Denise Napoli

CHICAGO — Excessively high and extremely low levels of glycosylated hemoglobin were associated with an increased risk for dementia in elderly patients with type 2 diabetes, according to the findings of a cohort study involving more than 22,000 patients.

Dr. Rachel Whitmer surveyed a cohort of 22,852 patients older than age 55 from the Kaiser Permanente Northern California diabetes registry who had their HbA_1c measured at least once between 1994 and 1996, and checked these same patients' records again between Jan. 1, 1997, and May 30, 2006, for a diagnosis of dementia, vascular dementia, or Alzheimer's disease. People who had a prior diagnosis of dementia at the initial survey were excluded from the study.

In presenting the data at the annual meeting of the American Academy of Neurology, Dr. Whitmer described the cohort, which was 48% female and 35% nonwhite, as a “very diverse sample.” The mean age at the time of the initial survey was 65 years.

A total of 2,488 participants (11%) were diagnosed with dementia during the follow-up period. Patients with dementia were more likely to be on insulin and have had a longer duration of diabetes than were those without dementia, said Dr. Whitmer, an investigator at the division of research, Kaiser Permanente Northern California.

The researchers used a reference glycosylated hemoglobin level of 7%, because this is the cutoff point that endocrinologists aim for to lower the risks of complications.

Surprisingly, “we really did not see an elevated risk of dementia until we got to values that were from 10% to 11.9% and really 12% or greater,” she said.

Diabetes patients with HbA_1c values of 15% and above were 83% more likely to receive a diagnosis of dementia during the follow-up period than were their diabetic peers with glycosylated hemoglobin levels under 7%.

Diabetics with values of 12% or more had a 22% elevated risk of dementia.

However, the investigators also looked at people with extremely low levels of HbA_1c—less than 5%–-and found that this group actually had the greatest risk of dementia. People with levels less than 5% were 2.2 times more likely to have dementia, compared with patients with levels between 5% and 7%.

All risk assessments were made after adjusting for age, education, race, sex, weight, treatment, diabetes duration, hypertension, hyperlipidemia, heart disease, and stroke.

“Most endocrinologists like to aim for [HbA_1c] levels less than 8% or less than 7%,” said Dr. Whitmer. “It's been shown that this lowers the risk of stroke and hypertension.” However, physicians would do well to take into account these new cutoff points for dementia risk in their assessment of patients. “When we're looking at elderly people with diabetes, overcontrol can be just as much as a problem as not as much control,” Dr. Whitmer said.

One of the study's limitations is that HbA_1c might have been underestimated for those patients whose dementia went undiagnosed. Furthermore, no brain imaging or cognitive tests were available to confirm the dementia diagnoses. Future studies are needed to confirm the findings.

It's unknown what the mechanism would be that links HbA_1c and dementia, added Dr. Whitmer.

Dr. Whitmer reported no disclosures in relation to her presentation. One of her fellow researchers on this study disclosed relationships to Novartis Corp., Myriad Genetics Inc., and Posit Science.

CHICAGO — Excessively high and extremely low levels of glycosylated hemoglobin were associated with an increased risk for dementia in elderly patients with type 2 diabetes, according to the findings of a cohort study involving more than 22,000 patients.

Dr. Rachel Whitmer surveyed a cohort of 22,852 patients older than age 55 from the Kaiser Permanente Northern California diabetes registry who had their HbA_1c measured at least once between 1994 and 1996, and checked these same patients' records again between Jan. 1, 1997, and May 30, 2006, for a diagnosis of dementia, vascular dementia, or Alzheimer's disease. People who had a prior diagnosis of dementia at the initial survey were excluded from the study.

In presenting the data at the annual meeting of the American Academy of Neurology, Dr. Whitmer described the cohort, which was 48% female and 35% nonwhite, as a “very diverse sample.” The mean age at the time of the initial survey was 65 years.

A total of 2,488 participants (11%) were diagnosed with dementia during the follow-up period. Patients with dementia were more likely to be on insulin and have had a longer duration of diabetes than were those without dementia, said Dr. Whitmer, an investigator at the division of research, Kaiser Permanente Northern California.

The researchers used a reference glycosylated hemoglobin level of 7%, because this is the cutoff point that endocrinologists aim for to lower the risks of complications.

Surprisingly, “we really did not see an elevated risk of dementia until we got to values that were from 10% to 11.9% and really 12% or greater,” she said.

Diabetes patients with HbA_1c values of 15% and above were 83% more likely to receive a diagnosis of dementia during the follow-up period than were their diabetic peers with glycosylated hemoglobin levels under 7%.

Diabetics with values of 12% or more had a 22% elevated risk of dementia.

However, the investigators also looked at people with extremely low levels of HbA_1c—less than 5%–-and found that this group actually had the greatest risk of dementia. People with levels less than 5% were 2.2 times more likely to have dementia, compared with patients with levels between 5% and 7%.

All risk assessments were made after adjusting for age, education, race, sex, weight, treatment, diabetes duration, hypertension, hyperlipidemia, heart disease, and stroke.

“Most endocrinologists like to aim for [HbA_1c] levels less than 8% or less than 7%,” said Dr. Whitmer. “It's been shown that this lowers the risk of stroke and hypertension.” However, physicians would do well to take into account these new cutoff points for dementia risk in their assessment of patients. “When we're looking at elderly people with diabetes, overcontrol can be just as much as a problem as not as much control,” Dr. Whitmer said.

One of the study's limitations is that HbA_1c might have been underestimated for those patients whose dementia went undiagnosed. Furthermore, no brain imaging or cognitive tests were available to confirm the dementia diagnoses. Future studies are needed to confirm the findings.

It's unknown what the mechanism would be that links HbA_1c and dementia, added Dr. Whitmer.

Dr. Whitmer reported no disclosures in relation to her presentation. One of her fellow researchers on this study disclosed relationships to Novartis Corp., Myriad Genetics Inc., and Posit Science.

CHICAGO — Excessively high and extremely low levels of glycosylated hemoglobin were associated with an increased risk for dementia in elderly patients with type 2 diabetes, according to the findings of a cohort study involving more than 22,000 patients.

Dr. Rachel Whitmer surveyed a cohort of 22,852 patients older than age 55 from the Kaiser Permanente Northern California diabetes registry who had their HbA_1c measured at least once between 1994 and 1996, and checked these same patients' records again between Jan. 1, 1997, and May 30, 2006, for a diagnosis of dementia, vascular dementia, or Alzheimer's disease. People who had a prior diagnosis of dementia at the initial survey were excluded from the study.

In presenting the data at the annual meeting of the American Academy of Neurology, Dr. Whitmer described the cohort, which was 48% female and 35% nonwhite, as a “very diverse sample.” The mean age at the time of the initial survey was 65 years.

A total of 2,488 participants (11%) were diagnosed with dementia during the follow-up period. Patients with dementia were more likely to be on insulin and have had a longer duration of diabetes than were those without dementia, said Dr. Whitmer, an investigator at the division of research, Kaiser Permanente Northern California.

The researchers used a reference glycosylated hemoglobin level of 7%, because this is the cutoff point that endocrinologists aim for to lower the risks of complications.

Surprisingly, “we really did not see an elevated risk of dementia until we got to values that were from 10% to 11.9% and really 12% or greater,” she said.

Diabetes patients with HbA_1c values of 15% and above were 83% more likely to receive a diagnosis of dementia during the follow-up period than were their diabetic peers with glycosylated hemoglobin levels under 7%.

Diabetics with values of 12% or more had a 22% elevated risk of dementia.

However, the investigators also looked at people with extremely low levels of HbA_1c—less than 5%–-and found that this group actually had the greatest risk of dementia. People with levels less than 5% were 2.2 times more likely to have dementia, compared with patients with levels between 5% and 7%.

All risk assessments were made after adjusting for age, education, race, sex, weight, treatment, diabetes duration, hypertension, hyperlipidemia, heart disease, and stroke.

“Most endocrinologists like to aim for [HbA_1c] levels less than 8% or less than 7%,” said Dr. Whitmer. “It's been shown that this lowers the risk of stroke and hypertension.” However, physicians would do well to take into account these new cutoff points for dementia risk in their assessment of patients. “When we're looking at elderly people with diabetes, overcontrol can be just as much as a problem as not as much control,” Dr. Whitmer said.

One of the study's limitations is that HbA_1c might have been underestimated for those patients whose dementia went undiagnosed. Furthermore, no brain imaging or cognitive tests were available to confirm the dementia diagnoses. Future studies are needed to confirm the findings.

It's unknown what the mechanism would be that links HbA_1c and dementia, added Dr. Whitmer.

Dr. Whitmer reported no disclosures in relation to her presentation. One of her fellow researchers on this study disclosed relationships to Novartis Corp., Myriad Genetics Inc., and Posit Science.

Following a ketogenic diet reduced mean seizure frequency by 38% in a group of children with treatment-resistant epilepsy, according to findings from a first-of-its-kind study.

“Throughout the 20th century, the reports of the effects of the [ketogenic] diet have been limited to case series and retrospective and prospective observational studies,” wrote Dr. Max Wiznitzer of the division of pediatric neurology at the Rainbow Babies and Children's Hospital, Cleveland, in a commentary accompanying the study.

The ketogenic diet establishes a very high-fat, low-carbohydrate regimen, with controlled amounts of protein. There are two versions, both of which were included in this study: the classic, (or LCT, for long-chain triglycerides) version, which has a 3:1 or 4:1 ratio of fat to protein and carbohydrates. A modified version, the MCT, uses medium-chain triglycerides and a slightly lower ratio of fat to carbohydrates and proteins.

In both versions, the fat content was gradually increased from day 1 until the maximum ratio was achieved (by 2 weeks in the LCT version and by 10 days in the MCT). All diets were supplemented with vitamins and minerals, and the children's other treatments were not changed.

In all, 145 patients were enrolled from two U.K. epilepsy clinics to follow a version of the ketogenic diet. The children all had at least one seizure per day or more than seven seizures per week; had not responded to at least two antiepileptic drugs; and had not ever followed a ketogenic diet, wrote Elizabeth G. Neal, Ph.D., of the Institute of Child Health and Great Ormond Street Hospital for Children, London, and colleagues. Patients were aged 2–16 years.

In all, 73 patients were randomly assigned to the diet group; however, 8 did not receive treatment for a variety of reasons, 1 was excluded for inadequate data, and 10 discontinued the diet before the 3-month follow-up, which was the end of the study, leaving 54 patients to be included in the final analysis.

Of the 72 patients initially randomized to the control group, 8 elected not to participate in the study or were not included for other reasons (death, change in diagnosis, or improvements in seizures) and 15 patients were ultimately excluded because of inadequate data, leaving 49 included in the final analysis.

Twice-daily urine tests assessed ketosis. Follow-up visits occurred at 6 weeks and at 3 months (the end of the study). Monitoring also took place via phone.

“The difference between the mean percentage of baseline seizures at 3 months in the diet and control groups was 74.9% (95% confidence interval, 42.4%–107.4%; P less than .0001),” wrote the authors. In addition, one child in the diet group and none in the control group attained complete freedom from seizures (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70092–9]).

A total of 28 children in the diet groups (38% of the original 73 patients who were randomized) had a greater-than-50% decrease in seizures, compared with 4 in the control group (6% of the original 72 children who were randomized).

A similar magnitude of improvement was seen in children who had symptomatic generalized epilepsy and in those who had focal epilepsy syndromes, both of whom were represented in the study.

Withdrawal from the treatment group resulted from parental unhappiness with the restrictions (three cases); behavioral food refusal (two cases); and one case each of increased seizures, extreme drowsiness, constipation, vomiting, and diarrhea—common side effects of this type of diet.

“Clinically, more information is needed about the long-term effects of the ketogenic diet, including changes in blood lipid concentrations and persistent ketosis,” commented Dr. Wiznitzer, who was not affiliated with the study.

“Furthermore, better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed.” Dr. Wiznitzer also called for “a better delineation of the mechanism of action of the diet and the development of a medication that would duplicate its effects.” (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70093–0]).

The study was funded by the HSA Charitable Trust, Smiths Charity, Scientific Hospital Supplies, and the Milk Development Council.

Following a ketogenic diet reduced mean seizure frequency by 38% in a group of children with treatment-resistant epilepsy, according to findings from a first-of-its-kind study.

“Throughout the 20th century, the reports of the effects of the [ketogenic] diet have been limited to case series and retrospective and prospective observational studies,” wrote Dr. Max Wiznitzer of the division of pediatric neurology at the Rainbow Babies and Children's Hospital, Cleveland, in a commentary accompanying the study.

The ketogenic diet establishes a very high-fat, low-carbohydrate regimen, with controlled amounts of protein. There are two versions, both of which were included in this study: the classic, (or LCT, for long-chain triglycerides) version, which has a 3:1 or 4:1 ratio of fat to protein and carbohydrates. A modified version, the MCT, uses medium-chain triglycerides and a slightly lower ratio of fat to carbohydrates and proteins.

In both versions, the fat content was gradually increased from day 1 until the maximum ratio was achieved (by 2 weeks in the LCT version and by 10 days in the MCT). All diets were supplemented with vitamins and minerals, and the children's other treatments were not changed.

In all, 145 patients were enrolled from two U.K. epilepsy clinics to follow a version of the ketogenic diet. The children all had at least one seizure per day or more than seven seizures per week; had not responded to at least two antiepileptic drugs; and had not ever followed a ketogenic diet, wrote Elizabeth G. Neal, Ph.D., of the Institute of Child Health and Great Ormond Street Hospital for Children, London, and colleagues. Patients were aged 2–16 years.

In all, 73 patients were randomly assigned to the diet group; however, 8 did not receive treatment for a variety of reasons, 1 was excluded for inadequate data, and 10 discontinued the diet before the 3-month follow-up, which was the end of the study, leaving 54 patients to be included in the final analysis.

Of the 72 patients initially randomized to the control group, 8 elected not to participate in the study or were not included for other reasons (death, change in diagnosis, or improvements in seizures) and 15 patients were ultimately excluded because of inadequate data, leaving 49 included in the final analysis.

Twice-daily urine tests assessed ketosis. Follow-up visits occurred at 6 weeks and at 3 months (the end of the study). Monitoring also took place via phone.

“The difference between the mean percentage of baseline seizures at 3 months in the diet and control groups was 74.9% (95% confidence interval, 42.4%–107.4%; P less than .0001),” wrote the authors. In addition, one child in the diet group and none in the control group attained complete freedom from seizures (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70092–9]).

A total of 28 children in the diet groups (38% of the original 73 patients who were randomized) had a greater-than-50% decrease in seizures, compared with 4 in the control group (6% of the original 72 children who were randomized).

A similar magnitude of improvement was seen in children who had symptomatic generalized epilepsy and in those who had focal epilepsy syndromes, both of whom were represented in the study.

Withdrawal from the treatment group resulted from parental unhappiness with the restrictions (three cases); behavioral food refusal (two cases); and one case each of increased seizures, extreme drowsiness, constipation, vomiting, and diarrhea—common side effects of this type of diet.

“Clinically, more information is needed about the long-term effects of the ketogenic diet, including changes in blood lipid concentrations and persistent ketosis,” commented Dr. Wiznitzer, who was not affiliated with the study.

“Furthermore, better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed.” Dr. Wiznitzer also called for “a better delineation of the mechanism of action of the diet and the development of a medication that would duplicate its effects.” (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70093–0]).

The study was funded by the HSA Charitable Trust, Smiths Charity, Scientific Hospital Supplies, and the Milk Development Council.

Following a ketogenic diet reduced mean seizure frequency by 38% in a group of children with treatment-resistant epilepsy, according to findings from a first-of-its-kind study.

“Throughout the 20th century, the reports of the effects of the [ketogenic] diet have been limited to case series and retrospective and prospective observational studies,” wrote Dr. Max Wiznitzer of the division of pediatric neurology at the Rainbow Babies and Children's Hospital, Cleveland, in a commentary accompanying the study.

The ketogenic diet establishes a very high-fat, low-carbohydrate regimen, with controlled amounts of protein. There are two versions, both of which were included in this study: the classic, (or LCT, for long-chain triglycerides) version, which has a 3:1 or 4:1 ratio of fat to protein and carbohydrates. A modified version, the MCT, uses medium-chain triglycerides and a slightly lower ratio of fat to carbohydrates and proteins.

In both versions, the fat content was gradually increased from day 1 until the maximum ratio was achieved (by 2 weeks in the LCT version and by 10 days in the MCT). All diets were supplemented with vitamins and minerals, and the children's other treatments were not changed.

In all, 145 patients were enrolled from two U.K. epilepsy clinics to follow a version of the ketogenic diet. The children all had at least one seizure per day or more than seven seizures per week; had not responded to at least two antiepileptic drugs; and had not ever followed a ketogenic diet, wrote Elizabeth G. Neal, Ph.D., of the Institute of Child Health and Great Ormond Street Hospital for Children, London, and colleagues. Patients were aged 2–16 years.

In all, 73 patients were randomly assigned to the diet group; however, 8 did not receive treatment for a variety of reasons, 1 was excluded for inadequate data, and 10 discontinued the diet before the 3-month follow-up, which was the end of the study, leaving 54 patients to be included in the final analysis.

Of the 72 patients initially randomized to the control group, 8 elected not to participate in the study or were not included for other reasons (death, change in diagnosis, or improvements in seizures) and 15 patients were ultimately excluded because of inadequate data, leaving 49 included in the final analysis.

Twice-daily urine tests assessed ketosis. Follow-up visits occurred at 6 weeks and at 3 months (the end of the study). Monitoring also took place via phone.

“The difference between the mean percentage of baseline seizures at 3 months in the diet and control groups was 74.9% (95% confidence interval, 42.4%–107.4%; P less than .0001),” wrote the authors. In addition, one child in the diet group and none in the control group attained complete freedom from seizures (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70092–9]).

A total of 28 children in the diet groups (38% of the original 73 patients who were randomized) had a greater-than-50% decrease in seizures, compared with 4 in the control group (6% of the original 72 children who were randomized).

A similar magnitude of improvement was seen in children who had symptomatic generalized epilepsy and in those who had focal epilepsy syndromes, both of whom were represented in the study.

Withdrawal from the treatment group resulted from parental unhappiness with the restrictions (three cases); behavioral food refusal (two cases); and one case each of increased seizures, extreme drowsiness, constipation, vomiting, and diarrhea—common side effects of this type of diet.

“Clinically, more information is needed about the long-term effects of the ketogenic diet, including changes in blood lipid concentrations and persistent ketosis,” commented Dr. Wiznitzer, who was not affiliated with the study.

“Furthermore, better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed.” Dr. Wiznitzer also called for “a better delineation of the mechanism of action of the diet and the development of a medication that would duplicate its effects.” (Lancet Neurol. 2008 May 3 [Epub doi:10.1016/S1474–4422(08)70093–0]).

The study was funded by the HSA Charitable Trust, Smiths Charity, Scientific Hospital Supplies, and the Milk Development Council.

WASHINGTON — The drugs of choice for children aged 12 and 13 years are inhalants, surpassing pain relievers, marijuana, and any other illegal drug, with 3.4% of 12-year-olds and 4.8% of 13-year-olds using in the past year, according to a recent report by the Substance Abuse and Mental Health Services Administration.

In addition, data from eighth-graders who participated in the Monitoring the Future survey conducted at the University of Michigan, Ann Arbor, revealed a 9.3% prevalence of inhalant abuse in females in that age group, and 8.3% overall prevalence.

These data were presented at a press briefing on inhalant abuse at which Dr. H. Westley Clark, director of SAMHSA's Center for Drug Abuse Treatment, and other experts spoke about identifying and preventing inhalant abuse in patients, especially teens.

“Products that we consider essential to our daily routines, that tend to be almost invisible because they are so common, can be deadly if used inappropriately,” he said.

Some of those products include model airplane glue, hair spray, air freshener, deodorant, computer cleaning spray, nail polish remover, gasoline, Freon, vegetable cooking spray, whipped cream, and the gases nitrous oxide, butane, propane, and helium.

“According to our data from the household survey, about 1 million adolescents used inhalants in 2006,” Dr. Clark said.

He also cited data from a companion study, based on data from admissions to substance abuse treatment programs, which found that there was a higher likelihood of co-occurring substance abuse and psychiatric disorders in those who used inhalants (45%) than in those who do not (29%).

In an interview, Dr. Clark said physicians need to be more vigilant of the potential for inhalant use in young people. If a child shows up for asthma, skin disease, or with behavior problems, one should ask about misuse of inhalants. And visits for medical checkups for school athletics or for vaccinations, provide “plenty of opportunity to raise the issue and have the discussion.”

Morbidity can manifest as a range of problems, from cardiac to neurological. Possible effects of inhalant abuse include “sudden sniffing death,” and long-term abuse can result in memory or hearing loss, brain or bone marrow damage, and liver and kidney problems.

The full report is available online at http://oas.samhsa.gov/inhalants.htm

WASHINGTON — The drugs of choice for children aged 12 and 13 years are inhalants, surpassing pain relievers, marijuana, and any other illegal drug, with 3.4% of 12-year-olds and 4.8% of 13-year-olds using in the past year, according to a recent report by the Substance Abuse and Mental Health Services Administration.

In addition, data from eighth-graders who participated in the Monitoring the Future survey conducted at the University of Michigan, Ann Arbor, revealed a 9.3% prevalence of inhalant abuse in females in that age group, and 8.3% overall prevalence.

These data were presented at a press briefing on inhalant abuse at which Dr. H. Westley Clark, director of SAMHSA's Center for Drug Abuse Treatment, and other experts spoke about identifying and preventing inhalant abuse in patients, especially teens.

“Products that we consider essential to our daily routines, that tend to be almost invisible because they are so common, can be deadly if used inappropriately,” he said.

Some of those products include model airplane glue, hair spray, air freshener, deodorant, computer cleaning spray, nail polish remover, gasoline, Freon, vegetable cooking spray, whipped cream, and the gases nitrous oxide, butane, propane, and helium.

“According to our data from the household survey, about 1 million adolescents used inhalants in 2006,” Dr. Clark said.

He also cited data from a companion study, based on data from admissions to substance abuse treatment programs, which found that there was a higher likelihood of co-occurring substance abuse and psychiatric disorders in those who used inhalants (45%) than in those who do not (29%).

In an interview, Dr. Clark said physicians need to be more vigilant of the potential for inhalant use in young people. If a child shows up for asthma, skin disease, or with behavior problems, one should ask about misuse of inhalants. And visits for medical checkups for school athletics or for vaccinations, provide “plenty of opportunity to raise the issue and have the discussion.”

Morbidity can manifest as a range of problems, from cardiac to neurological. Possible effects of inhalant abuse include “sudden sniffing death,” and long-term abuse can result in memory or hearing loss, brain or bone marrow damage, and liver and kidney problems.

The full report is available online at http://oas.samhsa.gov/inhalants.htm

WASHINGTON — The drugs of choice for children aged 12 and 13 years are inhalants, surpassing pain relievers, marijuana, and any other illegal drug, with 3.4% of 12-year-olds and 4.8% of 13-year-olds using in the past year, according to a recent report by the Substance Abuse and Mental Health Services Administration.

In addition, data from eighth-graders who participated in the Monitoring the Future survey conducted at the University of Michigan, Ann Arbor, revealed a 9.3% prevalence of inhalant abuse in females in that age group, and 8.3% overall prevalence.

These data were presented at a press briefing on inhalant abuse at which Dr. H. Westley Clark, director of SAMHSA's Center for Drug Abuse Treatment, and other experts spoke about identifying and preventing inhalant abuse in patients, especially teens.

“Products that we consider essential to our daily routines, that tend to be almost invisible because they are so common, can be deadly if used inappropriately,” he said.

Some of those products include model airplane glue, hair spray, air freshener, deodorant, computer cleaning spray, nail polish remover, gasoline, Freon, vegetable cooking spray, whipped cream, and the gases nitrous oxide, butane, propane, and helium.

“According to our data from the household survey, about 1 million adolescents used inhalants in 2006,” Dr. Clark said.

He also cited data from a companion study, based on data from admissions to substance abuse treatment programs, which found that there was a higher likelihood of co-occurring substance abuse and psychiatric disorders in those who used inhalants (45%) than in those who do not (29%).

In an interview, Dr. Clark said physicians need to be more vigilant of the potential for inhalant use in young people. If a child shows up for asthma, skin disease, or with behavior problems, one should ask about misuse of inhalants. And visits for medical checkups for school athletics or for vaccinations, provide “plenty of opportunity to raise the issue and have the discussion.”

Morbidity can manifest as a range of problems, from cardiac to neurological. Possible effects of inhalant abuse include “sudden sniffing death,” and long-term abuse can result in memory or hearing loss, brain or bone marrow damage, and liver and kidney problems.

The full report is available online at http://oas.samhsa.gov/inhalants.htm

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications of hypermobility include problems with proprioception, osteo- arthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints. “If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility. (For complete diagnostic criteria of hypermobility, see sidebar.)

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors. One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall. Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important. “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall. These patients also often have a high, arched palate. “You wouldn't see it unless you looked for it,” he said.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases.

“I have seen more and more [hypermobility] in patients that I see for other things … but you have to look for them; you have to be aware of them,” he said.

Patients with hypermobility often amaze others with their special skill, enabled by their joint laxity, in piano playing, ballet, and athletics. However this gift may become “a danger if we don't manage it appropriately,” he warned.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation. The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Diagnosis RequiresSeveral Criteria

A diagnosis can be made if a patient has both of the major criteria, or if the patient fulfills one major criteria and two minor criteria, or simply has four minor criteria. The Beighton hypermobility score assigns up to 9 points based on a patient's ability to bend and flex certain parts of the body.

Major criteria:

▸ A Beighton score of greater than 4 (out of 9).

▸ Arthralgias for greater than 3 months in more than four joints.

Minor criteria:

▸ A Beighton score of 1–3.

▸ Arthralgia in 1–3 joints.

▸ History of joint dislocation.

▸ More than three soft tissue lesions.

▸ Marfanoid habitus (tall and slim, with a span:height ratio greater than 1.03, and an upper:lower segment ratio less than 0.89).

▸ Skin striae, hyperextensibility, or scarring.

▸ Lid laxity.

▸ History of varicosity, hernia, visceral prolapse.

Source: J. Bone Joint Surg. Br. 1969;51:444–53.

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications of hypermobility include problems with proprioception, osteo- arthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints. “If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility. (For complete diagnostic criteria of hypermobility, see sidebar.)

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors. One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall. Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important. “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall. These patients also often have a high, arched palate. “You wouldn't see it unless you looked for it,” he said.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases.

“I have seen more and more [hypermobility] in patients that I see for other things … but you have to look for them; you have to be aware of them,” he said.

Patients with hypermobility often amaze others with their special skill, enabled by their joint laxity, in piano playing, ballet, and athletics. However this gift may become “a danger if we don't manage it appropriately,” he warned.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation. The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Diagnosis RequiresSeveral Criteria

A diagnosis can be made if a patient has both of the major criteria, or if the patient fulfills one major criteria and two minor criteria, or simply has four minor criteria. The Beighton hypermobility score assigns up to 9 points based on a patient's ability to bend and flex certain parts of the body.

Major criteria:

▸ A Beighton score of greater than 4 (out of 9).

▸ Arthralgias for greater than 3 months in more than four joints.

Minor criteria:

▸ A Beighton score of 1–3.

▸ Arthralgia in 1–3 joints.

▸ History of joint dislocation.

▸ More than three soft tissue lesions.

▸ Marfanoid habitus (tall and slim, with a span:height ratio greater than 1.03, and an upper:lower segment ratio less than 0.89).

▸ Skin striae, hyperextensibility, or scarring.

▸ Lid laxity.

▸ History of varicosity, hernia, visceral prolapse.

Source: J. Bone Joint Surg. Br. 1969;51:444–53.

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications of hypermobility include problems with proprioception, osteo- arthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints. “If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility. (For complete diagnostic criteria of hypermobility, see sidebar.)

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors. One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall. Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important. “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall. These patients also often have a high, arched palate. “You wouldn't see it unless you looked for it,” he said.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases.

“I have seen more and more [hypermobility] in patients that I see for other things … but you have to look for them; you have to be aware of them,” he said.

Patients with hypermobility often amaze others with their special skill, enabled by their joint laxity, in piano playing, ballet, and athletics. However this gift may become “a danger if we don't manage it appropriately,” he warned.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation. The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Diagnosis RequiresSeveral Criteria

A diagnosis can be made if a patient has both of the major criteria, or if the patient fulfills one major criteria and two minor criteria, or simply has four minor criteria. The Beighton hypermobility score assigns up to 9 points based on a patient's ability to bend and flex certain parts of the body.

Major criteria:

▸ A Beighton score of greater than 4 (out of 9).

▸ Arthralgias for greater than 3 months in more than four joints.

Minor criteria:

▸ A Beighton score of 1–3.

▸ Arthralgia in 1–3 joints.

▸ History of joint dislocation.

▸ More than three soft tissue lesions.

▸ Marfanoid habitus (tall and slim, with a span:height ratio greater than 1.03, and an upper:lower segment ratio less than 0.89).

▸ Skin striae, hyperextensibility, or scarring.

▸ Lid laxity.

▸ History of varicosity, hernia, visceral prolapse.

Source: J. Bone Joint Surg. Br. 1969;51:444–53.

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis, according to one expert.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications reported in hypermobile patients include problems with proprioception, osteoarthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and also heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints.

“If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility.

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors.

One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall.

Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important.

He added that “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall.

These patients also often have a high, arched palate.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases,” Dr. Gall said.

“I have seen more and more [hypermobility] in patients that I see for other things. … You have to look for them,” he added.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation.

The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis, according to one expert.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications reported in hypermobile patients include problems with proprioception, osteoarthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and also heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints.

“If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility.

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors.

One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall.

Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important.

He added that “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall.

These patients also often have a high, arched palate.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases,” Dr. Gall said.

“I have seen more and more [hypermobility] in patients that I see for other things. … You have to look for them,” he added.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation.

The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Patients with hypermobility have a significant and often unappreciated risk for osteoporosis, according to one expert.

The prevalence of osteopenia and osteoporosis is very high in this cohort, said Dr. Eric P. Gall, chief of rheumatology and allergy at the Chicago Medical School, North Chicago.

“In my patient population, this is something that I'm well aware of and I tend to screen for osteoporosis sooner rather than later, particularly if there are any other risk factors.” said Dr. Gall during an audioconference on the subject organized by the American College of Rheumatology.

Additional complications reported in hypermobile patients include problems with proprioception, osteoarthritis, mitral valve prolapse, hernias, passing out, palpitations, chest pain, fatigue, and also heat intolerance.

“These patients don't just complain of pain in their joints; they complain of lots of things,” he said. “They maybe have headaches and chronic pain. Sometimes pain disrupts their sleep and they get secondary fibromyalgia. [They could have] problems with sexual relations. They may have injuries and [psychological] reactions to the injuries. They have resistance to local anesthetics.”

One of the reasons why hypermobility can be difficult to diagnose is that patients may not always have pain in the affected joints.

“If a patient has pain, they protect their joint and develop arthritis in the joint,” he said, reducing range of motion and disguising the hypermobility.

One specific type of hypermobile disease is Ehlers-Danlos syndrome, which has 10 subtypes, all characterized by slightly different associated comorbidities and risk factors.

One of the most serious of these (type 4) may be fatal, but is also especially rare, with an estimated prevalence of 1 in 250,000, said Dr. Gall.

Hallmark signs are vascular aneurysms; bowel and organ rupture; milder hyperextensibility compared with other types; translucent skin; pinched nose; dystrophic scars; and severe ecchymosis, which can often lead doctors to think that the sufferer is being physically abused.

“So how do we manage these people?” asked Dr. Gall. He mentioned that screening for mitral valve prolapse—both by listening and, if indicated, echocardiogram—is very important.

He added that “We discourage the hypermobile activities of daily living, although in the musician and the dancer we have to put practicality together … and make compromises.” Additionally, physical therapy can help these patients, as can measures to protect fragile skin. Recurrent dislocations can be treated with surgery, but sutures must be very carefully and closely placed, with “careful hemostasis.” “All [of the patients] who have severe disease are in need of genetic counseling” as well, he added.

Another serious hypermobility disease is Marfan syndrome. The criteria for a Marfan diagnosis is complicated, but Dr. Gall said that from a practical standpoint, if a patient's arm span measures more than 1.1 times his height, that is a good sign that Marfan syndrome may be present.

These patients can suffer complications like scoliosis, pectus excavatum, and pectus carinatum, also known as a “pigeon chest.” “That can be so severe that it actually can compress the heart,” said Dr. Gall.

These patients also often have a high, arched palate.

In Marfan syndrome, Ehlers-Danlos syndrome, and all hypermobility disorders, Dr. Gall emphasized that “management is multidisciplinary. People really have to work together as a team: The patient, the rheumatologist, the orthopedist, and the primary care providers all need to work together with the physical and occupational care therapist in dealing with these diseases,” Dr. Gall said.

“I have seen more and more [hypermobility] in patients that I see for other things. … You have to look for them,” he added.

Dr. Gall said he had no conflicts of interest to disclose in relation to his presentation.

The conference was sponsored in part by the following pharmaceutical companies: Genentech Inc., Biogen Idec Inc., UCB Inc., Abbott Laboratories, Amgen Inc., Wyeth Pharmaceuticals, and Hoffman-LaRoche Inc.

Patients with rheumatoid arthritis are at an increased risk of contracting infections that are severe enough to require hospitalization, compared with people without rheumatoid arthritis, and the use of oral corticosteroids exacerbates that risk, according to results from a recent study.

The results further emphasize the notion that patients should be adequately informed about the heightened risk of infection with glucocorticoids.

“Patients should be routinely vaccinated against influenza, [and also] receive a pneumococcal vaccine,” Dr. Mark Hochberg, coinvestigator and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore, said in an interview.

The researchers conducted a retrospective cohort study based on records from 61 health plans across the United States from Jan. 1, 1999, through July 31, 2006.

A total of 24,530 patients were included in the RA cohort (inclusion criteria for this group were age over 18 years with at least two physician visits more than 2 months apart for RA with an ICD-9-CM diagnosis code of 714), and a random sample of 500,000 people were included in the non-RA cohort (age over 18 years and no RA diagnosis code at follow-up).

Patients in the RA cohort were more likely to be female than in the non-RA cohort, and a greater portion of RA patients were aged 45-64 years than in the non-RA cohort (66% vs. 39%, respectively).

During the study period, “there were 1,993 cases of a first hospitalized infection in the RA cohort, while 11,977 cases were observed in the non-RA cohort,” wrote the authors.

This translated to 3,864 cases per 100,000 person-years in the RA cohort and 1,250 cases per 100,000 years in the non-RA cohort and—adjusted for age, sex, and calendar year—gave a hazard ratio of 2.31 for hospitalized infection (95% confidence interval, 2.20-2.43).

Adjusted again for comorbid conditions and for prescription medication use, the hazard ratio was still 2.03 (95% CI, 1.93-2.13).

The most common infection in both groups was pneumonia, followed by urinary tract infections and after that, skin infections (J. Rheumatol. 2008;35:387-93).

The study investigators then performed a nested case-control analysis using all 1,993 hospitalized infection cases in the RA cohort and 9,965 RA controls, to ascertain whether the use of RA drugs further increased the patients' risk of infection.

Adjusted for age, sex, other current RA medication use, and a number of other chronic conditions, as well as the number of hospitalizations between the cohort entry and the index date, the researchers found a slightly increased risk when patients were taking biological disease modifying antirheumatic drugs (DMARDs).

These drugs included infliximab, etanercept, adalimumab, and anakinra (rate ratio 1.21, 95% CI 1.02-1.43).

However, the greatest risk for infection was conferred by current use of oral corticosteroids, and that risk was dose related.

Use of the drugs at less than or equal to 5 mg/day (in prednisone equivalents) was associated with a 1.32 relative risk of infection; use of between 6 mg/day and 10 mg/day, with a 1.94 relative risk.

And use of greater than 10 mg/day had a relative risk for infection of 2.98 (95% CI, 2.41-3.69).

In conclusion, the researchers wrote that methotrexate and hydroxychloroquine were actually associated with decreased risk of hospitalized infection, “whereas for sulfasalazine, leflunomide, and other traditional DMARDs, there was no association.”

The authors wrote that their study was limited by the possibility of misclassification of patients into the RA cohort and also by their inability to assess disease severity and patients' history of prior events.

The study received support from Bristol Myers Squibb Co.

Patients with rheumatoid arthritis are at an increased risk of contracting infections that are severe enough to require hospitalization, compared with people without rheumatoid arthritis, and the use of oral corticosteroids exacerbates that risk, according to results from a recent study.

The results further emphasize the notion that patients should be adequately informed about the heightened risk of infection with glucocorticoids.

“Patients should be routinely vaccinated against influenza, [and also] receive a pneumococcal vaccine,” Dr. Mark Hochberg, coinvestigator and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore, said in an interview.

The researchers conducted a retrospective cohort study based on records from 61 health plans across the United States from Jan. 1, 1999, through July 31, 2006.

A total of 24,530 patients were included in the RA cohort (inclusion criteria for this group were age over 18 years with at least two physician visits more than 2 months apart for RA with an ICD-9-CM diagnosis code of 714), and a random sample of 500,000 people were included in the non-RA cohort (age over 18 years and no RA diagnosis code at follow-up).

Patients in the RA cohort were more likely to be female than in the non-RA cohort, and a greater portion of RA patients were aged 45-64 years than in the non-RA cohort (66% vs. 39%, respectively).

During the study period, “there were 1,993 cases of a first hospitalized infection in the RA cohort, while 11,977 cases were observed in the non-RA cohort,” wrote the authors.

This translated to 3,864 cases per 100,000 person-years in the RA cohort and 1,250 cases per 100,000 years in the non-RA cohort and—adjusted for age, sex, and calendar year—gave a hazard ratio of 2.31 for hospitalized infection (95% confidence interval, 2.20-2.43).

Adjusted again for comorbid conditions and for prescription medication use, the hazard ratio was still 2.03 (95% CI, 1.93-2.13).

The most common infection in both groups was pneumonia, followed by urinary tract infections and after that, skin infections (J. Rheumatol. 2008;35:387-93).

The study investigators then performed a nested case-control analysis using all 1,993 hospitalized infection cases in the RA cohort and 9,965 RA controls, to ascertain whether the use of RA drugs further increased the patients' risk of infection.

Adjusted for age, sex, other current RA medication use, and a number of other chronic conditions, as well as the number of hospitalizations between the cohort entry and the index date, the researchers found a slightly increased risk when patients were taking biological disease modifying antirheumatic drugs (DMARDs).

These drugs included infliximab, etanercept, adalimumab, and anakinra (rate ratio 1.21, 95% CI 1.02-1.43).

However, the greatest risk for infection was conferred by current use of oral corticosteroids, and that risk was dose related.

Use of the drugs at less than or equal to 5 mg/day (in prednisone equivalents) was associated with a 1.32 relative risk of infection; use of between 6 mg/day and 10 mg/day, with a 1.94 relative risk.

And use of greater than 10 mg/day had a relative risk for infection of 2.98 (95% CI, 2.41-3.69).

In conclusion, the researchers wrote that methotrexate and hydroxychloroquine were actually associated with decreased risk of hospitalized infection, “whereas for sulfasalazine, leflunomide, and other traditional DMARDs, there was no association.”

The authors wrote that their study was limited by the possibility of misclassification of patients into the RA cohort and also by their inability to assess disease severity and patients' history of prior events.

The study received support from Bristol Myers Squibb Co.

Patients with rheumatoid arthritis are at an increased risk of contracting infections that are severe enough to require hospitalization, compared with people without rheumatoid arthritis, and the use of oral corticosteroids exacerbates that risk, according to results from a recent study.

The results further emphasize the notion that patients should be adequately informed about the heightened risk of infection with glucocorticoids.

“Patients should be routinely vaccinated against influenza, [and also] receive a pneumococcal vaccine,” Dr. Mark Hochberg, coinvestigator and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore, said in an interview.

The researchers conducted a retrospective cohort study based on records from 61 health plans across the United States from Jan. 1, 1999, through July 31, 2006.

A total of 24,530 patients were included in the RA cohort (inclusion criteria for this group were age over 18 years with at least two physician visits more than 2 months apart for RA with an ICD-9-CM diagnosis code of 714), and a random sample of 500,000 people were included in the non-RA cohort (age over 18 years and no RA diagnosis code at follow-up).

Patients in the RA cohort were more likely to be female than in the non-RA cohort, and a greater portion of RA patients were aged 45-64 years than in the non-RA cohort (66% vs. 39%, respectively).

During the study period, “there were 1,993 cases of a first hospitalized infection in the RA cohort, while 11,977 cases were observed in the non-RA cohort,” wrote the authors.

This translated to 3,864 cases per 100,000 person-years in the RA cohort and 1,250 cases per 100,000 years in the non-RA cohort and—adjusted for age, sex, and calendar year—gave a hazard ratio of 2.31 for hospitalized infection (95% confidence interval, 2.20-2.43).

Adjusted again for comorbid conditions and for prescription medication use, the hazard ratio was still 2.03 (95% CI, 1.93-2.13).

The most common infection in both groups was pneumonia, followed by urinary tract infections and after that, skin infections (J. Rheumatol. 2008;35:387-93).

The study investigators then performed a nested case-control analysis using all 1,993 hospitalized infection cases in the RA cohort and 9,965 RA controls, to ascertain whether the use of RA drugs further increased the patients' risk of infection.

Adjusted for age, sex, other current RA medication use, and a number of other chronic conditions, as well as the number of hospitalizations between the cohort entry and the index date, the researchers found a slightly increased risk when patients were taking biological disease modifying antirheumatic drugs (DMARDs).

These drugs included infliximab, etanercept, adalimumab, and anakinra (rate ratio 1.21, 95% CI 1.02-1.43).

However, the greatest risk for infection was conferred by current use of oral corticosteroids, and that risk was dose related.

Use of the drugs at less than or equal to 5 mg/day (in prednisone equivalents) was associated with a 1.32 relative risk of infection; use of between 6 mg/day and 10 mg/day, with a 1.94 relative risk.

And use of greater than 10 mg/day had a relative risk for infection of 2.98 (95% CI, 2.41-3.69).

In conclusion, the researchers wrote that methotrexate and hydroxychloroquine were actually associated with decreased risk of hospitalized infection, “whereas for sulfasalazine, leflunomide, and other traditional DMARDs, there was no association.”

The authors wrote that their study was limited by the possibility of misclassification of patients into the RA cohort and also by their inability to assess disease severity and patients' history of prior events.

The study received support from Bristol Myers Squibb Co.

In light of the recent Food and Drug Administration warnings against using over-the-counter cold medicines in children under 2 years of age, parents and physicians alike are wondering what nondrug treatments have proven safe and effective in treating and preventing the common cold.

“Most people know that there are warnings against giving young children medications,” Dr. Margot Weinberg, who practices pediatric integrative medicine in Pittsford, N.Y., said in an interview. “The cold medicines have not proven to be effective, and there's some concern that they might actually dry out the membranes.” However, try telling that to the parent of a sick, screaming child.

“We [as physicians] need to be armed with some advice to give the parents, because they get frustrated when we say, 'you can't use cold medicines,'” she added.

One remedy that might decrease the duration and severity of colds, but not necessarily the incidence, is the use of probiotics—live microorganisms that affect intestinal microflora, according to Dr. Weinberg. She cited a randomized, controlled, double-blind trial in which patients given probiotic supplementation had colds that lasted an average of 2 days less than colds of controls, and experienced less severe overall symptoms during their illness (Vaccine 2006:24;6670–4). Granted, the study was in adults, but Dr. Weinberg said that she believed the results were generalizable to children. She recommends probiotics to patients in the form of yogurt and other fermented foods, like sauerkraut and miso soup.

Dr. Kathi J. Kemper, chair of the American Academy of Pediatrics Provisional Section on Complementary, Holistic, and Integrative Medicine, also recommends probiotics to pediatric patients, occasionally in a supplement form, as with Culturelle (manufactured by Amerifit Brands Inc.). Probiotics “are generally safe and well tolerated by healthy toddlers and school-age children,” she said.

A second nondrug therapy for the common cold mentioned by Dr. Kemper was Andrographis paniculata, a bitter herb used in traditional Indian medicine.

Although the herb is relatively unknown in the United States, one systematic safety and efficacy review that included seven double-blind, controlled trials and nearly 900 patients concluded that the herb is “superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect” (Planta Med. 2004;70:293–8). Dr. Kemper cited the Swedish Herbal Institute's “Kan Jang” A. paniculata supplement as the one with which she was most familiar.

A better known, fairly controversial remedy typically used in holistic care of common colds is Echinacea. Dr. Kemper, also of Wake Forest University, Winston-Salem, N.C., conceded that there is “substantial variability” in the composition of products purporting to contain effective amounts of the agent. However, she cited one secondary analysis of data from a randomized, double blind, placebo-controlled trial of 524 children aged 2–11 years, in which researchers found that patients taking echinacea experienced a 28% decreased risk of subsequent infection after an initial infection, compared with patients taking placebo (J. Altern. Complement. Med. 2005;11:1021–6).

Vitamin C and zinc are two at-home remedies that are already familiar to most parents and physicians. In a Cochrane database systematic review (PLoS Med. 2005;2(6):e168[doi:10.1371/journal.pmed.0020168

Regarding the use of zinc, one study looked at 200 children randomized to either 15 mg oral zinc sulfate (n = 100) or placebo sulfate once daily for 7 months. The dosage was increased to twice daily at the onset of a cold, until symptoms resolved. Children in the zinc group had a significantly lower incidence of colds, a shorter mean duration of symptoms when they were sick, and less severe symptoms (Acta Paediatr. 2006;95:1175–81).

For parents not willing to give their children vitamin C and zinc supplements, which Dr. Kemper said can cause upset stomach in some patients, Dr. Weinberg often instructs about which foods are rich in those elements (see box).

According to Dr. Kemper, one of the most important steps a physician practicing holistic cold management can take is simply to ask the patient or parent what preferred home remedies they've already tried. She said to support culturally appropriate practices that you know are definitely safe, even when the evidence supporting them is sparse or nondefinitive. Ask parents to report to you on their experience with the remedy, she said, and then, try them on yourself. “Having your own experience will help you feel more comfortable advising patients.”

The FDA plans to issue a second recommendation this spring on the safety of cold medicines in patients aged 2–11, according to an agency advisory (www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

Both Dr. Weinberg and Dr. Kemper had no conflicts of interest to disclose in relation to this article.

Foods Rich in Vitamin C, Zinc

Vitamin C:

berries

broccoli

cantaloupe

carrots

green beans

honeydew melon

orange

papaya

peaches, dried

peas

romaine lettuce

spinach

strawberries

sweet potato

tomatoes

Zinc:

baked potato

brown rice

lentils

oatmeal

peas

salmon

spinach

whole wheat bread

yogurt

Source: Dr. Weinberg

In light of the recent Food and Drug Administration warnings against using over-the-counter cold medicines in children under 2 years of age, parents and physicians alike are wondering what nondrug treatments have proven safe and effective in treating and preventing the common cold.

“Most people know that there are warnings against giving young children medications,” Dr. Margot Weinberg, who practices pediatric integrative medicine in Pittsford, N.Y., said in an interview. “The cold medicines have not proven to be effective, and there's some concern that they might actually dry out the membranes.” However, try telling that to the parent of a sick, screaming child.

“We [as physicians] need to be armed with some advice to give the parents, because they get frustrated when we say, 'you can't use cold medicines,'” she added.

One remedy that might decrease the duration and severity of colds, but not necessarily the incidence, is the use of probiotics—live microorganisms that affect intestinal microflora, according to Dr. Weinberg. She cited a randomized, controlled, double-blind trial in which patients given probiotic supplementation had colds that lasted an average of 2 days less than colds of controls, and experienced less severe overall symptoms during their illness (Vaccine 2006:24;6670–4). Granted, the study was in adults, but Dr. Weinberg said that she believed the results were generalizable to children. She recommends probiotics to patients in the form of yogurt and other fermented foods, like sauerkraut and miso soup.

Dr. Kathi J. Kemper, chair of the American Academy of Pediatrics Provisional Section on Complementary, Holistic, and Integrative Medicine, also recommends probiotics to pediatric patients, occasionally in a supplement form, as with Culturelle (manufactured by Amerifit Brands Inc.). Probiotics “are generally safe and well tolerated by healthy toddlers and school-age children,” she said.

A second nondrug therapy for the common cold mentioned by Dr. Kemper was Andrographis paniculata, a bitter herb used in traditional Indian medicine.

Although the herb is relatively unknown in the United States, one systematic safety and efficacy review that included seven double-blind, controlled trials and nearly 900 patients concluded that the herb is “superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect” (Planta Med. 2004;70:293–8). Dr. Kemper cited the Swedish Herbal Institute's “Kan Jang” A. paniculata supplement as the one with which she was most familiar.

A better known, fairly controversial remedy typically used in holistic care of common colds is Echinacea. Dr. Kemper, also of Wake Forest University, Winston-Salem, N.C., conceded that there is “substantial variability” in the composition of products purporting to contain effective amounts of the agent. However, she cited one secondary analysis of data from a randomized, double blind, placebo-controlled trial of 524 children aged 2–11 years, in which researchers found that patients taking echinacea experienced a 28% decreased risk of subsequent infection after an initial infection, compared with patients taking placebo (J. Altern. Complement. Med. 2005;11:1021–6).

Vitamin C and zinc are two at-home remedies that are already familiar to most parents and physicians. In a Cochrane database systematic review (PLoS Med. 2005;2(6):e168[doi:10.1371/journal.pmed.0020168

Regarding the use of zinc, one study looked at 200 children randomized to either 15 mg oral zinc sulfate (n = 100) or placebo sulfate once daily for 7 months. The dosage was increased to twice daily at the onset of a cold, until symptoms resolved. Children in the zinc group had a significantly lower incidence of colds, a shorter mean duration of symptoms when they were sick, and less severe symptoms (Acta Paediatr. 2006;95:1175–81).

For parents not willing to give their children vitamin C and zinc supplements, which Dr. Kemper said can cause upset stomach in some patients, Dr. Weinberg often instructs about which foods are rich in those elements (see box).

According to Dr. Kemper, one of the most important steps a physician practicing holistic cold management can take is simply to ask the patient or parent what preferred home remedies they've already tried. She said to support culturally appropriate practices that you know are definitely safe, even when the evidence supporting them is sparse or nondefinitive. Ask parents to report to you on their experience with the remedy, she said, and then, try them on yourself. “Having your own experience will help you feel more comfortable advising patients.”

The FDA plans to issue a second recommendation this spring on the safety of cold medicines in patients aged 2–11, according to an agency advisory (www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

Both Dr. Weinberg and Dr. Kemper had no conflicts of interest to disclose in relation to this article.

Foods Rich in Vitamin C, Zinc

Vitamin C:

berries

broccoli

cantaloupe

carrots

green beans

honeydew melon

orange

papaya

peaches, dried

peas

romaine lettuce

spinach

strawberries

sweet potato

tomatoes

Zinc:

baked potato

brown rice

lentils

oatmeal

peas

salmon

spinach

whole wheat bread

yogurt

Source: Dr. Weinberg

In light of the recent Food and Drug Administration warnings against using over-the-counter cold medicines in children under 2 years of age, parents and physicians alike are wondering what nondrug treatments have proven safe and effective in treating and preventing the common cold.

“Most people know that there are warnings against giving young children medications,” Dr. Margot Weinberg, who practices pediatric integrative medicine in Pittsford, N.Y., said in an interview. “The cold medicines have not proven to be effective, and there's some concern that they might actually dry out the membranes.” However, try telling that to the parent of a sick, screaming child.

“We [as physicians] need to be armed with some advice to give the parents, because they get frustrated when we say, 'you can't use cold medicines,'” she added.

One remedy that might decrease the duration and severity of colds, but not necessarily the incidence, is the use of probiotics—live microorganisms that affect intestinal microflora, according to Dr. Weinberg. She cited a randomized, controlled, double-blind trial in which patients given probiotic supplementation had colds that lasted an average of 2 days less than colds of controls, and experienced less severe overall symptoms during their illness (Vaccine 2006:24;6670–4). Granted, the study was in adults, but Dr. Weinberg said that she believed the results were generalizable to children. She recommends probiotics to patients in the form of yogurt and other fermented foods, like sauerkraut and miso soup.

Dr. Kathi J. Kemper, chair of the American Academy of Pediatrics Provisional Section on Complementary, Holistic, and Integrative Medicine, also recommends probiotics to pediatric patients, occasionally in a supplement form, as with Culturelle (manufactured by Amerifit Brands Inc.). Probiotics “are generally safe and well tolerated by healthy toddlers and school-age children,” she said.

A second nondrug therapy for the common cold mentioned by Dr. Kemper was Andrographis paniculata, a bitter herb used in traditional Indian medicine.

Although the herb is relatively unknown in the United States, one systematic safety and efficacy review that included seven double-blind, controlled trials and nearly 900 patients concluded that the herb is “superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect” (Planta Med. 2004;70:293–8). Dr. Kemper cited the Swedish Herbal Institute's “Kan Jang” A. paniculata supplement as the one with which she was most familiar.

A better known, fairly controversial remedy typically used in holistic care of common colds is Echinacea. Dr. Kemper, also of Wake Forest University, Winston-Salem, N.C., conceded that there is “substantial variability” in the composition of products purporting to contain effective amounts of the agent. However, she cited one secondary analysis of data from a randomized, double blind, placebo-controlled trial of 524 children aged 2–11 years, in which researchers found that patients taking echinacea experienced a 28% decreased risk of subsequent infection after an initial infection, compared with patients taking placebo (J. Altern. Complement. Med. 2005;11:1021–6).

Vitamin C and zinc are two at-home remedies that are already familiar to most parents and physicians. In a Cochrane database systematic review (PLoS Med. 2005;2(6):e168[doi:10.1371/journal.pmed.0020168

Regarding the use of zinc, one study looked at 200 children randomized to either 15 mg oral zinc sulfate (n = 100) or placebo sulfate once daily for 7 months. The dosage was increased to twice daily at the onset of a cold, until symptoms resolved. Children in the zinc group had a significantly lower incidence of colds, a shorter mean duration of symptoms when they were sick, and less severe symptoms (Acta Paediatr. 2006;95:1175–81).

For parents not willing to give their children vitamin C and zinc supplements, which Dr. Kemper said can cause upset stomach in some patients, Dr. Weinberg often instructs about which foods are rich in those elements (see box).

According to Dr. Kemper, one of the most important steps a physician practicing holistic cold management can take is simply to ask the patient or parent what preferred home remedies they've already tried. She said to support culturally appropriate practices that you know are definitely safe, even when the evidence supporting them is sparse or nondefinitive. Ask parents to report to you on their experience with the remedy, she said, and then, try them on yourself. “Having your own experience will help you feel more comfortable advising patients.”

The FDA plans to issue a second recommendation this spring on the safety of cold medicines in patients aged 2–11, according to an agency advisory (www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

Both Dr. Weinberg and Dr. Kemper had no conflicts of interest to disclose in relation to this article.

Foods Rich in Vitamin C, Zinc

Vitamin C:

berries

broccoli

cantaloupe

carrots

green beans

honeydew melon

orange

papaya

peaches, dried

peas

romaine lettuce

spinach

strawberries

sweet potato

tomatoes

Zinc:

baked potato

brown rice

lentils

oatmeal

peas

salmon

spinach

whole wheat bread

yogurt

Source: Dr. Weinberg

Hospitals participating in year 3 of the Premier Hospital Quality Incentive Demonstration program raised quality scores across all measured areas by an average of 15.8%, with the greatest improvements in treatment of pneumonia and heart failure patients, according to the Centers for Medicare and Medicaid Services.

The Hospital Quality Incentive Demonstration (HQID), which began in 2003, measures what percentage of patients at 250 participating hospitals are getting appropriate care in five areas: heart attack, heart failure, pneumonia, coronary artery bypass graft, and hip and knee replacements. CMS awards bonuses based on the performance and improvement measures.

Data used for the program were collected by Premier, a network of not-for-profit hospitals. According to CMS and Premier, since the program's inception, gains have been made in percentage of patients receiving adequate care in all five of the measured areas. CMS reported that a total of 96% of heart attack patients at participating hospitals received adequate care in 2006, compared with 87% at baseline, according to the Premier measure. Similarly, 97% of coronary artery bypass graft patients, up from 85% 3 years ago, got adequate care.

The data from year 3 of the program also showed that 89% of heart failure patients, compared with 64% in 2003, received appropriate treatment, and among pneumonia patients, 90%, versus 69% 3 years ago, received quality care. A total of 97% of hip and knee replacement patients, compared with 85% in 2003, received proper care according to the measures.

Premier reported that hospitals in the top 10% in each area receive a bonus payment of 2% of the Diagnosis Related Group-based prospective payment for the patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the next highest 10% receive a 1% payment. Facilities in the top 50% of each area receive recognition on the CMS Web site (the complete list is at www.cms.hhs.gov/HospitalQualityInits/35_HospitalPremier.asp

Dr. Franklin Michota, of the department of hospital medicine at the Cleveland Clinic, said the HQID program is a useful tool to motivate even individual physicians. “That 1%-2% Medicare reimbursement update could be huge for the hospital's bottom line, which could affect lots of things in [the physician's] world. It could affect ancillary support, or your office space.”

But the program is not without problems. For example, Dr. Michota said, data on when to give antibiotics in pneumonia patients— part of the quality measures for treatment of pneumonia patients—is being challenged in the current literature. “It's not clear that [administering timed antibiotics] is consistently and reliably linked to mortality, and the adverse effect might be treating too many people with antibiotics who don't have pneumonia.”

Dr. Michota added that other areas where hospitalists can expect to see process-based quality measures like these enacted in the future include treatment for deep vein thrombosis, the use of anticoagulants, and checking the immunization status of incoming patients.

Hospitals participating in year 3 of the Premier Hospital Quality Incentive Demonstration program raised quality scores across all measured areas by an average of 15.8%, with the greatest improvements in treatment of pneumonia and heart failure patients, according to the Centers for Medicare and Medicaid Services.

The Hospital Quality Incentive Demonstration (HQID), which began in 2003, measures what percentage of patients at 250 participating hospitals are getting appropriate care in five areas: heart attack, heart failure, pneumonia, coronary artery bypass graft, and hip and knee replacements. CMS awards bonuses based on the performance and improvement measures.

Data used for the program were collected by Premier, a network of not-for-profit hospitals. According to CMS and Premier, since the program's inception, gains have been made in percentage of patients receiving adequate care in all five of the measured areas. CMS reported that a total of 96% of heart attack patients at participating hospitals received adequate care in 2006, compared with 87% at baseline, according to the Premier measure. Similarly, 97% of coronary artery bypass graft patients, up from 85% 3 years ago, got adequate care.

The data from year 3 of the program also showed that 89% of heart failure patients, compared with 64% in 2003, received appropriate treatment, and among pneumonia patients, 90%, versus 69% 3 years ago, received quality care. A total of 97% of hip and knee replacement patients, compared with 85% in 2003, received proper care according to the measures.

Premier reported that hospitals in the top 10% in each area receive a bonus payment of 2% of the Diagnosis Related Group-based prospective payment for the patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the next highest 10% receive a 1% payment. Facilities in the top 50% of each area receive recognition on the CMS Web site (the complete list is at www.cms.hhs.gov/HospitalQualityInits/35_HospitalPremier.asp

Dr. Franklin Michota, of the department of hospital medicine at the Cleveland Clinic, said the HQID program is a useful tool to motivate even individual physicians. “That 1%-2% Medicare reimbursement update could be huge for the hospital's bottom line, which could affect lots of things in [the physician's] world. It could affect ancillary support, or your office space.”

But the program is not without problems. For example, Dr. Michota said, data on when to give antibiotics in pneumonia patients— part of the quality measures for treatment of pneumonia patients—is being challenged in the current literature. “It's not clear that [administering timed antibiotics] is consistently and reliably linked to mortality, and the adverse effect might be treating too many people with antibiotics who don't have pneumonia.”

Dr. Michota added that other areas where hospitalists can expect to see process-based quality measures like these enacted in the future include treatment for deep vein thrombosis, the use of anticoagulants, and checking the immunization status of incoming patients.

Hospitals participating in year 3 of the Premier Hospital Quality Incentive Demonstration program raised quality scores across all measured areas by an average of 15.8%, with the greatest improvements in treatment of pneumonia and heart failure patients, according to the Centers for Medicare and Medicaid Services.

The Hospital Quality Incentive Demonstration (HQID), which began in 2003, measures what percentage of patients at 250 participating hospitals are getting appropriate care in five areas: heart attack, heart failure, pneumonia, coronary artery bypass graft, and hip and knee replacements. CMS awards bonuses based on the performance and improvement measures.

Data used for the program were collected by Premier, a network of not-for-profit hospitals. According to CMS and Premier, since the program's inception, gains have been made in percentage of patients receiving adequate care in all five of the measured areas. CMS reported that a total of 96% of heart attack patients at participating hospitals received adequate care in 2006, compared with 87% at baseline, according to the Premier measure. Similarly, 97% of coronary artery bypass graft patients, up from 85% 3 years ago, got adequate care.

The data from year 3 of the program also showed that 89% of heart failure patients, compared with 64% in 2003, received appropriate treatment, and among pneumonia patients, 90%, versus 69% 3 years ago, received quality care. A total of 97% of hip and knee replacement patients, compared with 85% in 2003, received proper care according to the measures.

Premier reported that hospitals in the top 10% in each area receive a bonus payment of 2% of the Diagnosis Related Group-based prospective payment for the patients with the measured condition for all Medicare fee-for-service beneficiaries. Hospitals in the next highest 10% receive a 1% payment. Facilities in the top 50% of each area receive recognition on the CMS Web site (the complete list is at www.cms.hhs.gov/HospitalQualityInits/35_HospitalPremier.asp

Dr. Franklin Michota, of the department of hospital medicine at the Cleveland Clinic, said the HQID program is a useful tool to motivate even individual physicians. “That 1%-2% Medicare reimbursement update could be huge for the hospital's bottom line, which could affect lots of things in [the physician's] world. It could affect ancillary support, or your office space.”

But the program is not without problems. For example, Dr. Michota said, data on when to give antibiotics in pneumonia patients— part of the quality measures for treatment of pneumonia patients—is being challenged in the current literature. “It's not clear that [administering timed antibiotics] is consistently and reliably linked to mortality, and the adverse effect might be treating too many people with antibiotics who don't have pneumonia.”

Dr. Michota added that other areas where hospitalists can expect to see process-based quality measures like these enacted in the future include treatment for deep vein thrombosis, the use of anticoagulants, and checking the immunization status of incoming patients.

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs).

First called for by the Institute of Medicine in its 1999 report "To Err is Human," PSOs will be entities to which physicians and other health care providers can voluntarily report "patient safety events" with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health-care associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, "a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs."

The term is intentionally more flexible than the more commonly used "medical errors" to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions," said Dr. Carolyn M. Clancy, AHRQ director. "The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients."

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

Dr. Bruce Bagley, medical director for quality improvement at the American Academy of Family Physicians, said in an interview that back in 2005, the AAFP had convened a work group to determine whether the academy ought to become a PSO. The proposed rule on what it would take to be a PSO was expected within the year, he said. But as implementation of the law languished, those plans were abandoned.

Now, Dr. Bagley said, he expects that the AAFP will once again look into becoming a PSO for its members, but he thinks that big institutions such as large hospital systems or the Mayo Clinic will be the best candidates for PSOs. Nevertheless, he said, "This is something that's been long needed, to be able to have medical professionals and other clinicians be open about reporting errors that can be analyzed in a systematic way."

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. "Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs," he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, "Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule… will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention."

Also in a statement, the American College of Surgeons said that it was in the process of reviewing the proposed rule and it planned on submitting comments. "Along with these other health care system stakeholders, the college has been waiting with eager anticipation for the guidance and protections these regulations should offer," a representative said.

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs).

First called for by the Institute of Medicine in its 1999 report "To Err is Human," PSOs will be entities to which physicians and other health care providers can voluntarily report "patient safety events" with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health-care associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, "a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs."

The term is intentionally more flexible than the more commonly used "medical errors" to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions," said Dr. Carolyn M. Clancy, AHRQ director. "The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients."

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

Dr. Bruce Bagley, medical director for quality improvement at the American Academy of Family Physicians, said in an interview that back in 2005, the AAFP had convened a work group to determine whether the academy ought to become a PSO. The proposed rule on what it would take to be a PSO was expected within the year, he said. But as implementation of the law languished, those plans were abandoned.

Now, Dr. Bagley said, he expects that the AAFP will once again look into becoming a PSO for its members, but he thinks that big institutions such as large hospital systems or the Mayo Clinic will be the best candidates for PSOs. Nevertheless, he said, "This is something that's been long needed, to be able to have medical professionals and other clinicians be open about reporting errors that can be analyzed in a systematic way."

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. "Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs," he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, "Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule… will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention."

Also in a statement, the American College of Surgeons said that it was in the process of reviewing the proposed rule and it planned on submitting comments. "Along with these other health care system stakeholders, the college has been waiting with eager anticipation for the guidance and protections these regulations should offer," a representative said.

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs).

First called for by the Institute of Medicine in its 1999 report "To Err is Human," PSOs will be entities to which physicians and other health care providers can voluntarily report "patient safety events" with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health-care associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, "a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs."

The term is intentionally more flexible than the more commonly used "medical errors" to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

"We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions," said Dr. Carolyn M. Clancy, AHRQ director. "The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients."

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

Dr. Bruce Bagley, medical director for quality improvement at the American Academy of Family Physicians, said in an interview that back in 2005, the AAFP had convened a work group to determine whether the academy ought to become a PSO. The proposed rule on what it would take to be a PSO was expected within the year, he said. But as implementation of the law languished, those plans were abandoned.

Now, Dr. Bagley said, he expects that the AAFP will once again look into becoming a PSO for its members, but he thinks that big institutions such as large hospital systems or the Mayo Clinic will be the best candidates for PSOs. Nevertheless, he said, "This is something that's been long needed, to be able to have medical professionals and other clinicians be open about reporting errors that can be analyzed in a systematic way."

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. "Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs," he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, "Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule… will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention."

Also in a statement, the American College of Surgeons said that it was in the process of reviewing the proposed rule and it planned on submitting comments. "Along with these other health care system stakeholders, the college has been waiting with eager anticipation for the guidance and protections these regulations should offer," a representative said.

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs). Comments on the proposed rule are being accepted until April 14.

First called for by the Institute of Medicine in its 1999 report “To Err Is Human,” PSOs will be entities to which physicians and other health care providers can voluntarily report patient safety events with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health care-associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, “a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs.”

The term is intentionally more flexible than the more commonly used “medical errors” to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

Insurance companies, accreditation boards, and licensure agencies cannot be PSOs because of potential conflicts of interest.

“We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions,” said Dr. Carolyn M. Clancy, AHRQ director. “The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients.”

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. “Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs,” he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, “Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule … will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention.”

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs). Comments on the proposed rule are being accepted until April 14.

First called for by the Institute of Medicine in its 1999 report “To Err Is Human,” PSOs will be entities to which physicians and other health care providers can voluntarily report patient safety events with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health care-associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, “a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs.”

The term is intentionally more flexible than the more commonly used “medical errors” to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

Insurance companies, accreditation boards, and licensure agencies cannot be PSOs because of potential conflicts of interest.

“We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions,” said Dr. Carolyn M. Clancy, AHRQ director. “The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients.”

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. “Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs,” he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, “Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule … will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention.”

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001

Draft federal regulations more than 2 years in the making aim to give hospital networks, physician groups, and similar organizations the ability to help doctors reduce medical errors and improve the quality of care they provide to patients.

The 72-page proposed rule offers the government's first pass on how to implement the Patient Safety and Quality Improvement Act of 2005 and gives guidance on how to create confidential patient safety organizations (PSOs). Comments on the proposed rule are being accepted until April 14.

First called for by the Institute of Medicine in its 1999 report “To Err Is Human,” PSOs will be entities to which physicians and other health care providers can voluntarily report patient safety events with anonymity and without fear of tort liability. PSOs will collect, aggregate, and analyze data and provide feedback to help clinicians and health care organizations improve on those events in the future, according to the law and proposed rule.

In an interview, Dr. Bill Munier, director of the Center for Quality Improvement and Patient Safety at the Agency for Health Care Research and Quality, said that patient safety events can be anything from health care-associated infections and patient falls to adverse drug reactions and wrong-site surgery.

According to the proposed rule, “a patient safety event may include an error of omission or commission, mistake, or malfunction in a patient care process; it may also involve an input to such process (such as a drug or device) or the environment in which such process occurs.”

The term is intentionally more flexible than the more commonly used “medical errors” to account for not only traditional health care settings, but also for patients participating in clinical trials, and for ambulances, school clinics, and even locations where a provider is not present, such as a patient's home, according to the rule.

Until now, there has been no clear guidance on how an organization can become a PSO. But according to the proposed rule, public and private entities, both for-profit and not-for-profit, can seek listing as a PSO. This includes individual hospitals, hospital networks, professional associations, and almost any group related to providers with a solid network through which safety information can be aggregated and analyzed, said Dr. Munier.

Insurance companies, accreditation boards, and licensure agencies cannot be PSOs because of potential conflicts of interest.

“We know that clinicians and health care organizations want to participate in efforts to improve patient care, but they often are inhibited by fears of liability and sanctions,” said Dr. Carolyn M. Clancy, AHRQ director. “The proposed regulation provides a framework for [PSOs] to facilitate a shared-learning approach that supports effective interventions that reduce risk of harm to patients.”

Dr. Munier said that the rule took a long time to issue partly because its authors had to be sure it didn't conflict with state reporting requirements and the Health Insurance Portability and Accountability Act (HIPAA).

In a statement, Rich Umbdenstock, president and CEO of the American Hospital Association, said that his group was in strong support of the creation of PSOs. “Hospitals have already waited 2 years for this rule and this is only a first step in the process toward establishing PSOs. We will continue to work with HHS to ensure the timely creation of PSOs,” he said.

Dr. J. James Rohack, a board member of the American Medical Association, agreed. In a statement, he said, “Since the passage of patient safety legislation in 2005, the American Medical Association and other patient safety advocates have eagerly awaited guidance for implementation from the administration. The proposed rule … will allow health care professionals to report errors voluntarily without fear of legal prosecution and transform the current culture of blame and punishment into one of open communication and prevention.”

To view the proposed rule and learn how to comment, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=AHRQ-2008-0001