Mary Ann Moon

Both the American College of Rheumatology 2010 criteria for diagnosing fibromyalgia and its modified version had “unsatisfactory” sensitivity and specificity in identifying the disorder in the general population, according to an analysis of findings from a cross-sectional survey.

Researchers compared the accuracy of these new criteria against that of the American College of Rheumatology (ACR) 1990 criteria in determining the prevalence of fibromyalgia in a general population sample of 1,604 adults in Scotland. They found that the newest criteria indicated almost a fourfold higher prevalence of the disorder, identified a greater proportion of male patients, and failed to identify as many comorbid rheumatologic conditions as the ACR 1990 criteria.

The investigators also found it difficult to “operationalize” – that is, to apply in a real-world patient population – both newer sets of criteria. “Both the ACR 2010 and the modified 2010 criteria are currently considered preliminary, and we strongly recommend that the ACR consider these important issues in deciding whether to confirm these proposed criteria for use in future clinical practice and/or research,” wrote Gareth T. Jones, Ph.D., of the Musculoskeletal Research Collaboration (Epidemiology Group), University of Aberdeen (Scotland), and his associates.

In an editorial accompanying their report, Dr. Frederick Wolfe responded to the critique and noted that numerous other studies have found excellent concordance between the older and newer criteria in identifying fibromyalgia. More importantly, the newer criteria were supposed to differ from the older criteria: For example, they were intended to address the symptoms that patients find most bothersome, rather than the more arbitrary 11 tender points that physicians must identify in the 1990 criteria, said Dr. Wolfe, who chaired the ACR committee that devised the newer criteria.

Dr. Jones and his associates compared the three sets of criteria for diagnosing fibromyalgia in a cross-sectional survey of adults aged 25 years and older (median age, 55 years) residing in suburban and rural areas in Scotland. They also performed a full clinical history and tender point examination on a subgroup of 104 of these respondents.

They found that the prevalence of fibromyalgia was 1.7% using the 1990 criteria, 1.2% using the ACR 2010 criteria, and 5.4% using the modified ACR 2010 criteria. This represents nearly a fourfold discrepancy between the old and the newest sets of criteria. Using the ACR 1990 criteria as a gold standard, the ACR 2010 criteria had a sensitivity of 55% and a specificity of 99%, while the modified ACR 2010 criteria had a sensitivity of 64% and a specificity of 78%. In particular, only 45% of patients previously classified as having fibromyalgia would now be classified that way, the investigators said (Arthritis Rheumatol. 2014 Oct. 16 [doi:10.1002/art.38905]).

In addition, “The new criteria define a demonstrably different patient group.” The ratio of female to male patients was approximately 14:1 using the 1990 criteria, 5:1 using the 2010 criteria, and 2:1 using the modified 2010 criteria. And more than half of patients who met the 1990 criteria reported rheumatologic comorbidities such as rheumatoid arthritis, osteoporosis, lupus, scleroderma, ankylosing spondylitis, or gout; in comparison, only one-fourth of patients who met the newer criteria reported such comorbidities.

Dr. Jones and his associates acknowledged that their study was limited by a “modest” 36% response rate to the initial survey and a similarly low response rate (39%) from participants invited to attend the physical examination.

In his editorial, Dr. Wolfe noted that the ACR 1990 criteria were revised specifically because they were problematic. The examination of 11 tender points by a physician was “inherently arbitrary, didn’t touch on symptoms that bothered patients or informed physicians, and was hard for most nonrheumatologists to perform.” The results were “far from reliable,” and “different physicians could and often did come up with different results,” he said (Arthritis Rheumatol. 2014 Oct. 9 [doi:10.1002/art.38908]).

The new criteria intentionally changed the case definition of fibromyalgia “to an illness characterized by self-reported multiple painful regions and characteristic symptoms, such as problems with fatigue, sleep, cognition, and a general increase in symptoms.” The revised ACR 2010 criteria also deliberately focus on the perceptions of the patient, without being filtered through the perceptions of the diagnosing physician. “That physicians and patients might differ in assessment of severity and consequences is the rule in rheumatology,” noted Dr. Wolfe, who is director of the National Data Bank for Rheumatic Diseases in Wichita, Kan.

Previous studies reporting that the new criteria have low sensitivity and specificity are biased by design flaws, including misclassification of “true” cases of fibromyalgia and low participation rates, he added.

This study was supported by the University of Aberdeen and charitable donations for research on fibromyalgia. Financial disclosures were not available for Dr. Jones and his associates or for Dr. Wolfe.

Both the American College of Rheumatology 2010 criteria for diagnosing fibromyalgia and its modified version had “unsatisfactory” sensitivity and specificity in identifying the disorder in the general population, according to an analysis of findings from a cross-sectional survey.

Researchers compared the accuracy of these new criteria against that of the American College of Rheumatology (ACR) 1990 criteria in determining the prevalence of fibromyalgia in a general population sample of 1,604 adults in Scotland. They found that the newest criteria indicated almost a fourfold higher prevalence of the disorder, identified a greater proportion of male patients, and failed to identify as many comorbid rheumatologic conditions as the ACR 1990 criteria.

The investigators also found it difficult to “operationalize” – that is, to apply in a real-world patient population – both newer sets of criteria. “Both the ACR 2010 and the modified 2010 criteria are currently considered preliminary, and we strongly recommend that the ACR consider these important issues in deciding whether to confirm these proposed criteria for use in future clinical practice and/or research,” wrote Gareth T. Jones, Ph.D., of the Musculoskeletal Research Collaboration (Epidemiology Group), University of Aberdeen (Scotland), and his associates.

In an editorial accompanying their report, Dr. Frederick Wolfe responded to the critique and noted that numerous other studies have found excellent concordance between the older and newer criteria in identifying fibromyalgia. More importantly, the newer criteria were supposed to differ from the older criteria: For example, they were intended to address the symptoms that patients find most bothersome, rather than the more arbitrary 11 tender points that physicians must identify in the 1990 criteria, said Dr. Wolfe, who chaired the ACR committee that devised the newer criteria.

Dr. Jones and his associates compared the three sets of criteria for diagnosing fibromyalgia in a cross-sectional survey of adults aged 25 years and older (median age, 55 years) residing in suburban and rural areas in Scotland. They also performed a full clinical history and tender point examination on a subgroup of 104 of these respondents.

They found that the prevalence of fibromyalgia was 1.7% using the 1990 criteria, 1.2% using the ACR 2010 criteria, and 5.4% using the modified ACR 2010 criteria. This represents nearly a fourfold discrepancy between the old and the newest sets of criteria. Using the ACR 1990 criteria as a gold standard, the ACR 2010 criteria had a sensitivity of 55% and a specificity of 99%, while the modified ACR 2010 criteria had a sensitivity of 64% and a specificity of 78%. In particular, only 45% of patients previously classified as having fibromyalgia would now be classified that way, the investigators said (Arthritis Rheumatol. 2014 Oct. 16 [doi:10.1002/art.38905]).

In addition, “The new criteria define a demonstrably different patient group.” The ratio of female to male patients was approximately 14:1 using the 1990 criteria, 5:1 using the 2010 criteria, and 2:1 using the modified 2010 criteria. And more than half of patients who met the 1990 criteria reported rheumatologic comorbidities such as rheumatoid arthritis, osteoporosis, lupus, scleroderma, ankylosing spondylitis, or gout; in comparison, only one-fourth of patients who met the newer criteria reported such comorbidities.

Dr. Jones and his associates acknowledged that their study was limited by a “modest” 36% response rate to the initial survey and a similarly low response rate (39%) from participants invited to attend the physical examination.

In his editorial, Dr. Wolfe noted that the ACR 1990 criteria were revised specifically because they were problematic. The examination of 11 tender points by a physician was “inherently arbitrary, didn’t touch on symptoms that bothered patients or informed physicians, and was hard for most nonrheumatologists to perform.” The results were “far from reliable,” and “different physicians could and often did come up with different results,” he said (Arthritis Rheumatol. 2014 Oct. 9 [doi:10.1002/art.38908]).

The new criteria intentionally changed the case definition of fibromyalgia “to an illness characterized by self-reported multiple painful regions and characteristic symptoms, such as problems with fatigue, sleep, cognition, and a general increase in symptoms.” The revised ACR 2010 criteria also deliberately focus on the perceptions of the patient, without being filtered through the perceptions of the diagnosing physician. “That physicians and patients might differ in assessment of severity and consequences is the rule in rheumatology,” noted Dr. Wolfe, who is director of the National Data Bank for Rheumatic Diseases in Wichita, Kan.

Previous studies reporting that the new criteria have low sensitivity and specificity are biased by design flaws, including misclassification of “true” cases of fibromyalgia and low participation rates, he added.

This study was supported by the University of Aberdeen and charitable donations for research on fibromyalgia. Financial disclosures were not available for Dr. Jones and his associates or for Dr. Wolfe.

Both the American College of Rheumatology 2010 criteria for diagnosing fibromyalgia and its modified version had “unsatisfactory” sensitivity and specificity in identifying the disorder in the general population, according to an analysis of findings from a cross-sectional survey.

Researchers compared the accuracy of these new criteria against that of the American College of Rheumatology (ACR) 1990 criteria in determining the prevalence of fibromyalgia in a general population sample of 1,604 adults in Scotland. They found that the newest criteria indicated almost a fourfold higher prevalence of the disorder, identified a greater proportion of male patients, and failed to identify as many comorbid rheumatologic conditions as the ACR 1990 criteria.

The investigators also found it difficult to “operationalize” – that is, to apply in a real-world patient population – both newer sets of criteria. “Both the ACR 2010 and the modified 2010 criteria are currently considered preliminary, and we strongly recommend that the ACR consider these important issues in deciding whether to confirm these proposed criteria for use in future clinical practice and/or research,” wrote Gareth T. Jones, Ph.D., of the Musculoskeletal Research Collaboration (Epidemiology Group), University of Aberdeen (Scotland), and his associates.

In an editorial accompanying their report, Dr. Frederick Wolfe responded to the critique and noted that numerous other studies have found excellent concordance between the older and newer criteria in identifying fibromyalgia. More importantly, the newer criteria were supposed to differ from the older criteria: For example, they were intended to address the symptoms that patients find most bothersome, rather than the more arbitrary 11 tender points that physicians must identify in the 1990 criteria, said Dr. Wolfe, who chaired the ACR committee that devised the newer criteria.

Dr. Jones and his associates compared the three sets of criteria for diagnosing fibromyalgia in a cross-sectional survey of adults aged 25 years and older (median age, 55 years) residing in suburban and rural areas in Scotland. They also performed a full clinical history and tender point examination on a subgroup of 104 of these respondents.

They found that the prevalence of fibromyalgia was 1.7% using the 1990 criteria, 1.2% using the ACR 2010 criteria, and 5.4% using the modified ACR 2010 criteria. This represents nearly a fourfold discrepancy between the old and the newest sets of criteria. Using the ACR 1990 criteria as a gold standard, the ACR 2010 criteria had a sensitivity of 55% and a specificity of 99%, while the modified ACR 2010 criteria had a sensitivity of 64% and a specificity of 78%. In particular, only 45% of patients previously classified as having fibromyalgia would now be classified that way, the investigators said (Arthritis Rheumatol. 2014 Oct. 16 [doi:10.1002/art.38905]).

In addition, “The new criteria define a demonstrably different patient group.” The ratio of female to male patients was approximately 14:1 using the 1990 criteria, 5:1 using the 2010 criteria, and 2:1 using the modified 2010 criteria. And more than half of patients who met the 1990 criteria reported rheumatologic comorbidities such as rheumatoid arthritis, osteoporosis, lupus, scleroderma, ankylosing spondylitis, or gout; in comparison, only one-fourth of patients who met the newer criteria reported such comorbidities.

Dr. Jones and his associates acknowledged that their study was limited by a “modest” 36% response rate to the initial survey and a similarly low response rate (39%) from participants invited to attend the physical examination.

In his editorial, Dr. Wolfe noted that the ACR 1990 criteria were revised specifically because they were problematic. The examination of 11 tender points by a physician was “inherently arbitrary, didn’t touch on symptoms that bothered patients or informed physicians, and was hard for most nonrheumatologists to perform.” The results were “far from reliable,” and “different physicians could and often did come up with different results,” he said (Arthritis Rheumatol. 2014 Oct. 9 [doi:10.1002/art.38908]).

The new criteria intentionally changed the case definition of fibromyalgia “to an illness characterized by self-reported multiple painful regions and characteristic symptoms, such as problems with fatigue, sleep, cognition, and a general increase in symptoms.” The revised ACR 2010 criteria also deliberately focus on the perceptions of the patient, without being filtered through the perceptions of the diagnosing physician. “That physicians and patients might differ in assessment of severity and consequences is the rule in rheumatology,” noted Dr. Wolfe, who is director of the National Data Bank for Rheumatic Diseases in Wichita, Kan.

Previous studies reporting that the new criteria have low sensitivity and specificity are biased by design flaws, including misclassification of “true” cases of fibromyalgia and low participation rates, he added.

This study was supported by the University of Aberdeen and charitable donations for research on fibromyalgia. Financial disclosures were not available for Dr. Jones and his associates or for Dr. Wolfe.

Obstructive sleep apnea is a common condition among patients in intensive care units, affecting nearly 8% treated at one large academic medical center during a 3-year period, according to a report published online in the Journal of Critical Care.

In what they described as the first study to document the prevalence of obstructive sleep apnea (OSA) in the ICU patient population, researchers found that 1,183 of 15,077 patients (7.8%) aged 16 years and older who were treated between 2003 and 2006 had a physician-documented diagnosis of OSA at admission. Surprisingly, however, OSA did not raise mortality risk, even though it is a well-known predictor of cardiovascular disease and is strongly associated with several comorbid conditions such as obesity, diabetes, and hypertension, said Dr. Enrique Bolona, a fellow in critical care medicine at the Mayo Clinic, Rochester, Minn., and his associates.

©Dorling Kindersley/thinkstockphotos.com

Patients treated in three medical, surgical, and mixed ICUs who had comorbid OSA had significantly lower ICU mortality (2.4%) than did ICU patients without OSA (6.2%), as well as significantly lower hospital mortality (3.9% vs. 11.4%). The OSA group also had a shorter median length of stay (1.13 vs. 1.50 days), the investigators reported (J. Crit. Care 2014 Oct. 10 [doi: 10.1016/j.jcrc.2014.10.001])

Patients with OSA had less severe illness than did ICU patients without OSA, as measured by their lower APACHE III scores (median, 45.3 vs. 54.9), lower scores on the Acute Physiology Scale (median, 35.3 vs. 41.8), and lower predicted mortality at admission (10.3% vs. 16.3%). But even after the data were adjusted to account for this discrepancy between the two patient groups in disease severity, OSA was still associated with significantly lower mortality (odds ratio, 0.40).

The reason for these “unexpected” findings is not yet known. It is possible that obesity, which strongly correlates with OSA, exerts a protective effect during critical illness by virtue of increased nutritional reserves. Data concerning patients’ body mass index were not available, so this hypothesis could not be confirmed, Dr. Bolona and his associates said.

Another possible explanation is that patients with diagnosed OSA have better access to the health care system than nonaffected patients, “resulting in closer follow-up and management of associated comorbidities.

“Once admitted to the ICU, stricter monitoring and a higher level of alertness with regard to detection of respiratory problems may also play a role, making patients with OSA more likely to receive therapies such as noninvasive positive pressure ventilation earlier,” they said.

This study was limited in that it was retrospective and involved only a single medical center. “The generalizability of our results is unknown,” the investigators noted.

Dr. Bolona and his associates reported having no financial disclosures.

Obstructive sleep apnea is a common condition among patients in intensive care units, affecting nearly 8% treated at one large academic medical center during a 3-year period, according to a report published online in the Journal of Critical Care.

In what they described as the first study to document the prevalence of obstructive sleep apnea (OSA) in the ICU patient population, researchers found that 1,183 of 15,077 patients (7.8%) aged 16 years and older who were treated between 2003 and 2006 had a physician-documented diagnosis of OSA at admission. Surprisingly, however, OSA did not raise mortality risk, even though it is a well-known predictor of cardiovascular disease and is strongly associated with several comorbid conditions such as obesity, diabetes, and hypertension, said Dr. Enrique Bolona, a fellow in critical care medicine at the Mayo Clinic, Rochester, Minn., and his associates.

©Dorling Kindersley/thinkstockphotos.com

Patients treated in three medical, surgical, and mixed ICUs who had comorbid OSA had significantly lower ICU mortality (2.4%) than did ICU patients without OSA (6.2%), as well as significantly lower hospital mortality (3.9% vs. 11.4%). The OSA group also had a shorter median length of stay (1.13 vs. 1.50 days), the investigators reported (J. Crit. Care 2014 Oct. 10 [doi: 10.1016/j.jcrc.2014.10.001])

Patients with OSA had less severe illness than did ICU patients without OSA, as measured by their lower APACHE III scores (median, 45.3 vs. 54.9), lower scores on the Acute Physiology Scale (median, 35.3 vs. 41.8), and lower predicted mortality at admission (10.3% vs. 16.3%). But even after the data were adjusted to account for this discrepancy between the two patient groups in disease severity, OSA was still associated with significantly lower mortality (odds ratio, 0.40).

The reason for these “unexpected” findings is not yet known. It is possible that obesity, which strongly correlates with OSA, exerts a protective effect during critical illness by virtue of increased nutritional reserves. Data concerning patients’ body mass index were not available, so this hypothesis could not be confirmed, Dr. Bolona and his associates said.

Another possible explanation is that patients with diagnosed OSA have better access to the health care system than nonaffected patients, “resulting in closer follow-up and management of associated comorbidities.

“Once admitted to the ICU, stricter monitoring and a higher level of alertness with regard to detection of respiratory problems may also play a role, making patients with OSA more likely to receive therapies such as noninvasive positive pressure ventilation earlier,” they said.

This study was limited in that it was retrospective and involved only a single medical center. “The generalizability of our results is unknown,” the investigators noted.

Dr. Bolona and his associates reported having no financial disclosures.

Obstructive sleep apnea is a common condition among patients in intensive care units, affecting nearly 8% treated at one large academic medical center during a 3-year period, according to a report published online in the Journal of Critical Care.

In what they described as the first study to document the prevalence of obstructive sleep apnea (OSA) in the ICU patient population, researchers found that 1,183 of 15,077 patients (7.8%) aged 16 years and older who were treated between 2003 and 2006 had a physician-documented diagnosis of OSA at admission. Surprisingly, however, OSA did not raise mortality risk, even though it is a well-known predictor of cardiovascular disease and is strongly associated with several comorbid conditions such as obesity, diabetes, and hypertension, said Dr. Enrique Bolona, a fellow in critical care medicine at the Mayo Clinic, Rochester, Minn., and his associates.

©Dorling Kindersley/thinkstockphotos.com

Patients treated in three medical, surgical, and mixed ICUs who had comorbid OSA had significantly lower ICU mortality (2.4%) than did ICU patients without OSA (6.2%), as well as significantly lower hospital mortality (3.9% vs. 11.4%). The OSA group also had a shorter median length of stay (1.13 vs. 1.50 days), the investigators reported (J. Crit. Care 2014 Oct. 10 [doi: 10.1016/j.jcrc.2014.10.001])

Patients with OSA had less severe illness than did ICU patients without OSA, as measured by their lower APACHE III scores (median, 45.3 vs. 54.9), lower scores on the Acute Physiology Scale (median, 35.3 vs. 41.8), and lower predicted mortality at admission (10.3% vs. 16.3%). But even after the data were adjusted to account for this discrepancy between the two patient groups in disease severity, OSA was still associated with significantly lower mortality (odds ratio, 0.40).

The reason for these “unexpected” findings is not yet known. It is possible that obesity, which strongly correlates with OSA, exerts a protective effect during critical illness by virtue of increased nutritional reserves. Data concerning patients’ body mass index were not available, so this hypothesis could not be confirmed, Dr. Bolona and his associates said.

Another possible explanation is that patients with diagnosed OSA have better access to the health care system than nonaffected patients, “resulting in closer follow-up and management of associated comorbidities.

“Once admitted to the ICU, stricter monitoring and a higher level of alertness with regard to detection of respiratory problems may also play a role, making patients with OSA more likely to receive therapies such as noninvasive positive pressure ventilation earlier,” they said.

This study was limited in that it was retrospective and involved only a single medical center. “The generalizability of our results is unknown,” the investigators noted.

Dr. Bolona and his associates reported having no financial disclosures.

Dopamine receptor agonists are suspected to have caused serious impulse control disorders in at least 710 cases reported to the Food and Drug Administration’s adverse drug events database during a 10-year period.

The drugs, which are often prescribed for Parkinson’s disease, restless legs syndrome, and hyperprolactinemia, were implicated in more than 1,000 separate adverse events that included pathological gambling, hypersexuality, compulsive shopping, poriomania (wandering away from home), binge eating, kleptomania, and compulsive sexual behavior. Although this retrospective disproportionality analysis of information in a public database could not prove causality, “the associations were significant, the magnitude of the effects was large, and the effects were seen for all 6 dopamine agonist drugs” available in the United States, reported Thomas J. Moore of the Institute for Safe Medication Practices, Alexandria, Va., and his associates (JAMA Int. Med. 2014 Oct. 20 [doi: 10.1001/jamainternmed.2014.5262]).

These findings confirm and extend those of several previous reports in the literature, but none of the dopamine receptor agonists – pramipexole, ropinirole, cabergoline, bromocriptine, rotigotine, and apomorphine – currently carry a boxed warning about the potential for developing severe impulse control disorders. These behaviors can have catastrophic effects on jobs, marriages, and family finances. “Physicians who prescribe dopamine agonists should vigilantly monitor their patients, and ensure that patients, families, and caregivers are counseled about [this] risk,” the investigators wrote.

Noting that these six agents accounted for 2.1 million dispensed outpatient prescriptions during a single quarter of 2012 in the United States alone, the researchers examined a Food and Drug Administration (FDA) database of all domestic and foreign reports of serious drug events during 2003-2012. They focused on 1,580 reports of serious impulse control disorders and excluded cases involved in litigation or clinical studies. A total of 710 cases were related to dopamine receptor agonists, of which 48% were reported from foreign countries, said Mr. Moore, who is also with the department of epidemiology and biostatistics, George Washington University, Washington, and his colleagues.

The investigators calculated the proportional reporting ratio, “a ratio similar in concept to the relative risk ratio,” between these cases and each individual dopamine receptor agonist. They found that the proportional reporting ratio of each drug was high and statistically significant. In addition, the number of case reports rose steadily over time, from both within and outside the United States.

“Our data, and data from prior studies, show the need for these prominent [boxed] warnings” in the prescribing information for these drugs, the investigators said.

Mr. Moore and one of his associates reported serving as consultants or expert witnesses in civil and criminal litigation involving many psychiatric drugs, not including the six dopamine receptor agonists in this study.

Dopamine receptor agonists are suspected to have caused serious impulse control disorders in at least 710 cases reported to the Food and Drug Administration’s adverse drug events database during a 10-year period.

The drugs, which are often prescribed for Parkinson’s disease, restless legs syndrome, and hyperprolactinemia, were implicated in more than 1,000 separate adverse events that included pathological gambling, hypersexuality, compulsive shopping, poriomania (wandering away from home), binge eating, kleptomania, and compulsive sexual behavior. Although this retrospective disproportionality analysis of information in a public database could not prove causality, “the associations were significant, the magnitude of the effects was large, and the effects were seen for all 6 dopamine agonist drugs” available in the United States, reported Thomas J. Moore of the Institute for Safe Medication Practices, Alexandria, Va., and his associates (JAMA Int. Med. 2014 Oct. 20 [doi: 10.1001/jamainternmed.2014.5262]).

These findings confirm and extend those of several previous reports in the literature, but none of the dopamine receptor agonists – pramipexole, ropinirole, cabergoline, bromocriptine, rotigotine, and apomorphine – currently carry a boxed warning about the potential for developing severe impulse control disorders. These behaviors can have catastrophic effects on jobs, marriages, and family finances. “Physicians who prescribe dopamine agonists should vigilantly monitor their patients, and ensure that patients, families, and caregivers are counseled about [this] risk,” the investigators wrote.

Noting that these six agents accounted for 2.1 million dispensed outpatient prescriptions during a single quarter of 2012 in the United States alone, the researchers examined a Food and Drug Administration (FDA) database of all domestic and foreign reports of serious drug events during 2003-2012. They focused on 1,580 reports of serious impulse control disorders and excluded cases involved in litigation or clinical studies. A total of 710 cases were related to dopamine receptor agonists, of which 48% were reported from foreign countries, said Mr. Moore, who is also with the department of epidemiology and biostatistics, George Washington University, Washington, and his colleagues.

The investigators calculated the proportional reporting ratio, “a ratio similar in concept to the relative risk ratio,” between these cases and each individual dopamine receptor agonist. They found that the proportional reporting ratio of each drug was high and statistically significant. In addition, the number of case reports rose steadily over time, from both within and outside the United States.

“Our data, and data from prior studies, show the need for these prominent [boxed] warnings” in the prescribing information for these drugs, the investigators said.

Mr. Moore and one of his associates reported serving as consultants or expert witnesses in civil and criminal litigation involving many psychiatric drugs, not including the six dopamine receptor agonists in this study.

Dopamine receptor agonists are suspected to have caused serious impulse control disorders in at least 710 cases reported to the Food and Drug Administration’s adverse drug events database during a 10-year period.

The drugs, which are often prescribed for Parkinson’s disease, restless legs syndrome, and hyperprolactinemia, were implicated in more than 1,000 separate adverse events that included pathological gambling, hypersexuality, compulsive shopping, poriomania (wandering away from home), binge eating, kleptomania, and compulsive sexual behavior. Although this retrospective disproportionality analysis of information in a public database could not prove causality, “the associations were significant, the magnitude of the effects was large, and the effects were seen for all 6 dopamine agonist drugs” available in the United States, reported Thomas J. Moore of the Institute for Safe Medication Practices, Alexandria, Va., and his associates (JAMA Int. Med. 2014 Oct. 20 [doi: 10.1001/jamainternmed.2014.5262]).

These findings confirm and extend those of several previous reports in the literature, but none of the dopamine receptor agonists – pramipexole, ropinirole, cabergoline, bromocriptine, rotigotine, and apomorphine – currently carry a boxed warning about the potential for developing severe impulse control disorders. These behaviors can have catastrophic effects on jobs, marriages, and family finances. “Physicians who prescribe dopamine agonists should vigilantly monitor their patients, and ensure that patients, families, and caregivers are counseled about [this] risk,” the investigators wrote.

Noting that these six agents accounted for 2.1 million dispensed outpatient prescriptions during a single quarter of 2012 in the United States alone, the researchers examined a Food and Drug Administration (FDA) database of all domestic and foreign reports of serious drug events during 2003-2012. They focused on 1,580 reports of serious impulse control disorders and excluded cases involved in litigation or clinical studies. A total of 710 cases were related to dopamine receptor agonists, of which 48% were reported from foreign countries, said Mr. Moore, who is also with the department of epidemiology and biostatistics, George Washington University, Washington, and his colleagues.

The investigators calculated the proportional reporting ratio, “a ratio similar in concept to the relative risk ratio,” between these cases and each individual dopamine receptor agonist. They found that the proportional reporting ratio of each drug was high and statistically significant. In addition, the number of case reports rose steadily over time, from both within and outside the United States.

“Our data, and data from prior studies, show the need for these prominent [boxed] warnings” in the prescribing information for these drugs, the investigators said.

Mr. Moore and one of his associates reported serving as consultants or expert witnesses in civil and criminal litigation involving many psychiatric drugs, not including the six dopamine receptor agonists in this study.

Tapered buprenorphine therapy is far less effective than maintenance therapy for patients dependent on prescription opioids who seek treatment in the primary care setting, to the extent that it should be used “sparingly, if at all,” according to a report published online Oct. 20 in JAMA Internal Medicine.

General practice and family medicine physicians are the most frequent prescribers of buprenorphine, and they routinely must decide between pharmacologically assisted withdrawal (tapering) and ongoing maintenance treatment, even though the data to guide these decisions are quite limited. “In practice, patients often request and receive medication taper instead of maintenance therapy, and office-based physicians may be enthusiastic to provide tapers because this method allows them to treat more patients, fits with what many patients request, and could reduce the need for long-term opioid therapy,” said Dr. David A. Fiellin, professor of medicine, public health, and investigative medicine at Yale University, New Haven, Conn., and his associates.

The investigators performed a single-center, open-label randomized clinical trial to compare the two approaches in 113 patients who were dependent on prescription opioids. All the study participants received ongoing care from primary care physicians and nurses trained in addiction medicine, as well as from drug counselors, throughout the 14-week treatment phase of the study, which included frequent 15- to 20-minute visits focused on drug abuse education, management of withdrawal symptoms, overdose risk, and relapse prevention.

All the study participants had a 2-week induction period in which they were stabilized on buprenorphine, followed by 14 weeks of active treatment, then 2 weeks of continuing clinical care after treatment completion. A total of 56 patients were assigned to a steady dose of buprenorphine for the 14-week treatment phase, while 57 were assigned to tapering: 4 weeks on a stable dose of buprenorphine followed by 3 weeks of gradually decreasing doses (approximately 2 mg every 3 days). The tapered group was given prescriptions for NSAIDs, an antiemetic, a sleeping aid, and clonidine to manage opioid withdrawal.

The primary outcome measure – the overall percentage of weekly urine samples that were negative for the presence of opioids – was significantly lower in the tapering group (35.2%) than in the maintenance group (53.2%). The two groups had similar percentages of negative samples for the first 7 weeks of the trial, when all patients were receiving full-dose buprenorphine, but the percentage then increased only in the tapering group, who were no longer receiving full-dose buprenorphine. Dr. Fiellin and his associates reported (JAMA Int. Med. 2014 Oct. 20 [doi:10.1001/jamainternmed.2014.5302]).

Patients in the tapering group also achieved fewer consecutive weeks of self-reported opioid abstinence (2.7 vs 5.0), were more likely to require transfer to a more intensive treatment program (28% vs 5%), and were less likely to complete the trial (11% vs 66%).

“Buprenorphine taper should be used sparingly, if at all, in primary care treatment of patients dependent on prescription opioids,” the investigators said.

This study was supported by the National Institute on Drug Abuse. Reckitt-Benckiser Pharmaceuticals supplied the buprenorphine through NIDA. Dr. Fiellin reported ties to Pinney Associates and ParagonRx for serving on expert advisory boards to monitor for diversion, misuse, and abuse of buprenorphine.

Tapered buprenorphine therapy is far less effective than maintenance therapy for patients dependent on prescription opioids who seek treatment in the primary care setting, to the extent that it should be used “sparingly, if at all,” according to a report published online Oct. 20 in JAMA Internal Medicine.

General practice and family medicine physicians are the most frequent prescribers of buprenorphine, and they routinely must decide between pharmacologically assisted withdrawal (tapering) and ongoing maintenance treatment, even though the data to guide these decisions are quite limited. “In practice, patients often request and receive medication taper instead of maintenance therapy, and office-based physicians may be enthusiastic to provide tapers because this method allows them to treat more patients, fits with what many patients request, and could reduce the need for long-term opioid therapy,” said Dr. David A. Fiellin, professor of medicine, public health, and investigative medicine at Yale University, New Haven, Conn., and his associates.

The investigators performed a single-center, open-label randomized clinical trial to compare the two approaches in 113 patients who were dependent on prescription opioids. All the study participants received ongoing care from primary care physicians and nurses trained in addiction medicine, as well as from drug counselors, throughout the 14-week treatment phase of the study, which included frequent 15- to 20-minute visits focused on drug abuse education, management of withdrawal symptoms, overdose risk, and relapse prevention.

All the study participants had a 2-week induction period in which they were stabilized on buprenorphine, followed by 14 weeks of active treatment, then 2 weeks of continuing clinical care after treatment completion. A total of 56 patients were assigned to a steady dose of buprenorphine for the 14-week treatment phase, while 57 were assigned to tapering: 4 weeks on a stable dose of buprenorphine followed by 3 weeks of gradually decreasing doses (approximately 2 mg every 3 days). The tapered group was given prescriptions for NSAIDs, an antiemetic, a sleeping aid, and clonidine to manage opioid withdrawal.

The primary outcome measure – the overall percentage of weekly urine samples that were negative for the presence of opioids – was significantly lower in the tapering group (35.2%) than in the maintenance group (53.2%). The two groups had similar percentages of negative samples for the first 7 weeks of the trial, when all patients were receiving full-dose buprenorphine, but the percentage then increased only in the tapering group, who were no longer receiving full-dose buprenorphine. Dr. Fiellin and his associates reported (JAMA Int. Med. 2014 Oct. 20 [doi:10.1001/jamainternmed.2014.5302]).

Patients in the tapering group also achieved fewer consecutive weeks of self-reported opioid abstinence (2.7 vs 5.0), were more likely to require transfer to a more intensive treatment program (28% vs 5%), and were less likely to complete the trial (11% vs 66%).

“Buprenorphine taper should be used sparingly, if at all, in primary care treatment of patients dependent on prescription opioids,” the investigators said.

This study was supported by the National Institute on Drug Abuse. Reckitt-Benckiser Pharmaceuticals supplied the buprenorphine through NIDA. Dr. Fiellin reported ties to Pinney Associates and ParagonRx for serving on expert advisory boards to monitor for diversion, misuse, and abuse of buprenorphine.

Tapered buprenorphine therapy is far less effective than maintenance therapy for patients dependent on prescription opioids who seek treatment in the primary care setting, to the extent that it should be used “sparingly, if at all,” according to a report published online Oct. 20 in JAMA Internal Medicine.

General practice and family medicine physicians are the most frequent prescribers of buprenorphine, and they routinely must decide between pharmacologically assisted withdrawal (tapering) and ongoing maintenance treatment, even though the data to guide these decisions are quite limited. “In practice, patients often request and receive medication taper instead of maintenance therapy, and office-based physicians may be enthusiastic to provide tapers because this method allows them to treat more patients, fits with what many patients request, and could reduce the need for long-term opioid therapy,” said Dr. David A. Fiellin, professor of medicine, public health, and investigative medicine at Yale University, New Haven, Conn., and his associates.

The investigators performed a single-center, open-label randomized clinical trial to compare the two approaches in 113 patients who were dependent on prescription opioids. All the study participants received ongoing care from primary care physicians and nurses trained in addiction medicine, as well as from drug counselors, throughout the 14-week treatment phase of the study, which included frequent 15- to 20-minute visits focused on drug abuse education, management of withdrawal symptoms, overdose risk, and relapse prevention.

All the study participants had a 2-week induction period in which they were stabilized on buprenorphine, followed by 14 weeks of active treatment, then 2 weeks of continuing clinical care after treatment completion. A total of 56 patients were assigned to a steady dose of buprenorphine for the 14-week treatment phase, while 57 were assigned to tapering: 4 weeks on a stable dose of buprenorphine followed by 3 weeks of gradually decreasing doses (approximately 2 mg every 3 days). The tapered group was given prescriptions for NSAIDs, an antiemetic, a sleeping aid, and clonidine to manage opioid withdrawal.

The primary outcome measure – the overall percentage of weekly urine samples that were negative for the presence of opioids – was significantly lower in the tapering group (35.2%) than in the maintenance group (53.2%). The two groups had similar percentages of negative samples for the first 7 weeks of the trial, when all patients were receiving full-dose buprenorphine, but the percentage then increased only in the tapering group, who were no longer receiving full-dose buprenorphine. Dr. Fiellin and his associates reported (JAMA Int. Med. 2014 Oct. 20 [doi:10.1001/jamainternmed.2014.5302]).

Patients in the tapering group also achieved fewer consecutive weeks of self-reported opioid abstinence (2.7 vs 5.0), were more likely to require transfer to a more intensive treatment program (28% vs 5%), and were less likely to complete the trial (11% vs 66%).

“Buprenorphine taper should be used sparingly, if at all, in primary care treatment of patients dependent on prescription opioids,” the investigators said.

This study was supported by the National Institute on Drug Abuse. Reckitt-Benckiser Pharmaceuticals supplied the buprenorphine through NIDA. Dr. Fiellin reported ties to Pinney Associates and ParagonRx for serving on expert advisory boards to monitor for diversion, misuse, and abuse of buprenorphine.

Engineered T-cell therapy using CTL019 (formerly known as CART19) rapidly induced complete remission in 27 of 30 children and adults with relapsed or refractory “incurable” acute lymphoblastic leukemia in an industry-sponsored phase I/IIA clinical trial reported online Oct. 16 in the New England Journal of Medicine.

These remissions were sustained for up to 2 years in 19 of the study participants, 15 of whom required no further therapy, said Dr. Shannon L. Maude of the University of Pennsylvania Medical Center, Philadelphia, and her associates.

Five adults aged 26-60 years and 25 children aged 5-22 years participated in the trial, which was funded largely by Novartis. A total of 26 of these patients had relapsed B-cell acute lymphoblastic leukemia (ALL), 3 had primary refractory B-cell ALL, and 1 had relapsed T-cell ALL that expressed CD19. Eighteen patients had relapsed after allogeneic stem-cell transplantation, and 3 had failed on blinatumomab therapy.

The treatment involved infusion of autologous T cells that had been engineered to express chimeric antibodies targeting tumor cells expressing CD19 (CTL019). Before now, “clinical progress has been limited by poor in vivo expansion of engineered T cells and failure of these cells to persist after infusion.” But, in this study, the infused cells showed robust proliferation and long-term persistence, the investigators said.

Within 1 month, 27 of the 30 patients (90%) attained complete morphologic remission. A test to detect minimal residual disease produced negative results in 22 of them; 3 patients who showed very low levels of residual disease subsequently tested negative at 3 months. After a median follow-up of 7 months (range, 2-24 months), 19 patients remained in remission: 15 of them required no further treatment and 4 withdrew from the trial to pursue additional therapies.

The 3 patients who had no initial response to CTL019 infusion showed very low levels of CTL019-modified T cells on blood flow cytometry, while the 27 who had an initial response showed high levels. These cells persisted in the blood for up to 11 months.

Event-free survival was 67% and overall survival was 78% at 6 months. In comparison, the most recently approved combination chemotherapy for relapsed ALL produces complete remission rates of less than 25% and has a median duration of response of 4-9 weeks, Dr. Maude and her associates said.

Seven patients died after disease progression or relapse, including one who developed myelodysplastic syndrome.

The most common and most serious adverse effect of chimeric antigen receptor T-cell therapy is the cytokine-release syndrome, a systemic inflammatory response produced by markedly high T-cell activation and proliferation. The syndrome ranges from a mild and self-limiting toxic response characterized by fever and myalgia to a severe, life-threatening response that may include vascular leakage, hypotension, respiratory and renal insufficiency, cytopenias, and coagulopathy.

All 30 patients in this study developed cytokine-release syndrome. “Some degree of cytokine-release syndrome is probably necessary for [treatment] efficacy,” the investigators said (N. Engl. J. Med 2014 Oct.16 [doi:10.1056/NEJMoa1407222]).

The syndrome was mild to moderate in 22 patients, but severe enough in the remaining 8 patients to require ICU care with varying degrees of respiratory support. The severity of cytokine-release syndrome was found to correlate with the burden of disease at baseline, with an increasing percentage of blast cells in bone marrow being significantly associated with increasing severity of the syndrome.

The use of the interleukin-6 receptor blocking antibody tocilizumab was found to rapidly resolve the syndrome, swiftly reducing fever and stabilizing blood pressure over 1-3 days. All the affected patients fully recovered, and the use of prophylactic tocilizumab for future patients is now being investigated.

Thirteen patients experienced neurotoxicity, ranging from delirium accompanying their fever to global encephalopathy characterized by aphasia, confusion, delirium, and hallucinations. These symptoms were self-limiting and resolved fully without apparent long-term sequelae in all cases.

Engineered T-cell therapy using CTL019 (formerly known as CART19) rapidly induced complete remission in 27 of 30 children and adults with relapsed or refractory “incurable” acute lymphoblastic leukemia in an industry-sponsored phase I/IIA clinical trial reported online Oct. 16 in the New England Journal of Medicine.

These remissions were sustained for up to 2 years in 19 of the study participants, 15 of whom required no further therapy, said Dr. Shannon L. Maude of the University of Pennsylvania Medical Center, Philadelphia, and her associates.

Five adults aged 26-60 years and 25 children aged 5-22 years participated in the trial, which was funded largely by Novartis. A total of 26 of these patients had relapsed B-cell acute lymphoblastic leukemia (ALL), 3 had primary refractory B-cell ALL, and 1 had relapsed T-cell ALL that expressed CD19. Eighteen patients had relapsed after allogeneic stem-cell transplantation, and 3 had failed on blinatumomab therapy.

The treatment involved infusion of autologous T cells that had been engineered to express chimeric antibodies targeting tumor cells expressing CD19 (CTL019). Before now, “clinical progress has been limited by poor in vivo expansion of engineered T cells and failure of these cells to persist after infusion.” But, in this study, the infused cells showed robust proliferation and long-term persistence, the investigators said.

Within 1 month, 27 of the 30 patients (90%) attained complete morphologic remission. A test to detect minimal residual disease produced negative results in 22 of them; 3 patients who showed very low levels of residual disease subsequently tested negative at 3 months. After a median follow-up of 7 months (range, 2-24 months), 19 patients remained in remission: 15 of them required no further treatment and 4 withdrew from the trial to pursue additional therapies.

The 3 patients who had no initial response to CTL019 infusion showed very low levels of CTL019-modified T cells on blood flow cytometry, while the 27 who had an initial response showed high levels. These cells persisted in the blood for up to 11 months.

Event-free survival was 67% and overall survival was 78% at 6 months. In comparison, the most recently approved combination chemotherapy for relapsed ALL produces complete remission rates of less than 25% and has a median duration of response of 4-9 weeks, Dr. Maude and her associates said.

Seven patients died after disease progression or relapse, including one who developed myelodysplastic syndrome.

The most common and most serious adverse effect of chimeric antigen receptor T-cell therapy is the cytokine-release syndrome, a systemic inflammatory response produced by markedly high T-cell activation and proliferation. The syndrome ranges from a mild and self-limiting toxic response characterized by fever and myalgia to a severe, life-threatening response that may include vascular leakage, hypotension, respiratory and renal insufficiency, cytopenias, and coagulopathy.

All 30 patients in this study developed cytokine-release syndrome. “Some degree of cytokine-release syndrome is probably necessary for [treatment] efficacy,” the investigators said (N. Engl. J. Med 2014 Oct.16 [doi:10.1056/NEJMoa1407222]).

The syndrome was mild to moderate in 22 patients, but severe enough in the remaining 8 patients to require ICU care with varying degrees of respiratory support. The severity of cytokine-release syndrome was found to correlate with the burden of disease at baseline, with an increasing percentage of blast cells in bone marrow being significantly associated with increasing severity of the syndrome.

The use of the interleukin-6 receptor blocking antibody tocilizumab was found to rapidly resolve the syndrome, swiftly reducing fever and stabilizing blood pressure over 1-3 days. All the affected patients fully recovered, and the use of prophylactic tocilizumab for future patients is now being investigated.

Thirteen patients experienced neurotoxicity, ranging from delirium accompanying their fever to global encephalopathy characterized by aphasia, confusion, delirium, and hallucinations. These symptoms were self-limiting and resolved fully without apparent long-term sequelae in all cases.

Engineered T-cell therapy using CTL019 (formerly known as CART19) rapidly induced complete remission in 27 of 30 children and adults with relapsed or refractory “incurable” acute lymphoblastic leukemia in an industry-sponsored phase I/IIA clinical trial reported online Oct. 16 in the New England Journal of Medicine.

These remissions were sustained for up to 2 years in 19 of the study participants, 15 of whom required no further therapy, said Dr. Shannon L. Maude of the University of Pennsylvania Medical Center, Philadelphia, and her associates.

Five adults aged 26-60 years and 25 children aged 5-22 years participated in the trial, which was funded largely by Novartis. A total of 26 of these patients had relapsed B-cell acute lymphoblastic leukemia (ALL), 3 had primary refractory B-cell ALL, and 1 had relapsed T-cell ALL that expressed CD19. Eighteen patients had relapsed after allogeneic stem-cell transplantation, and 3 had failed on blinatumomab therapy.

The treatment involved infusion of autologous T cells that had been engineered to express chimeric antibodies targeting tumor cells expressing CD19 (CTL019). Before now, “clinical progress has been limited by poor in vivo expansion of engineered T cells and failure of these cells to persist after infusion.” But, in this study, the infused cells showed robust proliferation and long-term persistence, the investigators said.

Within 1 month, 27 of the 30 patients (90%) attained complete morphologic remission. A test to detect minimal residual disease produced negative results in 22 of them; 3 patients who showed very low levels of residual disease subsequently tested negative at 3 months. After a median follow-up of 7 months (range, 2-24 months), 19 patients remained in remission: 15 of them required no further treatment and 4 withdrew from the trial to pursue additional therapies.

The 3 patients who had no initial response to CTL019 infusion showed very low levels of CTL019-modified T cells on blood flow cytometry, while the 27 who had an initial response showed high levels. These cells persisted in the blood for up to 11 months.

Event-free survival was 67% and overall survival was 78% at 6 months. In comparison, the most recently approved combination chemotherapy for relapsed ALL produces complete remission rates of less than 25% and has a median duration of response of 4-9 weeks, Dr. Maude and her associates said.

Seven patients died after disease progression or relapse, including one who developed myelodysplastic syndrome.

The most common and most serious adverse effect of chimeric antigen receptor T-cell therapy is the cytokine-release syndrome, a systemic inflammatory response produced by markedly high T-cell activation and proliferation. The syndrome ranges from a mild and self-limiting toxic response characterized by fever and myalgia to a severe, life-threatening response that may include vascular leakage, hypotension, respiratory and renal insufficiency, cytopenias, and coagulopathy.

All 30 patients in this study developed cytokine-release syndrome. “Some degree of cytokine-release syndrome is probably necessary for [treatment] efficacy,” the investigators said (N. Engl. J. Med 2014 Oct.16 [doi:10.1056/NEJMoa1407222]).

The syndrome was mild to moderate in 22 patients, but severe enough in the remaining 8 patients to require ICU care with varying degrees of respiratory support. The severity of cytokine-release syndrome was found to correlate with the burden of disease at baseline, with an increasing percentage of blast cells in bone marrow being significantly associated with increasing severity of the syndrome.

The use of the interleukin-6 receptor blocking antibody tocilizumab was found to rapidly resolve the syndrome, swiftly reducing fever and stabilizing blood pressure over 1-3 days. All the affected patients fully recovered, and the use of prophylactic tocilizumab for future patients is now being investigated.

Thirteen patients experienced neurotoxicity, ranging from delirium accompanying their fever to global encephalopathy characterized by aphasia, confusion, delirium, and hallucinations. These symptoms were self-limiting and resolved fully without apparent long-term sequelae in all cases.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Malpractice reforms enacted in three states approximately 10 years ago failed to reduce defensive medicine in the emergency department, according to a report published Oct. 16 in the New England Journal of Medicine.

The reforms changed the liability standard for emergency care from ordinary negligence to gross negligence, providing exceptionally broad protection to emergency physicians so they could feel safe from litigation if they stopped ordering unnecessary (and expensive) tests and stopped admitting patients who didn’t truly need inpatient care. The legal community in the three reform states – Texas, Georgia, and South Carolina – “characterizes the gross negligence standard as providing ‘virtual immunity’ to emergency physicians,” said Dr. Daniel A. Waxman of RAND Health and the University of California, Los Angeles, and his associates.

The researchers examined database information on 3,868,110 emergency department (ED) visits by Medicare patients to 1,166 hospitals across the 3 reform states, as well as to 10 neighboring control states, from 1997 through 2011. They found that the proportion of patients who underwent CT or MRI increased each year in both the reform states and the control states, and per-visit costs increased as well.

In a regression analysis, malpractice reform was not associated with a decline in CT or MRI use in any of the reform states. And in an analysis of ED costs, per-visit ED charges were not reduced after malpractice reform was enacted in either Texas or South Carolina; in Georgia, reforms were associated with a 3.6% reduction.

In addition, the rate of hospital admissions from the ED did not decrease in any of the reform states.

Data regarding the number of malpractice claims during the study period that were specifically related to ED care are not available. But the malpractice reforms in Texas were associated with a 60% reduction in malpractice claims and a 70% reduction in malpractice payments, the investigators noted.

Nevertheless, “we did not find evidence that these reforms decreased practice intensity, as measured by the rate of the use of advanced imaging, by the rate of hospital admission, or in two of three cases, by average charges. Although there was a small [3.6%] reduction in charges in one of the three sites, our results in aggregate suggest that these strongly protective laws caused little if any change in practice intensity among physicians caring for Medicare patients in emergency departments,” Dr. Waxman and his associates said (N. Engl. J. Med. 2014 October 16 [doi:10.1056/NEJMsa1313308]).

Many previous studies, including anonymous surveys of ED physicians, have reported that most practice defensive medicine; up to 30% of CT scans and 19% of MRIs were ordered “for defensive purposes” in one study, and as many as 70% of respondents in another study said they often ordered imaging studies or hospital admissions simply to protect themselves.

“Our findings suggest that physicians are less motivated by legal risk than they believe themselves to be. Although a practice culture of abundant caution clearly exists, it seems likely than aversion to legal risk exists in parallel with a more general risk aversion and with other behavioral, cultural, and economic motivations that might affect decision making.“When legal risk decreases, the ‘path of least resistance’ may still favor resource-intensive care. Our results suggest that malpractice reform may have less effect on costs than has been projected,” they noted.

Combined hormonal contraception raises the risk for venous thromboembolism fivefold overall, with certain formulations increasing that risk even further and with thrombophilic genotypes raising it further still, according to a report published online Aug. 5 in Obstetrics & Gynecology.

To assess the association between various types of hormonal contraception and venous thromboembolism (VTE) risk, Swedish investigators performed a nationwide case-control study involving 948 women aged 18-54 years who were treated for deep vein thrombosis of the leg or pelvis, pulmonary embolism, or both conditions during a 6-year period and 902 healthy control subjects from the general population. All the women provided a blood sample for genetic analysis and provided detailed information regarding their contraceptive use, body mass index (BMI), smoking status, and recent history of immobilization, said Dr. Annica Bergendal of the Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, and her associates.

©Kativ/iStockphoto

A total of 32.8% of the case group reported current use of combined hormonal contraception, compared with only 11.9% of the control group. Overall, current use of combined hormonal contraception was associated with a fivefold increased risk of VTE, with an adjusted OR of 5.3. "Combinations with the progestogen desogestrel yielded the highest risk estimate (adjusted OR, 11.4), followed by drospirenone (adjusted OR, 8.4). The adjusted OR could not be calculated for lynestrenol because there were no exposed women in the control group," the investigators wrote (Obstet. Gynecol. 2014;124:600-9).

In contrast, progestogen-only contraception did not increase the risk of VTE, except at the highest dose level.

Women who used combination contraception and were carriers of factor V Leiden or of the prothrombin gene mutation were at extremely high risk for VTE, nearly 20-fold for either, compared with nonusers and noncarriers. Women who used combination contraception and were carriers of factor XIII had a much lower, but still elevated, risk for VTE (OR, 2.8).

All of these differences in risk appeared to be independent of BMI, smoking status, and recent history of immobilization, Dr. Bergendal and her associates added.

This study was supported by unrestricted grants from Janssen-Cilag, Novartis, Organon, Schering, Wyeth, AFA Insurance, and the Medical Products Agency. Dr. Bergendal and her associates reported no relevant financial conflicts.

Combined hormonal contraception raises the risk for venous thromboembolism fivefold overall, with certain formulations increasing that risk even further and with thrombophilic genotypes raising it further still, according to a report published online Aug. 5 in Obstetrics & Gynecology.

To assess the association between various types of hormonal contraception and venous thromboembolism (VTE) risk, Swedish investigators performed a nationwide case-control study involving 948 women aged 18-54 years who were treated for deep vein thrombosis of the leg or pelvis, pulmonary embolism, or both conditions during a 6-year period and 902 healthy control subjects from the general population. All the women provided a blood sample for genetic analysis and provided detailed information regarding their contraceptive use, body mass index (BMI), smoking status, and recent history of immobilization, said Dr. Annica Bergendal of the Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, and her associates.

©Kativ/iStockphoto

A total of 32.8% of the case group reported current use of combined hormonal contraception, compared with only 11.9% of the control group. Overall, current use of combined hormonal contraception was associated with a fivefold increased risk of VTE, with an adjusted OR of 5.3. "Combinations with the progestogen desogestrel yielded the highest risk estimate (adjusted OR, 11.4), followed by drospirenone (adjusted OR, 8.4). The adjusted OR could not be calculated for lynestrenol because there were no exposed women in the control group," the investigators wrote (Obstet. Gynecol. 2014;124:600-9).

In contrast, progestogen-only contraception did not increase the risk of VTE, except at the highest dose level.

Women who used combination contraception and were carriers of factor V Leiden or of the prothrombin gene mutation were at extremely high risk for VTE, nearly 20-fold for either, compared with nonusers and noncarriers. Women who used combination contraception and were carriers of factor XIII had a much lower, but still elevated, risk for VTE (OR, 2.8).

All of these differences in risk appeared to be independent of BMI, smoking status, and recent history of immobilization, Dr. Bergendal and her associates added.

This study was supported by unrestricted grants from Janssen-Cilag, Novartis, Organon, Schering, Wyeth, AFA Insurance, and the Medical Products Agency. Dr. Bergendal and her associates reported no relevant financial conflicts.

Combined hormonal contraception raises the risk for venous thromboembolism fivefold overall, with certain formulations increasing that risk even further and with thrombophilic genotypes raising it further still, according to a report published online Aug. 5 in Obstetrics & Gynecology.

To assess the association between various types of hormonal contraception and venous thromboembolism (VTE) risk, Swedish investigators performed a nationwide case-control study involving 948 women aged 18-54 years who were treated for deep vein thrombosis of the leg or pelvis, pulmonary embolism, or both conditions during a 6-year period and 902 healthy control subjects from the general population. All the women provided a blood sample for genetic analysis and provided detailed information regarding their contraceptive use, body mass index (BMI), smoking status, and recent history of immobilization, said Dr. Annica Bergendal of the Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, and her associates.

©Kativ/iStockphoto

A total of 32.8% of the case group reported current use of combined hormonal contraception, compared with only 11.9% of the control group. Overall, current use of combined hormonal contraception was associated with a fivefold increased risk of VTE, with an adjusted OR of 5.3. "Combinations with the progestogen desogestrel yielded the highest risk estimate (adjusted OR, 11.4), followed by drospirenone (adjusted OR, 8.4). The adjusted OR could not be calculated for lynestrenol because there were no exposed women in the control group," the investigators wrote (Obstet. Gynecol. 2014;124:600-9).

In contrast, progestogen-only contraception did not increase the risk of VTE, except at the highest dose level.

Women who used combination contraception and were carriers of factor V Leiden or of the prothrombin gene mutation were at extremely high risk for VTE, nearly 20-fold for either, compared with nonusers and noncarriers. Women who used combination contraception and were carriers of factor XIII had a much lower, but still elevated, risk for VTE (OR, 2.8).

All of these differences in risk appeared to be independent of BMI, smoking status, and recent history of immobilization, Dr. Bergendal and her associates added.

This study was supported by unrestricted grants from Janssen-Cilag, Novartis, Organon, Schering, Wyeth, AFA Insurance, and the Medical Products Agency. Dr. Bergendal and her associates reported no relevant financial conflicts.

Children’s and adolescents’ use of emergency departments rose markedly in the late 2000s, a sharp contrast from their steady or decreasing rates of ED use throughout the 1990s and early 2000s, according to a Research Letter to the Editor published online Oct. 14 in JAMA.

The recent uptick in pediatric ED visits also contrasts with a notable decline in adult ED use during the same time period. “These findings suggest that the drivers for ED use differ significantly between youths and adults, and that policies regarding insurance expansion” – that is, coverage through the Affordable Care Act – “may also have varying effects,” said Dr. Renee Y. Hsia of the department of emergency medicine, University of California, San Francisco, and San Francisco General Hospital, and her associates.

© Fuse/Thinkstock

They performed a retrospective analysis using a database recording all ED visits by children and adolescents up to 18 years of age to general hospitals across California between 2005 and 2010. The overall number of visits rose from 2.5 million to 2.8 million per year during that period, an increase of 11%. The fastest increase in rates of ED use occurred among uninsured youths, who showed a 23% rise. The rate rose 15% among privately insured youths and 7% among youths covered by Medicaid, the investigators said (JAMA 2014;312:1587-8).

“The divergence from older trends in ED use among youths may also reflect the increasingly central role of the ED in the U.S. health care system, especially during a period of severe economic recession, and could signal an overall deterioration in access to primary care across payer groups, or that even privately insured youths with greater access to primary care physicians are being directed to the ED for care,” Dr. Hsia and her associates said.

Children’s and adolescents’ use of emergency departments rose markedly in the late 2000s, a sharp contrast from their steady or decreasing rates of ED use throughout the 1990s and early 2000s, according to a Research Letter to the Editor published online Oct. 14 in JAMA.

The recent uptick in pediatric ED visits also contrasts with a notable decline in adult ED use during the same time period. “These findings suggest that the drivers for ED use differ significantly between youths and adults, and that policies regarding insurance expansion” – that is, coverage through the Affordable Care Act – “may also have varying effects,” said Dr. Renee Y. Hsia of the department of emergency medicine, University of California, San Francisco, and San Francisco General Hospital, and her associates.

© Fuse/Thinkstock

They performed a retrospective analysis using a database recording all ED visits by children and adolescents up to 18 years of age to general hospitals across California between 2005 and 2010. The overall number of visits rose from 2.5 million to 2.8 million per year during that period, an increase of 11%. The fastest increase in rates of ED use occurred among uninsured youths, who showed a 23% rise. The rate rose 15% among privately insured youths and 7% among youths covered by Medicaid, the investigators said (JAMA 2014;312:1587-8).

“The divergence from older trends in ED use among youths may also reflect the increasingly central role of the ED in the U.S. health care system, especially during a period of severe economic recession, and could signal an overall deterioration in access to primary care across payer groups, or that even privately insured youths with greater access to primary care physicians are being directed to the ED for care,” Dr. Hsia and her associates said.

Children’s and adolescents’ use of emergency departments rose markedly in the late 2000s, a sharp contrast from their steady or decreasing rates of ED use throughout the 1990s and early 2000s, according to a Research Letter to the Editor published online Oct. 14 in JAMA.

The recent uptick in pediatric ED visits also contrasts with a notable decline in adult ED use during the same time period. “These findings suggest that the drivers for ED use differ significantly between youths and adults, and that policies regarding insurance expansion” – that is, coverage through the Affordable Care Act – “may also have varying effects,” said Dr. Renee Y. Hsia of the department of emergency medicine, University of California, San Francisco, and San Francisco General Hospital, and her associates.

© Fuse/Thinkstock

They performed a retrospective analysis using a database recording all ED visits by children and adolescents up to 18 years of age to general hospitals across California between 2005 and 2010. The overall number of visits rose from 2.5 million to 2.8 million per year during that period, an increase of 11%. The fastest increase in rates of ED use occurred among uninsured youths, who showed a 23% rise. The rate rose 15% among privately insured youths and 7% among youths covered by Medicaid, the investigators said (JAMA 2014;312:1587-8).

“The divergence from older trends in ED use among youths may also reflect the increasingly central role of the ED in the U.S. health care system, especially during a period of severe economic recession, and could signal an overall deterioration in access to primary care across payer groups, or that even privately insured youths with greater access to primary care physicians are being directed to the ED for care,” Dr. Hsia and her associates said.

Women who have inflammatory bowel disease, particularly those with Crohn’s disease, are at increased risk for developing cervical neoplasia, according to a report published online in Clinical Gastroenterology and Hepatology.

In a population-based nationwide cohort study involving 27,408 Danish women with newly diagnosed IBD and 1,508,334 control subjects matched for age and area of residence, a significant excess in cervical neoplasia also was observed for up to 10 years before the GI diagnosis. This bidirectional association indicates that an as-yet-unknown factor underlies susceptibility to both disorders, said Dr. Christine Rungoe of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

“Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients,” they noted.

Some previous studies have shown an increased risk of cervical neoplasia among IBD patients, but others have found no association. Some experts have proposed that either the underlying immunologic changes in IBD or the treatment of IBD with immunosuppressive drugs may impair patients’ ability to clear HPV infections, thus raising the risk of cervical neoplasia.

Dr. Rungoe and her colleagues examined the issue using data from Danish national registries that covered approximately 4 million women residing there during the past 32 years. They identified 18,691 women newly diagnosed with ulcerative colitis and 8,717 newly diagnosed as having Crohn’s disease and compared their rates of cervical neoplasia against those of control subjects during a median of 8 years of follow-up.

Women with ulcerative colitis showed a slightly but significantly increased risk of developing both low-grade (RR, 1.15) and high-grade (RR, 1.12) squamous intraepithelial lesions but no increased risk of cervical cancer. Women with Crohn’s disease showed a significantly increased risk of developing both low-grade (RR, 1.26) and high-grade (RR, 1.28) squamous intraepithelial lesions, as well as an even greater risk (RR, 1.53) of cervical cancer.

These associations were not the result of higher rates of cervical screening among the women with IBD than among the control subjects, since the two study groups had comparable screening rates. The associations also were not related to IBD therapy, since the use of mesalamine, azathioprine, and corticosteroids appeared to have no influence on rates of cervical neoplasia. The one exception to this finding was that women with Crohn’s disease who used TNF-alpha antagonists were at increased risk only for high-grade intraepithelial lesions of the cervix, the investigators said (Clin. Gastroenterol. Hepatol. 2014 July 30 [doi:10.1016/j.cgh.2014.07.036]).

An additional notable finding was that the odds of having a history of both high-grade intraepithelial and cancerous lesions of the cervix were markedly higher in the women with IBD than in the control subjects. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia rather than an etiologic role of IBD … in the development of cervical neoplasia,” Dr. Rungoe and her associates wrote.

This study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.

Women who have inflammatory bowel disease, particularly those with Crohn’s disease, are at increased risk for developing cervical neoplasia, according to a report published online in Clinical Gastroenterology and Hepatology.

In a population-based nationwide cohort study involving 27,408 Danish women with newly diagnosed IBD and 1,508,334 control subjects matched for age and area of residence, a significant excess in cervical neoplasia also was observed for up to 10 years before the GI diagnosis. This bidirectional association indicates that an as-yet-unknown factor underlies susceptibility to both disorders, said Dr. Christine Rungoe of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

“Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients,” they noted.

Some previous studies have shown an increased risk of cervical neoplasia among IBD patients, but others have found no association. Some experts have proposed that either the underlying immunologic changes in IBD or the treatment of IBD with immunosuppressive drugs may impair patients’ ability to clear HPV infections, thus raising the risk of cervical neoplasia.

Dr. Rungoe and her colleagues examined the issue using data from Danish national registries that covered approximately 4 million women residing there during the past 32 years. They identified 18,691 women newly diagnosed with ulcerative colitis and 8,717 newly diagnosed as having Crohn’s disease and compared their rates of cervical neoplasia against those of control subjects during a median of 8 years of follow-up.

Women with ulcerative colitis showed a slightly but significantly increased risk of developing both low-grade (RR, 1.15) and high-grade (RR, 1.12) squamous intraepithelial lesions but no increased risk of cervical cancer. Women with Crohn’s disease showed a significantly increased risk of developing both low-grade (RR, 1.26) and high-grade (RR, 1.28) squamous intraepithelial lesions, as well as an even greater risk (RR, 1.53) of cervical cancer.

These associations were not the result of higher rates of cervical screening among the women with IBD than among the control subjects, since the two study groups had comparable screening rates. The associations also were not related to IBD therapy, since the use of mesalamine, azathioprine, and corticosteroids appeared to have no influence on rates of cervical neoplasia. The one exception to this finding was that women with Crohn’s disease who used TNF-alpha antagonists were at increased risk only for high-grade intraepithelial lesions of the cervix, the investigators said (Clin. Gastroenterol. Hepatol. 2014 July 30 [doi:10.1016/j.cgh.2014.07.036]).

An additional notable finding was that the odds of having a history of both high-grade intraepithelial and cancerous lesions of the cervix were markedly higher in the women with IBD than in the control subjects. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia rather than an etiologic role of IBD … in the development of cervical neoplasia,” Dr. Rungoe and her associates wrote.

This study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.

Women who have inflammatory bowel disease, particularly those with Crohn’s disease, are at increased risk for developing cervical neoplasia, according to a report published online in Clinical Gastroenterology and Hepatology.

In a population-based nationwide cohort study involving 27,408 Danish women with newly diagnosed IBD and 1,508,334 control subjects matched for age and area of residence, a significant excess in cervical neoplasia also was observed for up to 10 years before the GI diagnosis. This bidirectional association indicates that an as-yet-unknown factor underlies susceptibility to both disorders, said Dr. Christine Rungoe of the department of epidemiology research, Statens Serum Institut, Copenhagen, and her associates.

“Patients with IBD should be encouraged to follow the screening program for cervical neoplasia, and clinicians should be aware of the slightly increased risk of HPV-related cervical lesions in IBD patients,” they noted.

Some previous studies have shown an increased risk of cervical neoplasia among IBD patients, but others have found no association. Some experts have proposed that either the underlying immunologic changes in IBD or the treatment of IBD with immunosuppressive drugs may impair patients’ ability to clear HPV infections, thus raising the risk of cervical neoplasia.

Dr. Rungoe and her colleagues examined the issue using data from Danish national registries that covered approximately 4 million women residing there during the past 32 years. They identified 18,691 women newly diagnosed with ulcerative colitis and 8,717 newly diagnosed as having Crohn’s disease and compared their rates of cervical neoplasia against those of control subjects during a median of 8 years of follow-up.

Women with ulcerative colitis showed a slightly but significantly increased risk of developing both low-grade (RR, 1.15) and high-grade (RR, 1.12) squamous intraepithelial lesions but no increased risk of cervical cancer. Women with Crohn’s disease showed a significantly increased risk of developing both low-grade (RR, 1.26) and high-grade (RR, 1.28) squamous intraepithelial lesions, as well as an even greater risk (RR, 1.53) of cervical cancer.

These associations were not the result of higher rates of cervical screening among the women with IBD than among the control subjects, since the two study groups had comparable screening rates. The associations also were not related to IBD therapy, since the use of mesalamine, azathioprine, and corticosteroids appeared to have no influence on rates of cervical neoplasia. The one exception to this finding was that women with Crohn’s disease who used TNF-alpha antagonists were at increased risk only for high-grade intraepithelial lesions of the cervix, the investigators said (Clin. Gastroenterol. Hepatol. 2014 July 30 [doi:10.1016/j.cgh.2014.07.036]).

An additional notable finding was that the odds of having a history of both high-grade intraepithelial and cancerous lesions of the cervix were markedly higher in the women with IBD than in the control subjects. “This is a novel finding that may suggest a yet unexplored common susceptibility to IBD and cervical neoplasia rather than an etiologic role of IBD … in the development of cervical neoplasia,” Dr. Rungoe and her associates wrote.

This study was funded in part by the Danish Council of Independent Research. The investigators reported having no relevant financial disclosures.