Denise Napoli

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases (cancer? AIDS?), researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” a researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right.

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. Now for the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired military general who just happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But an air force spokeswoman said the type of oxygen starvation mountaineers experience is different from that in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills in December, at Paris's Roissy airport. Said a pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper says students in an immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of lectures. Student Constance Chen, aged 18 years, told the newspaper: “As youngsters, we are into TV, and it's great fun to watch ['House'] rather than have regular lectures.” As future patients, we feel that no med student ought to be having “great fun” while learning how to perform a colonoscopy, for instance. Neither does a future doctor calling herself a “youngster” really make us want to hop up onto the examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” Tara Reid, he added, looked totally hot in “Dr. T. and the Women.”

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases (cancer? AIDS?), researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” a researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right.

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. Now for the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired military general who just happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But an air force spokeswoman said the type of oxygen starvation mountaineers experience is different from that in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills in December, at Paris's Roissy airport. Said a pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper says students in an immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of lectures. Student Constance Chen, aged 18 years, told the newspaper: “As youngsters, we are into TV, and it's great fun to watch ['House'] rather than have regular lectures.” As future patients, we feel that no med student ought to be having “great fun” while learning how to perform a colonoscopy, for instance. Neither does a future doctor calling herself a “youngster” really make us want to hop up onto the examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” Tara Reid, he added, looked totally hot in “Dr. T. and the Women.”

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases (cancer? AIDS?), researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” a researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right.

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. Now for the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired military general who just happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But an air force spokeswoman said the type of oxygen starvation mountaineers experience is different from that in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills in December, at Paris's Roissy airport. Said a pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper says students in an immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of lectures. Student Constance Chen, aged 18 years, told the newspaper: “As youngsters, we are into TV, and it's great fun to watch ['House'] rather than have regular lectures.” As future patients, we feel that no med student ought to be having “great fun” while learning how to perform a colonoscopy, for instance. Neither does a future doctor calling herself a “youngster” really make us want to hop up onto the examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” Tara Reid, he added, looked totally hot in “Dr. T. and the Women.”

European guidelines on diagnosing hand osteoarthritis aim to be more clinically useful in the practice setting than the 1990 classification criteria from the American College of Rheumatology, according to their authors.

“Until now, the main reference cited for the diagnosis [of hand osteoarthritis] has been the [American College of Rheumatology] criteria,” noted the authors of the guidelines issued by the European League Against Rheumatism (EULAR). The ACR criteria focus more on classifying disease rather than diagnosing it, they stated, adding that the updated guidelines provide evidence-based guidance from a multidisciplinary team of physicians representing 15 countries.

The strength of EULAR's recommendations is ranked 1–100 based on the quality of the supportive evidence. A strength of 100 is fully recommended and 0 is not at all recommended.

The first recommendation (strength: 69) spells out risk factors for hand OA, which include female sex, age over 40 years, family history of the disease, obesity, joint injury, and certain occupations. Although a reduction in estrogen at menopause may also be a risk factor for hand OA, this evidence is not supported by findings from hormone therapy (HT) studies. However, “as these studies were observational studies, they may be confounded by the increased bone density [a potential risk factor for hand OA] due to HT,” which would necessitate further studies on the link between estrogen and hand OA (Ann. Rheum. Dis. 2008 Feb. 4 [doi 10.1136/ard.2007.084772]).

“Pain on usage has limited value for the diagnosis of hand OA,” due to its extremely low sensitivity (strength: 85), wrote the investigators. “Limited duration of localized morning or inactivity stiffness is more specific to hand OA than inflammatory arthritis (stiffness persists 22 minutes on average for hand OA versus 58 minutes for rheumatoid arthritis affecting the hand).” Pain that is specific to the distal interphalangeal, proximal interphalangeal, and thumb base joints is also a hallmark of the disease.

Heberden's and Bouchard's nodes, which “have limited value as a single diagnostic marker” are nevertheless important, “especially when used in combination with other features of hand OA” (strength: 80).

The investigators also state that functional impairment resulting from hand OA may be as severe as is seen with rheumatoid arthritis (strength: 57).

As to associations between hand OA and other diseases, the authors wrote that “patients with hand OA have increased risk of both knee OA ([odds ratio] = 3.0, 95% [confidence interval] 1.2, 7.5) and hip OA (OR = 3.25, 95% CI 2.19, 4.84)” (strength: 77). However, “there is no clear justification to include assessment of other target joints for OA for the purpose of diagnosis and treatment planning of hand OA.”

The recommendations acknowledge that there may be specific subsets of hand OA, including interphalangeal joint (IPJ) OA (which can occur with or without nodes), thumb-base OA, and erosive OA, all of which carry unique risk factors, associations, and outcomes. “For example, hypermobility has been reported as a risk factor for thumb-base OA but a negative risk ('protective') factor for IPJ OA,” the researchers wrote (strength: 68). Furthermore, “erosive hand OA targets IPJs and shows radiographic subchondreal erosion, which may progress to marked bone and cartilage attrition.” In general, this type of OA has worse outcomes than nonerosive IPJ OA, they point out (strength: 87).

However, Dr. Altman expressed skepticism of this conclusion. “The question as to whether the erosive form of hand OA is indeed a separate subset or whether it is part of the spectrum of disease has been addressed but may not have been answered in this report,” said Dr. Altman, who is also professor of medicine of the University of California, Los Angeles.

A final recommendation states that since inflammatory markers like erythrocyte sedimentation rate, rheumatoid factor, and C-reactive protein are not typically elevated in patients with hand OA, blood tests are not required for a diagnosis. However, blood tests “may be required to exclude coexistent disease” (strength: 78).

European guidelines on diagnosing hand osteoarthritis aim to be more clinically useful in the practice setting than the 1990 classification criteria from the American College of Rheumatology, according to their authors.

“Until now, the main reference cited for the diagnosis [of hand osteoarthritis] has been the [American College of Rheumatology] criteria,” noted the authors of the guidelines issued by the European League Against Rheumatism (EULAR). The ACR criteria focus more on classifying disease rather than diagnosing it, they stated, adding that the updated guidelines provide evidence-based guidance from a multidisciplinary team of physicians representing 15 countries.

The strength of EULAR's recommendations is ranked 1–100 based on the quality of the supportive evidence. A strength of 100 is fully recommended and 0 is not at all recommended.

The first recommendation (strength: 69) spells out risk factors for hand OA, which include female sex, age over 40 years, family history of the disease, obesity, joint injury, and certain occupations. Although a reduction in estrogen at menopause may also be a risk factor for hand OA, this evidence is not supported by findings from hormone therapy (HT) studies. However, “as these studies were observational studies, they may be confounded by the increased bone density [a potential risk factor for hand OA] due to HT,” which would necessitate further studies on the link between estrogen and hand OA (Ann. Rheum. Dis. 2008 Feb. 4 [doi 10.1136/ard.2007.084772]).

“Pain on usage has limited value for the diagnosis of hand OA,” due to its extremely low sensitivity (strength: 85), wrote the investigators. “Limited duration of localized morning or inactivity stiffness is more specific to hand OA than inflammatory arthritis (stiffness persists 22 minutes on average for hand OA versus 58 minutes for rheumatoid arthritis affecting the hand).” Pain that is specific to the distal interphalangeal, proximal interphalangeal, and thumb base joints is also a hallmark of the disease.

Heberden's and Bouchard's nodes, which “have limited value as a single diagnostic marker” are nevertheless important, “especially when used in combination with other features of hand OA” (strength: 80).

The investigators also state that functional impairment resulting from hand OA may be as severe as is seen with rheumatoid arthritis (strength: 57).

As to associations between hand OA and other diseases, the authors wrote that “patients with hand OA have increased risk of both knee OA ([odds ratio] = 3.0, 95% [confidence interval] 1.2, 7.5) and hip OA (OR = 3.25, 95% CI 2.19, 4.84)” (strength: 77). However, “there is no clear justification to include assessment of other target joints for OA for the purpose of diagnosis and treatment planning of hand OA.”

The recommendations acknowledge that there may be specific subsets of hand OA, including interphalangeal joint (IPJ) OA (which can occur with or without nodes), thumb-base OA, and erosive OA, all of which carry unique risk factors, associations, and outcomes. “For example, hypermobility has been reported as a risk factor for thumb-base OA but a negative risk ('protective') factor for IPJ OA,” the researchers wrote (strength: 68). Furthermore, “erosive hand OA targets IPJs and shows radiographic subchondreal erosion, which may progress to marked bone and cartilage attrition.” In general, this type of OA has worse outcomes than nonerosive IPJ OA, they point out (strength: 87).

However, Dr. Altman expressed skepticism of this conclusion. “The question as to whether the erosive form of hand OA is indeed a separate subset or whether it is part of the spectrum of disease has been addressed but may not have been answered in this report,” said Dr. Altman, who is also professor of medicine of the University of California, Los Angeles.

A final recommendation states that since inflammatory markers like erythrocyte sedimentation rate, rheumatoid factor, and C-reactive protein are not typically elevated in patients with hand OA, blood tests are not required for a diagnosis. However, blood tests “may be required to exclude coexistent disease” (strength: 78).

European guidelines on diagnosing hand osteoarthritis aim to be more clinically useful in the practice setting than the 1990 classification criteria from the American College of Rheumatology, according to their authors.

“Until now, the main reference cited for the diagnosis [of hand osteoarthritis] has been the [American College of Rheumatology] criteria,” noted the authors of the guidelines issued by the European League Against Rheumatism (EULAR). The ACR criteria focus more on classifying disease rather than diagnosing it, they stated, adding that the updated guidelines provide evidence-based guidance from a multidisciplinary team of physicians representing 15 countries.

The strength of EULAR's recommendations is ranked 1–100 based on the quality of the supportive evidence. A strength of 100 is fully recommended and 0 is not at all recommended.

The first recommendation (strength: 69) spells out risk factors for hand OA, which include female sex, age over 40 years, family history of the disease, obesity, joint injury, and certain occupations. Although a reduction in estrogen at menopause may also be a risk factor for hand OA, this evidence is not supported by findings from hormone therapy (HT) studies. However, “as these studies were observational studies, they may be confounded by the increased bone density [a potential risk factor for hand OA] due to HT,” which would necessitate further studies on the link between estrogen and hand OA (Ann. Rheum. Dis. 2008 Feb. 4 [doi 10.1136/ard.2007.084772]).

“Pain on usage has limited value for the diagnosis of hand OA,” due to its extremely low sensitivity (strength: 85), wrote the investigators. “Limited duration of localized morning or inactivity stiffness is more specific to hand OA than inflammatory arthritis (stiffness persists 22 minutes on average for hand OA versus 58 minutes for rheumatoid arthritis affecting the hand).” Pain that is specific to the distal interphalangeal, proximal interphalangeal, and thumb base joints is also a hallmark of the disease.

Heberden's and Bouchard's nodes, which “have limited value as a single diagnostic marker” are nevertheless important, “especially when used in combination with other features of hand OA” (strength: 80).

The investigators also state that functional impairment resulting from hand OA may be as severe as is seen with rheumatoid arthritis (strength: 57).

As to associations between hand OA and other diseases, the authors wrote that “patients with hand OA have increased risk of both knee OA ([odds ratio] = 3.0, 95% [confidence interval] 1.2, 7.5) and hip OA (OR = 3.25, 95% CI 2.19, 4.84)” (strength: 77). However, “there is no clear justification to include assessment of other target joints for OA for the purpose of diagnosis and treatment planning of hand OA.”

The recommendations acknowledge that there may be specific subsets of hand OA, including interphalangeal joint (IPJ) OA (which can occur with or without nodes), thumb-base OA, and erosive OA, all of which carry unique risk factors, associations, and outcomes. “For example, hypermobility has been reported as a risk factor for thumb-base OA but a negative risk ('protective') factor for IPJ OA,” the researchers wrote (strength: 68). Furthermore, “erosive hand OA targets IPJs and shows radiographic subchondreal erosion, which may progress to marked bone and cartilage attrition.” In general, this type of OA has worse outcomes than nonerosive IPJ OA, they point out (strength: 87).

However, Dr. Altman expressed skepticism of this conclusion. “The question as to whether the erosive form of hand OA is indeed a separate subset or whether it is part of the spectrum of disease has been addressed but may not have been answered in this report,” said Dr. Altman, who is also professor of medicine of the University of California, Los Angeles.

A final recommendation states that since inflammatory markers like erythrocyte sedimentation rate, rheumatoid factor, and C-reactive protein are not typically elevated in patients with hand OA, blood tests are not required for a diagnosis. However, blood tests “may be required to exclude coexistent disease” (strength: 78).

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases, like cancer or AIDS, researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space in an effort to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles up into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which are used to sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” one of the researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one cool space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right …

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. But how about the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired (but not retired, if you know what we mean) military general who just so happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But a spokeswoman for the air force said the type of oxygen starvation experienced by mountaineers is different from that seen in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis pills in December, at Paris's Roissy airport. Said an amorous pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper reports that students in one immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of normal lectures. Commented student Constance Chen, 18 years old, to the newspaper: “As youngsters, we are all into TV, and it's great fun to watch the series ['House'] rather than have regular lectures.” As potential future patients, we'd like to say that no med student ought to be having “great fun” while learning how to properly perform a colonoscopy, for instance. Neither does a future doctor referring to herself as a “youngster” really make us want to hop up onto that examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” He added that Tara Reid looked totally hot in “Dr. T and the Women.”

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases, like cancer or AIDS, researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space in an effort to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles up into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which are used to sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” one of the researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one cool space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right …

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. But how about the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired (but not retired, if you know what we mean) military general who just so happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But a spokeswoman for the air force said the type of oxygen starvation experienced by mountaineers is different from that seen in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis pills in December, at Paris's Roissy airport. Said an amorous pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper reports that students in one immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of normal lectures. Commented student Constance Chen, 18 years old, to the newspaper: “As youngsters, we are all into TV, and it's great fun to watch the series ['House'] rather than have regular lectures.” As potential future patients, we'd like to say that no med student ought to be having “great fun” while learning how to properly perform a colonoscopy, for instance. Neither does a future doctor referring to herself as a “youngster” really make us want to hop up onto that examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” He added that Tara Reid looked totally hot in “Dr. T and the Women.”

Rocket Man—Er, Fish

Putting aside efforts to cure real diseases, like cancer or AIDS, researchers from the University of Stuttgart-Hohenheim's Department of Wasting Time and Money, in Germany, launched 60 baby cichlid fish into space in an effort to decode the causes of motion sickness, Reuters reports. The fish will take off from the Esrange Space Centre in Sweden, above the Arctic Circle, and journey 160 miles up into the atmosphere, where they will become weightless for 6 minutes. Cameras will record the fish's actions. After the fish land, the researchers will examine the subjects' otolith organs, which are used to sense gravity and acceleration. “Fish, when they get motion sick, begin tumbling around, swimming in circles, and miss their balance,” one of the researchers told the news outlet. Hey, that happens to us sometimes, too, though under slightly different circumstances. Said one cool space traveler: “All this science, I don't understand. It's just my job, 5 days a week. I'm a Rocket Man.” Um, right …

Top Gun, Chemically Enhanced

You've heard of airplane pilots hitting the bar before takeoff. But how about the newest trend: Israeli fighter pilots popping Cialis tablets, supposedly to improve breathing at high altitudes. The Israeli military's weekly magazine, Bamahaneh, recently presented an interview with a retired (but not retired, if you know what we mean) military general who just so happened to have a few pills on hand and conducted a single-subject study of the drug's effects on breathing on Mount Kilimanjaro. A secondhand report in Reuters quoted an unnamed air force officer saying the study's results justify further “testing” of the pills. But a spokeswoman for the air force said the type of oxygen starvation experienced by mountaineers is different from that seen in pilots, and there were no plans to issue the drug to members of the air force. In possibly related news, French customs officials intercepted a shipment of 224,000 fake Viagra and Cialis pills in December, at Paris's Roissy airport. Said an amorous pilot, who remained anonymous for fear of retribution: “Oui, oui! Eet is zee only way to fly. As they say: We have liftoff!”

Brain Surgery, Take One … Action!

In the most compelling story yet to refute the benefits of medical tourism, a Singapore newspaper reports that students in one immunology class at Nanyang Polytechnic medical school spend half a semester watching television shows like “House” and movies like “Outbreak” in lieu of normal lectures. Commented student Constance Chen, 18 years old, to the newspaper: “As youngsters, we are all into TV, and it's great fun to watch the series ['House'] rather than have regular lectures.” As potential future patients, we'd like to say that no med student ought to be having “great fun” while learning how to properly perform a colonoscopy, for instance. Neither does a future doctor referring to herself as a “youngster” really make us want to hop up onto that examining table. Professor Anand Krishnasamy, who has been supplementing his course with the shows for 2 years, said, “I have a collection of movies and programs related to the subject and show them to the students whenever the main themes are connected to what I am teaching in class.” He added that Tara Reid looked totally hot in “Dr. T and the Women.”

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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 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 Healthcare 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, Dr. Munier said.

Insurance companies, accreditation boards, and licensure agencies cannot function as 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. Clancy said.

Dr. Munier said 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).

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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 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 Healthcare 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, Dr. Munier said.

Insurance companies, accreditation boards, and licensure agencies cannot function as 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. Clancy said.

Dr. Munier said 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).

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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 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 Healthcare 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, Dr. Munier said.

Insurance companies, accreditation boards, and licensure agencies cannot function as 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. Clancy said.

Dr. Munier said 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).

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).

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, and see if we can prevent them in the future.”

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, which will enable us to … truly improve surgical patient safety in both the inpatient and outpatient settings,” said a representative of the college.

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).

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, and see if we can prevent them in the future.”

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, which will enable us to … truly improve surgical patient safety in both the inpatient and outpatient settings,” said a representative of the college.

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).

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, and see if we can prevent them in the future.”

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, which will enable us to … truly improve surgical patient safety in both the inpatient and outpatient settings,” said a representative of the college.

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

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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).

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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).

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.

Dr. Dan Solomon, chair of the American College of Rheumatology's Quality of Care committee, said that although the ACR does not have a specific position on this Act, the College is in support of any effort to increase patient safety. “PSOs may be a method for improving patient safety by improving the reporting of potential safety issues, but I think the devil is in the details with how this information flows from providers and patients to these organizations and then how it flows to the health care providers,” he said.

“I think it is too early to know [whether they will be effective].” 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).

With many female baby boomers reaching the age when Sjögren's syndrome presents, rheumatologists must sharpen their skills to diagnose and manage this second most common autoimmune disease in the United States, said several experts.

“It is not a benign disease, which is a perception that many physicians have,” said Dr. Frederick B. Vivino, director of the Sjögren's syndrome center at Penn Presbyterian Medical Center, Philadelphia. “It has significant morbidity, and even mortality, when people develop internal organ manifestations or complications like lymphomas.”

Dr. Arthur Weinstein, director of the section of rheumatology at the Washington Hospital Center, said that among internists and family physicians, Sjögren's syndrome (SS) is “grossly underrecognized.”

Whether or not physicians follow the diagnostic criteria for the disease is a matter of debate. “My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do rheumatoid arthritis,” said Dr. Vivino. “Most physicians, including rheumatologists, aren't really aware of the current diagnostic criteria for the disease, though they were published in 2002. Or if they are aware, they don't follow them.”

Dr. Weinstein is aware of the criteria (Ann. Rheum. Dis. 2002;61:554-8), but said he finds them better suited to classification than to diagnosis. Some criteria are major, he said, and indicative of disease, whereas others are minor. For instance, a biopsy plus ocular and oral symptoms, or autoantibodies (anti-SSA and/or anti-SSB) with the dryness symptoms, are often sufficient to make a diagnosis, he said.

Ultrasound of the salivary glands has recently been looked at as a diagnosis tool (RHEUMATOLOGY NEWS, February 2008, p. 18), but Dr. Vivino, chairman of the medical and scientific advisory board for the Sjögren's Syndrome Foundation, said, “We haven't used it, because it's not included in the current criteria.”

For now, misdiagnosis of SS is common. Dr. Weinstein said, “Many of the SS patients are misdiagnosed as having RA because they have rheumatoid factor, or lupus, or because of a positive [antinuclear antibody test]. … Early on, it could look like those, but ultimately [these patients] have different problems. So it takes an awareness to ask the right questions.”

Dr. Vivino said many women regard dryness, the primary symptom in SS, as a part of menopause, which is the approximate age of disease onset. On average, the mean time between symptom onset and diagnosis is 7 years, he added.

Mouth burning or oral ulcers from the dryness can make eating difficult, leading to weight loss. Many patients develop dental caries, yeast infections of the mouth, or bacterial infections of the salivary glands.

Ocular dryness can cause infections. “In some cases, the cornea can perforate,” said Dr. Vivino. Vaginal dryness also occurs.

More seriously, SS is tied to fatigue, muscle pain, joint pain, liver and kidney dysfunction, and non-Hodgkin's lymphoma.

The drug of choice for SS is hydroxychloroquine (Plaquenil), which came on the market in 1955. Dr. Weinstein said one new therapy that shows promise is B-cell-targeted rituximab. “There's this [fascinating] link between Sjögren's and the development of B-cell lymphomas,” he said; one study put the incidence of lymphoma in this cohort at more than 40 times higher than in the general population. In a study of 16 patients, rituximab was tied to remission in SS-associated lymphomas, but did little to lessen symptoms of dryness (Ann. Rheum. Dis. 2007;66:351-7).

Another investigational B-cell-targeted drug, epratuzumab, showed efficacy in a 16 patient-, open-label, phase I/II study. More than half of patients had a greater than 20% improvement in the Schirmer I test of tear production, unstimulated whole salivary flow, fatigue, erythrocyte sedimentation rate, and IgG levels (Arthritis Res. Ther. 2006;8:R129).

'My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do [RA].' DR. VIVINO

With many female baby boomers reaching the age when Sjögren's syndrome presents, rheumatologists must sharpen their skills to diagnose and manage this second most common autoimmune disease in the United States, said several experts.

“It is not a benign disease, which is a perception that many physicians have,” said Dr. Frederick B. Vivino, director of the Sjögren's syndrome center at Penn Presbyterian Medical Center, Philadelphia. “It has significant morbidity, and even mortality, when people develop internal organ manifestations or complications like lymphomas.”

Dr. Arthur Weinstein, director of the section of rheumatology at the Washington Hospital Center, said that among internists and family physicians, Sjögren's syndrome (SS) is “grossly underrecognized.”

Whether or not physicians follow the diagnostic criteria for the disease is a matter of debate. “My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do rheumatoid arthritis,” said Dr. Vivino. “Most physicians, including rheumatologists, aren't really aware of the current diagnostic criteria for the disease, though they were published in 2002. Or if they are aware, they don't follow them.”

Dr. Weinstein is aware of the criteria (Ann. Rheum. Dis. 2002;61:554-8), but said he finds them better suited to classification than to diagnosis. Some criteria are major, he said, and indicative of disease, whereas others are minor. For instance, a biopsy plus ocular and oral symptoms, or autoantibodies (anti-SSA and/or anti-SSB) with the dryness symptoms, are often sufficient to make a diagnosis, he said.

Ultrasound of the salivary glands has recently been looked at as a diagnosis tool (RHEUMATOLOGY NEWS, February 2008, p. 18), but Dr. Vivino, chairman of the medical and scientific advisory board for the Sjögren's Syndrome Foundation, said, “We haven't used it, because it's not included in the current criteria.”

For now, misdiagnosis of SS is common. Dr. Weinstein said, “Many of the SS patients are misdiagnosed as having RA because they have rheumatoid factor, or lupus, or because of a positive [antinuclear antibody test]. … Early on, it could look like those, but ultimately [these patients] have different problems. So it takes an awareness to ask the right questions.”

Dr. Vivino said many women regard dryness, the primary symptom in SS, as a part of menopause, which is the approximate age of disease onset. On average, the mean time between symptom onset and diagnosis is 7 years, he added.

Mouth burning or oral ulcers from the dryness can make eating difficult, leading to weight loss. Many patients develop dental caries, yeast infections of the mouth, or bacterial infections of the salivary glands.

Ocular dryness can cause infections. “In some cases, the cornea can perforate,” said Dr. Vivino. Vaginal dryness also occurs.

More seriously, SS is tied to fatigue, muscle pain, joint pain, liver and kidney dysfunction, and non-Hodgkin's lymphoma.

The drug of choice for SS is hydroxychloroquine (Plaquenil), which came on the market in 1955. Dr. Weinstein said one new therapy that shows promise is B-cell-targeted rituximab. “There's this [fascinating] link between Sjögren's and the development of B-cell lymphomas,” he said; one study put the incidence of lymphoma in this cohort at more than 40 times higher than in the general population. In a study of 16 patients, rituximab was tied to remission in SS-associated lymphomas, but did little to lessen symptoms of dryness (Ann. Rheum. Dis. 2007;66:351-7).

Another investigational B-cell-targeted drug, epratuzumab, showed efficacy in a 16 patient-, open-label, phase I/II study. More than half of patients had a greater than 20% improvement in the Schirmer I test of tear production, unstimulated whole salivary flow, fatigue, erythrocyte sedimentation rate, and IgG levels (Arthritis Res. Ther. 2006;8:R129).

'My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do [RA].' DR. VIVINO

With many female baby boomers reaching the age when Sjögren's syndrome presents, rheumatologists must sharpen their skills to diagnose and manage this second most common autoimmune disease in the United States, said several experts.

“It is not a benign disease, which is a perception that many physicians have,” said Dr. Frederick B. Vivino, director of the Sjögren's syndrome center at Penn Presbyterian Medical Center, Philadelphia. “It has significant morbidity, and even mortality, when people develop internal organ manifestations or complications like lymphomas.”

Dr. Arthur Weinstein, director of the section of rheumatology at the Washington Hospital Center, said that among internists and family physicians, Sjögren's syndrome (SS) is “grossly underrecognized.”

Whether or not physicians follow the diagnostic criteria for the disease is a matter of debate. “My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do rheumatoid arthritis,” said Dr. Vivino. “Most physicians, including rheumatologists, aren't really aware of the current diagnostic criteria for the disease, though they were published in 2002. Or if they are aware, they don't follow them.”

Dr. Weinstein is aware of the criteria (Ann. Rheum. Dis. 2002;61:554-8), but said he finds them better suited to classification than to diagnosis. Some criteria are major, he said, and indicative of disease, whereas others are minor. For instance, a biopsy plus ocular and oral symptoms, or autoantibodies (anti-SSA and/or anti-SSB) with the dryness symptoms, are often sufficient to make a diagnosis, he said.

Ultrasound of the salivary glands has recently been looked at as a diagnosis tool (RHEUMATOLOGY NEWS, February 2008, p. 18), but Dr. Vivino, chairman of the medical and scientific advisory board for the Sjögren's Syndrome Foundation, said, “We haven't used it, because it's not included in the current criteria.”

For now, misdiagnosis of SS is common. Dr. Weinstein said, “Many of the SS patients are misdiagnosed as having RA because they have rheumatoid factor, or lupus, or because of a positive [antinuclear antibody test]. … Early on, it could look like those, but ultimately [these patients] have different problems. So it takes an awareness to ask the right questions.”

Dr. Vivino said many women regard dryness, the primary symptom in SS, as a part of menopause, which is the approximate age of disease onset. On average, the mean time between symptom onset and diagnosis is 7 years, he added.

Mouth burning or oral ulcers from the dryness can make eating difficult, leading to weight loss. Many patients develop dental caries, yeast infections of the mouth, or bacterial infections of the salivary glands.

Ocular dryness can cause infections. “In some cases, the cornea can perforate,” said Dr. Vivino. Vaginal dryness also occurs.

More seriously, SS is tied to fatigue, muscle pain, joint pain, liver and kidney dysfunction, and non-Hodgkin's lymphoma.

The drug of choice for SS is hydroxychloroquine (Plaquenil), which came on the market in 1955. Dr. Weinstein said one new therapy that shows promise is B-cell-targeted rituximab. “There's this [fascinating] link between Sjögren's and the development of B-cell lymphomas,” he said; one study put the incidence of lymphoma in this cohort at more than 40 times higher than in the general population. In a study of 16 patients, rituximab was tied to remission in SS-associated lymphomas, but did little to lessen symptoms of dryness (Ann. Rheum. Dis. 2007;66:351-7).

Another investigational B-cell-targeted drug, epratuzumab, showed efficacy in a 16 patient-, open-label, phase I/II study. More than half of patients had a greater than 20% improvement in the Schirmer I test of tear production, unstimulated whole salivary flow, fatigue, erythrocyte sedimentation rate, and IgG levels (Arthritis Res. Ther. 2006;8:R129).

'My colleagues in rheumatology don't do as good a job diagnosing and treating Sjögren's as they do [RA].' DR. VIVINO

Nine new recommendations for the management of Behçet's disease have been issued by the European League Against Rheumatism, based on a literature review from 1966 through 2006.

Guidelines relating to the oral, dermatologic, ocular, and joint manifestations of Behçet's disease (BD) were mostly evidence based, but recommendations on BD-associated vascular, neurologic, and gastrointestinal problems were “mainly based on observational studies, retrospective analyses, and clinical experience of the experts” (Ann. Rheum. Dis. 2008 Jan. 31 [doi:10.1136/ard.2007.080432

Dr. Yusuf Yazici, who was not on the task force, said in an interview the lack of randomized clinical trials can be explained by the fact that “these are rare manifestations and hard to recruit for, and also vascular and neurologic involvement can be life threatening, and [it's] hard to do a RCT in that situation.” Dr. Yazici is the director of the Behçet's Syndrome Evaluation, Treatment and Research Center at the New York University Hospital for Joint Diseases. His father, Dr. Hasan Yazici, was one of the report's authors.

Dr. Yusuf Yazici added there are “no good numbers” to describe the prevalence of the disease in the U.S. BD affects between 1 and 6 people per 100,000, but “these are old numbers; no recent numbers are available,” he said.

The nine recommendations are as follows:

▸ Treat posterior inflammatory eye disease with azathioprine and systemic corticosteroids. The authors cite a study (N. Engl. J. Med. 1990;322:281-5) where 2.5 mL/kg per day of azathioprine was efficacious in visual acuity and in halting disease progression.

▸ Severe eye involvement–greater than a 2-point drop in visual acuity on a 10/10 scale, or retinal disease–calls for a second immunosuppressive. “Cyclosporine A 2-5 mg/kg per day shows its effect rapidly and is, here, usually the treatment of choice,” wrote the authors. Infliximab and interferon-α are also candidates, though the latter is considered a second choice.

▸ For BD-associated acute deep vein thrombosis, corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. However, “there are no RCTs addressing this issue.” The same treatment is recommended for pulmonary and peripheral artery aneurysms.

▸ Pulmonary embolism is rare, so anticoagulants, antiplatelets, and fibrinolytic agents are not recommended. This is doubly true because of the chance of a coexisting pulmonary arterial aneurysm. Again, however, “controlled trials are needed.”

▸ Immunosuppressants should be the first-line treatment over surgery in case of gastrointestinal ulcers, though no controlled trials exist to support one treatment specifically. “One study reported that azathioprine decreased reoperation rates and suggested that it should be used as maintenance therapy in patients who require surgery (Dis. Colon Rectum 2000;43:692-700),” wrote the authors.

▸ In most patients, arthritis can be managed with colchicine.

▸ For parenchymal involvement, “3-7 pulses of intravenous methylprednisone 1 g/day is given during attacks, followed by maintenance oral corticosteroids which is tapered over 2-3 months.” However, the authors caution that central nervous system (CNS) involvement in BD is mostly based on anecdotal reports.

▸ Neurotoxic cyclosporine A should not be used in BD patients with CNS involvement unless intraocular inflammation makes it an unavoidable choice.

▸ Regarding skin involvement, perceived severity should determine treatment. Topical steroids should be first-line treatment in genital and oral ulcers, while acnelike lesions can usually be treated with standard acne vulgaris treatments. In the literature, azathioprine was effective against resistant skin and mucosa lesions.

“With proper management, remission is frequent in eye disease, skin-mucosa disease, and arthritis,” said Dr. Yazici. He added that though CNS disease and thrombotic manifestations pose difficulties, “the disease usually gets better with time. The aim of treatment is to prevent any long-term damage while it is active, since in the long term most patients are doing better and require less medication.”

Nine new recommendations for the management of Behçet's disease have been issued by the European League Against Rheumatism, based on a literature review from 1966 through 2006.

Guidelines relating to the oral, dermatologic, ocular, and joint manifestations of Behçet's disease (BD) were mostly evidence based, but recommendations on BD-associated vascular, neurologic, and gastrointestinal problems were “mainly based on observational studies, retrospective analyses, and clinical experience of the experts” (Ann. Rheum. Dis. 2008 Jan. 31 [doi:10.1136/ard.2007.080432

Dr. Yusuf Yazici, who was not on the task force, said in an interview the lack of randomized clinical trials can be explained by the fact that “these are rare manifestations and hard to recruit for, and also vascular and neurologic involvement can be life threatening, and [it's] hard to do a RCT in that situation.” Dr. Yazici is the director of the Behçet's Syndrome Evaluation, Treatment and Research Center at the New York University Hospital for Joint Diseases. His father, Dr. Hasan Yazici, was one of the report's authors.

Dr. Yusuf Yazici added there are “no good numbers” to describe the prevalence of the disease in the U.S. BD affects between 1 and 6 people per 100,000, but “these are old numbers; no recent numbers are available,” he said.

The nine recommendations are as follows:

▸ Treat posterior inflammatory eye disease with azathioprine and systemic corticosteroids. The authors cite a study (N. Engl. J. Med. 1990;322:281-5) where 2.5 mL/kg per day of azathioprine was efficacious in visual acuity and in halting disease progression.

▸ Severe eye involvement–greater than a 2-point drop in visual acuity on a 10/10 scale, or retinal disease–calls for a second immunosuppressive. “Cyclosporine A 2-5 mg/kg per day shows its effect rapidly and is, here, usually the treatment of choice,” wrote the authors. Infliximab and interferon-α are also candidates, though the latter is considered a second choice.

▸ For BD-associated acute deep vein thrombosis, corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. However, “there are no RCTs addressing this issue.” The same treatment is recommended for pulmonary and peripheral artery aneurysms.

▸ Pulmonary embolism is rare, so anticoagulants, antiplatelets, and fibrinolytic agents are not recommended. This is doubly true because of the chance of a coexisting pulmonary arterial aneurysm. Again, however, “controlled trials are needed.”

▸ Immunosuppressants should be the first-line treatment over surgery in case of gastrointestinal ulcers, though no controlled trials exist to support one treatment specifically. “One study reported that azathioprine decreased reoperation rates and suggested that it should be used as maintenance therapy in patients who require surgery (Dis. Colon Rectum 2000;43:692-700),” wrote the authors.

▸ In most patients, arthritis can be managed with colchicine.

▸ For parenchymal involvement, “3-7 pulses of intravenous methylprednisone 1 g/day is given during attacks, followed by maintenance oral corticosteroids which is tapered over 2-3 months.” However, the authors caution that central nervous system (CNS) involvement in BD is mostly based on anecdotal reports.

▸ Neurotoxic cyclosporine A should not be used in BD patients with CNS involvement unless intraocular inflammation makes it an unavoidable choice.

▸ Regarding skin involvement, perceived severity should determine treatment. Topical steroids should be first-line treatment in genital and oral ulcers, while acnelike lesions can usually be treated with standard acne vulgaris treatments. In the literature, azathioprine was effective against resistant skin and mucosa lesions.

“With proper management, remission is frequent in eye disease, skin-mucosa disease, and arthritis,” said Dr. Yazici. He added that though CNS disease and thrombotic manifestations pose difficulties, “the disease usually gets better with time. The aim of treatment is to prevent any long-term damage while it is active, since in the long term most patients are doing better and require less medication.”

Nine new recommendations for the management of Behçet's disease have been issued by the European League Against Rheumatism, based on a literature review from 1966 through 2006.

Guidelines relating to the oral, dermatologic, ocular, and joint manifestations of Behçet's disease (BD) were mostly evidence based, but recommendations on BD-associated vascular, neurologic, and gastrointestinal problems were “mainly based on observational studies, retrospective analyses, and clinical experience of the experts” (Ann. Rheum. Dis. 2008 Jan. 31 [doi:10.1136/ard.2007.080432

Dr. Yusuf Yazici, who was not on the task force, said in an interview the lack of randomized clinical trials can be explained by the fact that “these are rare manifestations and hard to recruit for, and also vascular and neurologic involvement can be life threatening, and [it's] hard to do a RCT in that situation.” Dr. Yazici is the director of the Behçet's Syndrome Evaluation, Treatment and Research Center at the New York University Hospital for Joint Diseases. His father, Dr. Hasan Yazici, was one of the report's authors.

Dr. Yusuf Yazici added there are “no good numbers” to describe the prevalence of the disease in the U.S. BD affects between 1 and 6 people per 100,000, but “these are old numbers; no recent numbers are available,” he said.

The nine recommendations are as follows:

▸ Treat posterior inflammatory eye disease with azathioprine and systemic corticosteroids. The authors cite a study (N. Engl. J. Med. 1990;322:281-5) where 2.5 mL/kg per day of azathioprine was efficacious in visual acuity and in halting disease progression.

▸ Severe eye involvement–greater than a 2-point drop in visual acuity on a 10/10 scale, or retinal disease–calls for a second immunosuppressive. “Cyclosporine A 2-5 mg/kg per day shows its effect rapidly and is, here, usually the treatment of choice,” wrote the authors. Infliximab and interferon-α are also candidates, though the latter is considered a second choice.

▸ For BD-associated acute deep vein thrombosis, corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. However, “there are no RCTs addressing this issue.” The same treatment is recommended for pulmonary and peripheral artery aneurysms.

▸ Pulmonary embolism is rare, so anticoagulants, antiplatelets, and fibrinolytic agents are not recommended. This is doubly true because of the chance of a coexisting pulmonary arterial aneurysm. Again, however, “controlled trials are needed.”

▸ Immunosuppressants should be the first-line treatment over surgery in case of gastrointestinal ulcers, though no controlled trials exist to support one treatment specifically. “One study reported that azathioprine decreased reoperation rates and suggested that it should be used as maintenance therapy in patients who require surgery (Dis. Colon Rectum 2000;43:692-700),” wrote the authors.

▸ In most patients, arthritis can be managed with colchicine.

▸ For parenchymal involvement, “3-7 pulses of intravenous methylprednisone 1 g/day is given during attacks, followed by maintenance oral corticosteroids which is tapered over 2-3 months.” However, the authors caution that central nervous system (CNS) involvement in BD is mostly based on anecdotal reports.

▸ Neurotoxic cyclosporine A should not be used in BD patients with CNS involvement unless intraocular inflammation makes it an unavoidable choice.

▸ Regarding skin involvement, perceived severity should determine treatment. Topical steroids should be first-line treatment in genital and oral ulcers, while acnelike lesions can usually be treated with standard acne vulgaris treatments. In the literature, azathioprine was effective against resistant skin and mucosa lesions.

“With proper management, remission is frequent in eye disease, skin-mucosa disease, and arthritis,” said Dr. Yazici. He added that though CNS disease and thrombotic manifestations pose difficulties, “the disease usually gets better with time. The aim of treatment is to prevent any long-term damage while it is active, since in the long term most patients are doing better and require less medication.”

Beer, Food for Thought

As St. Patrick's Day approaches, the Bureau of Indications would like you to think on this: Beer is good for the brain. A recent study in Food and Chemical Toxicology looked at the effect of beer on lab rats' serum aluminum (Al) levels, given that aluminum has lately been implicated as a possible contributor to Alzheimer's disease, owing to its oxidative properties. The researchers hypothesized that the silicon content in beer, “by blocking uptake through the gastrointestinal tract and by impeding reabsorption in the kidneys,” could lessen the amount of Al in the rats' bodies. “During the experiment (3 months), the animals were trained in the Rotarod wheel in order to evaluate the possible cerebral damage, coordination, and fatigue resistance.” At the end of the study, the beer-fed rats had (yup, you guessed it) significantly lower serum Al, as well as decreased Al concentration in the brain tissue. The findings were so robust, “Moderate beer consumption could be included in the dietary habits of the population as a possible protective factor, an aspect that supports the recent inclusion of beer in the food guide pyramid,” concluded the authors. Wait a minute—beer in the food pyramid? How did we miss that?! And why was this study done on rats? Surely, there must be some human out there willing to drink beer for science? “This is the best gig we got,” commented a representative of the Lab Rodent's United union, “and we're prepared to fight for it.” Okay, okay—we're not really cut out for that Rotarod wheel, anyway.

News You Can Use

A recent study in the Journal of Hepatology looked at the effects of repeated whisky binges on the livers of rats fed either choline-deprived or regular “rat chow” diets—sometimes known as Taco Bell. Choline is a naturally occurring B-complex vitamin that helps prevent the accumulation of fat in the liver. Half of the rats were gavaged for 3 months with 1.5 mL/100 g body weight of Johnnie Walker Red Label whisky three times per week, explained the authors. (We would need to be gavaged with Red Label, too. On the other hand, give us a nice bourbon.) Upon hematoxylin and eosin tissue staining, rats fed the chow diet and given repeated alcohol binges showed minimal steatosis, while rats fed the [choline-deprived] diet and given repeated whisky binges showed periportal and pericentral microvesicular steatosis. In other words, a jolt of choline a day keeps the hepatologist away. To gear up for March 17 festivities, we recommend a diet high in the stuff, which includes, according to the U.S. Department of Agriculture, raw egg yolks, beef liver, and instant decaffeinated coffee—in other words, your standard Irish breakfast. Go ahead, make it an Irish coffee. Or three. You've earned it.

More Festive Than Green Beer

Obviously, the Bureau of Indications gets excited about St. Patrick's Day. But even we're not quite as exuberant as a trio of physicians from Ohio State University, Columbus, judging by their enthusiastically titled article in the Journal of the American Society of Echocardiography: “Not So Luck of the Irish: Four-Leaf Clover-Shaped Quadricusp Aortic Valve Found Around St. Patrick's Day.” According to the report, a 43-year-old man presented to his primary care physician with atypical chest pain and worsening dyspnea. A transthoracic echocardiogram was ordered. “Much to the surprise of the sonographer and the interpreting physician, the only abnormality discovered was a quadricusp aortic valve,” according to the investigators. Well, golly gee! The valve had four leaflets or cusps instead of the normal three-leaflet configuration and had associated mild to moderate aortic regurgitation, they added—which closely resembled, according to them, the outline of a four-leafed clover. The patient's physicians recommended that he return for a follow-up examination 1 year later. Would the patient consider surgery? “Never—they're always after me lucky charm!”

Beer, Food for Thought

As St. Patrick's Day approaches, the Bureau of Indications would like you to think on this: Beer is good for the brain. A recent study in Food and Chemical Toxicology looked at the effect of beer on lab rats' serum aluminum (Al) levels, given that aluminum has lately been implicated as a possible contributor to Alzheimer's disease, owing to its oxidative properties. The researchers hypothesized that the silicon content in beer, “by blocking uptake through the gastrointestinal tract and by impeding reabsorption in the kidneys,” could lessen the amount of Al in the rats' bodies. “During the experiment (3 months), the animals were trained in the Rotarod wheel in order to evaluate the possible cerebral damage, coordination, and fatigue resistance.” At the end of the study, the beer-fed rats had (yup, you guessed it) significantly lower serum Al, as well as decreased Al concentration in the brain tissue. The findings were so robust, “Moderate beer consumption could be included in the dietary habits of the population as a possible protective factor, an aspect that supports the recent inclusion of beer in the food guide pyramid,” concluded the authors. Wait a minute—beer in the food pyramid? How did we miss that?! And why was this study done on rats? Surely, there must be some human out there willing to drink beer for science? “This is the best gig we got,” commented a representative of the Lab Rodent's United union, “and we're prepared to fight for it.” Okay, okay—we're not really cut out for that Rotarod wheel, anyway.

News You Can Use

A recent study in the Journal of Hepatology looked at the effects of repeated whisky binges on the livers of rats fed either choline-deprived or regular “rat chow” diets—sometimes known as Taco Bell. Choline is a naturally occurring B-complex vitamin that helps prevent the accumulation of fat in the liver. Half of the rats were gavaged for 3 months with 1.5 mL/100 g body weight of Johnnie Walker Red Label whisky three times per week, explained the authors. (We would need to be gavaged with Red Label, too. On the other hand, give us a nice bourbon.) Upon hematoxylin and eosin tissue staining, rats fed the chow diet and given repeated alcohol binges showed minimal steatosis, while rats fed the [choline-deprived] diet and given repeated whisky binges showed periportal and pericentral microvesicular steatosis. In other words, a jolt of choline a day keeps the hepatologist away. To gear up for March 17 festivities, we recommend a diet high in the stuff, which includes, according to the U.S. Department of Agriculture, raw egg yolks, beef liver, and instant decaffeinated coffee—in other words, your standard Irish breakfast. Go ahead, make it an Irish coffee. Or three. You've earned it.

More Festive Than Green Beer

Obviously, the Bureau of Indications gets excited about St. Patrick's Day. But even we're not quite as exuberant as a trio of physicians from Ohio State University, Columbus, judging by their enthusiastically titled article in the Journal of the American Society of Echocardiography: “Not So Luck of the Irish: Four-Leaf Clover-Shaped Quadricusp Aortic Valve Found Around St. Patrick's Day.” According to the report, a 43-year-old man presented to his primary care physician with atypical chest pain and worsening dyspnea. A transthoracic echocardiogram was ordered. “Much to the surprise of the sonographer and the interpreting physician, the only abnormality discovered was a quadricusp aortic valve,” according to the investigators. Well, golly gee! The valve had four leaflets or cusps instead of the normal three-leaflet configuration and had associated mild to moderate aortic regurgitation, they added—which closely resembled, according to them, the outline of a four-leafed clover. The patient's physicians recommended that he return for a follow-up examination 1 year later. Would the patient consider surgery? “Never—they're always after me lucky charm!”

Beer, Food for Thought

As St. Patrick's Day approaches, the Bureau of Indications would like you to think on this: Beer is good for the brain. A recent study in Food and Chemical Toxicology looked at the effect of beer on lab rats' serum aluminum (Al) levels, given that aluminum has lately been implicated as a possible contributor to Alzheimer's disease, owing to its oxidative properties. The researchers hypothesized that the silicon content in beer, “by blocking uptake through the gastrointestinal tract and by impeding reabsorption in the kidneys,” could lessen the amount of Al in the rats' bodies. “During the experiment (3 months), the animals were trained in the Rotarod wheel in order to evaluate the possible cerebral damage, coordination, and fatigue resistance.” At the end of the study, the beer-fed rats had (yup, you guessed it) significantly lower serum Al, as well as decreased Al concentration in the brain tissue. The findings were so robust, “Moderate beer consumption could be included in the dietary habits of the population as a possible protective factor, an aspect that supports the recent inclusion of beer in the food guide pyramid,” concluded the authors. Wait a minute—beer in the food pyramid? How did we miss that?! And why was this study done on rats? Surely, there must be some human out there willing to drink beer for science? “This is the best gig we got,” commented a representative of the Lab Rodent's United union, “and we're prepared to fight for it.” Okay, okay—we're not really cut out for that Rotarod wheel, anyway.

News You Can Use

A recent study in the Journal of Hepatology looked at the effects of repeated whisky binges on the livers of rats fed either choline-deprived or regular “rat chow” diets—sometimes known as Taco Bell. Choline is a naturally occurring B-complex vitamin that helps prevent the accumulation of fat in the liver. Half of the rats were gavaged for 3 months with 1.5 mL/100 g body weight of Johnnie Walker Red Label whisky three times per week, explained the authors. (We would need to be gavaged with Red Label, too. On the other hand, give us a nice bourbon.) Upon hematoxylin and eosin tissue staining, rats fed the chow diet and given repeated alcohol binges showed minimal steatosis, while rats fed the [choline-deprived] diet and given repeated whisky binges showed periportal and pericentral microvesicular steatosis. In other words, a jolt of choline a day keeps the hepatologist away. To gear up for March 17 festivities, we recommend a diet high in the stuff, which includes, according to the U.S. Department of Agriculture, raw egg yolks, beef liver, and instant decaffeinated coffee—in other words, your standard Irish breakfast. Go ahead, make it an Irish coffee. Or three. You've earned it.

More Festive Than Green Beer

Obviously, the Bureau of Indications gets excited about St. Patrick's Day. But even we're not quite as exuberant as a trio of physicians from Ohio State University, Columbus, judging by their enthusiastically titled article in the Journal of the American Society of Echocardiography: “Not So Luck of the Irish: Four-Leaf Clover-Shaped Quadricusp Aortic Valve Found Around St. Patrick's Day.” According to the report, a 43-year-old man presented to his primary care physician with atypical chest pain and worsening dyspnea. A transthoracic echocardiogram was ordered. “Much to the surprise of the sonographer and the interpreting physician, the only abnormality discovered was a quadricusp aortic valve,” according to the investigators. Well, golly gee! The valve had four leaflets or cusps instead of the normal three-leaflet configuration and had associated mild to moderate aortic regurgitation, they added—which closely resembled, according to them, the outline of a four-leafed clover. The patient's physicians recommended that he return for a follow-up examination 1 year later. Would the patient consider surgery? “Never—they're always after me lucky charm!”

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, Dr. Munier said.

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 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 the AAFP to 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.

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.

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, Dr. Munier said.

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 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 the AAFP to 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.

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.

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, Dr. Munier said.

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 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 the AAFP to 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.

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.

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