Sharon Worcester

Patients with rheumatoid arthritis who began taking a tumor necrosis factor–alpha blocking agent had a lower cardiovascular event risk during the subsequent 6 months than did those who took a nonbiologic disease-modifying antirheumatic drug in a large, observational study of several administrative and health plan datasets.

The incidence rate for a composite cardiovascular endpoint through the first 6 months of follow-up was 2.52/100 person-years in 11,587 subjects with rheumatoid arthritis (RA) who added a TNF-alpha blocker to their treatment regimen, compared with a rate of 3.05/100 person-years in 8,656 subjects with RA who added a nonbiologic DMARD, Dr. Daniel H. Solomon of Brigham and Women’s Hospital, Boston, and his colleagues reported.

The findings were most pronounced among those aged 65 years and older (hazard ratio, 0.52), and the benefits waned after 6 months.

"In both the first exposure carried forward and the as-treated analyses, the cardiovascular event–free survival curves diverged over the first 6 months. The hazard ratio for the TNF-alpha blocking agent, compared with the nonbiologic DMARD in the first exposure, carried forward was 0.80, and the as-treated analysis at 6 months was 0.71. However, by 12 months the curves appeared to converge with the hazard ratios approaching the null," the investigators explained (Am. J. Med. 2013;126:730.e9-17).

The study involved participants older than 16 years (mean age of 56 years) in several U.S. insurance programs. Those included in the current study – which was part of a larger study collaborative known as SABER (Safety Assessment of Biologic Therapy) – were RA patients using methotrexate who were either adding or switching to a TNF-alpha blocker or a nonbiologic DMARD.

The study’s primary endpoint consisted of a composite cardiovascular outcome of myocardial infarction, stroke, or coronary revascularization; each of these components alone represented a secondary study endpoint.

"While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option."

"The component cardiovascular outcomes followed a similar pattern (to the composite outcome), except stroke, where the incidence rates were similar across exposures," the investigators noted.

Despite the limitations inherent in an observational study, the findings may have important clinical implications, they said.

"As greater evidence accumulates for the role of inflammation in atherosclerosis, consideration has been given to the use of immunosuppressive treatment regimens in cardiovascular disease. While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option. Because the use of potent immunosuppressive agents is common in a systemic inflammatory condition such as rheumatoid arthritis, studying the effect of these agents on cardiovascular disease may provide important insights into the potential role of this strategy in the general population."

The results of the current study generally agree with prior findings demonstrating a link between TNF-alpha blocker use and reduced risk of cardiovascular outcomes.

"TNF-alpha appears to affect several aspects of cardiovascular disease, such as plaque stabilization, endothelial function, and postinfarct remodeling. Thus, one would anticipate that blockade of TNF-alpha would reduce ischemic cardiovascular outcomes. This finding supports the inflammatory underpinnings of cardiovascular disease and highlights a potential role for immunosuppression in cardiovascular risk reduction," they wrote, concluding that randomized controlled clinical trials testing targeted immunosuppression to reduce cardiovascular risk are warranted.

This study was supported by the Agency for Healthcare Research and Quality and the Food and Drug Administration. Dr. Solomon reported receiving research grants from Abbott, Amgen, and Lilly, and serving in unpaid roles on two Pfizer trials. He also directed an educational course supported by Bristol-Myers Squibb, and serves as a consultant to the Consortium of Rheumatology Researchers of North America Inc. (CORRONA). Other study authors reported receiving research grants from, and/or serving as a consultant for Amgen, Abbott, BMS, Centocor, Genentech/Roche, Janssen, Pfizer, UCB, and CORRONA.

Patients with rheumatoid arthritis who began taking a tumor necrosis factor–alpha blocking agent had a lower cardiovascular event risk during the subsequent 6 months than did those who took a nonbiologic disease-modifying antirheumatic drug in a large, observational study of several administrative and health plan datasets.

The incidence rate for a composite cardiovascular endpoint through the first 6 months of follow-up was 2.52/100 person-years in 11,587 subjects with rheumatoid arthritis (RA) who added a TNF-alpha blocker to their treatment regimen, compared with a rate of 3.05/100 person-years in 8,656 subjects with RA who added a nonbiologic DMARD, Dr. Daniel H. Solomon of Brigham and Women’s Hospital, Boston, and his colleagues reported.

The findings were most pronounced among those aged 65 years and older (hazard ratio, 0.52), and the benefits waned after 6 months.

"In both the first exposure carried forward and the as-treated analyses, the cardiovascular event–free survival curves diverged over the first 6 months. The hazard ratio for the TNF-alpha blocking agent, compared with the nonbiologic DMARD in the first exposure, carried forward was 0.80, and the as-treated analysis at 6 months was 0.71. However, by 12 months the curves appeared to converge with the hazard ratios approaching the null," the investigators explained (Am. J. Med. 2013;126:730.e9-17).

The study involved participants older than 16 years (mean age of 56 years) in several U.S. insurance programs. Those included in the current study – which was part of a larger study collaborative known as SABER (Safety Assessment of Biologic Therapy) – were RA patients using methotrexate who were either adding or switching to a TNF-alpha blocker or a nonbiologic DMARD.

The study’s primary endpoint consisted of a composite cardiovascular outcome of myocardial infarction, stroke, or coronary revascularization; each of these components alone represented a secondary study endpoint.

"While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option."

"The component cardiovascular outcomes followed a similar pattern (to the composite outcome), except stroke, where the incidence rates were similar across exposures," the investigators noted.

Despite the limitations inherent in an observational study, the findings may have important clinical implications, they said.

"As greater evidence accumulates for the role of inflammation in atherosclerosis, consideration has been given to the use of immunosuppressive treatment regimens in cardiovascular disease. While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option. Because the use of potent immunosuppressive agents is common in a systemic inflammatory condition such as rheumatoid arthritis, studying the effect of these agents on cardiovascular disease may provide important insights into the potential role of this strategy in the general population."

The results of the current study generally agree with prior findings demonstrating a link between TNF-alpha blocker use and reduced risk of cardiovascular outcomes.

"TNF-alpha appears to affect several aspects of cardiovascular disease, such as plaque stabilization, endothelial function, and postinfarct remodeling. Thus, one would anticipate that blockade of TNF-alpha would reduce ischemic cardiovascular outcomes. This finding supports the inflammatory underpinnings of cardiovascular disease and highlights a potential role for immunosuppression in cardiovascular risk reduction," they wrote, concluding that randomized controlled clinical trials testing targeted immunosuppression to reduce cardiovascular risk are warranted.

This study was supported by the Agency for Healthcare Research and Quality and the Food and Drug Administration. Dr. Solomon reported receiving research grants from Abbott, Amgen, and Lilly, and serving in unpaid roles on two Pfizer trials. He also directed an educational course supported by Bristol-Myers Squibb, and serves as a consultant to the Consortium of Rheumatology Researchers of North America Inc. (CORRONA). Other study authors reported receiving research grants from, and/or serving as a consultant for Amgen, Abbott, BMS, Centocor, Genentech/Roche, Janssen, Pfizer, UCB, and CORRONA.

Patients with rheumatoid arthritis who began taking a tumor necrosis factor–alpha blocking agent had a lower cardiovascular event risk during the subsequent 6 months than did those who took a nonbiologic disease-modifying antirheumatic drug in a large, observational study of several administrative and health plan datasets.

The incidence rate for a composite cardiovascular endpoint through the first 6 months of follow-up was 2.52/100 person-years in 11,587 subjects with rheumatoid arthritis (RA) who added a TNF-alpha blocker to their treatment regimen, compared with a rate of 3.05/100 person-years in 8,656 subjects with RA who added a nonbiologic DMARD, Dr. Daniel H. Solomon of Brigham and Women’s Hospital, Boston, and his colleagues reported.

The findings were most pronounced among those aged 65 years and older (hazard ratio, 0.52), and the benefits waned after 6 months.

"In both the first exposure carried forward and the as-treated analyses, the cardiovascular event–free survival curves diverged over the first 6 months. The hazard ratio for the TNF-alpha blocking agent, compared with the nonbiologic DMARD in the first exposure, carried forward was 0.80, and the as-treated analysis at 6 months was 0.71. However, by 12 months the curves appeared to converge with the hazard ratios approaching the null," the investigators explained (Am. J. Med. 2013;126:730.e9-17).

The study involved participants older than 16 years (mean age of 56 years) in several U.S. insurance programs. Those included in the current study – which was part of a larger study collaborative known as SABER (Safety Assessment of Biologic Therapy) – were RA patients using methotrexate who were either adding or switching to a TNF-alpha blocker or a nonbiologic DMARD.

The study’s primary endpoint consisted of a composite cardiovascular outcome of myocardial infarction, stroke, or coronary revascularization; each of these components alone represented a secondary study endpoint.

"While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option."

"The component cardiovascular outcomes followed a similar pattern (to the composite outcome), except stroke, where the incidence rates were similar across exposures," the investigators noted.

Despite the limitations inherent in an observational study, the findings may have important clinical implications, they said.

"As greater evidence accumulates for the role of inflammation in atherosclerosis, consideration has been given to the use of immunosuppressive treatment regimens in cardiovascular disease. While statins and aspirin may reduce cardiovascular risk in part through their anti-inflammatory properties, targeting cytokines known to be part of cardiovascular disease is an attractive therapeutic option. Because the use of potent immunosuppressive agents is common in a systemic inflammatory condition such as rheumatoid arthritis, studying the effect of these agents on cardiovascular disease may provide important insights into the potential role of this strategy in the general population."

The results of the current study generally agree with prior findings demonstrating a link between TNF-alpha blocker use and reduced risk of cardiovascular outcomes.

"TNF-alpha appears to affect several aspects of cardiovascular disease, such as plaque stabilization, endothelial function, and postinfarct remodeling. Thus, one would anticipate that blockade of TNF-alpha would reduce ischemic cardiovascular outcomes. This finding supports the inflammatory underpinnings of cardiovascular disease and highlights a potential role for immunosuppression in cardiovascular risk reduction," they wrote, concluding that randomized controlled clinical trials testing targeted immunosuppression to reduce cardiovascular risk are warranted.

This study was supported by the Agency for Healthcare Research and Quality and the Food and Drug Administration. Dr. Solomon reported receiving research grants from Abbott, Amgen, and Lilly, and serving in unpaid roles on two Pfizer trials. He also directed an educational course supported by Bristol-Myers Squibb, and serves as a consultant to the Consortium of Rheumatology Researchers of North America Inc. (CORRONA). Other study authors reported receiving research grants from, and/or serving as a consultant for Amgen, Abbott, BMS, Centocor, Genentech/Roche, Janssen, Pfizer, UCB, and CORRONA.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

Little has changed over the years with respect to the proportion of unplanned pregnancies in the United States, but the emergence – and increasing acceptance – of safe and reliable long-acting reversible contraceptives, or LARCs, offers hope for improved reproductive management and outcomes.

Currently, about half of the 6.7 million pregnancies that occur each year in the United States are unplanned, and while that is a startling figure, more startling is the fact that although the distribution has changed – with decreases in unplanned pregnancies among wealthier women, and increases among low-income women and minorities – the percentage hasn’t changed in decades, Dr. Eve Espey said during a clinical seminar on contraception at the annual meeting of the American College of Obstetricians and Gynecologists in New Orleans.

Further, while only 11% of the women with unplanned pregnancies use no form of birth control, those women’s pregnancies make up only about 50% of the unplanned pregnancies overall; that means that half of all unplanned pregnancies occur in women who use at least one form of birth control, said Dr. Espey of the University of New Mexico, Albuquerque.

This is a problem that likely involves both contraceptive failures and user error.

"One of the things that I think we don’t appreciate is the extent to which women who do use contraceptives use them incorrectly or inconsistently, or use methods that have a high failure rate," she said.

These statistics, and the fact that unintended pregnancies are associated with an increased risk of numerous adverse outcomes, such as preterm birth and neonatal intensive care unit stays, underscore the importance of identifying and promoting contraceptive methods that will help women achieve better regulation of fertility, she said.

LARCs, according to burgeoning research – and a recent American College of Obstetricians and Gynecologists committee opinion – are the answer.

LARCs, including intrauterine devices and the contraceptive implant, should be first-line recommendations for all women and adolescents, according to an October 2012 opinion from the Committee on Adolescent Health Care LARC Working Group (Obstet. Gynecol. 2012;120:983-8). With both perfect and typical use, these contraceptive methods are associated with pregnancy rates of less than 1% per year – far better than reported rates among those using short-acting contraceptive methods such as condoms, oral contraceptives, the contraceptive patch, the vaginal ring, and depot medroxyprogesterone acetate injections, according to the committee opinion. Yet the use of short-acting methods, and particularly the use of oral contraceptives, dwarfs the use of LARC methods.

The use of IUDs is now about 7.5% – a substantial and encouraging increase over the 5.5% reported in recent years, but still far less than the 15%-20% of women who report oral contraceptive use, Dr. Espey said.

Findings from the Contraceptive CHOICE Project – a prospective cohort study designed to promote the use of LARCs among women and adolescents in the St. Louis area, and to reduce the rate of unintended pregnancies in the region, demonstrated that the unintended pregnancy rate was more than 20-fold greater with short-acting vs. LARC methods at 2- to 3-year follow-up. The rate was twice as high in adolescents as in adults (N. Engl. J. Med. 2012;366:1998-2007).

The CHOICE Project included 9,256 women who received a brief educational intervention and access to their contraceptive method of choice free of charge. The majority – 75% - chose LARC methods, suggesting that when cost and access barriers are removed, the typically low use of these highly effective methods (about 5.5% at the time of the study) increases substantially. The increased use of LARC methods was associated with an unplanned pregnancy rate of 35 per 1,000 women, compared with the national rate of 52 per 1,000 women, Dr. Jeffrey Peipert, the lead investigator for the project, said at the meeting.

Moreover, the continuation rate, which is strongly associated with outcomes, was 86% among LARC users at 12 months, compared with 55% for short-acting methods in a separate analysis of data from more than 4,100 project participants (Obstet. Gynecol. 2011;117:1105-13).

The abortion rate among CHOICE Project participants was 6 per 1,000 at follow-up, compared with the national rate of 20 per 1,000. The number needed to treat to prevent 1 abortion was 108.

"These are very reasonable numbers," said Dr. Peipert of Washington University in St. Louis, noting that the findings are all the more astounding given that the CHOICE population was much higher risk than the general population due to younger age, a high percentage of African Americans (about 50%), and lower socioeconomic status (about 40% had trouble affording basic necessities and 40% were uninsured).

If all women in the United States had access to LARC methods, more than 1 million unplanned pregnancies and nearly 900,000 abortions could be prevented each year, according to a CHOICE Project video he shared during his presentation.

"So if we truly want to reduce abortion in this country, what we need to do is increase contraceptive prevalence, and, in particular, talk about the advantages of LARCs," Dr. Espey said, referencing the CHOICE Project findings.

The currently available LARC methods include intrauterine devices and systems (the copper IUD and the hormonal intrauterine systems Mirena and Skyla) and the contraceptive implant (Nexplanon).

Skyla (Bayer HealthCare), approved in January, is the newest system on the market. Compared with Mirena (Bayer HealthCare) – a hormonal intrauterine system that has been available since 2000, the new system uses less levonorgestrel (14 mcg vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use, Dr. Espey said.

In her experience, some women prefer the 3- vs. 5-year product, even after they are told that the 5-year product can be removed early, she noted.

"It shouldn’t make a difference, but psychologically it does," she said.

As for the contraceptive implant, Nexplanon (Merck) is the latest-generation product, having replaced its predecessor, Implanon. The major difference between the two is that Nexplanon, which is approved for 3 years of use, can be seen on x-ray. Also, it only requires one hand for insertion, improving ease of use.

Overall, the implant, which works by preventing ovulation, is easy to learn, and is safe and highly effective, with very few contraindications, according to Dr. Tony Ogburn, who also spoke at the ACOG meeting.

Unpredictable bleeding can be an issue for some women, and is the most common reason for removal. Counseling and education, along with reassurance about Nexplanon’s safety, can promote continuation, he said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases. Physicians previously certified to insert Implanon can take an online training course to become certified for Nexplanon insertion; those not previously trained must attend a live course, said Dr. Ogburn of the University of New Mexico, Albuquerque.

Deciding which LARC method is appropriate in a given patient can be somewhat daunting, but an app available from the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (US MEC) for Contraceptive Use can help.

Dr. Espey, who swears by the app – even for "non-app people" like herself – said that it provides evidence-based reviews of every type of contraceptive method lined up against various patient characteristics and conditions, and coordinates recommendations.

For those averse to using an app, a chart is also available. Notably, the chart shows that most contraceptive use is safe.

There are a lot of misconceptions on the part of patients about the safety of one contraceptive method or another, and the fact is that contraception is "overmedicalized," Dr. Espey said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases, she added.

Of course, the low use of LARC methods is hardly the only hurdle when it comes to improving the unintended pregnancy rate in the United States. Compared with European Countries that have extremely low unintended pregnancy rates, the United States has a lack of comprehensive sex education that begins at a young age, and a greater cultural acceptance of teen motherhood. Progress in the United States also is hampered by patriarchal attitudes that may allow men control over reproductive health, and by a mismatch in cultural values that is apparent in the "wildly sexual" U.S. media and the puritanical views that limit conversations with children about sex and sexuality as a normal part of human behavior, Dr Espey said.

Additional hurdles include poverty, racism, and inadequate social and health care safety nets, she noted.

That’s not to say, however, that major inroads can’t be made by promoting LARC use. A flurry of research presented at the ACOG annual meeting that focused on various approaches to increasing use among patients highlights the increasing focus on, and commitment to, helping patients take control of their fertility. One study, for example, showed that the use of a short, simple counseling intervention – much like the one used for the CHOICE project, is feasible and effective for promoting LARC use when provided in the immediate postpartum period. Another suggested that while a postpartum educational script increased interest in LARC methods, certain barriers to access may limit uptake.

Dr. Espey said that it is important to focus first and foremost on LARC methods when counseling a patient about contraception.

"So often I think we approach contraceptive counseling as if we have to tell everybody about all the methods as if they were all equal, but in other kinds of medication we would naturally lean toward recommending methods that are most highly effective," she said.

For contraception, that’s intrauterine devices and implants, she added.

Dr. Peipert agreed, noting, "If we had a pill for hypertension that was 20-fold less effective, we wouldn’t offer it first line."

Not only are LARC methods the most effective contraceptive methods, but under the right circumstances they also have a high rate of acceptability, as demonstrated by the CHOICE Project, he said.

They also have the potential to dramatically reduce health care costs.

"We believe that family planning saves dollars. We spend over $11 billion each year on unintended pregnancy. No-cost contraception and wide access to contraception can prevent unintended pregnancy and save health care dollars," he said, adding that every dollar spent on family planning can save $3 or $4 down the road – and because of their effectiveness, the savings are even greater with LARC use.

"We really have an opportunity to impact public health. It’s been decades where we’ve been stuck at a rate of unintended pregnancy in the U.S. of close to 50%, and now, if we can shift our emphasis to LARC methods, I think we will finally see a reduction in unintended pregnancies," he said.

Dr. Espey and Dr. Ogburn reported having no disclosures. Dr. Peipert has received research funding from Bayer and Merck. The CHOICE Project was funded by an anonymous donation.

Little has changed over the years with respect to the proportion of unplanned pregnancies in the United States, but the emergence – and increasing acceptance – of safe and reliable long-acting reversible contraceptives, or LARCs, offers hope for improved reproductive management and outcomes.

Currently, about half of the 6.7 million pregnancies that occur each year in the United States are unplanned, and while that is a startling figure, more startling is the fact that although the distribution has changed – with decreases in unplanned pregnancies among wealthier women, and increases among low-income women and minorities – the percentage hasn’t changed in decades, Dr. Eve Espey said during a clinical seminar on contraception at the annual meeting of the American College of Obstetricians and Gynecologists in New Orleans.

Further, while only 11% of the women with unplanned pregnancies use no form of birth control, those women’s pregnancies make up only about 50% of the unplanned pregnancies overall; that means that half of all unplanned pregnancies occur in women who use at least one form of birth control, said Dr. Espey of the University of New Mexico, Albuquerque.

This is a problem that likely involves both contraceptive failures and user error.

"One of the things that I think we don’t appreciate is the extent to which women who do use contraceptives use them incorrectly or inconsistently, or use methods that have a high failure rate," she said.

These statistics, and the fact that unintended pregnancies are associated with an increased risk of numerous adverse outcomes, such as preterm birth and neonatal intensive care unit stays, underscore the importance of identifying and promoting contraceptive methods that will help women achieve better regulation of fertility, she said.

LARCs, according to burgeoning research – and a recent American College of Obstetricians and Gynecologists committee opinion – are the answer.

LARCs, including intrauterine devices and the contraceptive implant, should be first-line recommendations for all women and adolescents, according to an October 2012 opinion from the Committee on Adolescent Health Care LARC Working Group (Obstet. Gynecol. 2012;120:983-8). With both perfect and typical use, these contraceptive methods are associated with pregnancy rates of less than 1% per year – far better than reported rates among those using short-acting contraceptive methods such as condoms, oral contraceptives, the contraceptive patch, the vaginal ring, and depot medroxyprogesterone acetate injections, according to the committee opinion. Yet the use of short-acting methods, and particularly the use of oral contraceptives, dwarfs the use of LARC methods.

The use of IUDs is now about 7.5% – a substantial and encouraging increase over the 5.5% reported in recent years, but still far less than the 15%-20% of women who report oral contraceptive use, Dr. Espey said.

Findings from the Contraceptive CHOICE Project – a prospective cohort study designed to promote the use of LARCs among women and adolescents in the St. Louis area, and to reduce the rate of unintended pregnancies in the region, demonstrated that the unintended pregnancy rate was more than 20-fold greater with short-acting vs. LARC methods at 2- to 3-year follow-up. The rate was twice as high in adolescents as in adults (N. Engl. J. Med. 2012;366:1998-2007).

The CHOICE Project included 9,256 women who received a brief educational intervention and access to their contraceptive method of choice free of charge. The majority – 75% - chose LARC methods, suggesting that when cost and access barriers are removed, the typically low use of these highly effective methods (about 5.5% at the time of the study) increases substantially. The increased use of LARC methods was associated with an unplanned pregnancy rate of 35 per 1,000 women, compared with the national rate of 52 per 1,000 women, Dr. Jeffrey Peipert, the lead investigator for the project, said at the meeting.

Moreover, the continuation rate, which is strongly associated with outcomes, was 86% among LARC users at 12 months, compared with 55% for short-acting methods in a separate analysis of data from more than 4,100 project participants (Obstet. Gynecol. 2011;117:1105-13).

The abortion rate among CHOICE Project participants was 6 per 1,000 at follow-up, compared with the national rate of 20 per 1,000. The number needed to treat to prevent 1 abortion was 108.

"These are very reasonable numbers," said Dr. Peipert of Washington University in St. Louis, noting that the findings are all the more astounding given that the CHOICE population was much higher risk than the general population due to younger age, a high percentage of African Americans (about 50%), and lower socioeconomic status (about 40% had trouble affording basic necessities and 40% were uninsured).

If all women in the United States had access to LARC methods, more than 1 million unplanned pregnancies and nearly 900,000 abortions could be prevented each year, according to a CHOICE Project video he shared during his presentation.

"So if we truly want to reduce abortion in this country, what we need to do is increase contraceptive prevalence, and, in particular, talk about the advantages of LARCs," Dr. Espey said, referencing the CHOICE Project findings.

The currently available LARC methods include intrauterine devices and systems (the copper IUD and the hormonal intrauterine systems Mirena and Skyla) and the contraceptive implant (Nexplanon).

Skyla (Bayer HealthCare), approved in January, is the newest system on the market. Compared with Mirena (Bayer HealthCare) – a hormonal intrauterine system that has been available since 2000, the new system uses less levonorgestrel (14 mcg vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use, Dr. Espey said.

In her experience, some women prefer the 3- vs. 5-year product, even after they are told that the 5-year product can be removed early, she noted.

"It shouldn’t make a difference, but psychologically it does," she said.

As for the contraceptive implant, Nexplanon (Merck) is the latest-generation product, having replaced its predecessor, Implanon. The major difference between the two is that Nexplanon, which is approved for 3 years of use, can be seen on x-ray. Also, it only requires one hand for insertion, improving ease of use.

Overall, the implant, which works by preventing ovulation, is easy to learn, and is safe and highly effective, with very few contraindications, according to Dr. Tony Ogburn, who also spoke at the ACOG meeting.

Unpredictable bleeding can be an issue for some women, and is the most common reason for removal. Counseling and education, along with reassurance about Nexplanon’s safety, can promote continuation, he said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases. Physicians previously certified to insert Implanon can take an online training course to become certified for Nexplanon insertion; those not previously trained must attend a live course, said Dr. Ogburn of the University of New Mexico, Albuquerque.

Deciding which LARC method is appropriate in a given patient can be somewhat daunting, but an app available from the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (US MEC) for Contraceptive Use can help.

Dr. Espey, who swears by the app – even for "non-app people" like herself – said that it provides evidence-based reviews of every type of contraceptive method lined up against various patient characteristics and conditions, and coordinates recommendations.

For those averse to using an app, a chart is also available. Notably, the chart shows that most contraceptive use is safe.

There are a lot of misconceptions on the part of patients about the safety of one contraceptive method or another, and the fact is that contraception is "overmedicalized," Dr. Espey said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases, she added.

Of course, the low use of LARC methods is hardly the only hurdle when it comes to improving the unintended pregnancy rate in the United States. Compared with European Countries that have extremely low unintended pregnancy rates, the United States has a lack of comprehensive sex education that begins at a young age, and a greater cultural acceptance of teen motherhood. Progress in the United States also is hampered by patriarchal attitudes that may allow men control over reproductive health, and by a mismatch in cultural values that is apparent in the "wildly sexual" U.S. media and the puritanical views that limit conversations with children about sex and sexuality as a normal part of human behavior, Dr Espey said.

Additional hurdles include poverty, racism, and inadequate social and health care safety nets, she noted.

That’s not to say, however, that major inroads can’t be made by promoting LARC use. A flurry of research presented at the ACOG annual meeting that focused on various approaches to increasing use among patients highlights the increasing focus on, and commitment to, helping patients take control of their fertility. One study, for example, showed that the use of a short, simple counseling intervention – much like the one used for the CHOICE project, is feasible and effective for promoting LARC use when provided in the immediate postpartum period. Another suggested that while a postpartum educational script increased interest in LARC methods, certain barriers to access may limit uptake.

Dr. Espey said that it is important to focus first and foremost on LARC methods when counseling a patient about contraception.

"So often I think we approach contraceptive counseling as if we have to tell everybody about all the methods as if they were all equal, but in other kinds of medication we would naturally lean toward recommending methods that are most highly effective," she said.

For contraception, that’s intrauterine devices and implants, she added.

Dr. Peipert agreed, noting, "If we had a pill for hypertension that was 20-fold less effective, we wouldn’t offer it first line."

Not only are LARC methods the most effective contraceptive methods, but under the right circumstances they also have a high rate of acceptability, as demonstrated by the CHOICE Project, he said.

They also have the potential to dramatically reduce health care costs.

"We believe that family planning saves dollars. We spend over $11 billion each year on unintended pregnancy. No-cost contraception and wide access to contraception can prevent unintended pregnancy and save health care dollars," he said, adding that every dollar spent on family planning can save $3 or $4 down the road – and because of their effectiveness, the savings are even greater with LARC use.

"We really have an opportunity to impact public health. It’s been decades where we’ve been stuck at a rate of unintended pregnancy in the U.S. of close to 50%, and now, if we can shift our emphasis to LARC methods, I think we will finally see a reduction in unintended pregnancies," he said.

Dr. Espey and Dr. Ogburn reported having no disclosures. Dr. Peipert has received research funding from Bayer and Merck. The CHOICE Project was funded by an anonymous donation.

Little has changed over the years with respect to the proportion of unplanned pregnancies in the United States, but the emergence – and increasing acceptance – of safe and reliable long-acting reversible contraceptives, or LARCs, offers hope for improved reproductive management and outcomes.

Currently, about half of the 6.7 million pregnancies that occur each year in the United States are unplanned, and while that is a startling figure, more startling is the fact that although the distribution has changed – with decreases in unplanned pregnancies among wealthier women, and increases among low-income women and minorities – the percentage hasn’t changed in decades, Dr. Eve Espey said during a clinical seminar on contraception at the annual meeting of the American College of Obstetricians and Gynecologists in New Orleans.

Further, while only 11% of the women with unplanned pregnancies use no form of birth control, those women’s pregnancies make up only about 50% of the unplanned pregnancies overall; that means that half of all unplanned pregnancies occur in women who use at least one form of birth control, said Dr. Espey of the University of New Mexico, Albuquerque.

This is a problem that likely involves both contraceptive failures and user error.

"One of the things that I think we don’t appreciate is the extent to which women who do use contraceptives use them incorrectly or inconsistently, or use methods that have a high failure rate," she said.

These statistics, and the fact that unintended pregnancies are associated with an increased risk of numerous adverse outcomes, such as preterm birth and neonatal intensive care unit stays, underscore the importance of identifying and promoting contraceptive methods that will help women achieve better regulation of fertility, she said.

LARCs, according to burgeoning research – and a recent American College of Obstetricians and Gynecologists committee opinion – are the answer.

LARCs, including intrauterine devices and the contraceptive implant, should be first-line recommendations for all women and adolescents, according to an October 2012 opinion from the Committee on Adolescent Health Care LARC Working Group (Obstet. Gynecol. 2012;120:983-8). With both perfect and typical use, these contraceptive methods are associated with pregnancy rates of less than 1% per year – far better than reported rates among those using short-acting contraceptive methods such as condoms, oral contraceptives, the contraceptive patch, the vaginal ring, and depot medroxyprogesterone acetate injections, according to the committee opinion. Yet the use of short-acting methods, and particularly the use of oral contraceptives, dwarfs the use of LARC methods.

The use of IUDs is now about 7.5% – a substantial and encouraging increase over the 5.5% reported in recent years, but still far less than the 15%-20% of women who report oral contraceptive use, Dr. Espey said.

Findings from the Contraceptive CHOICE Project – a prospective cohort study designed to promote the use of LARCs among women and adolescents in the St. Louis area, and to reduce the rate of unintended pregnancies in the region, demonstrated that the unintended pregnancy rate was more than 20-fold greater with short-acting vs. LARC methods at 2- to 3-year follow-up. The rate was twice as high in adolescents as in adults (N. Engl. J. Med. 2012;366:1998-2007).

The CHOICE Project included 9,256 women who received a brief educational intervention and access to their contraceptive method of choice free of charge. The majority – 75% - chose LARC methods, suggesting that when cost and access barriers are removed, the typically low use of these highly effective methods (about 5.5% at the time of the study) increases substantially. The increased use of LARC methods was associated with an unplanned pregnancy rate of 35 per 1,000 women, compared with the national rate of 52 per 1,000 women, Dr. Jeffrey Peipert, the lead investigator for the project, said at the meeting.

Moreover, the continuation rate, which is strongly associated with outcomes, was 86% among LARC users at 12 months, compared with 55% for short-acting methods in a separate analysis of data from more than 4,100 project participants (Obstet. Gynecol. 2011;117:1105-13).

The abortion rate among CHOICE Project participants was 6 per 1,000 at follow-up, compared with the national rate of 20 per 1,000. The number needed to treat to prevent 1 abortion was 108.

"These are very reasonable numbers," said Dr. Peipert of Washington University in St. Louis, noting that the findings are all the more astounding given that the CHOICE population was much higher risk than the general population due to younger age, a high percentage of African Americans (about 50%), and lower socioeconomic status (about 40% had trouble affording basic necessities and 40% were uninsured).

If all women in the United States had access to LARC methods, more than 1 million unplanned pregnancies and nearly 900,000 abortions could be prevented each year, according to a CHOICE Project video he shared during his presentation.

"So if we truly want to reduce abortion in this country, what we need to do is increase contraceptive prevalence, and, in particular, talk about the advantages of LARCs," Dr. Espey said, referencing the CHOICE Project findings.

The currently available LARC methods include intrauterine devices and systems (the copper IUD and the hormonal intrauterine systems Mirena and Skyla) and the contraceptive implant (Nexplanon).

Skyla (Bayer HealthCare), approved in January, is the newest system on the market. Compared with Mirena (Bayer HealthCare) – a hormonal intrauterine system that has been available since 2000, the new system uses less levonorgestrel (14 mcg vs. 20 mcg), has a smaller frame and inserter tube that have been shown to be less painful on insertion in nulliparous women, is associated with more abnormal bleeding, and is approved for 3 years (vs. 5 years) of use, Dr. Espey said.

In her experience, some women prefer the 3- vs. 5-year product, even after they are told that the 5-year product can be removed early, she noted.

"It shouldn’t make a difference, but psychologically it does," she said.

As for the contraceptive implant, Nexplanon (Merck) is the latest-generation product, having replaced its predecessor, Implanon. The major difference between the two is that Nexplanon, which is approved for 3 years of use, can be seen on x-ray. Also, it only requires one hand for insertion, improving ease of use.

Overall, the implant, which works by preventing ovulation, is easy to learn, and is safe and highly effective, with very few contraindications, according to Dr. Tony Ogburn, who also spoke at the ACOG meeting.

Unpredictable bleeding can be an issue for some women, and is the most common reason for removal. Counseling and education, along with reassurance about Nexplanon’s safety, can promote continuation, he said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases. Physicians previously certified to insert Implanon can take an online training course to become certified for Nexplanon insertion; those not previously trained must attend a live course, said Dr. Ogburn of the University of New Mexico, Albuquerque.

Deciding which LARC method is appropriate in a given patient can be somewhat daunting, but an app available from the Centers for Disease Control and Prevention’s U.S. Medical Eligibility Criteria (US MEC) for Contraceptive Use can help.

Dr. Espey, who swears by the app – even for "non-app people" like herself – said that it provides evidence-based reviews of every type of contraceptive method lined up against various patient characteristics and conditions, and coordinates recommendations.

For those averse to using an app, a chart is also available. Notably, the chart shows that most contraceptive use is safe.

There are a lot of misconceptions on the part of patients about the safety of one contraceptive method or another, and the fact is that contraception is "overmedicalized," Dr. Espey said.

Contraceptives prevent pregnancy, which is inherently more dangerous than contraception in most cases, she added.

Of course, the low use of LARC methods is hardly the only hurdle when it comes to improving the unintended pregnancy rate in the United States. Compared with European Countries that have extremely low unintended pregnancy rates, the United States has a lack of comprehensive sex education that begins at a young age, and a greater cultural acceptance of teen motherhood. Progress in the United States also is hampered by patriarchal attitudes that may allow men control over reproductive health, and by a mismatch in cultural values that is apparent in the "wildly sexual" U.S. media and the puritanical views that limit conversations with children about sex and sexuality as a normal part of human behavior, Dr Espey said.

Additional hurdles include poverty, racism, and inadequate social and health care safety nets, she noted.

That’s not to say, however, that major inroads can’t be made by promoting LARC use. A flurry of research presented at the ACOG annual meeting that focused on various approaches to increasing use among patients highlights the increasing focus on, and commitment to, helping patients take control of their fertility. One study, for example, showed that the use of a short, simple counseling intervention – much like the one used for the CHOICE project, is feasible and effective for promoting LARC use when provided in the immediate postpartum period. Another suggested that while a postpartum educational script increased interest in LARC methods, certain barriers to access may limit uptake.

Dr. Espey said that it is important to focus first and foremost on LARC methods when counseling a patient about contraception.

"So often I think we approach contraceptive counseling as if we have to tell everybody about all the methods as if they were all equal, but in other kinds of medication we would naturally lean toward recommending methods that are most highly effective," she said.

For contraception, that’s intrauterine devices and implants, she added.

Dr. Peipert agreed, noting, "If we had a pill for hypertension that was 20-fold less effective, we wouldn’t offer it first line."

Not only are LARC methods the most effective contraceptive methods, but under the right circumstances they also have a high rate of acceptability, as demonstrated by the CHOICE Project, he said.

They also have the potential to dramatically reduce health care costs.

"We believe that family planning saves dollars. We spend over $11 billion each year on unintended pregnancy. No-cost contraception and wide access to contraception can prevent unintended pregnancy and save health care dollars," he said, adding that every dollar spent on family planning can save $3 or $4 down the road – and because of their effectiveness, the savings are even greater with LARC use.

"We really have an opportunity to impact public health. It’s been decades where we’ve been stuck at a rate of unintended pregnancy in the U.S. of close to 50%, and now, if we can shift our emphasis to LARC methods, I think we will finally see a reduction in unintended pregnancies," he said.

Dr. Espey and Dr. Ogburn reported having no disclosures. Dr. Peipert has received research funding from Bayer and Merck. The CHOICE Project was funded by an anonymous donation.

Older adults with vitamin D deficiency are more likely than those with adequate vitamin D levels to have functional limitations, findings from the Longitudinal Aging Study Amsterdam suggest.

These limitations became apparent within 3 years in a cohort aged 65-88 years, compared with 6 years in one aged 55-65 years.

In a cohort of 1,237 adults who were aged 65-88 years at baseline, 56% had at least one functional limitation, and in a second cohort of 725 adults aged 55-65 years at baseline, 30% had at least 1 functional limitation. Those in the older cohort who had vitamin D deficiency, defined as a 25-hydroxyvitamin D (25[OH]D) level of less than 20 ng/mL, had a nearly twofold increased risk of having a functional limitation, compared with those who had a 25(OH)D level greater than 30 ng/mL (odds ratio, 1.7), and those in the younger cohort who had vitamin D deficiency had more than a twofold increased risk (OR, 2.1), according to Dr. Evelien Sohl and her colleagues from the VU University Medical Center, Amsterdam.

©iStockphoto.com

Vitamin D status also was associated with the number of functional limitations cross-sectionally, the investigators reported online July 17 in the Journal of Clinical Endocrinology and Metabolism.

"In the fully adjusted models, participants in the older cohort with serum 25(OH)D levels of less than 20 ng/mL had a 1.6 times higher odds for having 1 more functional limitation than participants in the reference category. In the younger cohort, this odds ratio was 1.9," they said (J. Clin. Endocrinol. Metab. 2013 July 17 [doi: 10.1210/jc.2013-1698]).

The investigators also found that vitamin D deficiency was associated with an increase of two or more additional limitations at 3 years in the older cohort (OR, 2.0), but not at 6 years, while the association between vitamin D deficiency and an increase of two or more limitations did not reach significance until after 6 years in the younger cohort (OR, 3.3).

"Age and sex did not significantly modify the associations between serum 25(OH)D and functional status. Relevant confounders were age, sex, body mass index, number of chronic diseases, level of education, and level of urbanization," they said.

Specific functional limitations associated with vitamin D status in the older cohort included walking stairs (OR, 1.8), cutting toenails (OR, 1.5), and walking outside (OR, 2.1). Statistical power was insufficient for analyzing functional limitations in the younger cohort separately because of the low number of limitations in that group.

The Longitudinal Aging Study Amsterdam is an ongoing prospective cohort study of the older Dutch population. Functional limitations were assessed by an interviewer-administered questionnaire. Participants were asked about their ability and degree of difficulty with respect to walking up and down a staircase of 15 steps without resting; dressing and undressing oneself; sitting down and standing up from a chair; cutting one’s toenails; walking outside for 5 minutes without resting; and using one’s own or public transportation. Limitations were defined as any difficulty with performing a specific activity.

Although research on the association between vitamin D status and functional limitations is "scarce and not conclusive," according to the investigators, the findings "are in line with the results of most studies on vitamin D status and physical performance."

"Because functional limitations are a predictor of adverse outcomes, further research is necessary to explore underlying mechanisms and the potential benefits of vitamin D supplements on functional status," they concluded.

The study authors reported having no disclosures.

Older adults with vitamin D deficiency are more likely than those with adequate vitamin D levels to have functional limitations, findings from the Longitudinal Aging Study Amsterdam suggest.

These limitations became apparent within 3 years in a cohort aged 65-88 years, compared with 6 years in one aged 55-65 years.

In a cohort of 1,237 adults who were aged 65-88 years at baseline, 56% had at least one functional limitation, and in a second cohort of 725 adults aged 55-65 years at baseline, 30% had at least 1 functional limitation. Those in the older cohort who had vitamin D deficiency, defined as a 25-hydroxyvitamin D (25[OH]D) level of less than 20 ng/mL, had a nearly twofold increased risk of having a functional limitation, compared with those who had a 25(OH)D level greater than 30 ng/mL (odds ratio, 1.7), and those in the younger cohort who had vitamin D deficiency had more than a twofold increased risk (OR, 2.1), according to Dr. Evelien Sohl and her colleagues from the VU University Medical Center, Amsterdam.

©iStockphoto.com

Vitamin D status also was associated with the number of functional limitations cross-sectionally, the investigators reported online July 17 in the Journal of Clinical Endocrinology and Metabolism.

"In the fully adjusted models, participants in the older cohort with serum 25(OH)D levels of less than 20 ng/mL had a 1.6 times higher odds for having 1 more functional limitation than participants in the reference category. In the younger cohort, this odds ratio was 1.9," they said (J. Clin. Endocrinol. Metab. 2013 July 17 [doi: 10.1210/jc.2013-1698]).

The investigators also found that vitamin D deficiency was associated with an increase of two or more additional limitations at 3 years in the older cohort (OR, 2.0), but not at 6 years, while the association between vitamin D deficiency and an increase of two or more limitations did not reach significance until after 6 years in the younger cohort (OR, 3.3).

"Age and sex did not significantly modify the associations between serum 25(OH)D and functional status. Relevant confounders were age, sex, body mass index, number of chronic diseases, level of education, and level of urbanization," they said.

Specific functional limitations associated with vitamin D status in the older cohort included walking stairs (OR, 1.8), cutting toenails (OR, 1.5), and walking outside (OR, 2.1). Statistical power was insufficient for analyzing functional limitations in the younger cohort separately because of the low number of limitations in that group.

The Longitudinal Aging Study Amsterdam is an ongoing prospective cohort study of the older Dutch population. Functional limitations were assessed by an interviewer-administered questionnaire. Participants were asked about their ability and degree of difficulty with respect to walking up and down a staircase of 15 steps without resting; dressing and undressing oneself; sitting down and standing up from a chair; cutting one’s toenails; walking outside for 5 minutes without resting; and using one’s own or public transportation. Limitations were defined as any difficulty with performing a specific activity.

Although research on the association between vitamin D status and functional limitations is "scarce and not conclusive," according to the investigators, the findings "are in line with the results of most studies on vitamin D status and physical performance."

"Because functional limitations are a predictor of adverse outcomes, further research is necessary to explore underlying mechanisms and the potential benefits of vitamin D supplements on functional status," they concluded.

The study authors reported having no disclosures.

Older adults with vitamin D deficiency are more likely than those with adequate vitamin D levels to have functional limitations, findings from the Longitudinal Aging Study Amsterdam suggest.

These limitations became apparent within 3 years in a cohort aged 65-88 years, compared with 6 years in one aged 55-65 years.

In a cohort of 1,237 adults who were aged 65-88 years at baseline, 56% had at least one functional limitation, and in a second cohort of 725 adults aged 55-65 years at baseline, 30% had at least 1 functional limitation. Those in the older cohort who had vitamin D deficiency, defined as a 25-hydroxyvitamin D (25[OH]D) level of less than 20 ng/mL, had a nearly twofold increased risk of having a functional limitation, compared with those who had a 25(OH)D level greater than 30 ng/mL (odds ratio, 1.7), and those in the younger cohort who had vitamin D deficiency had more than a twofold increased risk (OR, 2.1), according to Dr. Evelien Sohl and her colleagues from the VU University Medical Center, Amsterdam.

©iStockphoto.com

Vitamin D status also was associated with the number of functional limitations cross-sectionally, the investigators reported online July 17 in the Journal of Clinical Endocrinology and Metabolism.

"In the fully adjusted models, participants in the older cohort with serum 25(OH)D levels of less than 20 ng/mL had a 1.6 times higher odds for having 1 more functional limitation than participants in the reference category. In the younger cohort, this odds ratio was 1.9," they said (J. Clin. Endocrinol. Metab. 2013 July 17 [doi: 10.1210/jc.2013-1698]).

The investigators also found that vitamin D deficiency was associated with an increase of two or more additional limitations at 3 years in the older cohort (OR, 2.0), but not at 6 years, while the association between vitamin D deficiency and an increase of two or more limitations did not reach significance until after 6 years in the younger cohort (OR, 3.3).

"Age and sex did not significantly modify the associations between serum 25(OH)D and functional status. Relevant confounders were age, sex, body mass index, number of chronic diseases, level of education, and level of urbanization," they said.

Specific functional limitations associated with vitamin D status in the older cohort included walking stairs (OR, 1.8), cutting toenails (OR, 1.5), and walking outside (OR, 2.1). Statistical power was insufficient for analyzing functional limitations in the younger cohort separately because of the low number of limitations in that group.

The Longitudinal Aging Study Amsterdam is an ongoing prospective cohort study of the older Dutch population. Functional limitations were assessed by an interviewer-administered questionnaire. Participants were asked about their ability and degree of difficulty with respect to walking up and down a staircase of 15 steps without resting; dressing and undressing oneself; sitting down and standing up from a chair; cutting one’s toenails; walking outside for 5 minutes without resting; and using one’s own or public transportation. Limitations were defined as any difficulty with performing a specific activity.

Although research on the association between vitamin D status and functional limitations is "scarce and not conclusive," according to the investigators, the findings "are in line with the results of most studies on vitamin D status and physical performance."

"Because functional limitations are a predictor of adverse outcomes, further research is necessary to explore underlying mechanisms and the potential benefits of vitamin D supplements on functional status," they concluded.

The study authors reported having no disclosures.

Venous duplex ultrasound is rarely appropriate as a screening tool for upper or lower extremity deep vein thrombosis in the absence of pain or swelling, according to new appropriate use criteria for noninvasive vascular laboratory testing issued by the American College of Cardiology.

The clinical scenarios involving venous duplex ultrasound for DVT screening that were deemed rarely appropriate – such as screening in those with a prolonged ICU stay and those with high DVT risk – represent just a few of the 116 scenarios included in the report, which was developed in collaboration with 10 other leading professional societies to promote the most effective and most efficient use of peripheral vascular ultrasound and physiological testing in clinical practice.

The report, published online on July 19 in the Journal of the American College of Cardiology, is the second in a two-part series evaluating noninvasive testing for peripheral vascular disorders. Part I, published last year (J. Am. Coll. Cardiol. 2012;60:242-76), addressed peripheral arterial disorders, and Part II (J. Am. Coll. Cardiol. 2013 July 19 [doi:10.1016/j.jacc.2013.05.001]) addresses venous disease and evaluation of hemodialysis access, according to Dr. Heather Gornik, chair of the Part II writing committee.

©Tom Merce/Cleveland Clinic

"Vascular laboratory tests really play a central role in evaluating patients with peripheral vascular disorders. They are noninvasive, they have good accuracy data, and they don’t require radiation or dye. But we want to make sure the right tests are being ordered for the right reasons," Dr. Gornik, a cardiologist and vascular medicine specialist at the Cleveland Clinic, said in an interview.

Because these tests are low risk and easily accessible, there is concern that they are sometimes used excessively, she explained – specifically mentioning the use of duplex ultrasound for DVT screening as a commonly overused procedure.

"There is very little evidence, if any, to support broad screening for blood clots in someone who has no symptoms," she said.

The goal of the ACC Foundation Appropriate Use Criteria Task Force responsible for developing the criteria was to help clinicians minimize unnecessary testing, and maximize the most effective and efficient testing, she added.

Each of the clinical scenarios that were developed by the writing committee were rated by a technical panel as to whether they represent an "appropriate use," or whether they are "maybe appropriate" or "rarely appropriate."

The various scenarios are listed, along with their rating, in eight "at-a-glance" tables that address the following more general categories: venous duplex of the upper extremities for assessing patency and thrombosis; venous duplex of the lower extremities for assessing patency and thrombosis; duplex evaluation for venous incompetency; venous physiological testing with provocative maneuvers to assess for patency and/or incompetency; duplex of the inferior vena cava and iliac veins for patency and thrombosis; duplex of the hepatoportal system for patency, thrombosis, and flow direction; duplex of the renal vein for patency and thrombosis; and preoperative planning and postoperative assessment of a vascular access site.

Considering venous duplex ultrasound in a patient with acute unilateral limb swelling? Table 1 lists this as an appropriate use. How about duplex evaluation for venous incompetency in a patient with asymptomatic varicose veins? Table 3 says this may be appropriate, but notes that it is rarely appropriate in a patient with spider veins.

The report also covers indications for vascular testing prior to or after placement of hemodialysis access, because "evaluation of the superficial, deep, and central veins of the upper extremity constitutes a large component of these examinations," the report states.

In general, vascular studies were deemed appropriate in the presence of clinical signs and symptoms. The report also shows that the vascular laboratory plays a central role in the evaluation of patients with chronic venous insufficiency, and that preoperative vascular testing for preparing a dialysis access site is appropriate within three months of the procedure – but not for general surveillance of a functional dialysis fistula or graft in the absence of an indication of a problem, such as a palpable mass or swelling in the arm.

The report is not intended to be comprehensive, but rather is an attempt to address common and important clinical scenarios encountered in the patient with manifestations of peripheral vascular disease, the authors noted.

"The beauty of this report is that it spans many disciplines," Dr. Gornik said, noting that numerous parties have an interest in peripheral vascular disease, and that many specialties order vascular laboratory tests.

A number of them were represented in the development of these appropriate use criteria. Collaborating organizations included the American College of Radiology, the American Institute of Ultrasound in Medicine, the American Society of Echocardiography, the American Society of Nephrology, Intersocietal Accreditation Commission, Society for Cardiovascular Angiography and Interventions, the Society of Cardiovascular Computed Tomography, the Society for Interventional Radiology, the Society for Vascular Medicine, and the Society for Vascular Surgery.

While other organizations have developed appropriate use criteria for other modalities, such as cardiac testing, few have specifically addressed vascular testing.

"I hope that these criteria will allow clinicians and vascular laboratories to really focus on doing the highest quality work, and to evaluate their use of vascular testing, maximize the use of the vascular lab, and assure that the right test is done for the right indication and that tests that are not needed are not performed just because they are readily available," she said.

Dr. Gornik disclosed financial or other relationships with Zin Medical, Summit Doppler Systems Inc., the Fibromuscular Dysplasia Society of America, and the Intersocietal Accreditation Commission. A detailed list of disclosures for all Appropriate Use Criteria Task Force Members is included with the full text of the report.

Venous duplex ultrasound is rarely appropriate as a screening tool for upper or lower extremity deep vein thrombosis in the absence of pain or swelling, according to new appropriate use criteria for noninvasive vascular laboratory testing issued by the American College of Cardiology.

The clinical scenarios involving venous duplex ultrasound for DVT screening that were deemed rarely appropriate – such as screening in those with a prolonged ICU stay and those with high DVT risk – represent just a few of the 116 scenarios included in the report, which was developed in collaboration with 10 other leading professional societies to promote the most effective and most efficient use of peripheral vascular ultrasound and physiological testing in clinical practice.

The report, published online on July 19 in the Journal of the American College of Cardiology, is the second in a two-part series evaluating noninvasive testing for peripheral vascular disorders. Part I, published last year (J. Am. Coll. Cardiol. 2012;60:242-76), addressed peripheral arterial disorders, and Part II (J. Am. Coll. Cardiol. 2013 July 19 [doi:10.1016/j.jacc.2013.05.001]) addresses venous disease and evaluation of hemodialysis access, according to Dr. Heather Gornik, chair of the Part II writing committee.

©Tom Merce/Cleveland Clinic

"Vascular laboratory tests really play a central role in evaluating patients with peripheral vascular disorders. They are noninvasive, they have good accuracy data, and they don’t require radiation or dye. But we want to make sure the right tests are being ordered for the right reasons," Dr. Gornik, a cardiologist and vascular medicine specialist at the Cleveland Clinic, said in an interview.

Because these tests are low risk and easily accessible, there is concern that they are sometimes used excessively, she explained – specifically mentioning the use of duplex ultrasound for DVT screening as a commonly overused procedure.

"There is very little evidence, if any, to support broad screening for blood clots in someone who has no symptoms," she said.

The goal of the ACC Foundation Appropriate Use Criteria Task Force responsible for developing the criteria was to help clinicians minimize unnecessary testing, and maximize the most effective and efficient testing, she added.

Each of the clinical scenarios that were developed by the writing committee were rated by a technical panel as to whether they represent an "appropriate use," or whether they are "maybe appropriate" or "rarely appropriate."

The various scenarios are listed, along with their rating, in eight "at-a-glance" tables that address the following more general categories: venous duplex of the upper extremities for assessing patency and thrombosis; venous duplex of the lower extremities for assessing patency and thrombosis; duplex evaluation for venous incompetency; venous physiological testing with provocative maneuvers to assess for patency and/or incompetency; duplex of the inferior vena cava and iliac veins for patency and thrombosis; duplex of the hepatoportal system for patency, thrombosis, and flow direction; duplex of the renal vein for patency and thrombosis; and preoperative planning and postoperative assessment of a vascular access site.

Considering venous duplex ultrasound in a patient with acute unilateral limb swelling? Table 1 lists this as an appropriate use. How about duplex evaluation for venous incompetency in a patient with asymptomatic varicose veins? Table 3 says this may be appropriate, but notes that it is rarely appropriate in a patient with spider veins.

The report also covers indications for vascular testing prior to or after placement of hemodialysis access, because "evaluation of the superficial, deep, and central veins of the upper extremity constitutes a large component of these examinations," the report states.

In general, vascular studies were deemed appropriate in the presence of clinical signs and symptoms. The report also shows that the vascular laboratory plays a central role in the evaluation of patients with chronic venous insufficiency, and that preoperative vascular testing for preparing a dialysis access site is appropriate within three months of the procedure – but not for general surveillance of a functional dialysis fistula or graft in the absence of an indication of a problem, such as a palpable mass or swelling in the arm.

The report is not intended to be comprehensive, but rather is an attempt to address common and important clinical scenarios encountered in the patient with manifestations of peripheral vascular disease, the authors noted.

"The beauty of this report is that it spans many disciplines," Dr. Gornik said, noting that numerous parties have an interest in peripheral vascular disease, and that many specialties order vascular laboratory tests.

A number of them were represented in the development of these appropriate use criteria. Collaborating organizations included the American College of Radiology, the American Institute of Ultrasound in Medicine, the American Society of Echocardiography, the American Society of Nephrology, Intersocietal Accreditation Commission, Society for Cardiovascular Angiography and Interventions, the Society of Cardiovascular Computed Tomography, the Society for Interventional Radiology, the Society for Vascular Medicine, and the Society for Vascular Surgery.

While other organizations have developed appropriate use criteria for other modalities, such as cardiac testing, few have specifically addressed vascular testing.

"I hope that these criteria will allow clinicians and vascular laboratories to really focus on doing the highest quality work, and to evaluate their use of vascular testing, maximize the use of the vascular lab, and assure that the right test is done for the right indication and that tests that are not needed are not performed just because they are readily available," she said.

Dr. Gornik disclosed financial or other relationships with Zin Medical, Summit Doppler Systems Inc., the Fibromuscular Dysplasia Society of America, and the Intersocietal Accreditation Commission. A detailed list of disclosures for all Appropriate Use Criteria Task Force Members is included with the full text of the report.

Venous duplex ultrasound is rarely appropriate as a screening tool for upper or lower extremity deep vein thrombosis in the absence of pain or swelling, according to new appropriate use criteria for noninvasive vascular laboratory testing issued by the American College of Cardiology.

The clinical scenarios involving venous duplex ultrasound for DVT screening that were deemed rarely appropriate – such as screening in those with a prolonged ICU stay and those with high DVT risk – represent just a few of the 116 scenarios included in the report, which was developed in collaboration with 10 other leading professional societies to promote the most effective and most efficient use of peripheral vascular ultrasound and physiological testing in clinical practice.

The report, published online on July 19 in the Journal of the American College of Cardiology, is the second in a two-part series evaluating noninvasive testing for peripheral vascular disorders. Part I, published last year (J. Am. Coll. Cardiol. 2012;60:242-76), addressed peripheral arterial disorders, and Part II (J. Am. Coll. Cardiol. 2013 July 19 [doi:10.1016/j.jacc.2013.05.001]) addresses venous disease and evaluation of hemodialysis access, according to Dr. Heather Gornik, chair of the Part II writing committee.

©Tom Merce/Cleveland Clinic

"Vascular laboratory tests really play a central role in evaluating patients with peripheral vascular disorders. They are noninvasive, they have good accuracy data, and they don’t require radiation or dye. But we want to make sure the right tests are being ordered for the right reasons," Dr. Gornik, a cardiologist and vascular medicine specialist at the Cleveland Clinic, said in an interview.

Because these tests are low risk and easily accessible, there is concern that they are sometimes used excessively, she explained – specifically mentioning the use of duplex ultrasound for DVT screening as a commonly overused procedure.

"There is very little evidence, if any, to support broad screening for blood clots in someone who has no symptoms," she said.

The goal of the ACC Foundation Appropriate Use Criteria Task Force responsible for developing the criteria was to help clinicians minimize unnecessary testing, and maximize the most effective and efficient testing, she added.

Each of the clinical scenarios that were developed by the writing committee were rated by a technical panel as to whether they represent an "appropriate use," or whether they are "maybe appropriate" or "rarely appropriate."

The various scenarios are listed, along with their rating, in eight "at-a-glance" tables that address the following more general categories: venous duplex of the upper extremities for assessing patency and thrombosis; venous duplex of the lower extremities for assessing patency and thrombosis; duplex evaluation for venous incompetency; venous physiological testing with provocative maneuvers to assess for patency and/or incompetency; duplex of the inferior vena cava and iliac veins for patency and thrombosis; duplex of the hepatoportal system for patency, thrombosis, and flow direction; duplex of the renal vein for patency and thrombosis; and preoperative planning and postoperative assessment of a vascular access site.

Considering venous duplex ultrasound in a patient with acute unilateral limb swelling? Table 1 lists this as an appropriate use. How about duplex evaluation for venous incompetency in a patient with asymptomatic varicose veins? Table 3 says this may be appropriate, but notes that it is rarely appropriate in a patient with spider veins.

The report also covers indications for vascular testing prior to or after placement of hemodialysis access, because "evaluation of the superficial, deep, and central veins of the upper extremity constitutes a large component of these examinations," the report states.

In general, vascular studies were deemed appropriate in the presence of clinical signs and symptoms. The report also shows that the vascular laboratory plays a central role in the evaluation of patients with chronic venous insufficiency, and that preoperative vascular testing for preparing a dialysis access site is appropriate within three months of the procedure – but not for general surveillance of a functional dialysis fistula or graft in the absence of an indication of a problem, such as a palpable mass or swelling in the arm.

The report is not intended to be comprehensive, but rather is an attempt to address common and important clinical scenarios encountered in the patient with manifestations of peripheral vascular disease, the authors noted.

"The beauty of this report is that it spans many disciplines," Dr. Gornik said, noting that numerous parties have an interest in peripheral vascular disease, and that many specialties order vascular laboratory tests.

A number of them were represented in the development of these appropriate use criteria. Collaborating organizations included the American College of Radiology, the American Institute of Ultrasound in Medicine, the American Society of Echocardiography, the American Society of Nephrology, Intersocietal Accreditation Commission, Society for Cardiovascular Angiography and Interventions, the Society of Cardiovascular Computed Tomography, the Society for Interventional Radiology, the Society for Vascular Medicine, and the Society for Vascular Surgery.

While other organizations have developed appropriate use criteria for other modalities, such as cardiac testing, few have specifically addressed vascular testing.

"I hope that these criteria will allow clinicians and vascular laboratories to really focus on doing the highest quality work, and to evaluate their use of vascular testing, maximize the use of the vascular lab, and assure that the right test is done for the right indication and that tests that are not needed are not performed just because they are readily available," she said.

Dr. Gornik disclosed financial or other relationships with Zin Medical, Summit Doppler Systems Inc., the Fibromuscular Dysplasia Society of America, and the Intersocietal Accreditation Commission. A detailed list of disclosures for all Appropriate Use Criteria Task Force Members is included with the full text of the report.

Psychotic symptoms in adolescents are a clinical marker of high risk for suicide attempts, particularly in those with psychopathology, according to findings from the Saving and Empowering Young Lives in Europe study.

Of 1,112 adolescents aged 13-16 years who were part of the randomized, prospective cohort study, 7% reported psychotic symptoms at baseline, and of those, 7% attempted suicide within 3 months, compared with 1% of the rest of the sample (odds ratio, 10.01), and 20% attempted suicide within 12 months, compared with 2.5% of the rest of the sample (OR, 11.27), Dr. Ian Kelleher of Beaumont Hospital, Dublin, and his colleagues reported July 17 online in JAMA Psychiatry.

Among those with baseline psychopathology, 23% reported psychotic symptoms, compared with 4% of the rest of the sample (OR, 8.13), and the percentage of those with both psychopathology and psychotic symptoms at baseline who reported a suicide attempt by 3 months was 14% (OR, 17.91). More than a third (34%) of those with both psychopathology and psychotic symptoms at baseline attempted suicide by 12 months (OR, 32.67), the investigators reported (JAMA Psychiatry 2013 July 17[doi:10.1001/jamapsychiatry.2013.140]).

"Although the presence of psychopathology without psychotic symptoms at baseline predicted suicide attempts over time, albeit to a lesser degree than psychopathology with psychotic symptoms, some participants who were not experiencing psychotic symptoms at the time of the assessment may have experienced such symptoms closer to the time of their suicide attempt," the investigators noted.

To assess for this possibility, they looked specifically at acute suicide attempts – those occurring within the 2 weeks prior to the 3- and 12-month assessments – and found that subjects with psychopathology who did not report psychotic symptoms did not have significantly increased odds of such suicide attempts (OR, 1.09).

"Those with psychopathology who did experience psychotic symptoms, on the other hand, had a nearly 70-fold increased odds of acute suicide attempts (OR, 67.50)," they wrote, adding that in absolute terms, those with psychotic symptoms comprised less than a quarter of the total groups with psychopathology, but accounted for nearly 80% of the acute suicide attempts in the group.

The association between psychotic symptoms and suicide attempts was not explained by nonpsychotic psychiatric symptom burden or by multimorbidity, the investigators added.

The findings underscore the importance of assessing psychotic symptoms in individuals with suspected psychopathology, and the need to recognize suicide risk when these symptoms are present, they said.

"It is also important to recognize that most such symptoms do not present as true hallucinations; that is, they may occur with intact reality testing and thus may be attenuated rather than frankly psychotic," they noted.

As for why psychotic symptoms predict suicidal behavior, the reasons are not readily clear, but it is possible that psychotic symptoms are a marker of increasing severity of psychopathology, the investigators said.

Also, individuals who experience psychotic symptoms may have increased sensitivity to stress, as well as poor coping skills, which might contribute to a greater risk of suicidal behavior in the face of acute life stressors, they said, adding that shared risk factors for suicidal behavior and psychotic symptoms, such as childhood traumatic experiences, also might play a role.

Given that suicide is among the leading causes of death worldwide, and that suicide risk assessment is recognized as one of the most difficult areas of clinical practice, the findings offer some hope for improving recognition of risk based on the presence of psychotic symptoms.

"An important clinical implication of these findings is the need for a new clinical focus on careful assessment of psychotic symptoms (both attenuated and frank) in patients with nonpsychotic disorders; this should be considered a key element of suicide risk assessment," the investigators said.

Participants in the Saving and Empowering Young Lives in Europe (SEYLE) study – a randomized clinical trial aimed at assessing prevention strategies for suicidal behavior – were school-age students from 11 countries. Those included in the current analysis were students from 17 randomly selected schools in Ireland who completed questionnaires that included information about psychopathology and psychotic symptoms, and who completed 12 months of follow-up.

Additional research, including research among older age groups, is needed, the investigators wrote.

"Further community and clinical research on suicidal behavior and psychotic symptoms would be valuable, as would research on underlying mechanisms that might explain this relationship and research that provides targets for intervention," they concluded

The SEYLE project is supported by a grant from the European Union Seventh Framework Programme. Dr. Kelleher was supported by an Interdisciplinary Capacity Enhancement Award from the Health Research Board Ireland.

Psychotic symptoms in adolescents are a clinical marker of high risk for suicide attempts, particularly in those with psychopathology, according to findings from the Saving and Empowering Young Lives in Europe study.

Of 1,112 adolescents aged 13-16 years who were part of the randomized, prospective cohort study, 7% reported psychotic symptoms at baseline, and of those, 7% attempted suicide within 3 months, compared with 1% of the rest of the sample (odds ratio, 10.01), and 20% attempted suicide within 12 months, compared with 2.5% of the rest of the sample (OR, 11.27), Dr. Ian Kelleher of Beaumont Hospital, Dublin, and his colleagues reported July 17 online in JAMA Psychiatry.

Among those with baseline psychopathology, 23% reported psychotic symptoms, compared with 4% of the rest of the sample (OR, 8.13), and the percentage of those with both psychopathology and psychotic symptoms at baseline who reported a suicide attempt by 3 months was 14% (OR, 17.91). More than a third (34%) of those with both psychopathology and psychotic symptoms at baseline attempted suicide by 12 months (OR, 32.67), the investigators reported (JAMA Psychiatry 2013 July 17[doi:10.1001/jamapsychiatry.2013.140]).

"Although the presence of psychopathology without psychotic symptoms at baseline predicted suicide attempts over time, albeit to a lesser degree than psychopathology with psychotic symptoms, some participants who were not experiencing psychotic symptoms at the time of the assessment may have experienced such symptoms closer to the time of their suicide attempt," the investigators noted.

To assess for this possibility, they looked specifically at acute suicide attempts – those occurring within the 2 weeks prior to the 3- and 12-month assessments – and found that subjects with psychopathology who did not report psychotic symptoms did not have significantly increased odds of such suicide attempts (OR, 1.09).

"Those with psychopathology who did experience psychotic symptoms, on the other hand, had a nearly 70-fold increased odds of acute suicide attempts (OR, 67.50)," they wrote, adding that in absolute terms, those with psychotic symptoms comprised less than a quarter of the total groups with psychopathology, but accounted for nearly 80% of the acute suicide attempts in the group.

The association between psychotic symptoms and suicide attempts was not explained by nonpsychotic psychiatric symptom burden or by multimorbidity, the investigators added.

The findings underscore the importance of assessing psychotic symptoms in individuals with suspected psychopathology, and the need to recognize suicide risk when these symptoms are present, they said.

"It is also important to recognize that most such symptoms do not present as true hallucinations; that is, they may occur with intact reality testing and thus may be attenuated rather than frankly psychotic," they noted.

As for why psychotic symptoms predict suicidal behavior, the reasons are not readily clear, but it is possible that psychotic symptoms are a marker of increasing severity of psychopathology, the investigators said.

Also, individuals who experience psychotic symptoms may have increased sensitivity to stress, as well as poor coping skills, which might contribute to a greater risk of suicidal behavior in the face of acute life stressors, they said, adding that shared risk factors for suicidal behavior and psychotic symptoms, such as childhood traumatic experiences, also might play a role.

Given that suicide is among the leading causes of death worldwide, and that suicide risk assessment is recognized as one of the most difficult areas of clinical practice, the findings offer some hope for improving recognition of risk based on the presence of psychotic symptoms.

"An important clinical implication of these findings is the need for a new clinical focus on careful assessment of psychotic symptoms (both attenuated and frank) in patients with nonpsychotic disorders; this should be considered a key element of suicide risk assessment," the investigators said.

Participants in the Saving and Empowering Young Lives in Europe (SEYLE) study – a randomized clinical trial aimed at assessing prevention strategies for suicidal behavior – were school-age students from 11 countries. Those included in the current analysis were students from 17 randomly selected schools in Ireland who completed questionnaires that included information about psychopathology and psychotic symptoms, and who completed 12 months of follow-up.

Additional research, including research among older age groups, is needed, the investigators wrote.

"Further community and clinical research on suicidal behavior and psychotic symptoms would be valuable, as would research on underlying mechanisms that might explain this relationship and research that provides targets for intervention," they concluded

The SEYLE project is supported by a grant from the European Union Seventh Framework Programme. Dr. Kelleher was supported by an Interdisciplinary Capacity Enhancement Award from the Health Research Board Ireland.

Psychotic symptoms in adolescents are a clinical marker of high risk for suicide attempts, particularly in those with psychopathology, according to findings from the Saving and Empowering Young Lives in Europe study.

Of 1,112 adolescents aged 13-16 years who were part of the randomized, prospective cohort study, 7% reported psychotic symptoms at baseline, and of those, 7% attempted suicide within 3 months, compared with 1% of the rest of the sample (odds ratio, 10.01), and 20% attempted suicide within 12 months, compared with 2.5% of the rest of the sample (OR, 11.27), Dr. Ian Kelleher of Beaumont Hospital, Dublin, and his colleagues reported July 17 online in JAMA Psychiatry.

Among those with baseline psychopathology, 23% reported psychotic symptoms, compared with 4% of the rest of the sample (OR, 8.13), and the percentage of those with both psychopathology and psychotic symptoms at baseline who reported a suicide attempt by 3 months was 14% (OR, 17.91). More than a third (34%) of those with both psychopathology and psychotic symptoms at baseline attempted suicide by 12 months (OR, 32.67), the investigators reported (JAMA Psychiatry 2013 July 17[doi:10.1001/jamapsychiatry.2013.140]).

"Although the presence of psychopathology without psychotic symptoms at baseline predicted suicide attempts over time, albeit to a lesser degree than psychopathology with psychotic symptoms, some participants who were not experiencing psychotic symptoms at the time of the assessment may have experienced such symptoms closer to the time of their suicide attempt," the investigators noted.

To assess for this possibility, they looked specifically at acute suicide attempts – those occurring within the 2 weeks prior to the 3- and 12-month assessments – and found that subjects with psychopathology who did not report psychotic symptoms did not have significantly increased odds of such suicide attempts (OR, 1.09).

"Those with psychopathology who did experience psychotic symptoms, on the other hand, had a nearly 70-fold increased odds of acute suicide attempts (OR, 67.50)," they wrote, adding that in absolute terms, those with psychotic symptoms comprised less than a quarter of the total groups with psychopathology, but accounted for nearly 80% of the acute suicide attempts in the group.

The association between psychotic symptoms and suicide attempts was not explained by nonpsychotic psychiatric symptom burden or by multimorbidity, the investigators added.

The findings underscore the importance of assessing psychotic symptoms in individuals with suspected psychopathology, and the need to recognize suicide risk when these symptoms are present, they said.

"It is also important to recognize that most such symptoms do not present as true hallucinations; that is, they may occur with intact reality testing and thus may be attenuated rather than frankly psychotic," they noted.

As for why psychotic symptoms predict suicidal behavior, the reasons are not readily clear, but it is possible that psychotic symptoms are a marker of increasing severity of psychopathology, the investigators said.

Also, individuals who experience psychotic symptoms may have increased sensitivity to stress, as well as poor coping skills, which might contribute to a greater risk of suicidal behavior in the face of acute life stressors, they said, adding that shared risk factors for suicidal behavior and psychotic symptoms, such as childhood traumatic experiences, also might play a role.

Given that suicide is among the leading causes of death worldwide, and that suicide risk assessment is recognized as one of the most difficult areas of clinical practice, the findings offer some hope for improving recognition of risk based on the presence of psychotic symptoms.

"An important clinical implication of these findings is the need for a new clinical focus on careful assessment of psychotic symptoms (both attenuated and frank) in patients with nonpsychotic disorders; this should be considered a key element of suicide risk assessment," the investigators said.

Participants in the Saving and Empowering Young Lives in Europe (SEYLE) study – a randomized clinical trial aimed at assessing prevention strategies for suicidal behavior – were school-age students from 11 countries. Those included in the current analysis were students from 17 randomly selected schools in Ireland who completed questionnaires that included information about psychopathology and psychotic symptoms, and who completed 12 months of follow-up.

Additional research, including research among older age groups, is needed, the investigators wrote.

"Further community and clinical research on suicidal behavior and psychotic symptoms would be valuable, as would research on underlying mechanisms that might explain this relationship and research that provides targets for intervention," they concluded

The SEYLE project is supported by a grant from the European Union Seventh Framework Programme. Dr. Kelleher was supported by an Interdisciplinary Capacity Enhancement Award from the Health Research Board Ireland.

Women and men with bipolar disorder were more likely to die prematurely than were those without bipolar disorder, according to results from a Swedish national cohort study involving nearly 6.6 million adults.

After adjustment for age, marital status, educational level, employment status, and income, all-cause mortality among the 6,618 adults with bipolar disorder in the cohort was increased twofold for both women (adjusted hazard ratio, 2.34) and men (AHR, 2.03), who died an average of 9.0 and 8.5 years earlier, respectively, did than those without bipolar disorder, according to Dr. Casey Crump of Stanford (Calif.) University, and his colleagues.

Those with bipolar disorder died prematurely from various causes, including cardiovascular disease, diabetes, chronic obstructive pulmonary disease (COPD), influenza or pneumonia, unintentional injuries, and suicide. Among women, stroke and cancer (particularly colon cancer) were also among the causes of premature death. Suicide was a particular risk for both women and men, who had 10-fold and 8-fold increases in risk, respectively (AHRs, 10.37 and 8.09), but the life expectancy differences were not fully explained by unnatural deaths, the investigators reported July 17 online in JAMA Psychiatry.

The most significant causes of death were influenza or pneumonia (3.7- and 4.4-fold increased risk for women and men, respectively), diabetes (3.6- and 2.6-fold increased risk, respectively), and COPD (2.9- and 2.6-fold increased risk).

In a separate model, the potential mediating effect of substance use disorders also was evaluated, and the effect was found to be modest, the investigators noted.

The associations between the various conditions and premature death were weakest for chronic diseases in those with a prior diagnosis, compared with those without a prior diagnosis (AHRs, 1.40 vs. 2.38), suggesting that earlier medical diagnosis and treatment might attenuate the increased mortality risk among affected individuals, they said (JAMA Psychiatry 2013 July 17 [doi: 10.1001/jamapsychiatry.2013.1394]).

"More complete provision of primary, preventive medical care among bipolar disorder patients is needed to reduce early mortality in this vulnerable population," they said, noting that multiple underlying mechanisms, including lifestyle factors, pathophysiologic mechanisms, genetic factors, and certain treatments for bipolar disorder, contribute to the disparities.

"The current study found evidence of modestly increased mortality among bipolar disorder patients who used carbamazepine, risperidone, or valproic acid or who solely used olanzapine, whereas users of aripiprazole, quetiapine, or lamotrigine had modestly reduced mortality compared with those who solely used lithium," they said.

However, consistent with prior research, those who used none of these medications had even higher rates of all-cause mortality – and twice the suicide risk – of those who used medication.

Study participants were 3,918 women and 2,700 men aged 20 years or older who lived in Sweden for at least 2 years as of Jan. 1, 2003. They were followed up to assess for physical comorbidities and mortality for 7 years. Bipolar disorder in the cohort was identified by any diagnosis during the preceding 2 years, and by the use of specific medications commonly used for bipolar disorder maintenance treatment.

The findings of this study, which is among the first to examine the association between bipolar disorder and mortality using complete diagnoses for a national population, adds to the increasing knowledge about factors that contribute to premature mortality in patients with bipolar disorder, but it is unclear to what extent the findings can be generalized to other health care systems, the investigators said.

"The substantial health disparities we found between bipolar disorder patients and the rest of the Swedish population may be even larger in other countries without universal health care," they noted.

This study was supported by a grant from the National Institute on Drug Abuse and an Agreement on Medical Training and Research (Lund, Sweden) project grant. The authors reported having no disclosures.

Women and men with bipolar disorder were more likely to die prematurely than were those without bipolar disorder, according to results from a Swedish national cohort study involving nearly 6.6 million adults.

After adjustment for age, marital status, educational level, employment status, and income, all-cause mortality among the 6,618 adults with bipolar disorder in the cohort was increased twofold for both women (adjusted hazard ratio, 2.34) and men (AHR, 2.03), who died an average of 9.0 and 8.5 years earlier, respectively, did than those without bipolar disorder, according to Dr. Casey Crump of Stanford (Calif.) University, and his colleagues.

Those with bipolar disorder died prematurely from various causes, including cardiovascular disease, diabetes, chronic obstructive pulmonary disease (COPD), influenza or pneumonia, unintentional injuries, and suicide. Among women, stroke and cancer (particularly colon cancer) were also among the causes of premature death. Suicide was a particular risk for both women and men, who had 10-fold and 8-fold increases in risk, respectively (AHRs, 10.37 and 8.09), but the life expectancy differences were not fully explained by unnatural deaths, the investigators reported July 17 online in JAMA Psychiatry.

The most significant causes of death were influenza or pneumonia (3.7- and 4.4-fold increased risk for women and men, respectively), diabetes (3.6- and 2.6-fold increased risk, respectively), and COPD (2.9- and 2.6-fold increased risk).

In a separate model, the potential mediating effect of substance use disorders also was evaluated, and the effect was found to be modest, the investigators noted.

The associations between the various conditions and premature death were weakest for chronic diseases in those with a prior diagnosis, compared with those without a prior diagnosis (AHRs, 1.40 vs. 2.38), suggesting that earlier medical diagnosis and treatment might attenuate the increased mortality risk among affected individuals, they said (JAMA Psychiatry 2013 July 17 [doi: 10.1001/jamapsychiatry.2013.1394]).

"More complete provision of primary, preventive medical care among bipolar disorder patients is needed to reduce early mortality in this vulnerable population," they said, noting that multiple underlying mechanisms, including lifestyle factors, pathophysiologic mechanisms, genetic factors, and certain treatments for bipolar disorder, contribute to the disparities.

"The current study found evidence of modestly increased mortality among bipolar disorder patients who used carbamazepine, risperidone, or valproic acid or who solely used olanzapine, whereas users of aripiprazole, quetiapine, or lamotrigine had modestly reduced mortality compared with those who solely used lithium," they said.

However, consistent with prior research, those who used none of these medications had even higher rates of all-cause mortality – and twice the suicide risk – of those who used medication.

Study participants were 3,918 women and 2,700 men aged 20 years or older who lived in Sweden for at least 2 years as of Jan. 1, 2003. They were followed up to assess for physical comorbidities and mortality for 7 years. Bipolar disorder in the cohort was identified by any diagnosis during the preceding 2 years, and by the use of specific medications commonly used for bipolar disorder maintenance treatment.

The findings of this study, which is among the first to examine the association between bipolar disorder and mortality using complete diagnoses for a national population, adds to the increasing knowledge about factors that contribute to premature mortality in patients with bipolar disorder, but it is unclear to what extent the findings can be generalized to other health care systems, the investigators said.

"The substantial health disparities we found between bipolar disorder patients and the rest of the Swedish population may be even larger in other countries without universal health care," they noted.

This study was supported by a grant from the National Institute on Drug Abuse and an Agreement on Medical Training and Research (Lund, Sweden) project grant. The authors reported having no disclosures.

Women and men with bipolar disorder were more likely to die prematurely than were those without bipolar disorder, according to results from a Swedish national cohort study involving nearly 6.6 million adults.

After adjustment for age, marital status, educational level, employment status, and income, all-cause mortality among the 6,618 adults with bipolar disorder in the cohort was increased twofold for both women (adjusted hazard ratio, 2.34) and men (AHR, 2.03), who died an average of 9.0 and 8.5 years earlier, respectively, did than those without bipolar disorder, according to Dr. Casey Crump of Stanford (Calif.) University, and his colleagues.

Those with bipolar disorder died prematurely from various causes, including cardiovascular disease, diabetes, chronic obstructive pulmonary disease (COPD), influenza or pneumonia, unintentional injuries, and suicide. Among women, stroke and cancer (particularly colon cancer) were also among the causes of premature death. Suicide was a particular risk for both women and men, who had 10-fold and 8-fold increases in risk, respectively (AHRs, 10.37 and 8.09), but the life expectancy differences were not fully explained by unnatural deaths, the investigators reported July 17 online in JAMA Psychiatry.

The most significant causes of death were influenza or pneumonia (3.7- and 4.4-fold increased risk for women and men, respectively), diabetes (3.6- and 2.6-fold increased risk, respectively), and COPD (2.9- and 2.6-fold increased risk).

In a separate model, the potential mediating effect of substance use disorders also was evaluated, and the effect was found to be modest, the investigators noted.

The associations between the various conditions and premature death were weakest for chronic diseases in those with a prior diagnosis, compared with those without a prior diagnosis (AHRs, 1.40 vs. 2.38), suggesting that earlier medical diagnosis and treatment might attenuate the increased mortality risk among affected individuals, they said (JAMA Psychiatry 2013 July 17 [doi: 10.1001/jamapsychiatry.2013.1394]).

"More complete provision of primary, preventive medical care among bipolar disorder patients is needed to reduce early mortality in this vulnerable population," they said, noting that multiple underlying mechanisms, including lifestyle factors, pathophysiologic mechanisms, genetic factors, and certain treatments for bipolar disorder, contribute to the disparities.

"The current study found evidence of modestly increased mortality among bipolar disorder patients who used carbamazepine, risperidone, or valproic acid or who solely used olanzapine, whereas users of aripiprazole, quetiapine, or lamotrigine had modestly reduced mortality compared with those who solely used lithium," they said.

However, consistent with prior research, those who used none of these medications had even higher rates of all-cause mortality – and twice the suicide risk – of those who used medication.

Study participants were 3,918 women and 2,700 men aged 20 years or older who lived in Sweden for at least 2 years as of Jan. 1, 2003. They were followed up to assess for physical comorbidities and mortality for 7 years. Bipolar disorder in the cohort was identified by any diagnosis during the preceding 2 years, and by the use of specific medications commonly used for bipolar disorder maintenance treatment.

The findings of this study, which is among the first to examine the association between bipolar disorder and mortality using complete diagnoses for a national population, adds to the increasing knowledge about factors that contribute to premature mortality in patients with bipolar disorder, but it is unclear to what extent the findings can be generalized to other health care systems, the investigators said.

"The substantial health disparities we found between bipolar disorder patients and the rest of the Swedish population may be even larger in other countries without universal health care," they noted.

This study was supported by a grant from the National Institute on Drug Abuse and an Agreement on Medical Training and Research (Lund, Sweden) project grant. The authors reported having no disclosures.

DESTIN, FLA. – Patients with lupus are at increased risk for a number of long-term health issues that should be considered during the course of their care, according to Dr. Susan Manzi.

Bone disease, cardiovascular disease, cancer, and infection are particular areas of concern, Dr. Manzi said at the Congress of Clinical Rheumatology.

• Bone health. Women with systemic lupus erythematosus are known to be at increased risk for fractures. A 1999 retrospective cohort study, for example, showed that the observed number of nontraumatic fractures in more than 700 women with SLE was about fivefold greater than in the general population (Arthritis Rheum. 1999;42:882-90).

The standardized morbidity ratios ranged from 2.4 to 12.1 for various age groups, with the greatest risks in those aged 18-24 years (12.1), 45-64 years (7.6), and 70 years and older (4.9).

"We know that we cause a lot of the bone loss; we know that the bone loss may be part of the underlying disease. The fact is it’s there. We need to monitor for it and treat it," Dr. Manzi said. She noted that American College of Rheumatology guidelines are available to help in reducing fracture risk in patients with connective tissue diseases, such as lupus (Arthritis Care Res. 2010;62:1515-26).

• Cardiovascular health. Similarly, myocardial infarctions per 1,000 person-years are significantly greater among those with SLE than in the general population, according to the 1997 Framingham Offspring Study.

In that study, Dr. Manzi and her colleagues found that the incidence of MI was higher in SLE patients in every age category. The risk was 50-fold greater in those with SLE who were aged 35-44 years, compared with the overall study population (Am. J. Epidemiol. 1997;145:408-15).

Of note, in 2011 the American Heart Association officially recognized women with lupus and rheumatoid arthritis as at-risk groups for cardiovascular disease, and developed treatment and management recommendations for these groups, said Dr. Manzi, director of the Lupus Center of Excellence at the University of Pittsburgh. The AHA noted that SLE and RA may be unrecognized risk factors and that women with these conditions, even without clinically relevant cardiovascular disease, should be considered at risk and should be screened accordingly. The AHA recommendations "actually suggested that any woman who comes in with a cardiovascular event, particularly if it’s unexplained and they are young, should be screened for lupus and rheumatoid arthritis," she said.

• Cancer. In a 2005 study of more than 13,000 women from 30 centers, patients with lupus had a 20% increased risk for cancer, compared with the general population. A recent update similarly showed a 15%-20% increased risk (J. Autoimmun. 2013;42:130-5).

The greatest risk was for hematologic cancers, such as lymphomas and leukemia. Lung cancer and thyroid cancer were also increased in the lupus patients. A trend toward an increased risk of cervical and vulvar cancers was also noted, which could be associated with human papillomavirus infection. "This means we should be doing more paps and pelvics," she said.

Interestingly, women with SLE appear to have a reduced risk of breast, ovarian, and endometrial cancers, possibly as a result of avoidance of hormone replacement therapy, she said (Arthritis Rheum. 2005;52:1481-90).

• Infection. Patients with lupus are known to have an increased risk for infection, and it is important to exercise caution when using live attenuated vaccines. These include the herpes zoster vaccine; bacillus Calmette-Guérin tuberculosis vaccine; oral typhoid vaccine; measles, mumps, and rubella vaccine; varicella vaccine; oral polio vaccine; intranasal influenza vaccine; yellow fever vaccine; and endemic typhus vaccine, Dr. Manzi said.

These vaccines are not recommended for SLE patients being treated with immunosuppressive or biologic medications or with low immunoglobulins or hypocomplementemia.

Dr. Manzi has served as a consultant and/or advisory board member for Bristol-Myers Squibb, Exagen Diagnostics, Genentech, and other companies.

DESTIN, FLA. – Patients with lupus are at increased risk for a number of long-term health issues that should be considered during the course of their care, according to Dr. Susan Manzi.

Bone disease, cardiovascular disease, cancer, and infection are particular areas of concern, Dr. Manzi said at the Congress of Clinical Rheumatology.

• Bone health. Women with systemic lupus erythematosus are known to be at increased risk for fractures. A 1999 retrospective cohort study, for example, showed that the observed number of nontraumatic fractures in more than 700 women with SLE was about fivefold greater than in the general population (Arthritis Rheum. 1999;42:882-90).

The standardized morbidity ratios ranged from 2.4 to 12.1 for various age groups, with the greatest risks in those aged 18-24 years (12.1), 45-64 years (7.6), and 70 years and older (4.9).

"We know that we cause a lot of the bone loss; we know that the bone loss may be part of the underlying disease. The fact is it’s there. We need to monitor for it and treat it," Dr. Manzi said. She noted that American College of Rheumatology guidelines are available to help in reducing fracture risk in patients with connective tissue diseases, such as lupus (Arthritis Care Res. 2010;62:1515-26).

• Cardiovascular health. Similarly, myocardial infarctions per 1,000 person-years are significantly greater among those with SLE than in the general population, according to the 1997 Framingham Offspring Study.

In that study, Dr. Manzi and her colleagues found that the incidence of MI was higher in SLE patients in every age category. The risk was 50-fold greater in those with SLE who were aged 35-44 years, compared with the overall study population (Am. J. Epidemiol. 1997;145:408-15).

Of note, in 2011 the American Heart Association officially recognized women with lupus and rheumatoid arthritis as at-risk groups for cardiovascular disease, and developed treatment and management recommendations for these groups, said Dr. Manzi, director of the Lupus Center of Excellence at the University of Pittsburgh. The AHA noted that SLE and RA may be unrecognized risk factors and that women with these conditions, even without clinically relevant cardiovascular disease, should be considered at risk and should be screened accordingly. The AHA recommendations "actually suggested that any woman who comes in with a cardiovascular event, particularly if it’s unexplained and they are young, should be screened for lupus and rheumatoid arthritis," she said.

• Cancer. In a 2005 study of more than 13,000 women from 30 centers, patients with lupus had a 20% increased risk for cancer, compared with the general population. A recent update similarly showed a 15%-20% increased risk (J. Autoimmun. 2013;42:130-5).

The greatest risk was for hematologic cancers, such as lymphomas and leukemia. Lung cancer and thyroid cancer were also increased in the lupus patients. A trend toward an increased risk of cervical and vulvar cancers was also noted, which could be associated with human papillomavirus infection. "This means we should be doing more paps and pelvics," she said.

Interestingly, women with SLE appear to have a reduced risk of breast, ovarian, and endometrial cancers, possibly as a result of avoidance of hormone replacement therapy, she said (Arthritis Rheum. 2005;52:1481-90).

• Infection. Patients with lupus are known to have an increased risk for infection, and it is important to exercise caution when using live attenuated vaccines. These include the herpes zoster vaccine; bacillus Calmette-Guérin tuberculosis vaccine; oral typhoid vaccine; measles, mumps, and rubella vaccine; varicella vaccine; oral polio vaccine; intranasal influenza vaccine; yellow fever vaccine; and endemic typhus vaccine, Dr. Manzi said.

These vaccines are not recommended for SLE patients being treated with immunosuppressive or biologic medications or with low immunoglobulins or hypocomplementemia.

Dr. Manzi has served as a consultant and/or advisory board member for Bristol-Myers Squibb, Exagen Diagnostics, Genentech, and other companies.

DESTIN, FLA. – Patients with lupus are at increased risk for a number of long-term health issues that should be considered during the course of their care, according to Dr. Susan Manzi.

Bone disease, cardiovascular disease, cancer, and infection are particular areas of concern, Dr. Manzi said at the Congress of Clinical Rheumatology.

• Bone health. Women with systemic lupus erythematosus are known to be at increased risk for fractures. A 1999 retrospective cohort study, for example, showed that the observed number of nontraumatic fractures in more than 700 women with SLE was about fivefold greater than in the general population (Arthritis Rheum. 1999;42:882-90).

The standardized morbidity ratios ranged from 2.4 to 12.1 for various age groups, with the greatest risks in those aged 18-24 years (12.1), 45-64 years (7.6), and 70 years and older (4.9).

"We know that we cause a lot of the bone loss; we know that the bone loss may be part of the underlying disease. The fact is it’s there. We need to monitor for it and treat it," Dr. Manzi said. She noted that American College of Rheumatology guidelines are available to help in reducing fracture risk in patients with connective tissue diseases, such as lupus (Arthritis Care Res. 2010;62:1515-26).

• Cardiovascular health. Similarly, myocardial infarctions per 1,000 person-years are significantly greater among those with SLE than in the general population, according to the 1997 Framingham Offspring Study.

In that study, Dr. Manzi and her colleagues found that the incidence of MI was higher in SLE patients in every age category. The risk was 50-fold greater in those with SLE who were aged 35-44 years, compared with the overall study population (Am. J. Epidemiol. 1997;145:408-15).

Of note, in 2011 the American Heart Association officially recognized women with lupus and rheumatoid arthritis as at-risk groups for cardiovascular disease, and developed treatment and management recommendations for these groups, said Dr. Manzi, director of the Lupus Center of Excellence at the University of Pittsburgh. The AHA noted that SLE and RA may be unrecognized risk factors and that women with these conditions, even without clinically relevant cardiovascular disease, should be considered at risk and should be screened accordingly. The AHA recommendations "actually suggested that any woman who comes in with a cardiovascular event, particularly if it’s unexplained and they are young, should be screened for lupus and rheumatoid arthritis," she said.

• Cancer. In a 2005 study of more than 13,000 women from 30 centers, patients with lupus had a 20% increased risk for cancer, compared with the general population. A recent update similarly showed a 15%-20% increased risk (J. Autoimmun. 2013;42:130-5).

The greatest risk was for hematologic cancers, such as lymphomas and leukemia. Lung cancer and thyroid cancer were also increased in the lupus patients. A trend toward an increased risk of cervical and vulvar cancers was also noted, which could be associated with human papillomavirus infection. "This means we should be doing more paps and pelvics," she said.

Interestingly, women with SLE appear to have a reduced risk of breast, ovarian, and endometrial cancers, possibly as a result of avoidance of hormone replacement therapy, she said (Arthritis Rheum. 2005;52:1481-90).

• Infection. Patients with lupus are known to have an increased risk for infection, and it is important to exercise caution when using live attenuated vaccines. These include the herpes zoster vaccine; bacillus Calmette-Guérin tuberculosis vaccine; oral typhoid vaccine; measles, mumps, and rubella vaccine; varicella vaccine; oral polio vaccine; intranasal influenza vaccine; yellow fever vaccine; and endemic typhus vaccine, Dr. Manzi said.

These vaccines are not recommended for SLE patients being treated with immunosuppressive or biologic medications or with low immunoglobulins or hypocomplementemia.

Dr. Manzi has served as a consultant and/or advisory board member for Bristol-Myers Squibb, Exagen Diagnostics, Genentech, and other companies.

A decline in both pediatric and adult pneumonia-related hospitalizations following the 2000 introduction of the 7-valent pneumococcal vaccine, or PCV7, into the U.S. childhood immunization schedule was sustained over the next decade, a comprehensive assessment of U.S. hospitalizations showed.

The findings allay concerns about whether increases in disease caused by nonvaccine serotypes had eroded the gains made in the years following the PCV7 introduction, according to Dr. Marie R. Griffin of Vanderbilt University, Nashville, Tenn., and her colleagues.

Compared with the estimated annual rates of hospitalization for pneumonia from 1997 through 1999 (the 3 years prior to PCV7 introduction), the rates from 2007 through 2009 (the 3 years prior to a switch to 13-valent pneumococcal conjugate vaccine, or PCV13, in 2010) indicate that the annual rate among children younger than age 2 years declined by 551.1/100,000 children, or 43.2%, which translates to 47,000 fewer hospitalizations annually. The rates among adults aged 85 years or older declined by 1,300.8/100,000, or 22.8%, which translates to 73,000 fewer hospitalizations, the investigators reported in the July 11 issue of the New England Journal of Medicine.

©Design Pics/thinkstockphotos.com

Although the declines were steepest in those at the "extremes of age," the rates also declined for adults aged 18-39 years, 65-74 years, and 75-84 years (by 8.4, 85.3, and 359.8/100,000, respectively), they said (N. Engl. J. Med. 2013;369:155-63).

"The overall, age-adjusted annual reduction in hospitalization rates from the pre-PCV7 years was 54.8 hospitalizations per 100,000, representing an estimated 168,000 fewer hospitalizations in 2009 than would have been expected," Dr. Griffin and her colleagues wrote.

Annual hospitalization rates for this study were estimated based on hospitalization for pneumonia from any cause as identified using the Nationwide Inpatient Sample database – the largest all-payer U.S. inpatient care database, which includes data from about 8 million hospitalizations each year. Data included in this study were for patients with a first-listed discharge diagnosis of pneumonia or a first-listed discharge diagnosis of meningitis, septicemia, or empyema in addition to a diagnosis of pneumonia.

The marked decline in pneumococcal disease among both vaccinated and unvaccinated individuals is attributable to "herd" immunity provided by PCV7, and although it was previously shown that the introduction of PCV7 had resulted in a nearly 40% reduction in pneumonia-related hospitalizations within 4 years, an increase in disease caused by nonvaccine serotypes – particularly serotype 19A – raised concerns that this "serotype replacement" represented a step backward, the investigators explained.

The findings suggest that these concerns were unwarranted.

Although the declines in hospitalization among adults was more modest and emerged more slowly than the "remarkable early declines" seen in children, they did result in "large absolute overall reductions in hospitalizations for pneumonia," the investigators said.

Still, unvaccinated age groups continue to have some residual burden of pneumococcal disease due to serotypes covered by PCV7, they noted.

"It is not known whether the direct vaccination of adults with PCV13 would prevent pneumonia in adults and whether such efforts would add substantially to the indirect benefits generated by the ongoing PCV13 vaccination program in infants, which may now be reducing the transmission of the additional six vaccine serotypes," they said.

This study was supported by grants from the Centers for Disease Control and Prevention and the Thrasher Research Fund. Dr. Griffin reported receiving grant support through her institution from Pfizer, and coauthor Dr. Carlos G. Grijalva reported receiving consulting fees from GlaxoSmithKline, and grant support through his institution from Pfizer. The remaining authors reported having no relevant financial disclosures.

A decline in both pediatric and adult pneumonia-related hospitalizations following the 2000 introduction of the 7-valent pneumococcal vaccine, or PCV7, into the U.S. childhood immunization schedule was sustained over the next decade, a comprehensive assessment of U.S. hospitalizations showed.

The findings allay concerns about whether increases in disease caused by nonvaccine serotypes had eroded the gains made in the years following the PCV7 introduction, according to Dr. Marie R. Griffin of Vanderbilt University, Nashville, Tenn., and her colleagues.

Compared with the estimated annual rates of hospitalization for pneumonia from 1997 through 1999 (the 3 years prior to PCV7 introduction), the rates from 2007 through 2009 (the 3 years prior to a switch to 13-valent pneumococcal conjugate vaccine, or PCV13, in 2010) indicate that the annual rate among children younger than age 2 years declined by 551.1/100,000 children, or 43.2%, which translates to 47,000 fewer hospitalizations annually. The rates among adults aged 85 years or older declined by 1,300.8/100,000, or 22.8%, which translates to 73,000 fewer hospitalizations, the investigators reported in the July 11 issue of the New England Journal of Medicine.

©Design Pics/thinkstockphotos.com

Although the declines were steepest in those at the "extremes of age," the rates also declined for adults aged 18-39 years, 65-74 years, and 75-84 years (by 8.4, 85.3, and 359.8/100,000, respectively), they said (N. Engl. J. Med. 2013;369:155-63).

"The overall, age-adjusted annual reduction in hospitalization rates from the pre-PCV7 years was 54.8 hospitalizations per 100,000, representing an estimated 168,000 fewer hospitalizations in 2009 than would have been expected," Dr. Griffin and her colleagues wrote.

Annual hospitalization rates for this study were estimated based on hospitalization for pneumonia from any cause as identified using the Nationwide Inpatient Sample database – the largest all-payer U.S. inpatient care database, which includes data from about 8 million hospitalizations each year. Data included in this study were for patients with a first-listed discharge diagnosis of pneumonia or a first-listed discharge diagnosis of meningitis, septicemia, or empyema in addition to a diagnosis of pneumonia.

The marked decline in pneumococcal disease among both vaccinated and unvaccinated individuals is attributable to "herd" immunity provided by PCV7, and although it was previously shown that the introduction of PCV7 had resulted in a nearly 40% reduction in pneumonia-related hospitalizations within 4 years, an increase in disease caused by nonvaccine serotypes – particularly serotype 19A – raised concerns that this "serotype replacement" represented a step backward, the investigators explained.

The findings suggest that these concerns were unwarranted.

Although the declines in hospitalization among adults was more modest and emerged more slowly than the "remarkable early declines" seen in children, they did result in "large absolute overall reductions in hospitalizations for pneumonia," the investigators said.

Still, unvaccinated age groups continue to have some residual burden of pneumococcal disease due to serotypes covered by PCV7, they noted.

"It is not known whether the direct vaccination of adults with PCV13 would prevent pneumonia in adults and whether such efforts would add substantially to the indirect benefits generated by the ongoing PCV13 vaccination program in infants, which may now be reducing the transmission of the additional six vaccine serotypes," they said.

This study was supported by grants from the Centers for Disease Control and Prevention and the Thrasher Research Fund. Dr. Griffin reported receiving grant support through her institution from Pfizer, and coauthor Dr. Carlos G. Grijalva reported receiving consulting fees from GlaxoSmithKline, and grant support through his institution from Pfizer. The remaining authors reported having no relevant financial disclosures.

A decline in both pediatric and adult pneumonia-related hospitalizations following the 2000 introduction of the 7-valent pneumococcal vaccine, or PCV7, into the U.S. childhood immunization schedule was sustained over the next decade, a comprehensive assessment of U.S. hospitalizations showed.

The findings allay concerns about whether increases in disease caused by nonvaccine serotypes had eroded the gains made in the years following the PCV7 introduction, according to Dr. Marie R. Griffin of Vanderbilt University, Nashville, Tenn., and her colleagues.

Compared with the estimated annual rates of hospitalization for pneumonia from 1997 through 1999 (the 3 years prior to PCV7 introduction), the rates from 2007 through 2009 (the 3 years prior to a switch to 13-valent pneumococcal conjugate vaccine, or PCV13, in 2010) indicate that the annual rate among children younger than age 2 years declined by 551.1/100,000 children, or 43.2%, which translates to 47,000 fewer hospitalizations annually. The rates among adults aged 85 years or older declined by 1,300.8/100,000, or 22.8%, which translates to 73,000 fewer hospitalizations, the investigators reported in the July 11 issue of the New England Journal of Medicine.

©Design Pics/thinkstockphotos.com

Although the declines were steepest in those at the "extremes of age," the rates also declined for adults aged 18-39 years, 65-74 years, and 75-84 years (by 8.4, 85.3, and 359.8/100,000, respectively), they said (N. Engl. J. Med. 2013;369:155-63).

"The overall, age-adjusted annual reduction in hospitalization rates from the pre-PCV7 years was 54.8 hospitalizations per 100,000, representing an estimated 168,000 fewer hospitalizations in 2009 than would have been expected," Dr. Griffin and her colleagues wrote.

Annual hospitalization rates for this study were estimated based on hospitalization for pneumonia from any cause as identified using the Nationwide Inpatient Sample database – the largest all-payer U.S. inpatient care database, which includes data from about 8 million hospitalizations each year. Data included in this study were for patients with a first-listed discharge diagnosis of pneumonia or a first-listed discharge diagnosis of meningitis, septicemia, or empyema in addition to a diagnosis of pneumonia.

The marked decline in pneumococcal disease among both vaccinated and unvaccinated individuals is attributable to "herd" immunity provided by PCV7, and although it was previously shown that the introduction of PCV7 had resulted in a nearly 40% reduction in pneumonia-related hospitalizations within 4 years, an increase in disease caused by nonvaccine serotypes – particularly serotype 19A – raised concerns that this "serotype replacement" represented a step backward, the investigators explained.

The findings suggest that these concerns were unwarranted.

Although the declines in hospitalization among adults was more modest and emerged more slowly than the "remarkable early declines" seen in children, they did result in "large absolute overall reductions in hospitalizations for pneumonia," the investigators said.

Still, unvaccinated age groups continue to have some residual burden of pneumococcal disease due to serotypes covered by PCV7, they noted.

"It is not known whether the direct vaccination of adults with PCV13 would prevent pneumonia in adults and whether such efforts would add substantially to the indirect benefits generated by the ongoing PCV13 vaccination program in infants, which may now be reducing the transmission of the additional six vaccine serotypes," they said.

This study was supported by grants from the Centers for Disease Control and Prevention and the Thrasher Research Fund. Dr. Griffin reported receiving grant support through her institution from Pfizer, and coauthor Dr. Carlos G. Grijalva reported receiving consulting fees from GlaxoSmithKline, and grant support through his institution from Pfizer. The remaining authors reported having no relevant financial disclosures.

Medicare beneficiaries enrolled in the Medicare Advantage programs have lower rates of angiography and percutaneous coronary intervention procedures than do those enrolled in fee-for-service Medicare, but procedure rates in both groups vary widely by geographic region, according to findings from a large cross-sectional study.

Compared with more than 5 million Medicare fee-for-service patients from across 32 hospital referral regions in 12 states, the more than 878,000 Medicare Advantage patients included in the study had lower age-, sex-, race-, and income-adjusted angiography procedure rates (16.5 vs. 25.9 per 1,000 person-years) and percutaneous coronary intervention (PCI) procedure rates (6.8 vs. 9.8). The differences persisted after adjusting for additional cardiac risk factors in the Medicare Advantage beneficiaries, Dr. Daniel D. Matlock of the University of Colorado, Aurora, and his colleagues reported July 9 in JAMA.

The rates of coronary artery bypass graft (CABG) surgery were similar in the two groups (3.1 vs. 3.4), as were the rates of urgent angiography and PCI (3.9 vs. 4.3, and 2.4 vs. 2.7, respectively), the investigators reported (JAMA 2013;310:155-62).

In addition to the variations in procedure rates by Medicare plan type, wide variations in procedure rates were also noted across hospital referral regions. For example, angiography rates per 1,000 person-years ranged from 9.8 to 40.6 for Medicare Advantage beneficiaries, and from 15.7 to 44.3 for Medicare fee-for-service beneficiaries; the PCI rates ranged from 3.5 to 16.8 and from 4.7 to 16.1 for the groups, respectively; and the rates for CABG surgery ranged from 1.5 to 6.1, and from 2.5 to 6.0 for the groups, respectively. The degree of variation was similar in the two groups, , the investigators noted.

No significant correlation was seen between the Medicare Advantage and fee-for-service beneficiaries for angiography across the regions, and only modest correlations were seen for PCI and CABG surgery, they said.

"The finding that Medicare Advantage patients have lower rates of angiography and PCI underscores the need for additional research to determine the extent to which this is attributable to differences in population characteristics, more efficient utilization of procedures among Medicare Advantage patients (i.e., overutilization in Medicare FFS), or harmfully restrictive management of utilization in Medicare Advantage," the investigators wrote.

The similarities in the degree of regional variations in the two groups suggest that "factors beyond payment mechanisms influence practice variations," they noted, adding that the variation in this study may be a function of the availability of the procedures – a possibility that they argued deserves further study, along with patient-level factors and "implicit professional norms or the local practice culture."

The investigators point out that "geographic variation in health services in the Medicare fee-for-service population has fueled the perception of an inefficient, ineffective U.S. health care system," and they argue that shedding light on the sources of variability will, therefore, remain an important "research and quality improvement endeavor" until the causes of geographic variation are understood.

The study was supported by the National Heart, Lung, and Blood Institute and the Cardiovascular Research Network. Medicare data were obtained under an Agency for Healthcare Research and Quality grant.

Medicare beneficiaries enrolled in the Medicare Advantage programs have lower rates of angiography and percutaneous coronary intervention procedures than do those enrolled in fee-for-service Medicare, but procedure rates in both groups vary widely by geographic region, according to findings from a large cross-sectional study.

Compared with more than 5 million Medicare fee-for-service patients from across 32 hospital referral regions in 12 states, the more than 878,000 Medicare Advantage patients included in the study had lower age-, sex-, race-, and income-adjusted angiography procedure rates (16.5 vs. 25.9 per 1,000 person-years) and percutaneous coronary intervention (PCI) procedure rates (6.8 vs. 9.8). The differences persisted after adjusting for additional cardiac risk factors in the Medicare Advantage beneficiaries, Dr. Daniel D. Matlock of the University of Colorado, Aurora, and his colleagues reported July 9 in JAMA.

The rates of coronary artery bypass graft (CABG) surgery were similar in the two groups (3.1 vs. 3.4), as were the rates of urgent angiography and PCI (3.9 vs. 4.3, and 2.4 vs. 2.7, respectively), the investigators reported (JAMA 2013;310:155-62).

In addition to the variations in procedure rates by Medicare plan type, wide variations in procedure rates were also noted across hospital referral regions. For example, angiography rates per 1,000 person-years ranged from 9.8 to 40.6 for Medicare Advantage beneficiaries, and from 15.7 to 44.3 for Medicare fee-for-service beneficiaries; the PCI rates ranged from 3.5 to 16.8 and from 4.7 to 16.1 for the groups, respectively; and the rates for CABG surgery ranged from 1.5 to 6.1, and from 2.5 to 6.0 for the groups, respectively. The degree of variation was similar in the two groups, , the investigators noted.

No significant correlation was seen between the Medicare Advantage and fee-for-service beneficiaries for angiography across the regions, and only modest correlations were seen for PCI and CABG surgery, they said.

"The finding that Medicare Advantage patients have lower rates of angiography and PCI underscores the need for additional research to determine the extent to which this is attributable to differences in population characteristics, more efficient utilization of procedures among Medicare Advantage patients (i.e., overutilization in Medicare FFS), or harmfully restrictive management of utilization in Medicare Advantage," the investigators wrote.

The similarities in the degree of regional variations in the two groups suggest that "factors beyond payment mechanisms influence practice variations," they noted, adding that the variation in this study may be a function of the availability of the procedures – a possibility that they argued deserves further study, along with patient-level factors and "implicit professional norms or the local practice culture."

The investigators point out that "geographic variation in health services in the Medicare fee-for-service population has fueled the perception of an inefficient, ineffective U.S. health care system," and they argue that shedding light on the sources of variability will, therefore, remain an important "research and quality improvement endeavor" until the causes of geographic variation are understood.

The study was supported by the National Heart, Lung, and Blood Institute and the Cardiovascular Research Network. Medicare data were obtained under an Agency for Healthcare Research and Quality grant.

Medicare beneficiaries enrolled in the Medicare Advantage programs have lower rates of angiography and percutaneous coronary intervention procedures than do those enrolled in fee-for-service Medicare, but procedure rates in both groups vary widely by geographic region, according to findings from a large cross-sectional study.

Compared with more than 5 million Medicare fee-for-service patients from across 32 hospital referral regions in 12 states, the more than 878,000 Medicare Advantage patients included in the study had lower age-, sex-, race-, and income-adjusted angiography procedure rates (16.5 vs. 25.9 per 1,000 person-years) and percutaneous coronary intervention (PCI) procedure rates (6.8 vs. 9.8). The differences persisted after adjusting for additional cardiac risk factors in the Medicare Advantage beneficiaries, Dr. Daniel D. Matlock of the University of Colorado, Aurora, and his colleagues reported July 9 in JAMA.

The rates of coronary artery bypass graft (CABG) surgery were similar in the two groups (3.1 vs. 3.4), as were the rates of urgent angiography and PCI (3.9 vs. 4.3, and 2.4 vs. 2.7, respectively), the investigators reported (JAMA 2013;310:155-62).

In addition to the variations in procedure rates by Medicare plan type, wide variations in procedure rates were also noted across hospital referral regions. For example, angiography rates per 1,000 person-years ranged from 9.8 to 40.6 for Medicare Advantage beneficiaries, and from 15.7 to 44.3 for Medicare fee-for-service beneficiaries; the PCI rates ranged from 3.5 to 16.8 and from 4.7 to 16.1 for the groups, respectively; and the rates for CABG surgery ranged from 1.5 to 6.1, and from 2.5 to 6.0 for the groups, respectively. The degree of variation was similar in the two groups, , the investigators noted.

No significant correlation was seen between the Medicare Advantage and fee-for-service beneficiaries for angiography across the regions, and only modest correlations were seen for PCI and CABG surgery, they said.

"The finding that Medicare Advantage patients have lower rates of angiography and PCI underscores the need for additional research to determine the extent to which this is attributable to differences in population characteristics, more efficient utilization of procedures among Medicare Advantage patients (i.e., overutilization in Medicare FFS), or harmfully restrictive management of utilization in Medicare Advantage," the investigators wrote.

The similarities in the degree of regional variations in the two groups suggest that "factors beyond payment mechanisms influence practice variations," they noted, adding that the variation in this study may be a function of the availability of the procedures – a possibility that they argued deserves further study, along with patient-level factors and "implicit professional norms or the local practice culture."

The investigators point out that "geographic variation in health services in the Medicare fee-for-service population has fueled the perception of an inefficient, ineffective U.S. health care system," and they argue that shedding light on the sources of variability will, therefore, remain an important "research and quality improvement endeavor" until the causes of geographic variation are understood.

The study was supported by the National Heart, Lung, and Blood Institute and the Cardiovascular Research Network. Medicare data were obtained under an Agency for Healthcare Research and Quality grant.