported receiving research funding from Celgene, GlaxoSmithKline, and Abraxis BioScience, as well as serving as a consultant or in an advisory role for Genentech, Amgen, and GTx. The study was supported in part by a philanthropic gift from Ann Cazalot and Clarence Cazalot.

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

Case reports that have raised concerns about a possible link between drugs used to treat attention-deficit/hyperactivity disorder and an increased risk of serious cardiovascular events, but no evidence of such a link was found in a large retrospective cohort study involving data from more than 1.2 million children and young adults.

Although case reports from adverse-event reporting systems are important for helping to identify safety signals, they cannot be relied upon to quantify risk, and the findings of the current study, which are consistent with several other studies, suggest that risk is low, according to Dr. William O. Cooper of Vanderbilt University, Nashville, Tenn., and his colleagues.

The findings also raise questions about regulatory and policy decisions that followed a number of adverse-event reports in the United States and Canada.

"In Canada, Health Canada removed and then reinstated marketing of extended-release mixed amphetamine salts. In the United States, three different [Food and Drug Administration] advisory committees considered the issue and recommended a black-box warning for stimulants, as well as a medication guide for patients," the investigators wrote online in the Nov. 1 issue of the New England Journal of Medicine.

These and others policies, they wrote, "led to concern and confusion among health care providers, patients, and families about the risks of these drugs."

The current study involved nearly 2.6 million person-years of follow-up, including more than 373,000 person-years of current use of ADHD drugs. Neither current use nor former use was associated with an increased risk for serious cardiovascular events, compared with non-use. The adjusted hazard ratios were 0.75 for current use and 1.03 for former use (N. Engl. J. Med. 2011 Nov. 1 [doi:10.1056/NEJMoa1110212]).

Furthermore, current use was not associated with an increased risk for any individual end points in the study, including sudden cardiac death, acute myocardial infarction, and stroke. The investigators also saw no increase in risk in current users when former users (rather than nonusers) served as the reference group. That yielded an adjusted hazard ratio of 0.70.

The study cohort included participants aged 2 to 24 years in four large health plans. The investigators matched data from computerized health records to state death certificates and the National Death Index to identify serious cardiovascular events. They compared event rates in users of the ADHD drugs methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, atomoxetine, and pemoline, and up to two nonuser controls subjects. In all, there were 3.1 serious cardiovascular events per 100,000 person-years.

The point estimates of the relative risks for ADHD drugs in this study did not indicate increased risk, but the upper limit of the 95% confidence interval suggested that a doubling in the risk could not be ruled out. However, several alternative analyses to test the robustness of the findings supported those of the primary analysis, the investigators explained, concluding that "the absolute magnitude of any increased risk would be low."

The Agency for Healthcare Research and Quality, the Department of Health and Human Services, and the Food and Drug Administration funded the study. Some authors reported disclosures other than grant funding from these organizations, including receiving grant funding or owning stock or stock options from various pharmaceutical companies.

Youth at risk, including those at risk for substance use and those at risk for HIV infection, are the focus of two new policy statements from the American Academy of Pediatrics that aim to improve prevention and outcomes in adolescents.

One of the statements, "Substance Use Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Pediatricians," provides an algorithm-based approach to bolster pediatricians’ confidence and ability to address the matter of substance use with patients in the primary care setting (Pediatrics 2011;128:e1330-40).

Substance use is both common and risky in adolescence, and pediatricians are "ideally suited for preventing problem behaviors and consistently screening for them, including the development of mental health disorder and psychosocial problems, among which are substance use and addiction," according to lead authors Dr. Sharon J.L. Levy and Dr. Patricia K. Kokotailo of the AAP Committee on Substance Abuse.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care," Dr. Levy, director of the adolescent substance abuse program at Children’s Hospital Boston, said in an interview.

"What is unique about this statement is that we reviewed the literature and presented advice on how to use screening results to determine risk level, and we suggested brief, office-based interventions for every level – even positive reinforcement for those who have not initiated substance use," she added.

"HIV testing should be considered a routine part of health care and a step to increased HIV prevention."

The goal of universal SBIRT for adolescents, according to the statement, is to identify an individual’s experience along the spectrum from primary abstinence to addiction for each adolescent at each visit. The policy builds on the AAP’s existing statements on tobacco, alcohol, and other drug use by providing additional guidance and tools for preventing, detecting, and influencing the course of adolescent substance use.

In addition to providing tips and tools for screening, intervening, and referring, the statement also addresses the matter of dual diagnosis, as well as billing and payment issues.

"We hope that this statement will make it easier for pediatricians to not only screen, but use the results for a meaningful clinical interaction targeted at preventing or reducing substance use by teens," said Dr. Levy, also of Harvard Medical School, Boston.

Improving HIV Prevention in Adolescents

Similarly, the authors of "Adolescents and HIV Infection: The Pediatrician’s Role in Promoting Routine Testing" hope their new policy statement will pave the way for improved screening and prevention efforts in adolescents (Pediatrics 2011;128:1023-29).

Lead authors Dr. Patricia J. Emmanuel and Dr. Jaime Martinez of the AAP Committee on Pediatric AIDS noted that despite great progress in treatment and continued efforts to screen targeted populations, more than 1 million Americans were living with HIV in 2006, including 55,320 adolescents and young adults.

Approximately 20% of Americans with HIV are unaware of their infection, and 48% of youth aged 13-24 years with HIV are unaware of their infection, they said, noting that such individuals contribute to more than half of all new HIV infections.

Given these startling statistics, the new policy statement emphasizes the fact that most sexually active youth do not consider themselves to be at risk for contracting HIV, and promotes nonjudgmental risk counseling as a key part of health care visits with adolescents.

In one survey, 65% of high school students reported being sexually active by the 12th grade, and more than 85% had received education about HIV/AIDS, but only 13% had been tested.

Risk assessment and counseling, therefore, are imperative, according to the statement, which emphasizes that to reach youth, a supportive atmosphere and factual, nonjudgmental counseling are essential.

"Pediatricians should provide an environment of tolerance and facilitate open discussions regarding sexual risk and sexual orientation. In addition, physicians should know and recognize the symptoms of HIV, understand state laws regarding testing of youth, and routinely assess patient sexual and substance use behaviors," Dr. Emmanuel, professor of pediatrics and director of the clinical and translational science institute at the University of South Florida, Tampa, said in an interview.

The statement recommends that "routine HIV screening should be offered to all adolescents at least once by 16-18 years of age in health care settings when the prevalence of HIV in the patient population is more than 0.1%."

In areas where the prevalence is 0.1% or lower, routine HIV testing is nonetheless encouraged for all sexually active adolescents, as well as for those with other risk factors, such as substance use. Those at high risk should be tested annually.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care."

The statement also says that adolescents tested for other sexually transmitted infections should be tested for HIV at the same visit, and testing in emergency departments and urgent care settings in high-risk areas can reach youth who do not receive regular preventive services.

The policy statement not only outlines the screening that should take place, but addresses the barriers, both real and perceived, that pediatricians must overcome to promote routine testing, including matters of parental consent, confidentiality, and disclosure.

"This statement is timely because we are seeing increased infections in young males who have sex with men," Dr. Emmanuel said, noting that the fact that a significant proportion of infected patients are unaware of their status not only contributes to the transmission of infection to others, but also puts their health at greater risk because of the damaging impact of untreated HIV infection on the immune system.

"We hope that this statement will increase awareness that HIV continues to be a disease of youth and young adults, and that HIV testing should be considered a routine part of health care and a step to increased HIV prevention," she said, adding: "This statement promotes the goal of making discussions of sexual risk and HIV testing a routine part of adolescent health care."

Any conflicts of interest of members of the AAP committees have been resolved through a process approved by the AAP board of directors, according to the statements.

Youth at risk, including those at risk for substance use and those at risk for HIV infection, are the focus of two new policy statements from the American Academy of Pediatrics that aim to improve prevention and outcomes in adolescents.

One of the statements, "Substance Use Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Pediatricians," provides an algorithm-based approach to bolster pediatricians’ confidence and ability to address the matter of substance use with patients in the primary care setting (Pediatrics 2011;128:e1330-40).

Substance use is both common and risky in adolescence, and pediatricians are "ideally suited for preventing problem behaviors and consistently screening for them, including the development of mental health disorder and psychosocial problems, among which are substance use and addiction," according to lead authors Dr. Sharon J.L. Levy and Dr. Patricia K. Kokotailo of the AAP Committee on Substance Abuse.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care," Dr. Levy, director of the adolescent substance abuse program at Children’s Hospital Boston, said in an interview.

"What is unique about this statement is that we reviewed the literature and presented advice on how to use screening results to determine risk level, and we suggested brief, office-based interventions for every level – even positive reinforcement for those who have not initiated substance use," she added.

"HIV testing should be considered a routine part of health care and a step to increased HIV prevention."

The goal of universal SBIRT for adolescents, according to the statement, is to identify an individual’s experience along the spectrum from primary abstinence to addiction for each adolescent at each visit. The policy builds on the AAP’s existing statements on tobacco, alcohol, and other drug use by providing additional guidance and tools for preventing, detecting, and influencing the course of adolescent substance use.

In addition to providing tips and tools for screening, intervening, and referring, the statement also addresses the matter of dual diagnosis, as well as billing and payment issues.

"We hope that this statement will make it easier for pediatricians to not only screen, but use the results for a meaningful clinical interaction targeted at preventing or reducing substance use by teens," said Dr. Levy, also of Harvard Medical School, Boston.

Improving HIV Prevention in Adolescents

Similarly, the authors of "Adolescents and HIV Infection: The Pediatrician’s Role in Promoting Routine Testing" hope their new policy statement will pave the way for improved screening and prevention efforts in adolescents (Pediatrics 2011;128:1023-29).

Lead authors Dr. Patricia J. Emmanuel and Dr. Jaime Martinez of the AAP Committee on Pediatric AIDS noted that despite great progress in treatment and continued efforts to screen targeted populations, more than 1 million Americans were living with HIV in 2006, including 55,320 adolescents and young adults.

Approximately 20% of Americans with HIV are unaware of their infection, and 48% of youth aged 13-24 years with HIV are unaware of their infection, they said, noting that such individuals contribute to more than half of all new HIV infections.

Given these startling statistics, the new policy statement emphasizes the fact that most sexually active youth do not consider themselves to be at risk for contracting HIV, and promotes nonjudgmental risk counseling as a key part of health care visits with adolescents.

In one survey, 65% of high school students reported being sexually active by the 12th grade, and more than 85% had received education about HIV/AIDS, but only 13% had been tested.

Risk assessment and counseling, therefore, are imperative, according to the statement, which emphasizes that to reach youth, a supportive atmosphere and factual, nonjudgmental counseling are essential.

"Pediatricians should provide an environment of tolerance and facilitate open discussions regarding sexual risk and sexual orientation. In addition, physicians should know and recognize the symptoms of HIV, understand state laws regarding testing of youth, and routinely assess patient sexual and substance use behaviors," Dr. Emmanuel, professor of pediatrics and director of the clinical and translational science institute at the University of South Florida, Tampa, said in an interview.

The statement recommends that "routine HIV screening should be offered to all adolescents at least once by 16-18 years of age in health care settings when the prevalence of HIV in the patient population is more than 0.1%."

In areas where the prevalence is 0.1% or lower, routine HIV testing is nonetheless encouraged for all sexually active adolescents, as well as for those with other risk factors, such as substance use. Those at high risk should be tested annually.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care."

The statement also says that adolescents tested for other sexually transmitted infections should be tested for HIV at the same visit, and testing in emergency departments and urgent care settings in high-risk areas can reach youth who do not receive regular preventive services.

The policy statement not only outlines the screening that should take place, but addresses the barriers, both real and perceived, that pediatricians must overcome to promote routine testing, including matters of parental consent, confidentiality, and disclosure.

"This statement is timely because we are seeing increased infections in young males who have sex with men," Dr. Emmanuel said, noting that the fact that a significant proportion of infected patients are unaware of their status not only contributes to the transmission of infection to others, but also puts their health at greater risk because of the damaging impact of untreated HIV infection on the immune system.

"We hope that this statement will increase awareness that HIV continues to be a disease of youth and young adults, and that HIV testing should be considered a routine part of health care and a step to increased HIV prevention," she said, adding: "This statement promotes the goal of making discussions of sexual risk and HIV testing a routine part of adolescent health care."

Any conflicts of interest of members of the AAP committees have been resolved through a process approved by the AAP board of directors, according to the statements.

Youth at risk, including those at risk for substance use and those at risk for HIV infection, are the focus of two new policy statements from the American Academy of Pediatrics that aim to improve prevention and outcomes in adolescents.

One of the statements, "Substance Use Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Pediatricians," provides an algorithm-based approach to bolster pediatricians’ confidence and ability to address the matter of substance use with patients in the primary care setting (Pediatrics 2011;128:e1330-40).

Substance use is both common and risky in adolescence, and pediatricians are "ideally suited for preventing problem behaviors and consistently screening for them, including the development of mental health disorder and psychosocial problems, among which are substance use and addiction," according to lead authors Dr. Sharon J.L. Levy and Dr. Patricia K. Kokotailo of the AAP Committee on Substance Abuse.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care," Dr. Levy, director of the adolescent substance abuse program at Children’s Hospital Boston, said in an interview.

"What is unique about this statement is that we reviewed the literature and presented advice on how to use screening results to determine risk level, and we suggested brief, office-based interventions for every level – even positive reinforcement for those who have not initiated substance use," she added.

"HIV testing should be considered a routine part of health care and a step to increased HIV prevention."

The goal of universal SBIRT for adolescents, according to the statement, is to identify an individual’s experience along the spectrum from primary abstinence to addiction for each adolescent at each visit. The policy builds on the AAP’s existing statements on tobacco, alcohol, and other drug use by providing additional guidance and tools for preventing, detecting, and influencing the course of adolescent substance use.

In addition to providing tips and tools for screening, intervening, and referring, the statement also addresses the matter of dual diagnosis, as well as billing and payment issues.

"We hope that this statement will make it easier for pediatricians to not only screen, but use the results for a meaningful clinical interaction targeted at preventing or reducing substance use by teens," said Dr. Levy, also of Harvard Medical School, Boston.

Improving HIV Prevention in Adolescents

Similarly, the authors of "Adolescents and HIV Infection: The Pediatrician’s Role in Promoting Routine Testing" hope their new policy statement will pave the way for improved screening and prevention efforts in adolescents (Pediatrics 2011;128:1023-29).

Lead authors Dr. Patricia J. Emmanuel and Dr. Jaime Martinez of the AAP Committee on Pediatric AIDS noted that despite great progress in treatment and continued efforts to screen targeted populations, more than 1 million Americans were living with HIV in 2006, including 55,320 adolescents and young adults.

Approximately 20% of Americans with HIV are unaware of their infection, and 48% of youth aged 13-24 years with HIV are unaware of their infection, they said, noting that such individuals contribute to more than half of all new HIV infections.

Given these startling statistics, the new policy statement emphasizes the fact that most sexually active youth do not consider themselves to be at risk for contracting HIV, and promotes nonjudgmental risk counseling as a key part of health care visits with adolescents.

In one survey, 65% of high school students reported being sexually active by the 12th grade, and more than 85% had received education about HIV/AIDS, but only 13% had been tested.

Risk assessment and counseling, therefore, are imperative, according to the statement, which emphasizes that to reach youth, a supportive atmosphere and factual, nonjudgmental counseling are essential.

"Pediatricians should provide an environment of tolerance and facilitate open discussions regarding sexual risk and sexual orientation. In addition, physicians should know and recognize the symptoms of HIV, understand state laws regarding testing of youth, and routinely assess patient sexual and substance use behaviors," Dr. Emmanuel, professor of pediatrics and director of the clinical and translational science institute at the University of South Florida, Tampa, said in an interview.

The statement recommends that "routine HIV screening should be offered to all adolescents at least once by 16-18 years of age in health care settings when the prevalence of HIV in the patient population is more than 0.1%."

In areas where the prevalence is 0.1% or lower, routine HIV testing is nonetheless encouraged for all sexually active adolescents, as well as for those with other risk factors, such as substance use. Those at high risk should be tested annually.

"The SBIRT policy statement reinforces the recommendation that pediatricians screen all adolescent patients for alcohol and drug use as part of routine medical health care."

The statement also says that adolescents tested for other sexually transmitted infections should be tested for HIV at the same visit, and testing in emergency departments and urgent care settings in high-risk areas can reach youth who do not receive regular preventive services.

The policy statement not only outlines the screening that should take place, but addresses the barriers, both real and perceived, that pediatricians must overcome to promote routine testing, including matters of parental consent, confidentiality, and disclosure.

"This statement is timely because we are seeing increased infections in young males who have sex with men," Dr. Emmanuel said, noting that the fact that a significant proportion of infected patients are unaware of their status not only contributes to the transmission of infection to others, but also puts their health at greater risk because of the damaging impact of untreated HIV infection on the immune system.

"We hope that this statement will increase awareness that HIV continues to be a disease of youth and young adults, and that HIV testing should be considered a routine part of health care and a step to increased HIV prevention," she said, adding: "This statement promotes the goal of making discussions of sexual risk and HIV testing a routine part of adolescent health care."

Any conflicts of interest of members of the AAP committees have been resolved through a process approved by the AAP board of directors, according to the statements.

Compared with usual care, the use of annual chest radiographs as a screening tool for lung cancer did not reduce lung cancer mortality in the large, randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

The results dovetail with findings published earlier this year from the NLST (National Lung Screening Trial), which demonstrated a 20% mortality advantage with computed tomography screening vs. chest radiograph screening (N. Engl. J. Med. 2011;365:395-409), according to Dr. Martin M. Oken of the University of Minnesota, Minneapolis, and his colleagues from the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) Project Team.

It follows that CT screening also has a similar advantage over usual care, the investigators said.

In the PLCO trial, the cumulative incidence rates of lung cancer after 13 years of follow-up were 20.1 and 19.2 per 10,000 person-years in the 77,445 trial participants randomized to receive screening with annual chest radiographs and the 77,456 participants assigned to usual care, respectively (relative risk, 1.05). The number of lung cancer deaths was 1,213 in the radiograph group and 1,230 in the usual care group, for cumulative incidence rates of 14.0 and 14.2 per 10,000 person-years, respectively (RR, 0.99), they reported online in the Oct. 26 issue of JAMA.

The lung cancer mortality relative risks were 0.94 for never smokers, 1.02 for former smokers, and 0.99 for current smokers, and for men and women, respectively, they were 1.02 and 0.92.

In a subset of 15,183 intervention patients and 15,138 usual care patients from the PLCO trial who would have met eligibility criteria for the NLST, which was initiated 9 years after the PLCO trial, the cumulative lung cancer incidence rates per 10,000 person-years through 6 years of follow-up were 60.6 and 60.8 in the groups, respectively, the investigators also noted.

Cumulative lung cancer mortality rates in that subset of patients were 36.1 and 38.3 per 10,000 person-years in the radiograph and usual care groups, respectively (RR, 0.94).

"The corresponding [relative risk] for the total PLCO cohort at 6 years was 1.02 for lung cancer incidence and 0.91 for lung cancer mortality," the investigators said.

The PLCO findings, which were published simultaneously with their presentation at CHEST 2011, not only facilitate interpretation of the NLST results, but also "provide important information about the benefits and harms of annual chest radiographic screening," the investigators said, noting that although there were some modest differences between the PLCO and NLST cohorts, "it seems reasonable to consider the chest radiograph vs. usual care comparison in the NLST-eligible cohort in the PLCO to be an adequate surrogate for such a comparison with NLST (JAMA 2011 Oct. 26 [doi:10.1001/jama.2011.1591]).

"As such, the 20% mortality benefit of low-dose spiral CT vs. chest radiograph observed in NLST is likely a good approximation for the mortality benefit that must have been observed of low-dose spiral CT vs. usual care if this latter group had been added to NLST," they said.

PLCO participants were adults aged 55-74 years who were randomly assigned between November 1993 and July 2001 to receive annual screening with posterior-anterior view chest radiographs for 4 years or usual care, which included their usual medical care with no interventions. Adherence to the assigned screening protocol was 86.6% at baseline and 79%-84% at years 1-3. In the usual care group, an estimated 11% (the "contamination rate") underwent chest radiograph screening.

The primary treatment for lung cancer in both groups was similar: The predominant therapy for stage I and II non–small cell lung cancers was resection without chemotherapy, and for stage III or IV non–small cell lung cancers, the predominant therapy was chemotherapy without resection, the investigators noted.

"The randomized groups in the PLCO were comparable at baseline, there was relatively high screening adherence in the intervention group and low contamination in the usual care group, and the treatment distributions across the groups were similar. Therefore, these findings provide good evidence that there is not a substantial lung cancer mortality benefit from lung cancer screening with 4 annual chest radiographs," the investigators wrote.

The PLCO Cancer Screening Trial was funded by the National Cancer Institute (NCI) and was also supported by contracts from the NCI’s Division of Cancer Prevention and by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics NCI, National Institutes of Health, Department of Health and Human Services. Several authors disclosed potential conflicts of interest, including financial relationships with a number of pharmaceutical companies; the complete list of disclosures is provided in the JAMA article.

Compared with usual care, the use of annual chest radiographs as a screening tool for lung cancer did not reduce lung cancer mortality in the large, randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

The results dovetail with findings published earlier this year from the NLST (National Lung Screening Trial), which demonstrated a 20% mortality advantage with computed tomography screening vs. chest radiograph screening (N. Engl. J. Med. 2011;365:395-409), according to Dr. Martin M. Oken of the University of Minnesota, Minneapolis, and his colleagues from the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) Project Team.

It follows that CT screening also has a similar advantage over usual care, the investigators said.

In the PLCO trial, the cumulative incidence rates of lung cancer after 13 years of follow-up were 20.1 and 19.2 per 10,000 person-years in the 77,445 trial participants randomized to receive screening with annual chest radiographs and the 77,456 participants assigned to usual care, respectively (relative risk, 1.05). The number of lung cancer deaths was 1,213 in the radiograph group and 1,230 in the usual care group, for cumulative incidence rates of 14.0 and 14.2 per 10,000 person-years, respectively (RR, 0.99), they reported online in the Oct. 26 issue of JAMA.

The lung cancer mortality relative risks were 0.94 for never smokers, 1.02 for former smokers, and 0.99 for current smokers, and for men and women, respectively, they were 1.02 and 0.92.

In a subset of 15,183 intervention patients and 15,138 usual care patients from the PLCO trial who would have met eligibility criteria for the NLST, which was initiated 9 years after the PLCO trial, the cumulative lung cancer incidence rates per 10,000 person-years through 6 years of follow-up were 60.6 and 60.8 in the groups, respectively, the investigators also noted.

Cumulative lung cancer mortality rates in that subset of patients were 36.1 and 38.3 per 10,000 person-years in the radiograph and usual care groups, respectively (RR, 0.94).

"The corresponding [relative risk] for the total PLCO cohort at 6 years was 1.02 for lung cancer incidence and 0.91 for lung cancer mortality," the investigators said.

The PLCO findings, which were published simultaneously with their presentation at CHEST 2011, not only facilitate interpretation of the NLST results, but also "provide important information about the benefits and harms of annual chest radiographic screening," the investigators said, noting that although there were some modest differences between the PLCO and NLST cohorts, "it seems reasonable to consider the chest radiograph vs. usual care comparison in the NLST-eligible cohort in the PLCO to be an adequate surrogate for such a comparison with NLST (JAMA 2011 Oct. 26 [doi:10.1001/jama.2011.1591]).

"As such, the 20% mortality benefit of low-dose spiral CT vs. chest radiograph observed in NLST is likely a good approximation for the mortality benefit that must have been observed of low-dose spiral CT vs. usual care if this latter group had been added to NLST," they said.

PLCO participants were adults aged 55-74 years who were randomly assigned between November 1993 and July 2001 to receive annual screening with posterior-anterior view chest radiographs for 4 years or usual care, which included their usual medical care with no interventions. Adherence to the assigned screening protocol was 86.6% at baseline and 79%-84% at years 1-3. In the usual care group, an estimated 11% (the "contamination rate") underwent chest radiograph screening.

The primary treatment for lung cancer in both groups was similar: The predominant therapy for stage I and II non–small cell lung cancers was resection without chemotherapy, and for stage III or IV non–small cell lung cancers, the predominant therapy was chemotherapy without resection, the investigators noted.

"The randomized groups in the PLCO were comparable at baseline, there was relatively high screening adherence in the intervention group and low contamination in the usual care group, and the treatment distributions across the groups were similar. Therefore, these findings provide good evidence that there is not a substantial lung cancer mortality benefit from lung cancer screening with 4 annual chest radiographs," the investigators wrote.

The PLCO Cancer Screening Trial was funded by the National Cancer Institute (NCI) and was also supported by contracts from the NCI’s Division of Cancer Prevention and by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics NCI, National Institutes of Health, Department of Health and Human Services. Several authors disclosed potential conflicts of interest, including financial relationships with a number of pharmaceutical companies; the complete list of disclosures is provided in the JAMA article.

Compared with usual care, the use of annual chest radiographs as a screening tool for lung cancer did not reduce lung cancer mortality in the large, randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

The results dovetail with findings published earlier this year from the NLST (National Lung Screening Trial), which demonstrated a 20% mortality advantage with computed tomography screening vs. chest radiograph screening (N. Engl. J. Med. 2011;365:395-409), according to Dr. Martin M. Oken of the University of Minnesota, Minneapolis, and his colleagues from the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) Project Team.

It follows that CT screening also has a similar advantage over usual care, the investigators said.

In the PLCO trial, the cumulative incidence rates of lung cancer after 13 years of follow-up were 20.1 and 19.2 per 10,000 person-years in the 77,445 trial participants randomized to receive screening with annual chest radiographs and the 77,456 participants assigned to usual care, respectively (relative risk, 1.05). The number of lung cancer deaths was 1,213 in the radiograph group and 1,230 in the usual care group, for cumulative incidence rates of 14.0 and 14.2 per 10,000 person-years, respectively (RR, 0.99), they reported online in the Oct. 26 issue of JAMA.

The lung cancer mortality relative risks were 0.94 for never smokers, 1.02 for former smokers, and 0.99 for current smokers, and for men and women, respectively, they were 1.02 and 0.92.

In a subset of 15,183 intervention patients and 15,138 usual care patients from the PLCO trial who would have met eligibility criteria for the NLST, which was initiated 9 years after the PLCO trial, the cumulative lung cancer incidence rates per 10,000 person-years through 6 years of follow-up were 60.6 and 60.8 in the groups, respectively, the investigators also noted.

Cumulative lung cancer mortality rates in that subset of patients were 36.1 and 38.3 per 10,000 person-years in the radiograph and usual care groups, respectively (RR, 0.94).

"The corresponding [relative risk] for the total PLCO cohort at 6 years was 1.02 for lung cancer incidence and 0.91 for lung cancer mortality," the investigators said.

The PLCO findings, which were published simultaneously with their presentation at CHEST 2011, not only facilitate interpretation of the NLST results, but also "provide important information about the benefits and harms of annual chest radiographic screening," the investigators said, noting that although there were some modest differences between the PLCO and NLST cohorts, "it seems reasonable to consider the chest radiograph vs. usual care comparison in the NLST-eligible cohort in the PLCO to be an adequate surrogate for such a comparison with NLST (JAMA 2011 Oct. 26 [doi:10.1001/jama.2011.1591]).

"As such, the 20% mortality benefit of low-dose spiral CT vs. chest radiograph observed in NLST is likely a good approximation for the mortality benefit that must have been observed of low-dose spiral CT vs. usual care if this latter group had been added to NLST," they said.

PLCO participants were adults aged 55-74 years who were randomly assigned between November 1993 and July 2001 to receive annual screening with posterior-anterior view chest radiographs for 4 years or usual care, which included their usual medical care with no interventions. Adherence to the assigned screening protocol was 86.6% at baseline and 79%-84% at years 1-3. In the usual care group, an estimated 11% (the "contamination rate") underwent chest radiograph screening.

The primary treatment for lung cancer in both groups was similar: The predominant therapy for stage I and II non–small cell lung cancers was resection without chemotherapy, and for stage III or IV non–small cell lung cancers, the predominant therapy was chemotherapy without resection, the investigators noted.

"The randomized groups in the PLCO were comparable at baseline, there was relatively high screening adherence in the intervention group and low contamination in the usual care group, and the treatment distributions across the groups were similar. Therefore, these findings provide good evidence that there is not a substantial lung cancer mortality benefit from lung cancer screening with 4 annual chest radiographs," the investigators wrote.

The PLCO Cancer Screening Trial was funded by the National Cancer Institute (NCI) and was also supported by contracts from the NCI’s Division of Cancer Prevention and by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics NCI, National Institutes of Health, Department of Health and Human Services. Several authors disclosed potential conflicts of interest, including financial relationships with a number of pharmaceutical companies; the complete list of disclosures is provided in the JAMA article.

Use of a Foley catheter for labor induction in women with an unfavorable cervix at term resulted in a similar cesarean section rate to use of prostaglandin E2 gel for labor induction, but with fewer maternal and neonatal side effects, according to findings from an open-label randomized controlled trial involving more than 800 women.

Cesarean section, most often done for failure to progress during the first stage of labor, was performed in 23% of 411 women induced using a Foley catheter, and in 20% of 408 women induced using vaginal prostaglandin E2 gel (relative risk, 1.13), Dr. Marta Jozwiak of Groene Hart Hospital, Gouda, the Netherlands, and her colleagues from the PROBAAT Study Group reported online in the Oct. 25 issue of The Lancet.

The frequency of vaginal instrumental deliveries was similar in the two groups as well (11% and 13% in the Foley catheter and prostaglandin E2 groups, respectively), the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)61484-0]).

Two serious maternal adverse events occurred, both in the prostaglandin group. These included one uterine perforation after insertion of an intrauterine pressure catheter and one uterine rupture during oxytocin augmentation, they said, noting that both neonates were born in good clinical condition, but were admitted to the neonatal ward with suspected infection.

Four minor maternal adverse events occurred, including three allergic reactions (in one woman in the Foley catheter group and in two women in the prostaglandin E2 group), and blood loss on a second insertion of the catheter in one woman. Also, the rate of suspected intrapartum infection was significantly lower in the Foley catheter group (1% vs. 3%).

As for neonatal adverse events, the rate of admissions to the neonatal ward was significantly higher in the prostaglandin E2 group (12% vs. 20%), Dr. Jozwiak and her associates said.

Patients in the PROBAAT trial included women beyond 37 weeks’ gestation with a singleton pregnancy in cephalic presentation, with intact membranes and an unfavorable cervix as defined by a Bishop score less than 6. The women were enrolled at 12 centers throughout the Netherlands between Feb. 10, 2009 and May 17, 2010, and all had an indication for labor induction, and had no prior cesarean sections.

The findings in regard to cesarean section rates when labor induction is performed using a Foley catheter vs. prostaglandin E2 were confirmed by a meta-analysis that included data from this study. The meta-analysis also demonstrated that Foley catheter induction was associated with reduced rates of hyperstimulation (odds ratio, 0.44) and postpartum hemorrhage (OR, 0.60), the investigators reported, noting that although the use of a Foley catheter for labor induction did not increase the vaginal delivery rate when compared with use of prostaglandin E2 as they had hypothesized, the findings nonetheless support the use of Foley catheters.

"After induction with a Foley catheter, the overall number of operative deliveries for suspected fetal distress was lower, fewer mothers were treated with intrapartum antibiotics, and significantly fewer neonates were admitted to the neonatal ward," they said, adding: "We therefore think that a Foley catheter should be considered for induction of labor in women with an unfavorable cervix at term."

Also, in light of the low cost and easy storage of Foley catheters, their use could be suitable for developing countries and low-resource settings, Dr. Jozwiak and her associates noted.

Future studies should compare the use of Foley catheters with other prostaglandin preparations such as prostaglandin E1 (misoprostol) which is becoming increasingly popular worldwide, and should evaluate the use of Foley catheters in women with a prior cesarean section, they suggested.

The study’s findings could have important implications for women with a prior cesarean section, said Dr. Jane E. Norman and Dr. Sarah Stock, of the MRC Centre for Reproductive Health and the Queen’s Medical Research Center at the University of Edinburgh.

In these women, induction with prostaglandins is associated with uterine rupture, they noted in an editorial accompanying the article, explaining that prostaglandins affect both cervical ripening and contractions simultaneously, whereas the ideal strategy for induction is likely administration of a cervical ripening agent before stimulation of contractions. This, they argue, would decrease the need for fetal monitoring during ripening and reduce the risk of uterine rupture (Lancet 2011 [doi:10.1016/S0140-6736(11)61581-X]).

"Although women with a previous cesarean section were excluded from Jozwiak and colleagues’ study, a Foley catheter could be the ideal induction agent in this situation and should be assessed further in randomized trials," they said, adding that if such trials are done, avoidance of maternal and neonatal mortality and morbidity should be included as primary outcome measures, as they are "arguably as important as speed and avoidance of cesarean section."

Dr. Jozwiak and her associates said they had no relevant financial disclosures. Dr. Norman reported receiving fees for acting as a consultant for Preglem and is an unpaid member of an advisory board for Hologic. Dr. Stock had no relevant financial disclosures.

Use of a Foley catheter for labor induction in women with an unfavorable cervix at term resulted in a similar cesarean section rate to use of prostaglandin E2 gel for labor induction, but with fewer maternal and neonatal side effects, according to findings from an open-label randomized controlled trial involving more than 800 women.

Cesarean section, most often done for failure to progress during the first stage of labor, was performed in 23% of 411 women induced using a Foley catheter, and in 20% of 408 women induced using vaginal prostaglandin E2 gel (relative risk, 1.13), Dr. Marta Jozwiak of Groene Hart Hospital, Gouda, the Netherlands, and her colleagues from the PROBAAT Study Group reported online in the Oct. 25 issue of The Lancet.

The frequency of vaginal instrumental deliveries was similar in the two groups as well (11% and 13% in the Foley catheter and prostaglandin E2 groups, respectively), the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)61484-0]).

Two serious maternal adverse events occurred, both in the prostaglandin group. These included one uterine perforation after insertion of an intrauterine pressure catheter and one uterine rupture during oxytocin augmentation, they said, noting that both neonates were born in good clinical condition, but were admitted to the neonatal ward with suspected infection.

Four minor maternal adverse events occurred, including three allergic reactions (in one woman in the Foley catheter group and in two women in the prostaglandin E2 group), and blood loss on a second insertion of the catheter in one woman. Also, the rate of suspected intrapartum infection was significantly lower in the Foley catheter group (1% vs. 3%).

As for neonatal adverse events, the rate of admissions to the neonatal ward was significantly higher in the prostaglandin E2 group (12% vs. 20%), Dr. Jozwiak and her associates said.

Patients in the PROBAAT trial included women beyond 37 weeks’ gestation with a singleton pregnancy in cephalic presentation, with intact membranes and an unfavorable cervix as defined by a Bishop score less than 6. The women were enrolled at 12 centers throughout the Netherlands between Feb. 10, 2009 and May 17, 2010, and all had an indication for labor induction, and had no prior cesarean sections.

The findings in regard to cesarean section rates when labor induction is performed using a Foley catheter vs. prostaglandin E2 were confirmed by a meta-analysis that included data from this study. The meta-analysis also demonstrated that Foley catheter induction was associated with reduced rates of hyperstimulation (odds ratio, 0.44) and postpartum hemorrhage (OR, 0.60), the investigators reported, noting that although the use of a Foley catheter for labor induction did not increase the vaginal delivery rate when compared with use of prostaglandin E2 as they had hypothesized, the findings nonetheless support the use of Foley catheters.

"After induction with a Foley catheter, the overall number of operative deliveries for suspected fetal distress was lower, fewer mothers were treated with intrapartum antibiotics, and significantly fewer neonates were admitted to the neonatal ward," they said, adding: "We therefore think that a Foley catheter should be considered for induction of labor in women with an unfavorable cervix at term."

Also, in light of the low cost and easy storage of Foley catheters, their use could be suitable for developing countries and low-resource settings, Dr. Jozwiak and her associates noted.

Future studies should compare the use of Foley catheters with other prostaglandin preparations such as prostaglandin E1 (misoprostol) which is becoming increasingly popular worldwide, and should evaluate the use of Foley catheters in women with a prior cesarean section, they suggested.

The study’s findings could have important implications for women with a prior cesarean section, said Dr. Jane E. Norman and Dr. Sarah Stock, of the MRC Centre for Reproductive Health and the Queen’s Medical Research Center at the University of Edinburgh.

In these women, induction with prostaglandins is associated with uterine rupture, they noted in an editorial accompanying the article, explaining that prostaglandins affect both cervical ripening and contractions simultaneously, whereas the ideal strategy for induction is likely administration of a cervical ripening agent before stimulation of contractions. This, they argue, would decrease the need for fetal monitoring during ripening and reduce the risk of uterine rupture (Lancet 2011 [doi:10.1016/S0140-6736(11)61581-X]).

"Although women with a previous cesarean section were excluded from Jozwiak and colleagues’ study, a Foley catheter could be the ideal induction agent in this situation and should be assessed further in randomized trials," they said, adding that if such trials are done, avoidance of maternal and neonatal mortality and morbidity should be included as primary outcome measures, as they are "arguably as important as speed and avoidance of cesarean section."

Dr. Jozwiak and her associates said they had no relevant financial disclosures. Dr. Norman reported receiving fees for acting as a consultant for Preglem and is an unpaid member of an advisory board for Hologic. Dr. Stock had no relevant financial disclosures.

Use of a Foley catheter for labor induction in women with an unfavorable cervix at term resulted in a similar cesarean section rate to use of prostaglandin E2 gel for labor induction, but with fewer maternal and neonatal side effects, according to findings from an open-label randomized controlled trial involving more than 800 women.

Cesarean section, most often done for failure to progress during the first stage of labor, was performed in 23% of 411 women induced using a Foley catheter, and in 20% of 408 women induced using vaginal prostaglandin E2 gel (relative risk, 1.13), Dr. Marta Jozwiak of Groene Hart Hospital, Gouda, the Netherlands, and her colleagues from the PROBAAT Study Group reported online in the Oct. 25 issue of The Lancet.

The frequency of vaginal instrumental deliveries was similar in the two groups as well (11% and 13% in the Foley catheter and prostaglandin E2 groups, respectively), the investigators said (Lancet 2011 [doi:10.1016/S0140-6736(11)61484-0]).

Two serious maternal adverse events occurred, both in the prostaglandin group. These included one uterine perforation after insertion of an intrauterine pressure catheter and one uterine rupture during oxytocin augmentation, they said, noting that both neonates were born in good clinical condition, but were admitted to the neonatal ward with suspected infection.

Four minor maternal adverse events occurred, including three allergic reactions (in one woman in the Foley catheter group and in two women in the prostaglandin E2 group), and blood loss on a second insertion of the catheter in one woman. Also, the rate of suspected intrapartum infection was significantly lower in the Foley catheter group (1% vs. 3%).

As for neonatal adverse events, the rate of admissions to the neonatal ward was significantly higher in the prostaglandin E2 group (12% vs. 20%), Dr. Jozwiak and her associates said.

Patients in the PROBAAT trial included women beyond 37 weeks’ gestation with a singleton pregnancy in cephalic presentation, with intact membranes and an unfavorable cervix as defined by a Bishop score less than 6. The women were enrolled at 12 centers throughout the Netherlands between Feb. 10, 2009 and May 17, 2010, and all had an indication for labor induction, and had no prior cesarean sections.

The findings in regard to cesarean section rates when labor induction is performed using a Foley catheter vs. prostaglandin E2 were confirmed by a meta-analysis that included data from this study. The meta-analysis also demonstrated that Foley catheter induction was associated with reduced rates of hyperstimulation (odds ratio, 0.44) and postpartum hemorrhage (OR, 0.60), the investigators reported, noting that although the use of a Foley catheter for labor induction did not increase the vaginal delivery rate when compared with use of prostaglandin E2 as they had hypothesized, the findings nonetheless support the use of Foley catheters.

"After induction with a Foley catheter, the overall number of operative deliveries for suspected fetal distress was lower, fewer mothers were treated with intrapartum antibiotics, and significantly fewer neonates were admitted to the neonatal ward," they said, adding: "We therefore think that a Foley catheter should be considered for induction of labor in women with an unfavorable cervix at term."

Also, in light of the low cost and easy storage of Foley catheters, their use could be suitable for developing countries and low-resource settings, Dr. Jozwiak and her associates noted.

Future studies should compare the use of Foley catheters with other prostaglandin preparations such as prostaglandin E1 (misoprostol) which is becoming increasingly popular worldwide, and should evaluate the use of Foley catheters in women with a prior cesarean section, they suggested.

The study’s findings could have important implications for women with a prior cesarean section, said Dr. Jane E. Norman and Dr. Sarah Stock, of the MRC Centre for Reproductive Health and the Queen’s Medical Research Center at the University of Edinburgh.

In these women, induction with prostaglandins is associated with uterine rupture, they noted in an editorial accompanying the article, explaining that prostaglandins affect both cervical ripening and contractions simultaneously, whereas the ideal strategy for induction is likely administration of a cervical ripening agent before stimulation of contractions. This, they argue, would decrease the need for fetal monitoring during ripening and reduce the risk of uterine rupture (Lancet 2011 [doi:10.1016/S0140-6736(11)61581-X]).

"Although women with a previous cesarean section were excluded from Jozwiak and colleagues’ study, a Foley catheter could be the ideal induction agent in this situation and should be assessed further in randomized trials," they said, adding that if such trials are done, avoidance of maternal and neonatal mortality and morbidity should be included as primary outcome measures, as they are "arguably as important as speed and avoidance of cesarean section."

Dr. Jozwiak and her associates said they had no relevant financial disclosures. Dr. Norman reported receiving fees for acting as a consultant for Preglem and is an unpaid member of an advisory board for Hologic. Dr. Stock had no relevant financial disclosures.

A 2-cm resection margin resulted in the same 5-year overall survival and recurrence-free survival as did a 4-cm margin in a randomized controlled trial of more than 900 patients with cutaneous melanoma thicker than 2 mm.

The findings suggest that in patients with thicker melanomas, a 2-cm margin is safe and sufficient, according to Dr. Peter Gillgren of Karolinska Institute, Stockholm, and Stockholm Söder Hospital and his colleagues.

At a median follow-up of 6.7 years, the 5-year overall survival was 65% in 465 patients randomized to treatment with a 2-cm surgical resection margin, as well as in 471 patients randomized to treatment with a 4-cm resection margin. Recurrence-free survival at 5 years was 56% in both groups, and 10-year survival was 50% in both groups, the investigators reported (Lancet 2011 Oct. 24 [doi:10.1016/S0140-6736(11)61546-8]).

"The failure to clear genetically abnormal melanocytes with an adequately wide excision might be the precursor to locoregional recurrence."

Surgical resection margin size in patients with cutaneous melanoma thicker than 2 mm has been a point of controversy, largely due to a paucity of data comparing outcomes based on margin size, but most international guidelines suggest an excision margin of 2-3 cm for thick melanomas, the investigators noted. "A trade-off exists between a wide excision, with consequent surgical difficulties, and the relapse risk with a narrow excision, which could compromise disease-free survival, or worse, overall survival," they wrote.

However, the findings of this study indicate that not only is survival similar with 2-cm and 4-cm margins, but that the smaller margin size also improves the likelihood of skin closure without skin grafting or skin flaps. Primary closure was possible in 69% vs. 37% of patients in the 2-cm and 4-cm groups, respectively, while split skin grafts were used in 12% and 47% of the patients in the two groups. And surgical flaps were used in 4% and 6% of patients in the two groups, noted the investigators.

Patients in this study, which was launched by the Swedish Melanoma Study Group in cooperation with the Danish Melanoma Group, were adults aged 75 years or younger with a primary cutaneous melanoma thicker than 2 mm and with clinically localized disease on the trunk or upper or lower extremities. Patients were enrolled from Jan. 22, 1992, to May 19, 2004. One patient in each group was lost to follow-up but was included in the analysis.

Despite some limitations, such as protocol violations in 15% of cases and the fact that the study was planned as an equivalency trial that was to include 2,000 patients, the investigators noted that the study is the largest randomized controlled trial to date of resection margins for thick melanomas, and that they believe the results provide "the best evidence yet about the size of surgical excision margins."

"We show that with a surgical margin of 2 cm, the skin can be closed without skin grafting or skin flaps in most cases," they wrote, noting that previous data have already shown that hospital stay is longer in patients treated with a 4-cm margin, and that complication rates are higher in patients treated with split skin grafts, compared with primary sutures.

A meta-analysis of all randomized trials of cutaneous melanoma thicker than 2 mm should be conducted, they concluded.

The study was funded by the Swedish Cancer Society and the Stockholm Cancer Society. The authors reported having no relevant financial disclosures.

A 2-cm resection margin resulted in the same 5-year overall survival and recurrence-free survival as did a 4-cm margin in a randomized controlled trial of more than 900 patients with cutaneous melanoma thicker than 2 mm.

The findings suggest that in patients with thicker melanomas, a 2-cm margin is safe and sufficient, according to Dr. Peter Gillgren of Karolinska Institute, Stockholm, and Stockholm Söder Hospital and his colleagues.

At a median follow-up of 6.7 years, the 5-year overall survival was 65% in 465 patients randomized to treatment with a 2-cm surgical resection margin, as well as in 471 patients randomized to treatment with a 4-cm resection margin. Recurrence-free survival at 5 years was 56% in both groups, and 10-year survival was 50% in both groups, the investigators reported (Lancet 2011 Oct. 24 [doi:10.1016/S0140-6736(11)61546-8]).

"The failure to clear genetically abnormal melanocytes with an adequately wide excision might be the precursor to locoregional recurrence."

Surgical resection margin size in patients with cutaneous melanoma thicker than 2 mm has been a point of controversy, largely due to a paucity of data comparing outcomes based on margin size, but most international guidelines suggest an excision margin of 2-3 cm for thick melanomas, the investigators noted. "A trade-off exists between a wide excision, with consequent surgical difficulties, and the relapse risk with a narrow excision, which could compromise disease-free survival, or worse, overall survival," they wrote.

However, the findings of this study indicate that not only is survival similar with 2-cm and 4-cm margins, but that the smaller margin size also improves the likelihood of skin closure without skin grafting or skin flaps. Primary closure was possible in 69% vs. 37% of patients in the 2-cm and 4-cm groups, respectively, while split skin grafts were used in 12% and 47% of the patients in the two groups. And surgical flaps were used in 4% and 6% of patients in the two groups, noted the investigators.

Patients in this study, which was launched by the Swedish Melanoma Study Group in cooperation with the Danish Melanoma Group, were adults aged 75 years or younger with a primary cutaneous melanoma thicker than 2 mm and with clinically localized disease on the trunk or upper or lower extremities. Patients were enrolled from Jan. 22, 1992, to May 19, 2004. One patient in each group was lost to follow-up but was included in the analysis.

Despite some limitations, such as protocol violations in 15% of cases and the fact that the study was planned as an equivalency trial that was to include 2,000 patients, the investigators noted that the study is the largest randomized controlled trial to date of resection margins for thick melanomas, and that they believe the results provide "the best evidence yet about the size of surgical excision margins."

"We show that with a surgical margin of 2 cm, the skin can be closed without skin grafting or skin flaps in most cases," they wrote, noting that previous data have already shown that hospital stay is longer in patients treated with a 4-cm margin, and that complication rates are higher in patients treated with split skin grafts, compared with primary sutures.

A meta-analysis of all randomized trials of cutaneous melanoma thicker than 2 mm should be conducted, they concluded.

The study was funded by the Swedish Cancer Society and the Stockholm Cancer Society. The authors reported having no relevant financial disclosures.

A 2-cm resection margin resulted in the same 5-year overall survival and recurrence-free survival as did a 4-cm margin in a randomized controlled trial of more than 900 patients with cutaneous melanoma thicker than 2 mm.

The findings suggest that in patients with thicker melanomas, a 2-cm margin is safe and sufficient, according to Dr. Peter Gillgren of Karolinska Institute, Stockholm, and Stockholm Söder Hospital and his colleagues.

At a median follow-up of 6.7 years, the 5-year overall survival was 65% in 465 patients randomized to treatment with a 2-cm surgical resection margin, as well as in 471 patients randomized to treatment with a 4-cm resection margin. Recurrence-free survival at 5 years was 56% in both groups, and 10-year survival was 50% in both groups, the investigators reported (Lancet 2011 Oct. 24 [doi:10.1016/S0140-6736(11)61546-8]).

"The failure to clear genetically abnormal melanocytes with an adequately wide excision might be the precursor to locoregional recurrence."

Surgical resection margin size in patients with cutaneous melanoma thicker than 2 mm has been a point of controversy, largely due to a paucity of data comparing outcomes based on margin size, but most international guidelines suggest an excision margin of 2-3 cm for thick melanomas, the investigators noted. "A trade-off exists between a wide excision, with consequent surgical difficulties, and the relapse risk with a narrow excision, which could compromise disease-free survival, or worse, overall survival," they wrote.

However, the findings of this study indicate that not only is survival similar with 2-cm and 4-cm margins, but that the smaller margin size also improves the likelihood of skin closure without skin grafting or skin flaps. Primary closure was possible in 69% vs. 37% of patients in the 2-cm and 4-cm groups, respectively, while split skin grafts were used in 12% and 47% of the patients in the two groups. And surgical flaps were used in 4% and 6% of patients in the two groups, noted the investigators.

Patients in this study, which was launched by the Swedish Melanoma Study Group in cooperation with the Danish Melanoma Group, were adults aged 75 years or younger with a primary cutaneous melanoma thicker than 2 mm and with clinically localized disease on the trunk or upper or lower extremities. Patients were enrolled from Jan. 22, 1992, to May 19, 2004. One patient in each group was lost to follow-up but was included in the analysis.

Despite some limitations, such as protocol violations in 15% of cases and the fact that the study was planned as an equivalency trial that was to include 2,000 patients, the investigators noted that the study is the largest randomized controlled trial to date of resection margins for thick melanomas, and that they believe the results provide "the best evidence yet about the size of surgical excision margins."

"We show that with a surgical margin of 2 cm, the skin can be closed without skin grafting or skin flaps in most cases," they wrote, noting that previous data have already shown that hospital stay is longer in patients treated with a 4-cm margin, and that complication rates are higher in patients treated with split skin grafts, compared with primary sutures.

A meta-analysis of all randomized trials of cutaneous melanoma thicker than 2 mm should be conducted, they concluded.

The study was funded by the Swedish Cancer Society and the Stockholm Cancer Society. The authors reported having no relevant financial disclosures.

Patients with inflammatory bowel disease who undergo surgery have a twofold increase in the risk of deep vein thrombosis or pulmonary embolism, compared with those without IBD, and the risk is even greater among those with IBD who undergo nonintestinal surgery, according to findings from the American College of Surgeons National Surgical Quality Improvement Program.

In a retrospective cohort study of nearly 269,000 patients from the National Surgical Quality Improvement Program (NSQIP) 2008, 2,249 (0.8%) had IBD. Deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred in 1% of those without IBD, in 2.5% of those with IBD, and in 5% of those with IBD who underwent nonintestinal surgery.

Dr. Andrea Merrill of Massachusetts General Hospital and Dr. Frederick Millham of Newton Wellesley Hospital, both in Boston, reported the research online in the Oct. 17 issue of Archives of Surgery. The findings suggest that the standard DVT and PE prophylaxis for patients undergoing surgery should be reconsidered for those with IBD, they concluded.

After adjustment for more than 30 possible confounders available in the NSQIP that add to the power to predict DVT or PE, a significant association remained between IBD and DVT or PE overall (odds ratio, 2.03) and among those undergoing nonintestinal surgery (OR, 4.45), the investigators found (Arch. Surg. 2011 Oct. 17 [doi:10.1001/archsurg.2011.297]).

No difference was seen between the patients with and without IBD in regard to the occurrence of cerebrovascular accident or myocardial infarction, with 0.4% of patients in both groups experiencing such events.

Although IBD has long been known to be associated with an increased risk of thromboembolic events, data on those undergoing surgery has been scarce, and standard DVT and PE prophylaxis guidelines in the IBD population have not been adjusted to include enhanced prophylaxis.

In light of one recent study suggesting a very high risk of postoperative DVT in those undergoing surgery, the investigators sought to evaluate the risk among IBD patients in the NSQIP, which collected data from 170 hospitals in 2008, resulting in a Participant Use Data File (PUF). The de-identified research database is made available to the participating hospitals.

"As such, the NSQIP PUF data set presents an opportunity to examine the relationship of DVT and PE with IBD in a large group of patients for whom data on comorbid conditions and other potential confounding variables are available and well defined. Furthermore, hospitals participating in the NSQIP, having invested in quality improvement, might be expected to treat patients with best practices, at least with respect to DVT prophylaxis," the investigators said, explaining that this would reduce the opportunity for treatment bias between centers.

The finding of an increased risk of DVT or PE in IBD patients was consistent with others in both surgical and nonsurgical IBD patients, they found.

An exception is with the lethality of DVT or PE in the setting of IBD. One prior study demonstrated an increased risk of death among IBD patients with DVT or PE, but the investigators of the current study found no support for this finding. Mortality occurred in 8.6% and 8.8% of those without IBD who had DVT or PE, and those with IBD who had DVT or PE, respectively.

They also found no support for one prior study’s finding of an increased risk of arterial thromboembolic events in patients with IBD, but they noted that the current study may have been limited by the lack of data on arterial thrombotic events not involving the coronary or cerebral vessels.

"It may be that if arterial thromboembolism were a reported NSQIP complication, such a relationship would appear," they said.

Although this study is limited by the fact that the NSQIP was designed to compare overall outcomes across many hospitals rather than to answer specific research questions regarding specific diseases or procedures, its strengths – namely the fact that the data were gathered by specially trained nurses who were accountable to a rigid quality-assurance program, and who were working from a well-defined data dictionary – likely outweigh any potential sources of bias, they said.

The authors reported that they had no disclosures.

Patients with inflammatory bowel disease who undergo surgery have a twofold increase in the risk of deep vein thrombosis or pulmonary embolism, compared with those without IBD, and the risk is even greater among those with IBD who undergo nonintestinal surgery, according to findings from the American College of Surgeons National Surgical Quality Improvement Program.

In a retrospective cohort study of nearly 269,000 patients from the National Surgical Quality Improvement Program (NSQIP) 2008, 2,249 (0.8%) had IBD. Deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred in 1% of those without IBD, in 2.5% of those with IBD, and in 5% of those with IBD who underwent nonintestinal surgery.

Dr. Andrea Merrill of Massachusetts General Hospital and Dr. Frederick Millham of Newton Wellesley Hospital, both in Boston, reported the research online in the Oct. 17 issue of Archives of Surgery. The findings suggest that the standard DVT and PE prophylaxis for patients undergoing surgery should be reconsidered for those with IBD, they concluded.

After adjustment for more than 30 possible confounders available in the NSQIP that add to the power to predict DVT or PE, a significant association remained between IBD and DVT or PE overall (odds ratio, 2.03) and among those undergoing nonintestinal surgery (OR, 4.45), the investigators found (Arch. Surg. 2011 Oct. 17 [doi:10.1001/archsurg.2011.297]).

No difference was seen between the patients with and without IBD in regard to the occurrence of cerebrovascular accident or myocardial infarction, with 0.4% of patients in both groups experiencing such events.

Although IBD has long been known to be associated with an increased risk of thromboembolic events, data on those undergoing surgery has been scarce, and standard DVT and PE prophylaxis guidelines in the IBD population have not been adjusted to include enhanced prophylaxis.

In light of one recent study suggesting a very high risk of postoperative DVT in those undergoing surgery, the investigators sought to evaluate the risk among IBD patients in the NSQIP, which collected data from 170 hospitals in 2008, resulting in a Participant Use Data File (PUF). The de-identified research database is made available to the participating hospitals.

"As such, the NSQIP PUF data set presents an opportunity to examine the relationship of DVT and PE with IBD in a large group of patients for whom data on comorbid conditions and other potential confounding variables are available and well defined. Furthermore, hospitals participating in the NSQIP, having invested in quality improvement, might be expected to treat patients with best practices, at least with respect to DVT prophylaxis," the investigators said, explaining that this would reduce the opportunity for treatment bias between centers.

The finding of an increased risk of DVT or PE in IBD patients was consistent with others in both surgical and nonsurgical IBD patients, they found.

An exception is with the lethality of DVT or PE in the setting of IBD. One prior study demonstrated an increased risk of death among IBD patients with DVT or PE, but the investigators of the current study found no support for this finding. Mortality occurred in 8.6% and 8.8% of those without IBD who had DVT or PE, and those with IBD who had DVT or PE, respectively.

They also found no support for one prior study’s finding of an increased risk of arterial thromboembolic events in patients with IBD, but they noted that the current study may have been limited by the lack of data on arterial thrombotic events not involving the coronary or cerebral vessels.

"It may be that if arterial thromboembolism were a reported NSQIP complication, such a relationship would appear," they said.

Although this study is limited by the fact that the NSQIP was designed to compare overall outcomes across many hospitals rather than to answer specific research questions regarding specific diseases or procedures, its strengths – namely the fact that the data were gathered by specially trained nurses who were accountable to a rigid quality-assurance program, and who were working from a well-defined data dictionary – likely outweigh any potential sources of bias, they said.

The authors reported that they had no disclosures.

Patients with inflammatory bowel disease who undergo surgery have a twofold increase in the risk of deep vein thrombosis or pulmonary embolism, compared with those without IBD, and the risk is even greater among those with IBD who undergo nonintestinal surgery, according to findings from the American College of Surgeons National Surgical Quality Improvement Program.

In a retrospective cohort study of nearly 269,000 patients from the National Surgical Quality Improvement Program (NSQIP) 2008, 2,249 (0.8%) had IBD. Deep vein thrombosis (DVT) or pulmonary embolism (PE) occurred in 1% of those without IBD, in 2.5% of those with IBD, and in 5% of those with IBD who underwent nonintestinal surgery.

Dr. Andrea Merrill of Massachusetts General Hospital and Dr. Frederick Millham of Newton Wellesley Hospital, both in Boston, reported the research online in the Oct. 17 issue of Archives of Surgery. The findings suggest that the standard DVT and PE prophylaxis for patients undergoing surgery should be reconsidered for those with IBD, they concluded.

After adjustment for more than 30 possible confounders available in the NSQIP that add to the power to predict DVT or PE, a significant association remained between IBD and DVT or PE overall (odds ratio, 2.03) and among those undergoing nonintestinal surgery (OR, 4.45), the investigators found (Arch. Surg. 2011 Oct. 17 [doi:10.1001/archsurg.2011.297]).

No difference was seen between the patients with and without IBD in regard to the occurrence of cerebrovascular accident or myocardial infarction, with 0.4% of patients in both groups experiencing such events.

Although IBD has long been known to be associated with an increased risk of thromboembolic events, data on those undergoing surgery has been scarce, and standard DVT and PE prophylaxis guidelines in the IBD population have not been adjusted to include enhanced prophylaxis.

In light of one recent study suggesting a very high risk of postoperative DVT in those undergoing surgery, the investigators sought to evaluate the risk among IBD patients in the NSQIP, which collected data from 170 hospitals in 2008, resulting in a Participant Use Data File (PUF). The de-identified research database is made available to the participating hospitals.

"As such, the NSQIP PUF data set presents an opportunity to examine the relationship of DVT and PE with IBD in a large group of patients for whom data on comorbid conditions and other potential confounding variables are available and well defined. Furthermore, hospitals participating in the NSQIP, having invested in quality improvement, might be expected to treat patients with best practices, at least with respect to DVT prophylaxis," the investigators said, explaining that this would reduce the opportunity for treatment bias between centers.

The finding of an increased risk of DVT or PE in IBD patients was consistent with others in both surgical and nonsurgical IBD patients, they found.

An exception is with the lethality of DVT or PE in the setting of IBD. One prior study demonstrated an increased risk of death among IBD patients with DVT or PE, but the investigators of the current study found no support for this finding. Mortality occurred in 8.6% and 8.8% of those without IBD who had DVT or PE, and those with IBD who had DVT or PE, respectively.

They also found no support for one prior study’s finding of an increased risk of arterial thromboembolic events in patients with IBD, but they noted that the current study may have been limited by the lack of data on arterial thrombotic events not involving the coronary or cerebral vessels.

"It may be that if arterial thromboembolism were a reported NSQIP complication, such a relationship would appear," they said.

Although this study is limited by the fact that the NSQIP was designed to compare overall outcomes across many hospitals rather than to answer specific research questions regarding specific diseases or procedures, its strengths – namely the fact that the data were gathered by specially trained nurses who were accountable to a rigid quality-assurance program, and who were working from a well-defined data dictionary – likely outweigh any potential sources of bias, they said.

The authors reported that they had no disclosures.