Christine Kilgore

In response to new technologies and expected decreases in reimbursement for “traditional” procedures, gastroenterologists “will need to change what they do, where they practice, and how they practice,” according to a report issued by the American Gastroenterological Association Institute's Future Trends Committee.

Above all, computed tomographic colonography (CTC) “is likely to become an accepted colorectal cancer screening option within 3 years,” said the report, which was based on expert presentations at a conference convened last spring.

To maintain their practices, gastroenterologists will need to consider new services, which could include providing and interpreting CTC, obesity care, gastroenterological cancer treatment, and natural orifice transluminal endoscopic surgery.

Chronic or difficult-to-treat conditions, like hepatitis and motility and functional disorders, might also assume a bigger role in practice. Nurse-practitioners and physician assistants will likely play larger roles as gastroenterologists “embrace and act on the philosophy that the gastroenterologist is the leader and manager, and not necessarily the direct provider” of digestive disease care, according to the report (Gastroenterology 2006;131:1287–312).

Dr. Timothy C. Wang, who chaired the 10-member consensus development panel, said that CTC will likely be the first technology to take a share of colorectal cancer screening, but that members found it “difficult to predict what percentage of the screening market will shift to CTC.

“Further studies will likely show that CTC is comparable to optical colonoscopy in terms of sensitivity and specificity; however, other advances also may prove to detect polyps.” Also, gastroenterologists “should not completely cede colon imaging to radiologists,” said Dr. Wang, chief of the division of digestive and liver diseases at Columbia University, New York. Some gastroenterology groups have expressed interest in purchasing CT scanners, and the committee recommended that the American Gastroenterological Association (AGA) Institute develop training programs for CTC interpretation.

Gastroenterologists contacted for their perspectives on the report called the conclusions provocative but differed about whether the report is realistic or alarmist.

The report “is thorough and thought provoking … and anything that the AGA Institute can do to raise the level of thought and discussion is laudable,” said Dr. Ronald Vender, professor of medicine at Yale University, New Haven, Conn. “I think the impact [of CTC and other changes] will be much less than they're predicting,” he said, especially when considered from a cost-benefit perspective.

“Colonoscopy rates will probably go up rather than down,” commented Dr. James T. Frakes, professor of medicine at the University of Illinois, Rockford. “But even it that's not the case, gastroenterologists should always be looking for ways to improve and broaden their services,” he said.

“Colonoscopy has become the tail that's wagged the dog,” Dr. John L. Petrini of Sansum Clinic in Santa Barbara, Calif., said. “It's become a huge part of what we do, and I'm not sure it's going to stay that way. … But I don't think that CTC is going to be the one that's a keeper.”

Optical colonoscopy also is getting better, and lesions can be removed immediately in patients who are found to have adenomatous polyps during screening. Avoiding the need for a second procedure makes optical colonoscopy a cost-effective, attractive screening option, he said.

Many patients, said Dr. Douglas K. Rex, professor of medicine at Indiana University, Indianapolis, “will be disillusioned if they have a polyp and have to go on to have another test. … Americans like effectiveness. There will be other effective devices, but it's going to be hard for them to be as effective as colonoscopy.”

There also “hasn't been adequate discussion or education of the public regarding the potential risks of radiation” associated with screening CTC, he added.

Technologies ranging from wireless capsule endoscopy to simplified endoscopes will allow generalists and even nonphysician providers to perform colon surveillance. And over the long term, it will become possible to stratify cancer risk through serum-based proteomics, for example, and genetic or epigenetic markers, eliminating “unnecessary” colonoscopies, the committee said in its report.

One major challenge in CTC interpretation, however, is the presence of significant extracolonic findings in 4.5%–12% of procedures. Direct costs would rise rapidly if all CTCs must be reviewed by radiologists for extracolonic findings after a CTC-trained gastroenterologist has reviewed the colon, the report stated.

Gastroenterologists overall may modify their scope of practice by offering services that don't require extensive retraining. Obesity care may already be too competitive a niche for gastroenterologists to claim, according to those interviewed for this article, but they largely agreed with the committee's conclusion that obesity treatment is a “natural opportunity” for gastroenterologists, especially those who are willing to be part of a multidisciplinary team.

The demand for physicians to treat functional and motility disorders is likely to increase as the population ages. New tools on the horizon should expand and improve the evaluation and management of these disorders.

The same holds true for hepatitis C therapy. “We're only at the tip of the iceberg in taking care of patients with hepatitis C and chronic liver disease,” Dr. Frakes said.

As the committee points out in its report, however, limited reimbursement for such labor-intensive cognitive services means that midlevel providers increasingly will need to be utilized to make services effective and financially viable.

In response to new technologies and expected decreases in reimbursement for “traditional” procedures, gastroenterologists “will need to change what they do, where they practice, and how they practice,” according to a report issued by the American Gastroenterological Association Institute's Future Trends Committee.

Above all, computed tomographic colonography (CTC) “is likely to become an accepted colorectal cancer screening option within 3 years,” said the report, which was based on expert presentations at a conference convened last spring.

To maintain their practices, gastroenterologists will need to consider new services, which could include providing and interpreting CTC, obesity care, gastroenterological cancer treatment, and natural orifice transluminal endoscopic surgery.

Chronic or difficult-to-treat conditions, like hepatitis and motility and functional disorders, might also assume a bigger role in practice. Nurse-practitioners and physician assistants will likely play larger roles as gastroenterologists “embrace and act on the philosophy that the gastroenterologist is the leader and manager, and not necessarily the direct provider” of digestive disease care, according to the report (Gastroenterology 2006;131:1287–312).

Dr. Timothy C. Wang, who chaired the 10-member consensus development panel, said that CTC will likely be the first technology to take a share of colorectal cancer screening, but that members found it “difficult to predict what percentage of the screening market will shift to CTC.

“Further studies will likely show that CTC is comparable to optical colonoscopy in terms of sensitivity and specificity; however, other advances also may prove to detect polyps.” Also, gastroenterologists “should not completely cede colon imaging to radiologists,” said Dr. Wang, chief of the division of digestive and liver diseases at Columbia University, New York. Some gastroenterology groups have expressed interest in purchasing CT scanners, and the committee recommended that the American Gastroenterological Association (AGA) Institute develop training programs for CTC interpretation.

Gastroenterologists contacted for their perspectives on the report called the conclusions provocative but differed about whether the report is realistic or alarmist.

The report “is thorough and thought provoking … and anything that the AGA Institute can do to raise the level of thought and discussion is laudable,” said Dr. Ronald Vender, professor of medicine at Yale University, New Haven, Conn. “I think the impact [of CTC and other changes] will be much less than they're predicting,” he said, especially when considered from a cost-benefit perspective.

“Colonoscopy rates will probably go up rather than down,” commented Dr. James T. Frakes, professor of medicine at the University of Illinois, Rockford. “But even it that's not the case, gastroenterologists should always be looking for ways to improve and broaden their services,” he said.

“Colonoscopy has become the tail that's wagged the dog,” Dr. John L. Petrini of Sansum Clinic in Santa Barbara, Calif., said. “It's become a huge part of what we do, and I'm not sure it's going to stay that way. … But I don't think that CTC is going to be the one that's a keeper.”

Optical colonoscopy also is getting better, and lesions can be removed immediately in patients who are found to have adenomatous polyps during screening. Avoiding the need for a second procedure makes optical colonoscopy a cost-effective, attractive screening option, he said.

Many patients, said Dr. Douglas K. Rex, professor of medicine at Indiana University, Indianapolis, “will be disillusioned if they have a polyp and have to go on to have another test. … Americans like effectiveness. There will be other effective devices, but it's going to be hard for them to be as effective as colonoscopy.”

There also “hasn't been adequate discussion or education of the public regarding the potential risks of radiation” associated with screening CTC, he added.

Technologies ranging from wireless capsule endoscopy to simplified endoscopes will allow generalists and even nonphysician providers to perform colon surveillance. And over the long term, it will become possible to stratify cancer risk through serum-based proteomics, for example, and genetic or epigenetic markers, eliminating “unnecessary” colonoscopies, the committee said in its report.

One major challenge in CTC interpretation, however, is the presence of significant extracolonic findings in 4.5%–12% of procedures. Direct costs would rise rapidly if all CTCs must be reviewed by radiologists for extracolonic findings after a CTC-trained gastroenterologist has reviewed the colon, the report stated.

Gastroenterologists overall may modify their scope of practice by offering services that don't require extensive retraining. Obesity care may already be too competitive a niche for gastroenterologists to claim, according to those interviewed for this article, but they largely agreed with the committee's conclusion that obesity treatment is a “natural opportunity” for gastroenterologists, especially those who are willing to be part of a multidisciplinary team.

The demand for physicians to treat functional and motility disorders is likely to increase as the population ages. New tools on the horizon should expand and improve the evaluation and management of these disorders.

The same holds true for hepatitis C therapy. “We're only at the tip of the iceberg in taking care of patients with hepatitis C and chronic liver disease,” Dr. Frakes said.

As the committee points out in its report, however, limited reimbursement for such labor-intensive cognitive services means that midlevel providers increasingly will need to be utilized to make services effective and financially viable.

In response to new technologies and expected decreases in reimbursement for “traditional” procedures, gastroenterologists “will need to change what they do, where they practice, and how they practice,” according to a report issued by the American Gastroenterological Association Institute's Future Trends Committee.

Above all, computed tomographic colonography (CTC) “is likely to become an accepted colorectal cancer screening option within 3 years,” said the report, which was based on expert presentations at a conference convened last spring.

To maintain their practices, gastroenterologists will need to consider new services, which could include providing and interpreting CTC, obesity care, gastroenterological cancer treatment, and natural orifice transluminal endoscopic surgery.

Chronic or difficult-to-treat conditions, like hepatitis and motility and functional disorders, might also assume a bigger role in practice. Nurse-practitioners and physician assistants will likely play larger roles as gastroenterologists “embrace and act on the philosophy that the gastroenterologist is the leader and manager, and not necessarily the direct provider” of digestive disease care, according to the report (Gastroenterology 2006;131:1287–312).

Dr. Timothy C. Wang, who chaired the 10-member consensus development panel, said that CTC will likely be the first technology to take a share of colorectal cancer screening, but that members found it “difficult to predict what percentage of the screening market will shift to CTC.

“Further studies will likely show that CTC is comparable to optical colonoscopy in terms of sensitivity and specificity; however, other advances also may prove to detect polyps.” Also, gastroenterologists “should not completely cede colon imaging to radiologists,” said Dr. Wang, chief of the division of digestive and liver diseases at Columbia University, New York. Some gastroenterology groups have expressed interest in purchasing CT scanners, and the committee recommended that the American Gastroenterological Association (AGA) Institute develop training programs for CTC interpretation.

Gastroenterologists contacted for their perspectives on the report called the conclusions provocative but differed about whether the report is realistic or alarmist.

The report “is thorough and thought provoking … and anything that the AGA Institute can do to raise the level of thought and discussion is laudable,” said Dr. Ronald Vender, professor of medicine at Yale University, New Haven, Conn. “I think the impact [of CTC and other changes] will be much less than they're predicting,” he said, especially when considered from a cost-benefit perspective.

“Colonoscopy rates will probably go up rather than down,” commented Dr. James T. Frakes, professor of medicine at the University of Illinois, Rockford. “But even it that's not the case, gastroenterologists should always be looking for ways to improve and broaden their services,” he said.

“Colonoscopy has become the tail that's wagged the dog,” Dr. John L. Petrini of Sansum Clinic in Santa Barbara, Calif., said. “It's become a huge part of what we do, and I'm not sure it's going to stay that way. … But I don't think that CTC is going to be the one that's a keeper.”

Optical colonoscopy also is getting better, and lesions can be removed immediately in patients who are found to have adenomatous polyps during screening. Avoiding the need for a second procedure makes optical colonoscopy a cost-effective, attractive screening option, he said.

Many patients, said Dr. Douglas K. Rex, professor of medicine at Indiana University, Indianapolis, “will be disillusioned if they have a polyp and have to go on to have another test. … Americans like effectiveness. There will be other effective devices, but it's going to be hard for them to be as effective as colonoscopy.”

There also “hasn't been adequate discussion or education of the public regarding the potential risks of radiation” associated with screening CTC, he added.

Technologies ranging from wireless capsule endoscopy to simplified endoscopes will allow generalists and even nonphysician providers to perform colon surveillance. And over the long term, it will become possible to stratify cancer risk through serum-based proteomics, for example, and genetic or epigenetic markers, eliminating “unnecessary” colonoscopies, the committee said in its report.

One major challenge in CTC interpretation, however, is the presence of significant extracolonic findings in 4.5%–12% of procedures. Direct costs would rise rapidly if all CTCs must be reviewed by radiologists for extracolonic findings after a CTC-trained gastroenterologist has reviewed the colon, the report stated.

Gastroenterologists overall may modify their scope of practice by offering services that don't require extensive retraining. Obesity care may already be too competitive a niche for gastroenterologists to claim, according to those interviewed for this article, but they largely agreed with the committee's conclusion that obesity treatment is a “natural opportunity” for gastroenterologists, especially those who are willing to be part of a multidisciplinary team.

The demand for physicians to treat functional and motility disorders is likely to increase as the population ages. New tools on the horizon should expand and improve the evaluation and management of these disorders.

The same holds true for hepatitis C therapy. “We're only at the tip of the iceberg in taking care of patients with hepatitis C and chronic liver disease,” Dr. Frakes said.

As the committee points out in its report, however, limited reimbursement for such labor-intensive cognitive services means that midlevel providers increasingly will need to be utilized to make services effective and financially viable.

Pediatric emergency medicine has grown to become the third most popular pediatric subspecialty choice, but experts say the reasons are unclear.

Since 1997, the year in which the American Board of Pediatrics (ABP) began tracking subspecialty fellows in all training programs, the number of fellows enrolled in pediatric emergency medicine (EM) programs has increased by 64%, from 197 fellows in the 1997–1998 training year to 323 fellows in the 2005–2006 year. Approximately 1,300 physicians are now certified in the subspeciality by the ABP.

The data, which provide a “supply-side” perspective only, were released by the ABP as part of a series on workforce trends.

Dr. Aaron Friedman, who chairs the American Academy of Pediatrics Committee on the Pediatric Workforce, said the increasing interest in emergency medicine is not surprising but, on the other hand, it is not well understood.

“This isn't just a pediatrics issue. Medical students are choosing this direction [of emergency medicine] more than they did 10 years ago, and there's speculation about why students are interested in it. Is it [about] lifestyle issues, for instance, or [being on] call? We really don't know,” said Dr. Friedman, of Brown University, Providence, R.I. “We also don't know whether going into a pediatrics residency and then going into an emergency medicine subspecialty was a choice these students made initially,” he said in an interview.

Research into general pediatrics has shown an increasing trend toward part-time work, according to the ABP report, but there “are no current data to indicate this is the case in pediatric emergency medicine.”

The percentage of women fellows is at a peak of about 56%, but overall the proportion of male to female physicians in pediatric EM has not changed drastically, wrote report authors Linda A. Althouse, Ph.D., and Dr. James A. Stockman III (J. Pediatr. 2006;149:600–2). Similarly, the percentage of fellows who are U.S. medical school graduates has remained “relatively steady,” above 80% since 1997.

It also is not clear what the demand is for pediatric EM physicians, Dr. Friedman said. The ABP report points out that six states do not currently have a practicing ABP-certified pediatric EM physician, and that more than half of the states have a pediatric EM physician-to-child ratio of at least 1:100,000 (see chart).

The ABP's new training data capture emergency medicine physicians as well as pediatricians. However, the report indicates that the pediatric emergency medicine certificate, which the ABP established in collaboration with the American Board of Emergency Medicine more than 15 years ago, is clearly more popular among pediatricians. Whereas the ABEM has thus far awarded approximately 170 certificates to emergency medicine physicians, the ABP has certified 1,300 physicians to date, the report says.

Overall, the ABP and ABEM use similar eligibility criteria, and candidates applying to either board are given the same exam. ABEM does require 2 years of fellowship while ABP requires 3 years to cover an ABP research requirement, said Lee Currin, manager of credentialing and examinations administration at the ABP.

Elsevier Global Medical News

Pediatric emergency medicine has grown to become the third most popular pediatric subspecialty choice, but experts say the reasons are unclear.

Since 1997, the year in which the American Board of Pediatrics (ABP) began tracking subspecialty fellows in all training programs, the number of fellows enrolled in pediatric emergency medicine (EM) programs has increased by 64%, from 197 fellows in the 1997–1998 training year to 323 fellows in the 2005–2006 year. Approximately 1,300 physicians are now certified in the subspeciality by the ABP.

The data, which provide a “supply-side” perspective only, were released by the ABP as part of a series on workforce trends.

Dr. Aaron Friedman, who chairs the American Academy of Pediatrics Committee on the Pediatric Workforce, said the increasing interest in emergency medicine is not surprising but, on the other hand, it is not well understood.

“This isn't just a pediatrics issue. Medical students are choosing this direction [of emergency medicine] more than they did 10 years ago, and there's speculation about why students are interested in it. Is it [about] lifestyle issues, for instance, or [being on] call? We really don't know,” said Dr. Friedman, of Brown University, Providence, R.I. “We also don't know whether going into a pediatrics residency and then going into an emergency medicine subspecialty was a choice these students made initially,” he said in an interview.

Research into general pediatrics has shown an increasing trend toward part-time work, according to the ABP report, but there “are no current data to indicate this is the case in pediatric emergency medicine.”

The percentage of women fellows is at a peak of about 56%, but overall the proportion of male to female physicians in pediatric EM has not changed drastically, wrote report authors Linda A. Althouse, Ph.D., and Dr. James A. Stockman III (J. Pediatr. 2006;149:600–2). Similarly, the percentage of fellows who are U.S. medical school graduates has remained “relatively steady,” above 80% since 1997.

It also is not clear what the demand is for pediatric EM physicians, Dr. Friedman said. The ABP report points out that six states do not currently have a practicing ABP-certified pediatric EM physician, and that more than half of the states have a pediatric EM physician-to-child ratio of at least 1:100,000 (see chart).

The ABP's new training data capture emergency medicine physicians as well as pediatricians. However, the report indicates that the pediatric emergency medicine certificate, which the ABP established in collaboration with the American Board of Emergency Medicine more than 15 years ago, is clearly more popular among pediatricians. Whereas the ABEM has thus far awarded approximately 170 certificates to emergency medicine physicians, the ABP has certified 1,300 physicians to date, the report says.

Overall, the ABP and ABEM use similar eligibility criteria, and candidates applying to either board are given the same exam. ABEM does require 2 years of fellowship while ABP requires 3 years to cover an ABP research requirement, said Lee Currin, manager of credentialing and examinations administration at the ABP.

Elsevier Global Medical News

Pediatric emergency medicine has grown to become the third most popular pediatric subspecialty choice, but experts say the reasons are unclear.

Since 1997, the year in which the American Board of Pediatrics (ABP) began tracking subspecialty fellows in all training programs, the number of fellows enrolled in pediatric emergency medicine (EM) programs has increased by 64%, from 197 fellows in the 1997–1998 training year to 323 fellows in the 2005–2006 year. Approximately 1,300 physicians are now certified in the subspeciality by the ABP.

The data, which provide a “supply-side” perspective only, were released by the ABP as part of a series on workforce trends.

Dr. Aaron Friedman, who chairs the American Academy of Pediatrics Committee on the Pediatric Workforce, said the increasing interest in emergency medicine is not surprising but, on the other hand, it is not well understood.

“This isn't just a pediatrics issue. Medical students are choosing this direction [of emergency medicine] more than they did 10 years ago, and there's speculation about why students are interested in it. Is it [about] lifestyle issues, for instance, or [being on] call? We really don't know,” said Dr. Friedman, of Brown University, Providence, R.I. “We also don't know whether going into a pediatrics residency and then going into an emergency medicine subspecialty was a choice these students made initially,” he said in an interview.

Research into general pediatrics has shown an increasing trend toward part-time work, according to the ABP report, but there “are no current data to indicate this is the case in pediatric emergency medicine.”

The percentage of women fellows is at a peak of about 56%, but overall the proportion of male to female physicians in pediatric EM has not changed drastically, wrote report authors Linda A. Althouse, Ph.D., and Dr. James A. Stockman III (J. Pediatr. 2006;149:600–2). Similarly, the percentage of fellows who are U.S. medical school graduates has remained “relatively steady,” above 80% since 1997.

It also is not clear what the demand is for pediatric EM physicians, Dr. Friedman said. The ABP report points out that six states do not currently have a practicing ABP-certified pediatric EM physician, and that more than half of the states have a pediatric EM physician-to-child ratio of at least 1:100,000 (see chart).

The ABP's new training data capture emergency medicine physicians as well as pediatricians. However, the report indicates that the pediatric emergency medicine certificate, which the ABP established in collaboration with the American Board of Emergency Medicine more than 15 years ago, is clearly more popular among pediatricians. Whereas the ABEM has thus far awarded approximately 170 certificates to emergency medicine physicians, the ABP has certified 1,300 physicians to date, the report says.

Overall, the ABP and ABEM use similar eligibility criteria, and candidates applying to either board are given the same exam. ABEM does require 2 years of fellowship while ABP requires 3 years to cover an ABP research requirement, said Lee Currin, manager of credentialing and examinations administration at the ABP.

Elsevier Global Medical News

A new validated definition of response to therapy in juvenile systemic lupus erythematosus may help standardize the conduct and reporting of clinical trials and help physicians decide whether a child has responded adequately to therapy, authors of the definition reported.

The standard for improvement is set high: Juvenile lupus can be considered to have improved only when the symptoms have lessened by at least 50% in three of five specific outcome measures. The definition of improvement culminates a three-stage process undertaken by the Pediatric Rheumatology International Trials Organization (PRINTO) to develop and validate a set of outcome measures and a definition of clinical improvement that can be used to evaluate “global response” to therapy by a child with systemic lupus erythematosus (SLE).

The definition includes a global measure of SLE activity and measurement of 24-hour proteinuria, but it also considers a physician's subjective assessment of the level of disease activity as well as parent-reported outcomes.

“One of the reasons we don't have drugs approved, for instance, is that we haven't had good methods for assessing drugs in clinical trials,” said Dr. Edward H. Giannini of Children's Hospital Medical Center in Cincinnati, one of the authors and a facilitator of the consensus conference.

PRINTO worked on the definition in conjunction with the Pediatric Rheumatology Collaborative Study Group. The criteria were approved by the American College of Rheumatology board of directors as “provisional,” according to the report (Arthritis Rheum. 2006;55:355–63). “Now the criteria will be used in trials, in larger databases… and we'll look to see whether they continue to be valid,” Dr. Giannini said.

The new criteria define “improvement” in children with juvenile SLE as at least 50% improvement from baseline in any two of the five outcomes measures that were earlier developed and validated by PRINTO, with no more than one of the remaining measures worsening by more than 30%.

The outcomes measures include:

▸ The physician's global assessment of the patient's overall disease activity on a 10-cm visual analog scale.

▸ Global disease activity as measured using the European Consensus Lupus Activity Measurement (ECLAM) tool, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), or the Systemic Lupus Activity Measure (SLAM).

▸ Renal involvement as assessed by 24-hour proteinuria.

▸ The parent's global assessment of the child's overall well-being on a 1-cm visual analog scale.

▸ A quality of life assessment using the parent's version of the Child Health Questionnaire (physical summary score).

A new validated definition of response to therapy in juvenile systemic lupus erythematosus may help standardize the conduct and reporting of clinical trials and help physicians decide whether a child has responded adequately to therapy, authors of the definition reported.

The standard for improvement is set high: Juvenile lupus can be considered to have improved only when the symptoms have lessened by at least 50% in three of five specific outcome measures. The definition of improvement culminates a three-stage process undertaken by the Pediatric Rheumatology International Trials Organization (PRINTO) to develop and validate a set of outcome measures and a definition of clinical improvement that can be used to evaluate “global response” to therapy by a child with systemic lupus erythematosus (SLE).

The definition includes a global measure of SLE activity and measurement of 24-hour proteinuria, but it also considers a physician's subjective assessment of the level of disease activity as well as parent-reported outcomes.

“One of the reasons we don't have drugs approved, for instance, is that we haven't had good methods for assessing drugs in clinical trials,” said Dr. Edward H. Giannini of Children's Hospital Medical Center in Cincinnati, one of the authors and a facilitator of the consensus conference.

PRINTO worked on the definition in conjunction with the Pediatric Rheumatology Collaborative Study Group. The criteria were approved by the American College of Rheumatology board of directors as “provisional,” according to the report (Arthritis Rheum. 2006;55:355–63). “Now the criteria will be used in trials, in larger databases… and we'll look to see whether they continue to be valid,” Dr. Giannini said.

The new criteria define “improvement” in children with juvenile SLE as at least 50% improvement from baseline in any two of the five outcomes measures that were earlier developed and validated by PRINTO, with no more than one of the remaining measures worsening by more than 30%.

The outcomes measures include:

▸ The physician's global assessment of the patient's overall disease activity on a 10-cm visual analog scale.

▸ Global disease activity as measured using the European Consensus Lupus Activity Measurement (ECLAM) tool, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), or the Systemic Lupus Activity Measure (SLAM).

▸ Renal involvement as assessed by 24-hour proteinuria.

▸ The parent's global assessment of the child's overall well-being on a 1-cm visual analog scale.

▸ A quality of life assessment using the parent's version of the Child Health Questionnaire (physical summary score).

A new validated definition of response to therapy in juvenile systemic lupus erythematosus may help standardize the conduct and reporting of clinical trials and help physicians decide whether a child has responded adequately to therapy, authors of the definition reported.

The standard for improvement is set high: Juvenile lupus can be considered to have improved only when the symptoms have lessened by at least 50% in three of five specific outcome measures. The definition of improvement culminates a three-stage process undertaken by the Pediatric Rheumatology International Trials Organization (PRINTO) to develop and validate a set of outcome measures and a definition of clinical improvement that can be used to evaluate “global response” to therapy by a child with systemic lupus erythematosus (SLE).

The definition includes a global measure of SLE activity and measurement of 24-hour proteinuria, but it also considers a physician's subjective assessment of the level of disease activity as well as parent-reported outcomes.

“One of the reasons we don't have drugs approved, for instance, is that we haven't had good methods for assessing drugs in clinical trials,” said Dr. Edward H. Giannini of Children's Hospital Medical Center in Cincinnati, one of the authors and a facilitator of the consensus conference.

PRINTO worked on the definition in conjunction with the Pediatric Rheumatology Collaborative Study Group. The criteria were approved by the American College of Rheumatology board of directors as “provisional,” according to the report (Arthritis Rheum. 2006;55:355–63). “Now the criteria will be used in trials, in larger databases… and we'll look to see whether they continue to be valid,” Dr. Giannini said.

The new criteria define “improvement” in children with juvenile SLE as at least 50% improvement from baseline in any two of the five outcomes measures that were earlier developed and validated by PRINTO, with no more than one of the remaining measures worsening by more than 30%.

The outcomes measures include:

▸ The physician's global assessment of the patient's overall disease activity on a 10-cm visual analog scale.

▸ Global disease activity as measured using the European Consensus Lupus Activity Measurement (ECLAM) tool, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), or the Systemic Lupus Activity Measure (SLAM).

▸ Renal involvement as assessed by 24-hour proteinuria.

▸ The parent's global assessment of the child's overall well-being on a 1-cm visual analog scale.

▸ A quality of life assessment using the parent's version of the Child Health Questionnaire (physical summary score).

A small group of physicians and investigators plan to market a removable tattoo ink next year, and if the ink lives up to the inventors' expectations, physicians will be able to remove permanent tattoos with a single laser treatment.

The ink is made of microencapsulated biocompatible pigments that are absorbed by the body when the capsule—beads of a polymer used in a variety of products approved by the Food and Drug Administration—is broken up by a laser treatment.

“If we can't change the lasers to take the ink out, why don't we change the ink? It's simple. And the inks are safe,” said Dr. Eric F. Bernstein, a dermatologist who runs two centers for cosmetic laser surgery in the Philadelphia area.

Dr. Bernstein joined the company that has been developing the technology, Freedom-2, about 2 years ago and recently completed the first test removal of the ink. “It looks like it's going [to go] away in a single treatment,” he said.

Physicians who routinely use lasers for tattoo removal say it can take anywhere from 6 to 16 sessions, and even then, removal is incomplete and possibly unsafe, given that conventional tattoo inks may contain heavy metals and other toxic and carcinogenic materials.

The market for the ink, which is not regulated by the Food and Drug Administration, could be sizable. According to a recent survey, almost one-quarter of Americans between 18 and 50 years of age are tattooed, and about one-quarter of these men and women had regrets about their tattoos. About 5% had already covered a tattoo with a new tattoo, and another 17% said they were considering tattoo removal (J. Am. Acad. Dermatol. 2006;55:413–21).

The anticipated release of the ink will mark the culmination of years of patent filing and legal haggling, which resulted in the collaboration between Dr. R. Rox Anderson, associate professor of dermatology at Harvard University and laser treatment expert, and two plastic surgery experts, Bruce Klitzman, Ph.D., and Dr. Kim E. Koger, who met at Duke University a decade ago and who developed a removable ink for use in breast reconstruction.

Dr. Klitzman, senior director of the Kenan Plastic Surgery Research Labs at Duke University Medical Center in Durham, N.C., said that he and Dr. Koger, a plastic surgeon, had received a patent for the ink technology in 2000, when they learned that the U.S. patent office was initiating an “interference action” based on the similarities between their patent and another filed by Dr. Anderson.

The parties went before an administrative patent judge, who encouraged them to settle out of court, Dr. Klitzman said.

After about a year, the investigators agreed to merge the two companies they had formed to develop the technology and to use the name of Dr. Anderson's company, Freedom-2, for the new business.

Option Technologies, the company formed by Dr. Klitzman and Dr. Koger, “gave the rights to their invention” to the new company, and Freedom-2 provided all financing, Dr. Klitzman said.

The investigators then collaborated in their research, working to create bioabsorbable pigments that would be coated with a shell that could be disrupted with laser energy.

Dr. Anderson was not available for comment.

Martin Schmeig, president and CEO of the new company, based in West Conshohocken, Pa., said that the tattoo removed by Dr. Bernstein in the first test removal was made with a red-brown iron oxide encapsulated in beads of polymethylmethacrylate (PMMA), a polymer that is used in surgical glues, hip implants, and various other FDA-approved products. Each PMMA “microsphere” contains an absorption pigment that can be targeted by a specific laser wavelength.

Dr. Anderson and his partners are planning to recruit at least 50 people from various ethnic group, to receive test tattoos and over the course of several years, they will look at skin reactions and at the durability and vibrancy of the ink while also testing the removal process.

The long-term studies will enable the company to “build a data profile” for the FDA and European regulators, should they become interested in regulating tattoos in the future. “The Europeans are ahead of the FDA in thinking about” this, Mr. Schmeig said. “They're starting to … get concerned about ink components.”

In the meantime, the company plans to market the ink in 2007, releasing it color by color. Black, the color that is least difficult to remove with a laser, will be released first.

Mr. Schmeig said it may take time for tattoo artists to change their practices and start using the ink. He said his company envisioned a consumer-driven change, that would be achieved by targeting most of its marketing toward tattoo seekers.

The company's goal for artists, meanwhile, would be “to make sure the ink acts and performs exactly like the [current] inks,” he said.

A small group of physicians and investigators plan to market a removable tattoo ink next year, and if the ink lives up to the inventors' expectations, physicians will be able to remove permanent tattoos with a single laser treatment.

The ink is made of microencapsulated biocompatible pigments that are absorbed by the body when the capsule—beads of a polymer used in a variety of products approved by the Food and Drug Administration—is broken up by a laser treatment.

“If we can't change the lasers to take the ink out, why don't we change the ink? It's simple. And the inks are safe,” said Dr. Eric F. Bernstein, a dermatologist who runs two centers for cosmetic laser surgery in the Philadelphia area.

Dr. Bernstein joined the company that has been developing the technology, Freedom-2, about 2 years ago and recently completed the first test removal of the ink. “It looks like it's going [to go] away in a single treatment,” he said.

Physicians who routinely use lasers for tattoo removal say it can take anywhere from 6 to 16 sessions, and even then, removal is incomplete and possibly unsafe, given that conventional tattoo inks may contain heavy metals and other toxic and carcinogenic materials.

The market for the ink, which is not regulated by the Food and Drug Administration, could be sizable. According to a recent survey, almost one-quarter of Americans between 18 and 50 years of age are tattooed, and about one-quarter of these men and women had regrets about their tattoos. About 5% had already covered a tattoo with a new tattoo, and another 17% said they were considering tattoo removal (J. Am. Acad. Dermatol. 2006;55:413–21).

The anticipated release of the ink will mark the culmination of years of patent filing and legal haggling, which resulted in the collaboration between Dr. R. Rox Anderson, associate professor of dermatology at Harvard University and laser treatment expert, and two plastic surgery experts, Bruce Klitzman, Ph.D., and Dr. Kim E. Koger, who met at Duke University a decade ago and who developed a removable ink for use in breast reconstruction.

Dr. Klitzman, senior director of the Kenan Plastic Surgery Research Labs at Duke University Medical Center in Durham, N.C., said that he and Dr. Koger, a plastic surgeon, had received a patent for the ink technology in 2000, when they learned that the U.S. patent office was initiating an “interference action” based on the similarities between their patent and another filed by Dr. Anderson.

The parties went before an administrative patent judge, who encouraged them to settle out of court, Dr. Klitzman said.

After about a year, the investigators agreed to merge the two companies they had formed to develop the technology and to use the name of Dr. Anderson's company, Freedom-2, for the new business.

Option Technologies, the company formed by Dr. Klitzman and Dr. Koger, “gave the rights to their invention” to the new company, and Freedom-2 provided all financing, Dr. Klitzman said.

The investigators then collaborated in their research, working to create bioabsorbable pigments that would be coated with a shell that could be disrupted with laser energy.

Dr. Anderson was not available for comment.

Martin Schmeig, president and CEO of the new company, based in West Conshohocken, Pa., said that the tattoo removed by Dr. Bernstein in the first test removal was made with a red-brown iron oxide encapsulated in beads of polymethylmethacrylate (PMMA), a polymer that is used in surgical glues, hip implants, and various other FDA-approved products. Each PMMA “microsphere” contains an absorption pigment that can be targeted by a specific laser wavelength.

Dr. Anderson and his partners are planning to recruit at least 50 people from various ethnic group, to receive test tattoos and over the course of several years, they will look at skin reactions and at the durability and vibrancy of the ink while also testing the removal process.

The long-term studies will enable the company to “build a data profile” for the FDA and European regulators, should they become interested in regulating tattoos in the future. “The Europeans are ahead of the FDA in thinking about” this, Mr. Schmeig said. “They're starting to … get concerned about ink components.”

In the meantime, the company plans to market the ink in 2007, releasing it color by color. Black, the color that is least difficult to remove with a laser, will be released first.

Mr. Schmeig said it may take time for tattoo artists to change their practices and start using the ink. He said his company envisioned a consumer-driven change, that would be achieved by targeting most of its marketing toward tattoo seekers.

The company's goal for artists, meanwhile, would be “to make sure the ink acts and performs exactly like the [current] inks,” he said.

A small group of physicians and investigators plan to market a removable tattoo ink next year, and if the ink lives up to the inventors' expectations, physicians will be able to remove permanent tattoos with a single laser treatment.

The ink is made of microencapsulated biocompatible pigments that are absorbed by the body when the capsule—beads of a polymer used in a variety of products approved by the Food and Drug Administration—is broken up by a laser treatment.

“If we can't change the lasers to take the ink out, why don't we change the ink? It's simple. And the inks are safe,” said Dr. Eric F. Bernstein, a dermatologist who runs two centers for cosmetic laser surgery in the Philadelphia area.

Dr. Bernstein joined the company that has been developing the technology, Freedom-2, about 2 years ago and recently completed the first test removal of the ink. “It looks like it's going [to go] away in a single treatment,” he said.

Physicians who routinely use lasers for tattoo removal say it can take anywhere from 6 to 16 sessions, and even then, removal is incomplete and possibly unsafe, given that conventional tattoo inks may contain heavy metals and other toxic and carcinogenic materials.

The market for the ink, which is not regulated by the Food and Drug Administration, could be sizable. According to a recent survey, almost one-quarter of Americans between 18 and 50 years of age are tattooed, and about one-quarter of these men and women had regrets about their tattoos. About 5% had already covered a tattoo with a new tattoo, and another 17% said they were considering tattoo removal (J. Am. Acad. Dermatol. 2006;55:413–21).

The anticipated release of the ink will mark the culmination of years of patent filing and legal haggling, which resulted in the collaboration between Dr. R. Rox Anderson, associate professor of dermatology at Harvard University and laser treatment expert, and two plastic surgery experts, Bruce Klitzman, Ph.D., and Dr. Kim E. Koger, who met at Duke University a decade ago and who developed a removable ink for use in breast reconstruction.

Dr. Klitzman, senior director of the Kenan Plastic Surgery Research Labs at Duke University Medical Center in Durham, N.C., said that he and Dr. Koger, a plastic surgeon, had received a patent for the ink technology in 2000, when they learned that the U.S. patent office was initiating an “interference action” based on the similarities between their patent and another filed by Dr. Anderson.

The parties went before an administrative patent judge, who encouraged them to settle out of court, Dr. Klitzman said.

After about a year, the investigators agreed to merge the two companies they had formed to develop the technology and to use the name of Dr. Anderson's company, Freedom-2, for the new business.

Option Technologies, the company formed by Dr. Klitzman and Dr. Koger, “gave the rights to their invention” to the new company, and Freedom-2 provided all financing, Dr. Klitzman said.

The investigators then collaborated in their research, working to create bioabsorbable pigments that would be coated with a shell that could be disrupted with laser energy.

Dr. Anderson was not available for comment.

Martin Schmeig, president and CEO of the new company, based in West Conshohocken, Pa., said that the tattoo removed by Dr. Bernstein in the first test removal was made with a red-brown iron oxide encapsulated in beads of polymethylmethacrylate (PMMA), a polymer that is used in surgical glues, hip implants, and various other FDA-approved products. Each PMMA “microsphere” contains an absorption pigment that can be targeted by a specific laser wavelength.

Dr. Anderson and his partners are planning to recruit at least 50 people from various ethnic group, to receive test tattoos and over the course of several years, they will look at skin reactions and at the durability and vibrancy of the ink while also testing the removal process.

The long-term studies will enable the company to “build a data profile” for the FDA and European regulators, should they become interested in regulating tattoos in the future. “The Europeans are ahead of the FDA in thinking about” this, Mr. Schmeig said. “They're starting to … get concerned about ink components.”

In the meantime, the company plans to market the ink in 2007, releasing it color by color. Black, the color that is least difficult to remove with a laser, will be released first.

Mr. Schmeig said it may take time for tattoo artists to change their practices and start using the ink. He said his company envisioned a consumer-driven change, that would be achieved by targeting most of its marketing toward tattoo seekers.

The company's goal for artists, meanwhile, would be “to make sure the ink acts and performs exactly like the [current] inks,” he said.

The Endocrine Society is sounding a strong word of caution on the topic of androgen therapy with a new clinical practice guideline that recommends against diagnosing and treating androgen deficiency in women.

The guideline, published in the October issue of the Journal of Clinical Endocrinology and Metabolism, cites the “lack of a well-defined clinical syndrome” and the “lack of normative data on total or free testosterone levels across the life span” as reasons why a diagnosis should not be made.

On the issue of treatment, the document acknowledges “evidence for short-term efficacy of testosterone in selected populations, such as surgically menopausal women,” but says that inadequate indications and insufficient evidence of long-term safety means that the “generalized use of testosterone in women” cannot be recommended.

“Based on [our literature review], we felt that at this time, we could not, as a committee and a society, recommend either for making the diagnosis or for treatment,” said Dr. Margaret E. Wierman, the endocrinologist who chaired the seven-member task force that developed the guidelines.

“The quality of the literature was just not up to a standard [needed] to make a global recommendation,” said Dr. Wierman, who serves as chief of endocrinology at the Veterans Affairs Medical Center in Denver and professor of medicine, physiology, and biophysics at the University of Colorado, Denver. “The sort of hype that testosterone has been given is not yet based on a lot of scientific fact.”

The guideline, which also details basic research that must be done and calls for the development of more sensitive and specific assays for testosterone and free testosterone in women, has a tone and reach that differs from the less conservative “androgen deficiency” section in the American Association of Clinical Endocrinologists' recently updated menopause guidelines.

As observers—and even Dr. Wierman—see it, the guideline is bound to intensify debate about an already controversial issue. And if Dr. André Guay is any indication, it is endocrinologists who specialize in sexual dysfunction who may take issue with the guidelines most passionately.

“This isn't a guideline at all,” said Dr. Guay, director of the Center for Sexual Function at the Lahey Clinic in Peabody, Mass. “I was hoping they would say, 'we don't have all the answers, but here are the answers we do have, and here is the best we can do,' just as we say with men—that I'll buy.

“But there's nothing in here that shows you how to deal with the problem given the knowledge we currently have. … It's a disservice,” said Dr. Guay, who has argued for years in articles and at meetings that evidence supports off-label androgen therapy in women.

Not so, said Dr. Neil Goodman, professor of medicine at the University of Miami. The guideline is “excellently done” by “leading people in the field,” he said. “They went through the literature systematically and documented levels of evidence … and they do point out the one area where there is good positive data—in the surgically menopausal group.

“I see it as a request for action,” said Dr. Goodman, also a private-practice endocrinologist specializing in reproductive medicine. “It's a plea for better work to be done.”

The guideline recommends that researchers use particular “human model systems” to study the benefits and risks of androgen therapy (for instance, it says that women with hypopituitarism can be used to study the physiological replacement of ovarian and adrenal androgen precursors).

It also recommends that particular end points—from appearance of or change in hirsutism to effects in the breast and alterations in the endometrium with and without estrogen coadministration—be considered in safety and risk assessments of androgen administration (J. Clin. Endocrinol. Metab. 2006;91;3697–710).

Dr. Wierman said she also hopes that the new guideline—as well as a document to be released by the Endocrine Society in the next 18–24 months on problems with sex steroid assays for both men and women—will drive development of more sensitive and specific assays. “I think the assay issue will soon be improved,” she said.

Physicians also must appreciate the fact that the findings on estrogen from the Women's Health Initiative had some impact on the task force, Dr. Wierman said.

“At this point, we felt that the Endocrine Society needs to act as the word of caution so we're not coming back 5 years from now and saying, 'Why weren't we cautious? Why didn't we push our colleagues across academia to do the studies to better understand [androgens], so that patients will benefit and won't be harmed?'” she said.

Dr. Steven Petak, president of the American Association of Clinical Endocrinologists (AACE), said his organization took a different approach last year as they addressed the issue of androgen therapy when updating their menopause guidelines.

“We also were quite cautious, and we agree that long-term safety issues need to be clarified,” he said. “But we still went on and stated that there are some criteria for diagnosis, and we gave some recommendations [for use of androgen].”

The Endocrine Society's guidelines “don't do much for patients whose therapies are being considered now,” said Dr. Petak of the Texas Institute for Reproduction and Endocrinology. “The Endocrine Society's recommendations for further basic and clinical research in the field are of prime importance and we agree wholeheartedly.”

Dr. Goodman cautioned against comparing the guidelines of the two organizations. “The Endocrine Society is looking at the entire, broader issue. They take a more universal kind of approach,” he said.

The Endocrine Society is sounding a strong word of caution on the topic of androgen therapy with a new clinical practice guideline that recommends against diagnosing and treating androgen deficiency in women.

The guideline, published in the October issue of the Journal of Clinical Endocrinology and Metabolism, cites the “lack of a well-defined clinical syndrome” and the “lack of normative data on total or free testosterone levels across the life span” as reasons why a diagnosis should not be made.

On the issue of treatment, the document acknowledges “evidence for short-term efficacy of testosterone in selected populations, such as surgically menopausal women,” but says that inadequate indications and insufficient evidence of long-term safety means that the “generalized use of testosterone in women” cannot be recommended.

“Based on [our literature review], we felt that at this time, we could not, as a committee and a society, recommend either for making the diagnosis or for treatment,” said Dr. Margaret E. Wierman, the endocrinologist who chaired the seven-member task force that developed the guidelines.

“The quality of the literature was just not up to a standard [needed] to make a global recommendation,” said Dr. Wierman, who serves as chief of endocrinology at the Veterans Affairs Medical Center in Denver and professor of medicine, physiology, and biophysics at the University of Colorado, Denver. “The sort of hype that testosterone has been given is not yet based on a lot of scientific fact.”

The guideline, which also details basic research that must be done and calls for the development of more sensitive and specific assays for testosterone and free testosterone in women, has a tone and reach that differs from the less conservative “androgen deficiency” section in the American Association of Clinical Endocrinologists' recently updated menopause guidelines.

As observers—and even Dr. Wierman—see it, the guideline is bound to intensify debate about an already controversial issue. And if Dr. André Guay is any indication, it is endocrinologists who specialize in sexual dysfunction who may take issue with the guidelines most passionately.

“This isn't a guideline at all,” said Dr. Guay, director of the Center for Sexual Function at the Lahey Clinic in Peabody, Mass. “I was hoping they would say, 'we don't have all the answers, but here are the answers we do have, and here is the best we can do,' just as we say with men—that I'll buy.

“But there's nothing in here that shows you how to deal with the problem given the knowledge we currently have. … It's a disservice,” said Dr. Guay, who has argued for years in articles and at meetings that evidence supports off-label androgen therapy in women.

Not so, said Dr. Neil Goodman, professor of medicine at the University of Miami. The guideline is “excellently done” by “leading people in the field,” he said. “They went through the literature systematically and documented levels of evidence … and they do point out the one area where there is good positive data—in the surgically menopausal group.

“I see it as a request for action,” said Dr. Goodman, also a private-practice endocrinologist specializing in reproductive medicine. “It's a plea for better work to be done.”

The guideline recommends that researchers use particular “human model systems” to study the benefits and risks of androgen therapy (for instance, it says that women with hypopituitarism can be used to study the physiological replacement of ovarian and adrenal androgen precursors).

It also recommends that particular end points—from appearance of or change in hirsutism to effects in the breast and alterations in the endometrium with and without estrogen coadministration—be considered in safety and risk assessments of androgen administration (J. Clin. Endocrinol. Metab. 2006;91;3697–710).

Dr. Wierman said she also hopes that the new guideline—as well as a document to be released by the Endocrine Society in the next 18–24 months on problems with sex steroid assays for both men and women—will drive development of more sensitive and specific assays. “I think the assay issue will soon be improved,” she said.

Physicians also must appreciate the fact that the findings on estrogen from the Women's Health Initiative had some impact on the task force, Dr. Wierman said.

“At this point, we felt that the Endocrine Society needs to act as the word of caution so we're not coming back 5 years from now and saying, 'Why weren't we cautious? Why didn't we push our colleagues across academia to do the studies to better understand [androgens], so that patients will benefit and won't be harmed?'” she said.

Dr. Steven Petak, president of the American Association of Clinical Endocrinologists (AACE), said his organization took a different approach last year as they addressed the issue of androgen therapy when updating their menopause guidelines.

“We also were quite cautious, and we agree that long-term safety issues need to be clarified,” he said. “But we still went on and stated that there are some criteria for diagnosis, and we gave some recommendations [for use of androgen].”

The Endocrine Society's guidelines “don't do much for patients whose therapies are being considered now,” said Dr. Petak of the Texas Institute for Reproduction and Endocrinology. “The Endocrine Society's recommendations for further basic and clinical research in the field are of prime importance and we agree wholeheartedly.”

Dr. Goodman cautioned against comparing the guidelines of the two organizations. “The Endocrine Society is looking at the entire, broader issue. They take a more universal kind of approach,” he said.

The Endocrine Society is sounding a strong word of caution on the topic of androgen therapy with a new clinical practice guideline that recommends against diagnosing and treating androgen deficiency in women.

The guideline, published in the October issue of the Journal of Clinical Endocrinology and Metabolism, cites the “lack of a well-defined clinical syndrome” and the “lack of normative data on total or free testosterone levels across the life span” as reasons why a diagnosis should not be made.

On the issue of treatment, the document acknowledges “evidence for short-term efficacy of testosterone in selected populations, such as surgically menopausal women,” but says that inadequate indications and insufficient evidence of long-term safety means that the “generalized use of testosterone in women” cannot be recommended.

“Based on [our literature review], we felt that at this time, we could not, as a committee and a society, recommend either for making the diagnosis or for treatment,” said Dr. Margaret E. Wierman, the endocrinologist who chaired the seven-member task force that developed the guidelines.

“The quality of the literature was just not up to a standard [needed] to make a global recommendation,” said Dr. Wierman, who serves as chief of endocrinology at the Veterans Affairs Medical Center in Denver and professor of medicine, physiology, and biophysics at the University of Colorado, Denver. “The sort of hype that testosterone has been given is not yet based on a lot of scientific fact.”

The guideline, which also details basic research that must be done and calls for the development of more sensitive and specific assays for testosterone and free testosterone in women, has a tone and reach that differs from the less conservative “androgen deficiency” section in the American Association of Clinical Endocrinologists' recently updated menopause guidelines.

As observers—and even Dr. Wierman—see it, the guideline is bound to intensify debate about an already controversial issue. And if Dr. André Guay is any indication, it is endocrinologists who specialize in sexual dysfunction who may take issue with the guidelines most passionately.

“This isn't a guideline at all,” said Dr. Guay, director of the Center for Sexual Function at the Lahey Clinic in Peabody, Mass. “I was hoping they would say, 'we don't have all the answers, but here are the answers we do have, and here is the best we can do,' just as we say with men—that I'll buy.

“But there's nothing in here that shows you how to deal with the problem given the knowledge we currently have. … It's a disservice,” said Dr. Guay, who has argued for years in articles and at meetings that evidence supports off-label androgen therapy in women.

Not so, said Dr. Neil Goodman, professor of medicine at the University of Miami. The guideline is “excellently done” by “leading people in the field,” he said. “They went through the literature systematically and documented levels of evidence … and they do point out the one area where there is good positive data—in the surgically menopausal group.

“I see it as a request for action,” said Dr. Goodman, also a private-practice endocrinologist specializing in reproductive medicine. “It's a plea for better work to be done.”

The guideline recommends that researchers use particular “human model systems” to study the benefits and risks of androgen therapy (for instance, it says that women with hypopituitarism can be used to study the physiological replacement of ovarian and adrenal androgen precursors).

It also recommends that particular end points—from appearance of or change in hirsutism to effects in the breast and alterations in the endometrium with and without estrogen coadministration—be considered in safety and risk assessments of androgen administration (J. Clin. Endocrinol. Metab. 2006;91;3697–710).

Dr. Wierman said she also hopes that the new guideline—as well as a document to be released by the Endocrine Society in the next 18–24 months on problems with sex steroid assays for both men and women—will drive development of more sensitive and specific assays. “I think the assay issue will soon be improved,” she said.

Physicians also must appreciate the fact that the findings on estrogen from the Women's Health Initiative had some impact on the task force, Dr. Wierman said.

“At this point, we felt that the Endocrine Society needs to act as the word of caution so we're not coming back 5 years from now and saying, 'Why weren't we cautious? Why didn't we push our colleagues across academia to do the studies to better understand [androgens], so that patients will benefit and won't be harmed?'” she said.

Dr. Steven Petak, president of the American Association of Clinical Endocrinologists (AACE), said his organization took a different approach last year as they addressed the issue of androgen therapy when updating their menopause guidelines.

“We also were quite cautious, and we agree that long-term safety issues need to be clarified,” he said. “But we still went on and stated that there are some criteria for diagnosis, and we gave some recommendations [for use of androgen].”

The Endocrine Society's guidelines “don't do much for patients whose therapies are being considered now,” said Dr. Petak of the Texas Institute for Reproduction and Endocrinology. “The Endocrine Society's recommendations for further basic and clinical research in the field are of prime importance and we agree wholeheartedly.”

Dr. Goodman cautioned against comparing the guidelines of the two organizations. “The Endocrine Society is looking at the entire, broader issue. They take a more universal kind of approach,” he said.

When a diabetic patient needs to see a diabetes educator, convenient access can boost compliance and help improve health outcomes.

That's the experience of Dr. Francis X. Solano Jr. and his primary care colleagues, who refer patients with newly diagnosed or uncontrolled diabetes to a certified diabetes educator, who meets patients on site.

By having the educator in the office on designated days, most patients follow through and receive the prescribed diabetes self-management education (DSME). As a result, they have improved their health outcomes, Dr. Solano said in an interview.

The on-site education has also shown the physicians what can be achieved with outliers and new diabetics. “Some 65% of our patients now have an A_1c less than 7, and only 8% have an A_1c greater than 9. When we started [the project], at least 20% of our patients were above 9,” he said.

Dr. Solano's practice is one of six primary care practices in Community Medicine Inc. (a group of 65 practices owned and managed by the University of Pittsburgh Medical Center) that are participating in a project aimed at integrating DSME directly into primary care offices, where it can be most easily accessed.

Although details of the project may not all be replicable outside such a large medical system, experts at the University of Pittsburgh Medical Center believe they are demonstrating why more primary care physicians should contract with diabetes education programs to bring educators in-house.

Physicians “need to think outside the box and look at what kinds of relationships they can develop with hospital program leaders,” said Linda M. Siminerio, Ph.D., director of the University of Pittsburgh's Diabetes Institute and senior vice president of the International Diabetes Federation.

The University of Pittsburgh Medical Center is a logical place to try out such an approach. It's a large system with 19 hospitals and 21 diabetes education programs that are recognized by the American Diabetes Association (ADA) and overseen by the diabetes institute. Each year, 80,000 patients access diabetes care through the system. Yet despite the system's infrastructure and availability of services, a “disappointing number of patients [within it] receive DSME,” said Sharlene Emerson, the certified diabetes educator involved in the program.

“Doctors don't know where the programs are, when they are [run], and they don't know how to refer a patient,” Ms. Emerson said during a presentation at the annual meeting of the American Diabetes Association in Washington. And when they do refer, patients don't always follow through, she said.

Dr. Jennifer Mayfield, a family physician from Seattle, said such problems are common. “I don't think insurers understand how difficult it is for us to do the education—we don't have the training and the expertise. And insurers don't appreciate the fact that many patients won't go across town.”

The University of Pittsburgh Medical Center project was started after physicians and other leaders of Community Medicine met in 2003 to discuss the state of diabetes management in primary care. They agreed on two things: A lack of diabetes education was a barrier to quality diabetes care, and implementing diabetes education in the primary care setting—where 90% of diabetes care is delivered—would improve access to education and boost outcomes.

Community Medicine drew up a contract in 2004 with the University of Pittsburgh's Diabetes Institute. Participating primary care practices in the project would provide space for Ms. Emerson during specific times, do the scheduling, bill for the diabetes education services (CDEs are not Medicare-recognized providers and cannot bill insurers directly), and pay the diabetes institute a set fraction of the reimbursement for Ms. Emerson's time.

At that point, Ms. Emerson had begun working on a pilot basis (with grant money from University of Pittsburgh Medical Center) at Dr. Solano's practice on one 8-hour day a week, alongside the practice's registered dietitian. She and other University of Pittsburgh Medical Center experts had secured recognition for the practice's education program from the American Diabetes Association. (Providers must have program recognition from the ADA or the Indian Health Service to bill Medicare for DSME.)

Now, five other Community Medicine primary care practices have ADA recognition and are opening their doors regularly for Ms. Emerson. Other University of Pittsburgh Medical Center-affiliated practices, including a large cardiology practice, have expressed interest in signing contracts.

Of all the issues involved in implementing DSME in primary care, scheduling and space have been among the most easily resolved, Ms. Emerson said at the ADA meeting and in an interview.

At one practice, she was allotted her own space. In another practice, she uses a physician's personal office to meet with patients. In others, she holds group classes in waiting rooms at times when there are no other patients—an approach that affords the privacy mandated by federal law.

Thus far, she has scheduled initial visits for 90 minutes and return visits for 45 minutes. Her approach exemplifies the trend in diabetes education, away from didactic programs to sessions aimed at getting patients engaged in setting goals, changing behaviors, and solving problems.

Most patients decide to return for 2–4 group sessions per year—most of which fall within Medicare's allowed coverage of 10 hours in the initial year (including 9 hours of group education) and 2 hours each subsequent year. The physician is responsible for maintaining the plan of care in the patient's medical record.

It will become easier for physicians to get ADA certification for education programs as the association becomes more flexible. For example, the ADA is now allowing programs to apply for “expansion site” recognition, an arrangement that could apply to a partnership between a primary care practice and a hospital, Dr. Siminerio said.

Reimbursement Issues Pose Challenges

The finances of the program are a work in progress—and, not surprisingly, reimbursement is the most challenging issue the project leaders face. “Insurer issues,” as Ms. Emerson calls them, are at the forefront.

“Many insurers were concerned that DSME in primary care was being provided by the physicians and/or staff as opposed to an ADA-recognized program,” she said at the meeting. “They just thought it was a physician-driven program and they weren't going to pay for it, no matter how we explained it.”

In the first quarter of 2006, the three practices that had begun billing by that point together billed for $31,560; this covered 109 encounters (61 group sessions and 48 individual) in 19 days, with 70 different patients and 20 insurance plans. Community Medicine's reimbursement: $5,907. Of this, $4,197 went to the University of Pittsburgh's Diabetes Institute.

“We were actually quite pleased with how much we were able to charge, and we weren't displeased with the reimbursement, though we need to recover more to make the program sustainable,” Ms. Emerson said. Recouping even 50% of the charges would make a difference, she said.

Dr. Solano, however, thinks it's going to take more to be truly “cost-effective for primary care.”

“The question is, how can you get it funded by insurers—really, fully underwritten by insurers—but have diabetes educators do true education and not just the 'disease management' that insurers [have touted]?” said the internist, who, in addition to practicing, serves as medical director of the's Center for Quality Improvement and Innovation at the University of Pittsburgh Medical Center.

“Even with better reimbursement levels, the amount of money people get paid certainly is not going to support their salary,” he said.

A model that builds on the CDE model and uses a practice-based educator for a broader swath of education—asthma education and depression education, for example, in addition to the diabetes education—may be more cost effective, he said.

Dr. Siminerio, however, expects reimbursement for diabetes education to increase as insurers realize that CDEs can deliver services in physicians' offices effectively—and particularly, as insurers see outcomes data from the sources such as the Community Medicine practices. “At this point, it's such a new model,” she said.

When a diabetic patient needs to see a diabetes educator, convenient access can boost compliance and help improve health outcomes.

That's the experience of Dr. Francis X. Solano Jr. and his primary care colleagues, who refer patients with newly diagnosed or uncontrolled diabetes to a certified diabetes educator, who meets patients on site.

By having the educator in the office on designated days, most patients follow through and receive the prescribed diabetes self-management education (DSME). As a result, they have improved their health outcomes, Dr. Solano said in an interview.

The on-site education has also shown the physicians what can be achieved with outliers and new diabetics. “Some 65% of our patients now have an A_1c less than 7, and only 8% have an A_1c greater than 9. When we started [the project], at least 20% of our patients were above 9,” he said.

Dr. Solano's practice is one of six primary care practices in Community Medicine Inc. (a group of 65 practices owned and managed by the University of Pittsburgh Medical Center) that are participating in a project aimed at integrating DSME directly into primary care offices, where it can be most easily accessed.

Although details of the project may not all be replicable outside such a large medical system, experts at the University of Pittsburgh Medical Center believe they are demonstrating why more primary care physicians should contract with diabetes education programs to bring educators in-house.

Physicians “need to think outside the box and look at what kinds of relationships they can develop with hospital program leaders,” said Linda M. Siminerio, Ph.D., director of the University of Pittsburgh's Diabetes Institute and senior vice president of the International Diabetes Federation.

The University of Pittsburgh Medical Center is a logical place to try out such an approach. It's a large system with 19 hospitals and 21 diabetes education programs that are recognized by the American Diabetes Association (ADA) and overseen by the diabetes institute. Each year, 80,000 patients access diabetes care through the system. Yet despite the system's infrastructure and availability of services, a “disappointing number of patients [within it] receive DSME,” said Sharlene Emerson, the certified diabetes educator involved in the program.

“Doctors don't know where the programs are, when they are [run], and they don't know how to refer a patient,” Ms. Emerson said during a presentation at the annual meeting of the American Diabetes Association in Washington. And when they do refer, patients don't always follow through, she said.

Dr. Jennifer Mayfield, a family physician from Seattle, said such problems are common. “I don't think insurers understand how difficult it is for us to do the education—we don't have the training and the expertise. And insurers don't appreciate the fact that many patients won't go across town.”

The University of Pittsburgh Medical Center project was started after physicians and other leaders of Community Medicine met in 2003 to discuss the state of diabetes management in primary care. They agreed on two things: A lack of diabetes education was a barrier to quality diabetes care, and implementing diabetes education in the primary care setting—where 90% of diabetes care is delivered—would improve access to education and boost outcomes.

Community Medicine drew up a contract in 2004 with the University of Pittsburgh's Diabetes Institute. Participating primary care practices in the project would provide space for Ms. Emerson during specific times, do the scheduling, bill for the diabetes education services (CDEs are not Medicare-recognized providers and cannot bill insurers directly), and pay the diabetes institute a set fraction of the reimbursement for Ms. Emerson's time.

At that point, Ms. Emerson had begun working on a pilot basis (with grant money from University of Pittsburgh Medical Center) at Dr. Solano's practice on one 8-hour day a week, alongside the practice's registered dietitian. She and other University of Pittsburgh Medical Center experts had secured recognition for the practice's education program from the American Diabetes Association. (Providers must have program recognition from the ADA or the Indian Health Service to bill Medicare for DSME.)

Now, five other Community Medicine primary care practices have ADA recognition and are opening their doors regularly for Ms. Emerson. Other University of Pittsburgh Medical Center-affiliated practices, including a large cardiology practice, have expressed interest in signing contracts.

Of all the issues involved in implementing DSME in primary care, scheduling and space have been among the most easily resolved, Ms. Emerson said at the ADA meeting and in an interview.

At one practice, she was allotted her own space. In another practice, she uses a physician's personal office to meet with patients. In others, she holds group classes in waiting rooms at times when there are no other patients—an approach that affords the privacy mandated by federal law.

Thus far, she has scheduled initial visits for 90 minutes and return visits for 45 minutes. Her approach exemplifies the trend in diabetes education, away from didactic programs to sessions aimed at getting patients engaged in setting goals, changing behaviors, and solving problems.

Most patients decide to return for 2–4 group sessions per year—most of which fall within Medicare's allowed coverage of 10 hours in the initial year (including 9 hours of group education) and 2 hours each subsequent year. The physician is responsible for maintaining the plan of care in the patient's medical record.

It will become easier for physicians to get ADA certification for education programs as the association becomes more flexible. For example, the ADA is now allowing programs to apply for “expansion site” recognition, an arrangement that could apply to a partnership between a primary care practice and a hospital, Dr. Siminerio said.

Reimbursement Issues Pose Challenges

The finances of the program are a work in progress—and, not surprisingly, reimbursement is the most challenging issue the project leaders face. “Insurer issues,” as Ms. Emerson calls them, are at the forefront.

“Many insurers were concerned that DSME in primary care was being provided by the physicians and/or staff as opposed to an ADA-recognized program,” she said at the meeting. “They just thought it was a physician-driven program and they weren't going to pay for it, no matter how we explained it.”

In the first quarter of 2006, the three practices that had begun billing by that point together billed for $31,560; this covered 109 encounters (61 group sessions and 48 individual) in 19 days, with 70 different patients and 20 insurance plans. Community Medicine's reimbursement: $5,907. Of this, $4,197 went to the University of Pittsburgh's Diabetes Institute.

“We were actually quite pleased with how much we were able to charge, and we weren't displeased with the reimbursement, though we need to recover more to make the program sustainable,” Ms. Emerson said. Recouping even 50% of the charges would make a difference, she said.

Dr. Solano, however, thinks it's going to take more to be truly “cost-effective for primary care.”

“The question is, how can you get it funded by insurers—really, fully underwritten by insurers—but have diabetes educators do true education and not just the 'disease management' that insurers [have touted]?” said the internist, who, in addition to practicing, serves as medical director of the's Center for Quality Improvement and Innovation at the University of Pittsburgh Medical Center.

“Even with better reimbursement levels, the amount of money people get paid certainly is not going to support their salary,” he said.

A model that builds on the CDE model and uses a practice-based educator for a broader swath of education—asthma education and depression education, for example, in addition to the diabetes education—may be more cost effective, he said.

Dr. Siminerio, however, expects reimbursement for diabetes education to increase as insurers realize that CDEs can deliver services in physicians' offices effectively—and particularly, as insurers see outcomes data from the sources such as the Community Medicine practices. “At this point, it's such a new model,” she said.

When a diabetic patient needs to see a diabetes educator, convenient access can boost compliance and help improve health outcomes.

That's the experience of Dr. Francis X. Solano Jr. and his primary care colleagues, who refer patients with newly diagnosed or uncontrolled diabetes to a certified diabetes educator, who meets patients on site.

By having the educator in the office on designated days, most patients follow through and receive the prescribed diabetes self-management education (DSME). As a result, they have improved their health outcomes, Dr. Solano said in an interview.

The on-site education has also shown the physicians what can be achieved with outliers and new diabetics. “Some 65% of our patients now have an A_1c less than 7, and only 8% have an A_1c greater than 9. When we started [the project], at least 20% of our patients were above 9,” he said.

Dr. Solano's practice is one of six primary care practices in Community Medicine Inc. (a group of 65 practices owned and managed by the University of Pittsburgh Medical Center) that are participating in a project aimed at integrating DSME directly into primary care offices, where it can be most easily accessed.

Although details of the project may not all be replicable outside such a large medical system, experts at the University of Pittsburgh Medical Center believe they are demonstrating why more primary care physicians should contract with diabetes education programs to bring educators in-house.

Physicians “need to think outside the box and look at what kinds of relationships they can develop with hospital program leaders,” said Linda M. Siminerio, Ph.D., director of the University of Pittsburgh's Diabetes Institute and senior vice president of the International Diabetes Federation.

The University of Pittsburgh Medical Center is a logical place to try out such an approach. It's a large system with 19 hospitals and 21 diabetes education programs that are recognized by the American Diabetes Association (ADA) and overseen by the diabetes institute. Each year, 80,000 patients access diabetes care through the system. Yet despite the system's infrastructure and availability of services, a “disappointing number of patients [within it] receive DSME,” said Sharlene Emerson, the certified diabetes educator involved in the program.

“Doctors don't know where the programs are, when they are [run], and they don't know how to refer a patient,” Ms. Emerson said during a presentation at the annual meeting of the American Diabetes Association in Washington. And when they do refer, patients don't always follow through, she said.

Dr. Jennifer Mayfield, a family physician from Seattle, said such problems are common. “I don't think insurers understand how difficult it is for us to do the education—we don't have the training and the expertise. And insurers don't appreciate the fact that many patients won't go across town.”

The University of Pittsburgh Medical Center project was started after physicians and other leaders of Community Medicine met in 2003 to discuss the state of diabetes management in primary care. They agreed on two things: A lack of diabetes education was a barrier to quality diabetes care, and implementing diabetes education in the primary care setting—where 90% of diabetes care is delivered—would improve access to education and boost outcomes.

Community Medicine drew up a contract in 2004 with the University of Pittsburgh's Diabetes Institute. Participating primary care practices in the project would provide space for Ms. Emerson during specific times, do the scheduling, bill for the diabetes education services (CDEs are not Medicare-recognized providers and cannot bill insurers directly), and pay the diabetes institute a set fraction of the reimbursement for Ms. Emerson's time.

At that point, Ms. Emerson had begun working on a pilot basis (with grant money from University of Pittsburgh Medical Center) at Dr. Solano's practice on one 8-hour day a week, alongside the practice's registered dietitian. She and other University of Pittsburgh Medical Center experts had secured recognition for the practice's education program from the American Diabetes Association. (Providers must have program recognition from the ADA or the Indian Health Service to bill Medicare for DSME.)

Now, five other Community Medicine primary care practices have ADA recognition and are opening their doors regularly for Ms. Emerson. Other University of Pittsburgh Medical Center-affiliated practices, including a large cardiology practice, have expressed interest in signing contracts.

Of all the issues involved in implementing DSME in primary care, scheduling and space have been among the most easily resolved, Ms. Emerson said at the ADA meeting and in an interview.

At one practice, she was allotted her own space. In another practice, she uses a physician's personal office to meet with patients. In others, she holds group classes in waiting rooms at times when there are no other patients—an approach that affords the privacy mandated by federal law.

Thus far, she has scheduled initial visits for 90 minutes and return visits for 45 minutes. Her approach exemplifies the trend in diabetes education, away from didactic programs to sessions aimed at getting patients engaged in setting goals, changing behaviors, and solving problems.

Most patients decide to return for 2–4 group sessions per year—most of which fall within Medicare's allowed coverage of 10 hours in the initial year (including 9 hours of group education) and 2 hours each subsequent year. The physician is responsible for maintaining the plan of care in the patient's medical record.

It will become easier for physicians to get ADA certification for education programs as the association becomes more flexible. For example, the ADA is now allowing programs to apply for “expansion site” recognition, an arrangement that could apply to a partnership between a primary care practice and a hospital, Dr. Siminerio said.

Reimbursement Issues Pose Challenges

The finances of the program are a work in progress—and, not surprisingly, reimbursement is the most challenging issue the project leaders face. “Insurer issues,” as Ms. Emerson calls them, are at the forefront.

“Many insurers were concerned that DSME in primary care was being provided by the physicians and/or staff as opposed to an ADA-recognized program,” she said at the meeting. “They just thought it was a physician-driven program and they weren't going to pay for it, no matter how we explained it.”

In the first quarter of 2006, the three practices that had begun billing by that point together billed for $31,560; this covered 109 encounters (61 group sessions and 48 individual) in 19 days, with 70 different patients and 20 insurance plans. Community Medicine's reimbursement: $5,907. Of this, $4,197 went to the University of Pittsburgh's Diabetes Institute.

“We were actually quite pleased with how much we were able to charge, and we weren't displeased with the reimbursement, though we need to recover more to make the program sustainable,” Ms. Emerson said. Recouping even 50% of the charges would make a difference, she said.

Dr. Solano, however, thinks it's going to take more to be truly “cost-effective for primary care.”

“The question is, how can you get it funded by insurers—really, fully underwritten by insurers—but have diabetes educators do true education and not just the 'disease management' that insurers [have touted]?” said the internist, who, in addition to practicing, serves as medical director of the's Center for Quality Improvement and Innovation at the University of Pittsburgh Medical Center.

“Even with better reimbursement levels, the amount of money people get paid certainly is not going to support their salary,” he said.

A model that builds on the CDE model and uses a practice-based educator for a broader swath of education—asthma education and depression education, for example, in addition to the diabetes education—may be more cost effective, he said.

Dr. Siminerio, however, expects reimbursement for diabetes education to increase as insurers realize that CDEs can deliver services in physicians' offices effectively—and particularly, as insurers see outcomes data from the sources such as the Community Medicine practices. “At this point, it's such a new model,” she said.

Findings from a study of olanzapine, quetiapine, and risperidone in patients with Alzheimer's disease call into question the clinical value of these second-generation antipsychotic drugs and suggest that physicians should use them judiciously.

The double-blind, placebo-controlled trial of more than 400 patients demonstrated no clear benefit from treatment with the atypical antipsychotic medications in patients with psychosis, aggression, and agitation associated with Alzheimer's disease (N. Engl. J. Med. 2006;355:1525–38).

Overall, drug-related adverse events offset any advantages, said Dr. Lon S. Schneider, of the Keck School of Medicine at the University of Southern California, Los Angeles, and the other investigators of the National Institute of Mental Health's “Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer's Disease” (CATIE-AD) study group.

The 42-site trial assessed the effectiveness of olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) in 421 patients with a broad spectrum of disease severity and behavioral problems that were severe enough to disrupt their functioning.

The patients, who were ambulatory and living at home or in an assisted-living facility, were randomized to receive one of the drugs or placebo and were followed for 36 weeks.

In a trial designed to reflect real-world clinical practice, physicians participating in the study determined their patients' starting doses and adjusted the doses or discontinued treatment as they saw necessary.

Medications were dispensed as identically-appearing small and large capsules containing lower and higher doses of the drugs.

During the study period, the physicians increased initial doses to a mean daily dose of 5.5 mg of olanzapine, 1 mg of risperidone, and 57 mg of quetiapine.

There was no significant difference between the groups in terms of the primary outcome, the length of time patients remained on the drugs before physicians decided to discontinue for any reason. The median time to discontinuation ranged from approximately 5 weeks with quetiapine to 8 weeks for olanzapine and placebo. Overall, 63% of patients were no longer receiving their medications at 12 weeks.

Nor were there significant differences between groups in terms of the number of patients with at least minimal improvement on the Clinical Global Impression of Change scale at 12 weeks.

Improvement was seen in 32% of patients on olanzapine, 29% of patients taking risperidone, 26% of patients on quetiapine, and 21% of patients assigned to placebo

Olanzapine and risperidone fared best in terms of the time to discontinuation of treatment because of “lack of efficacy,” (a median time of 22 weeks and 27 weeks, respectively).

This finding was offset, however, by increased rates of discontinuation because of “intolerability” or “adverse events” such as sedation or extrapyramidal symptoms. Treatment was stopped for these reasons in 24% of patients who received olanzapine, 18% of those on risperidone, 16% who received quetiapine, and 5% of those receiving placebo.

In an accompanying editorial, Dr. Jason Karlawish, who is with the Alzheimer's Disease Center in the University of Pennsylvania's Institute on Aging in Philadelphia, said that despite the Food and Drug Administration's warnings against the use of atypical antipsychotics in elderly patients with dementia-related psychosis, “clinicians, including me, continue to prescribe these drugs.”

Physicians “have done this without clear evidence of the nature and extent of the clinical value of antipsychotic medications–until now,” he wrote (N. Engl. J. Med. 2006;355:1604).

Dr. Karlawish noted that previous trials of treatment for behavioral problems in patients with Alzheimer's disease have assigned patients to fixed doses of drugs for fixed periods of time and have measured efficacy using measures of symptom severity, such as the Neuropsychiatric Inventory, that are not used in clinical practice.

Such study designs do not reflect clinical practice and “hence, will not likely lead to appropriate changes in clinical practice,” he said.

These new findings suggest that atypical antipsychotics may be “best prescribed in systems of care that can provide the skills and expertise needed to ensure that the risks associated with the drugs are justified by their potential benefits,” Dr Karlawish concluded.

The recent NEJM report covers phase I of the CATIE-AD study.

In a second phase of CATIE-AD, to be reported in the future, patients whose treatment was discontinued during the 36-week period of phase I could be randomly assigned to receive another one of the three atypical antipsychotic drugs. Or they might be assigned to receive the antidepressant medication citalopram (Celexa).

ELSEVIER GLOBAL MEDICAL NEWS

Findings from a study of olanzapine, quetiapine, and risperidone in patients with Alzheimer's disease call into question the clinical value of these second-generation antipsychotic drugs and suggest that physicians should use them judiciously.

The double-blind, placebo-controlled trial of more than 400 patients demonstrated no clear benefit from treatment with the atypical antipsychotic medications in patients with psychosis, aggression, and agitation associated with Alzheimer's disease (N. Engl. J. Med. 2006;355:1525–38).

Overall, drug-related adverse events offset any advantages, said Dr. Lon S. Schneider, of the Keck School of Medicine at the University of Southern California, Los Angeles, and the other investigators of the National Institute of Mental Health's “Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer's Disease” (CATIE-AD) study group.

The 42-site trial assessed the effectiveness of olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) in 421 patients with a broad spectrum of disease severity and behavioral problems that were severe enough to disrupt their functioning.

The patients, who were ambulatory and living at home or in an assisted-living facility, were randomized to receive one of the drugs or placebo and were followed for 36 weeks.

In a trial designed to reflect real-world clinical practice, physicians participating in the study determined their patients' starting doses and adjusted the doses or discontinued treatment as they saw necessary.

Medications were dispensed as identically-appearing small and large capsules containing lower and higher doses of the drugs.

During the study period, the physicians increased initial doses to a mean daily dose of 5.5 mg of olanzapine, 1 mg of risperidone, and 57 mg of quetiapine.

There was no significant difference between the groups in terms of the primary outcome, the length of time patients remained on the drugs before physicians decided to discontinue for any reason. The median time to discontinuation ranged from approximately 5 weeks with quetiapine to 8 weeks for olanzapine and placebo. Overall, 63% of patients were no longer receiving their medications at 12 weeks.

Nor were there significant differences between groups in terms of the number of patients with at least minimal improvement on the Clinical Global Impression of Change scale at 12 weeks.

Improvement was seen in 32% of patients on olanzapine, 29% of patients taking risperidone, 26% of patients on quetiapine, and 21% of patients assigned to placebo

Olanzapine and risperidone fared best in terms of the time to discontinuation of treatment because of “lack of efficacy,” (a median time of 22 weeks and 27 weeks, respectively).

This finding was offset, however, by increased rates of discontinuation because of “intolerability” or “adverse events” such as sedation or extrapyramidal symptoms. Treatment was stopped for these reasons in 24% of patients who received olanzapine, 18% of those on risperidone, 16% who received quetiapine, and 5% of those receiving placebo.

In an accompanying editorial, Dr. Jason Karlawish, who is with the Alzheimer's Disease Center in the University of Pennsylvania's Institute on Aging in Philadelphia, said that despite the Food and Drug Administration's warnings against the use of atypical antipsychotics in elderly patients with dementia-related psychosis, “clinicians, including me, continue to prescribe these drugs.”

Physicians “have done this without clear evidence of the nature and extent of the clinical value of antipsychotic medications–until now,” he wrote (N. Engl. J. Med. 2006;355:1604).

Dr. Karlawish noted that previous trials of treatment for behavioral problems in patients with Alzheimer's disease have assigned patients to fixed doses of drugs for fixed periods of time and have measured efficacy using measures of symptom severity, such as the Neuropsychiatric Inventory, that are not used in clinical practice.

Such study designs do not reflect clinical practice and “hence, will not likely lead to appropriate changes in clinical practice,” he said.

These new findings suggest that atypical antipsychotics may be “best prescribed in systems of care that can provide the skills and expertise needed to ensure that the risks associated with the drugs are justified by their potential benefits,” Dr Karlawish concluded.

The recent NEJM report covers phase I of the CATIE-AD study.

In a second phase of CATIE-AD, to be reported in the future, patients whose treatment was discontinued during the 36-week period of phase I could be randomly assigned to receive another one of the three atypical antipsychotic drugs. Or they might be assigned to receive the antidepressant medication citalopram (Celexa).

ELSEVIER GLOBAL MEDICAL NEWS

Findings from a study of olanzapine, quetiapine, and risperidone in patients with Alzheimer's disease call into question the clinical value of these second-generation antipsychotic drugs and suggest that physicians should use them judiciously.

The double-blind, placebo-controlled trial of more than 400 patients demonstrated no clear benefit from treatment with the atypical antipsychotic medications in patients with psychosis, aggression, and agitation associated with Alzheimer's disease (N. Engl. J. Med. 2006;355:1525–38).

Overall, drug-related adverse events offset any advantages, said Dr. Lon S. Schneider, of the Keck School of Medicine at the University of Southern California, Los Angeles, and the other investigators of the National Institute of Mental Health's “Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer's Disease” (CATIE-AD) study group.

The 42-site trial assessed the effectiveness of olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) in 421 patients with a broad spectrum of disease severity and behavioral problems that were severe enough to disrupt their functioning.

The patients, who were ambulatory and living at home or in an assisted-living facility, were randomized to receive one of the drugs or placebo and were followed for 36 weeks.

In a trial designed to reflect real-world clinical practice, physicians participating in the study determined their patients' starting doses and adjusted the doses or discontinued treatment as they saw necessary.

Medications were dispensed as identically-appearing small and large capsules containing lower and higher doses of the drugs.

During the study period, the physicians increased initial doses to a mean daily dose of 5.5 mg of olanzapine, 1 mg of risperidone, and 57 mg of quetiapine.

There was no significant difference between the groups in terms of the primary outcome, the length of time patients remained on the drugs before physicians decided to discontinue for any reason. The median time to discontinuation ranged from approximately 5 weeks with quetiapine to 8 weeks for olanzapine and placebo. Overall, 63% of patients were no longer receiving their medications at 12 weeks.

Nor were there significant differences between groups in terms of the number of patients with at least minimal improvement on the Clinical Global Impression of Change scale at 12 weeks.

Improvement was seen in 32% of patients on olanzapine, 29% of patients taking risperidone, 26% of patients on quetiapine, and 21% of patients assigned to placebo

Olanzapine and risperidone fared best in terms of the time to discontinuation of treatment because of “lack of efficacy,” (a median time of 22 weeks and 27 weeks, respectively).

This finding was offset, however, by increased rates of discontinuation because of “intolerability” or “adverse events” such as sedation or extrapyramidal symptoms. Treatment was stopped for these reasons in 24% of patients who received olanzapine, 18% of those on risperidone, 16% who received quetiapine, and 5% of those receiving placebo.

In an accompanying editorial, Dr. Jason Karlawish, who is with the Alzheimer's Disease Center in the University of Pennsylvania's Institute on Aging in Philadelphia, said that despite the Food and Drug Administration's warnings against the use of atypical antipsychotics in elderly patients with dementia-related psychosis, “clinicians, including me, continue to prescribe these drugs.”

Physicians “have done this without clear evidence of the nature and extent of the clinical value of antipsychotic medications–until now,” he wrote (N. Engl. J. Med. 2006;355:1604).

Dr. Karlawish noted that previous trials of treatment for behavioral problems in patients with Alzheimer's disease have assigned patients to fixed doses of drugs for fixed periods of time and have measured efficacy using measures of symptom severity, such as the Neuropsychiatric Inventory, that are not used in clinical practice.

Such study designs do not reflect clinical practice and “hence, will not likely lead to appropriate changes in clinical practice,” he said.

These new findings suggest that atypical antipsychotics may be “best prescribed in systems of care that can provide the skills and expertise needed to ensure that the risks associated with the drugs are justified by their potential benefits,” Dr Karlawish concluded.

The recent NEJM report covers phase I of the CATIE-AD study.

In a second phase of CATIE-AD, to be reported in the future, patients whose treatment was discontinued during the 36-week period of phase I could be randomly assigned to receive another one of the three atypical antipsychotic drugs. Or they might be assigned to receive the antidepressant medication citalopram (Celexa).

ELSEVIER GLOBAL MEDICAL NEWS

A simple serum lipid test may identify patients with systemic lupus erythematosus who are at an increased risk for renal dysfunction, according to investigators.

Data collected on 1,060 patients with SLE who were registered at the University of Toronto Lupus Databank were analyzed by Annaliese Tisseveras and her colleagues.

They found that an elevated serum total cholesterol level in the first sample obtained from patients and recorded in the databank was significantly associated with subsequent renal deterioration and death associated with kidney dysfunction (Arthritis Rheum. 2006;54:2211-9).

“Independent of any association with proteinuria or steroid therapy, an elevated total cholesterol level portends a worse renal outcome,” reported Ms. Tisseveras and her colleagues at Toronto Western Hospital. More research is needed, they noted, but “the predictive value of an elevated cholesterol level on renal function … cannot be discounted.”

The patients, who were mostly women, had a mean age of 36 years and a mean duration of SLE of 4 years when the first total cholesterol measurement was recorded. The first measurement ranged from 1.6 to 17.1 mmol/L, with a mean of 5.3 mmol/L (205 mg/dL).

During an average follow-up of almost 9 years, 9% of patients experienced renal deterioration, 4% developed end-stage renal disease (ESRD), and 15% died (30% of the deaths were associated with renal dysfunction). The investigators stratified patients into two groups: those with normal total cholesterol levels and those with elevated levels. They then looked at Kaplan-Meier survival estimates for each of the three outcomes—renal deterioration, ESRD, and death. The estimates for each of the outcomes, they found, were significantly different between the two groups, with worse outcomes in the group with elevated total cholesterol levels.

In multivariate analyses that included other variables, baseline proteinuria and serum creatinine level were predictive of both ESRD and renal deterioration. Total cholesterol level did not retain its significance with regard to ESRD, however, which may be due to the low number of patients with ESRD.

Total cholesterol level did, however, correlate again with death, and significantly with renal death—a finding that is “strongly supportive of a pathogenic role for hypercholesterolemia in SLE renal disease,” the investigators reported.

A simple serum lipid test may identify patients with systemic lupus erythematosus who are at an increased risk for renal dysfunction, according to investigators.

Data collected on 1,060 patients with SLE who were registered at the University of Toronto Lupus Databank were analyzed by Annaliese Tisseveras and her colleagues.

They found that an elevated serum total cholesterol level in the first sample obtained from patients and recorded in the databank was significantly associated with subsequent renal deterioration and death associated with kidney dysfunction (Arthritis Rheum. 2006;54:2211-9).

“Independent of any association with proteinuria or steroid therapy, an elevated total cholesterol level portends a worse renal outcome,” reported Ms. Tisseveras and her colleagues at Toronto Western Hospital. More research is needed, they noted, but “the predictive value of an elevated cholesterol level on renal function … cannot be discounted.”

The patients, who were mostly women, had a mean age of 36 years and a mean duration of SLE of 4 years when the first total cholesterol measurement was recorded. The first measurement ranged from 1.6 to 17.1 mmol/L, with a mean of 5.3 mmol/L (205 mg/dL).

During an average follow-up of almost 9 years, 9% of patients experienced renal deterioration, 4% developed end-stage renal disease (ESRD), and 15% died (30% of the deaths were associated with renal dysfunction). The investigators stratified patients into two groups: those with normal total cholesterol levels and those with elevated levels. They then looked at Kaplan-Meier survival estimates for each of the three outcomes—renal deterioration, ESRD, and death. The estimates for each of the outcomes, they found, were significantly different between the two groups, with worse outcomes in the group with elevated total cholesterol levels.

In multivariate analyses that included other variables, baseline proteinuria and serum creatinine level were predictive of both ESRD and renal deterioration. Total cholesterol level did not retain its significance with regard to ESRD, however, which may be due to the low number of patients with ESRD.

Total cholesterol level did, however, correlate again with death, and significantly with renal death—a finding that is “strongly supportive of a pathogenic role for hypercholesterolemia in SLE renal disease,” the investigators reported.

A simple serum lipid test may identify patients with systemic lupus erythematosus who are at an increased risk for renal dysfunction, according to investigators.

Data collected on 1,060 patients with SLE who were registered at the University of Toronto Lupus Databank were analyzed by Annaliese Tisseveras and her colleagues.

They found that an elevated serum total cholesterol level in the first sample obtained from patients and recorded in the databank was significantly associated with subsequent renal deterioration and death associated with kidney dysfunction (Arthritis Rheum. 2006;54:2211-9).

“Independent of any association with proteinuria or steroid therapy, an elevated total cholesterol level portends a worse renal outcome,” reported Ms. Tisseveras and her colleagues at Toronto Western Hospital. More research is needed, they noted, but “the predictive value of an elevated cholesterol level on renal function … cannot be discounted.”

The patients, who were mostly women, had a mean age of 36 years and a mean duration of SLE of 4 years when the first total cholesterol measurement was recorded. The first measurement ranged from 1.6 to 17.1 mmol/L, with a mean of 5.3 mmol/L (205 mg/dL).

During an average follow-up of almost 9 years, 9% of patients experienced renal deterioration, 4% developed end-stage renal disease (ESRD), and 15% died (30% of the deaths were associated with renal dysfunction). The investigators stratified patients into two groups: those with normal total cholesterol levels and those with elevated levels. They then looked at Kaplan-Meier survival estimates for each of the three outcomes—renal deterioration, ESRD, and death. The estimates for each of the outcomes, they found, were significantly different between the two groups, with worse outcomes in the group with elevated total cholesterol levels.

In multivariate analyses that included other variables, baseline proteinuria and serum creatinine level were predictive of both ESRD and renal deterioration. Total cholesterol level did not retain its significance with regard to ESRD, however, which may be due to the low number of patients with ESRD.

Total cholesterol level did, however, correlate again with death, and significantly with renal death—a finding that is “strongly supportive of a pathogenic role for hypercholesterolemia in SLE renal disease,” the investigators reported.

Daily supplementation with calcium and vitamin D boosted bone mineral density by a small but statistically significant amount in children with juvenile rheumatoid arthritis who were not being treated with corticosteroids, according to findings from a randomized, double-blind, placebo-controlled trial.

“Since peak bone mass is achieved no later than the end of the second decade of life, efforts to increase bone mineralization in children with JRA must be started at an early age,” said Dr. Daniel J. Lovell of the Cincinnati Children's Hospital Medical Center and his associates.

The investigators were cautious in their interpretation of the findings, however, concluding that the increase in bone mineral density (BMD) was not enough to provide “strong support” for the use of routine calcium supplementation in children with JRA who are not taking corticosteroids. The 198 children in the study had not received corticosteroids for at least 3 months prior to the 24-month study, and many had normal or nearly normal baseline BMD.

The children, aged 6-18 years (mean age of 12 years), had had JRA for a mean of 6 years. They were randomized to receive two daily oral tablets—either an oral supplement of 1,000 mg calcium (taken as 2,500 mg calcium carbonate) and a tablet containing 400 IU of vitamin D, or a matched placebo tablet and 400 IU of vitamin D, for 24 months.

They underwent dual x-ray absorptiometry at baseline and then every 6 months, and their adherence to the treatment regimen was regularly assessed. They were permitted to continue taking nonsteroidal anti-inflammatory drugs and antirheumatic medications. Patients in both treatment groups had similar levels of physical activity and dietary intake of calcium at baseline and throughout the study.

At baseline, the mean total body BMD was 0.89 gm/cm2 among patients randomized to receive calcium, and 0.87 gm/cm2 among those randomized to receive placebo. At 24 months, the total body BMD had increased to 0.95 gm/cm2 in the calcium group (a 6.7% increase) and 0.92 gm/cm2 (a 5.8% increase) in the placebo group.

Similarly, patients treated with calcium had a higher lumbar spine BMD—and a higher percentage change in lumbar spine BMD—than did control patients. But, “as expected, all patients demonstrated increases in (total body BMD) and lumbar spine BMD,” Dr. Lovell and his associates said (Arthritis Rheum. 2006;54:2235-42).

When the investigators adjusted for baseline differences in BMD and relevant “outcome effect modifiers,” they found significantly higher total body and mean lumbar spine BMD in patients who received calcium.

The increased rate of bone mineralization in the calcium group was seen during the first 18 months only, however. For the last 6 months of the study, BMD increased at a similar rate in both groups, “suggesting that a threshold for the biologic effect of Ca supplementation had been reached,” the investigators said.

And although statistically significant, the increases in BMD were surprisingly small, they said. Based on an earlier small, open study that showed increased bone mineralization with calcium supplementation, the investigators had projected a 10% greater increase in total body BMD in calcium-treated patients.

The “modest response … may be a reflection of the pathogenic mechanisms of JRA-associated osteopenia,” they wrote. “The potency of [inflammatory cytokines] to mediate BMD, and their systemic overproduction in autoimmune diseases such as JRA may be difficult to overcome with oral calcium treatment alone.”

Adherence to the supplementation regimen was “very good overall” in the study—much higher than in other studies—which means that “the effect of calcium supplementation, when used as part of routine clinical care … may therefore be less than the effect seen [here],” they said.

The study did not address the role of calcium supplementation in patients with JRA who require treatment with corticosteroids or who already have significantly decreased BMD, they noted.

Daily supplementation with calcium and vitamin D boosted bone mineral density by a small but statistically significant amount in children with juvenile rheumatoid arthritis who were not being treated with corticosteroids, according to findings from a randomized, double-blind, placebo-controlled trial.

“Since peak bone mass is achieved no later than the end of the second decade of life, efforts to increase bone mineralization in children with JRA must be started at an early age,” said Dr. Daniel J. Lovell of the Cincinnati Children's Hospital Medical Center and his associates.

The investigators were cautious in their interpretation of the findings, however, concluding that the increase in bone mineral density (BMD) was not enough to provide “strong support” for the use of routine calcium supplementation in children with JRA who are not taking corticosteroids. The 198 children in the study had not received corticosteroids for at least 3 months prior to the 24-month study, and many had normal or nearly normal baseline BMD.

The children, aged 6-18 years (mean age of 12 years), had had JRA for a mean of 6 years. They were randomized to receive two daily oral tablets—either an oral supplement of 1,000 mg calcium (taken as 2,500 mg calcium carbonate) and a tablet containing 400 IU of vitamin D, or a matched placebo tablet and 400 IU of vitamin D, for 24 months.

They underwent dual x-ray absorptiometry at baseline and then every 6 months, and their adherence to the treatment regimen was regularly assessed. They were permitted to continue taking nonsteroidal anti-inflammatory drugs and antirheumatic medications. Patients in both treatment groups had similar levels of physical activity and dietary intake of calcium at baseline and throughout the study.

At baseline, the mean total body BMD was 0.89 gm/cm2 among patients randomized to receive calcium, and 0.87 gm/cm2 among those randomized to receive placebo. At 24 months, the total body BMD had increased to 0.95 gm/cm2 in the calcium group (a 6.7% increase) and 0.92 gm/cm2 (a 5.8% increase) in the placebo group.

Similarly, patients treated with calcium had a higher lumbar spine BMD—and a higher percentage change in lumbar spine BMD—than did control patients. But, “as expected, all patients demonstrated increases in (total body BMD) and lumbar spine BMD,” Dr. Lovell and his associates said (Arthritis Rheum. 2006;54:2235-42).

When the investigators adjusted for baseline differences in BMD and relevant “outcome effect modifiers,” they found significantly higher total body and mean lumbar spine BMD in patients who received calcium.

The increased rate of bone mineralization in the calcium group was seen during the first 18 months only, however. For the last 6 months of the study, BMD increased at a similar rate in both groups, “suggesting that a threshold for the biologic effect of Ca supplementation had been reached,” the investigators said.

And although statistically significant, the increases in BMD were surprisingly small, they said. Based on an earlier small, open study that showed increased bone mineralization with calcium supplementation, the investigators had projected a 10% greater increase in total body BMD in calcium-treated patients.

The “modest response … may be a reflection of the pathogenic mechanisms of JRA-associated osteopenia,” they wrote. “The potency of [inflammatory cytokines] to mediate BMD, and their systemic overproduction in autoimmune diseases such as JRA may be difficult to overcome with oral calcium treatment alone.”

Adherence to the supplementation regimen was “very good overall” in the study—much higher than in other studies—which means that “the effect of calcium supplementation, when used as part of routine clinical care … may therefore be less than the effect seen [here],” they said.

The study did not address the role of calcium supplementation in patients with JRA who require treatment with corticosteroids or who already have significantly decreased BMD, they noted.

Daily supplementation with calcium and vitamin D boosted bone mineral density by a small but statistically significant amount in children with juvenile rheumatoid arthritis who were not being treated with corticosteroids, according to findings from a randomized, double-blind, placebo-controlled trial.

“Since peak bone mass is achieved no later than the end of the second decade of life, efforts to increase bone mineralization in children with JRA must be started at an early age,” said Dr. Daniel J. Lovell of the Cincinnati Children's Hospital Medical Center and his associates.

The investigators were cautious in their interpretation of the findings, however, concluding that the increase in bone mineral density (BMD) was not enough to provide “strong support” for the use of routine calcium supplementation in children with JRA who are not taking corticosteroids. The 198 children in the study had not received corticosteroids for at least 3 months prior to the 24-month study, and many had normal or nearly normal baseline BMD.

The children, aged 6-18 years (mean age of 12 years), had had JRA for a mean of 6 years. They were randomized to receive two daily oral tablets—either an oral supplement of 1,000 mg calcium (taken as 2,500 mg calcium carbonate) and a tablet containing 400 IU of vitamin D, or a matched placebo tablet and 400 IU of vitamin D, for 24 months.

They underwent dual x-ray absorptiometry at baseline and then every 6 months, and their adherence to the treatment regimen was regularly assessed. They were permitted to continue taking nonsteroidal anti-inflammatory drugs and antirheumatic medications. Patients in both treatment groups had similar levels of physical activity and dietary intake of calcium at baseline and throughout the study.

At baseline, the mean total body BMD was 0.89 gm/cm2 among patients randomized to receive calcium, and 0.87 gm/cm2 among those randomized to receive placebo. At 24 months, the total body BMD had increased to 0.95 gm/cm2 in the calcium group (a 6.7% increase) and 0.92 gm/cm2 (a 5.8% increase) in the placebo group.

Similarly, patients treated with calcium had a higher lumbar spine BMD—and a higher percentage change in lumbar spine BMD—than did control patients. But, “as expected, all patients demonstrated increases in (total body BMD) and lumbar spine BMD,” Dr. Lovell and his associates said (Arthritis Rheum. 2006;54:2235-42).

When the investigators adjusted for baseline differences in BMD and relevant “outcome effect modifiers,” they found significantly higher total body and mean lumbar spine BMD in patients who received calcium.

The increased rate of bone mineralization in the calcium group was seen during the first 18 months only, however. For the last 6 months of the study, BMD increased at a similar rate in both groups, “suggesting that a threshold for the biologic effect of Ca supplementation had been reached,” the investigators said.

And although statistically significant, the increases in BMD were surprisingly small, they said. Based on an earlier small, open study that showed increased bone mineralization with calcium supplementation, the investigators had projected a 10% greater increase in total body BMD in calcium-treated patients.

The “modest response … may be a reflection of the pathogenic mechanisms of JRA-associated osteopenia,” they wrote. “The potency of [inflammatory cytokines] to mediate BMD, and their systemic overproduction in autoimmune diseases such as JRA may be difficult to overcome with oral calcium treatment alone.”

Adherence to the supplementation regimen was “very good overall” in the study—much higher than in other studies—which means that “the effect of calcium supplementation, when used as part of routine clinical care … may therefore be less than the effect seen [here],” they said.

The study did not address the role of calcium supplementation in patients with JRA who require treatment with corticosteroids or who already have significantly decreased BMD, they noted.

WASHINGTON — Measures of thyroperoxidase autoantibody and thyroid-stimulating hormone once every 2 years are a reliable alternative to annual screens for thyroid disease in children with type 1 diabetes, Dr. Linda A. DiMeglio reported at the annual scientific sessions of the American Diabetes Association.

After thyroperoxidase (TPO) autoantibody results come back positive, thyroid-stimulating hormone (TSH) and thyroxine (T4) tests are performed annually.

Thyroid disease screening in children with diabetes often consists of annual TSH and T4 tests. Endocrinologists at the James Whitcomb Riley Hospital for Children in Indianapolis, decided to modify the protocol by using TPO testing, after the results of studies at their institution and others showed that elevated TPO levels were highly predictive of autoimmune thyroid disease, Dr. DiMeglio said.

Antibodies against TPO and thyroglobulin are found in approximately 10% of the general population and in up to 25% of people with type 1 diabetes, said Dr. DiMeglio of the Indiana University School of Medicine.

Although both are helpful in predicting the development of autoimmune thyroiditis in diabetic patients, “more patients with autoimmune thyroid disease have high TPO levels than have high thyroglobulin levels, and TPO levels correlate with the active phase of disease.”

Investigators at Riley Hospital did a retrospective study of 462 diabetic children (mean age of 13) who had both TSH and thyroid-specific autoantibodies measured. The prevalence of thyroid autoimmunity was approximately 20% and the prevalence of autoimmune thyroid disease was about 5%, she said.

“All the patients in this population who were diagnosed with autoimmune thyroid disease also had thyroid autoimmunity,” she said. Disease prevalence increased as autoantibody levels rose and as children got older.

More data are needed to predict the rate of progression from detection of autoimmunity to development of hypothyroidism. “The rate of decline in thyroid hormone secretion is slow, which is important to realize when you look at screening every 2 years versus annual screening,” Dr. DiMeglio said. “By doing TPO as an anticipatory measure and TSH as a point-in-time measure, it's unlikely that you'll miss kids who have developed severe hypothyroidism over the 2-year period.”

Endocrinologists at Riley Hospital now perform their first screening for TSH and TPO at the first visit after the diagnosis of type 1 diabetes. After TPO antibodies are detected, the endocrinologists are divided about whether to measure total or free T4 at annual testing for TSH and T4. “I prefer using a total T4, but some of my colleagues feel differently,” Dr. DiMeglio said.

Thyroid disease is difficult to diagnose clinically in diabetes. The presentation of hypothyroidism, in particular, can resemble that of nephropathy and neuropathy. And the symptoms of hyperthyroidism can be similar to those of poor glycemic control.

Hypothyroidism can directly affect the course of diabetes, reducing the insulin degradation rate and causing abnormalities in lipid metabolism such as elevated triglycerides and LDL cholesterol, Dr. DiMeglio said.

Hypothyroidism will affect 15%–30% of patients with diabetes over their lifetimes. As in the general population, thyroid disease is associated with increasing age, female gender, and white ethnicity.

Hyperthyroidism appears to affect people with diabetes at about the same rate as it does the general population, DiMeglio noted.

Although the TSH assay is the most reliable screening test for thyroid dysfunction of either type, “it's important to remember that it's not perfect,” and that poorly controlled diabetes can result in “inappropriately low” serum TSH concentrations, she said.

WASHINGTON — Measures of thyroperoxidase autoantibody and thyroid-stimulating hormone once every 2 years are a reliable alternative to annual screens for thyroid disease in children with type 1 diabetes, Dr. Linda A. DiMeglio reported at the annual scientific sessions of the American Diabetes Association.

After thyroperoxidase (TPO) autoantibody results come back positive, thyroid-stimulating hormone (TSH) and thyroxine (T4) tests are performed annually.

Thyroid disease screening in children with diabetes often consists of annual TSH and T4 tests. Endocrinologists at the James Whitcomb Riley Hospital for Children in Indianapolis, decided to modify the protocol by using TPO testing, after the results of studies at their institution and others showed that elevated TPO levels were highly predictive of autoimmune thyroid disease, Dr. DiMeglio said.

Antibodies against TPO and thyroglobulin are found in approximately 10% of the general population and in up to 25% of people with type 1 diabetes, said Dr. DiMeglio of the Indiana University School of Medicine.

Although both are helpful in predicting the development of autoimmune thyroiditis in diabetic patients, “more patients with autoimmune thyroid disease have high TPO levels than have high thyroglobulin levels, and TPO levels correlate with the active phase of disease.”

Investigators at Riley Hospital did a retrospective study of 462 diabetic children (mean age of 13) who had both TSH and thyroid-specific autoantibodies measured. The prevalence of thyroid autoimmunity was approximately 20% and the prevalence of autoimmune thyroid disease was about 5%, she said.

“All the patients in this population who were diagnosed with autoimmune thyroid disease also had thyroid autoimmunity,” she said. Disease prevalence increased as autoantibody levels rose and as children got older.

More data are needed to predict the rate of progression from detection of autoimmunity to development of hypothyroidism. “The rate of decline in thyroid hormone secretion is slow, which is important to realize when you look at screening every 2 years versus annual screening,” Dr. DiMeglio said. “By doing TPO as an anticipatory measure and TSH as a point-in-time measure, it's unlikely that you'll miss kids who have developed severe hypothyroidism over the 2-year period.”

Endocrinologists at Riley Hospital now perform their first screening for TSH and TPO at the first visit after the diagnosis of type 1 diabetes. After TPO antibodies are detected, the endocrinologists are divided about whether to measure total or free T4 at annual testing for TSH and T4. “I prefer using a total T4, but some of my colleagues feel differently,” Dr. DiMeglio said.

Thyroid disease is difficult to diagnose clinically in diabetes. The presentation of hypothyroidism, in particular, can resemble that of nephropathy and neuropathy. And the symptoms of hyperthyroidism can be similar to those of poor glycemic control.

Hypothyroidism can directly affect the course of diabetes, reducing the insulin degradation rate and causing abnormalities in lipid metabolism such as elevated triglycerides and LDL cholesterol, Dr. DiMeglio said.

Hypothyroidism will affect 15%–30% of patients with diabetes over their lifetimes. As in the general population, thyroid disease is associated with increasing age, female gender, and white ethnicity.

Hyperthyroidism appears to affect people with diabetes at about the same rate as it does the general population, DiMeglio noted.

Although the TSH assay is the most reliable screening test for thyroid dysfunction of either type, “it's important to remember that it's not perfect,” and that poorly controlled diabetes can result in “inappropriately low” serum TSH concentrations, she said.

WASHINGTON — Measures of thyroperoxidase autoantibody and thyroid-stimulating hormone once every 2 years are a reliable alternative to annual screens for thyroid disease in children with type 1 diabetes, Dr. Linda A. DiMeglio reported at the annual scientific sessions of the American Diabetes Association.

After thyroperoxidase (TPO) autoantibody results come back positive, thyroid-stimulating hormone (TSH) and thyroxine (T4) tests are performed annually.

Thyroid disease screening in children with diabetes often consists of annual TSH and T4 tests. Endocrinologists at the James Whitcomb Riley Hospital for Children in Indianapolis, decided to modify the protocol by using TPO testing, after the results of studies at their institution and others showed that elevated TPO levels were highly predictive of autoimmune thyroid disease, Dr. DiMeglio said.

Antibodies against TPO and thyroglobulin are found in approximately 10% of the general population and in up to 25% of people with type 1 diabetes, said Dr. DiMeglio of the Indiana University School of Medicine.

Although both are helpful in predicting the development of autoimmune thyroiditis in diabetic patients, “more patients with autoimmune thyroid disease have high TPO levels than have high thyroglobulin levels, and TPO levels correlate with the active phase of disease.”

Investigators at Riley Hospital did a retrospective study of 462 diabetic children (mean age of 13) who had both TSH and thyroid-specific autoantibodies measured. The prevalence of thyroid autoimmunity was approximately 20% and the prevalence of autoimmune thyroid disease was about 5%, she said.

“All the patients in this population who were diagnosed with autoimmune thyroid disease also had thyroid autoimmunity,” she said. Disease prevalence increased as autoantibody levels rose and as children got older.

More data are needed to predict the rate of progression from detection of autoimmunity to development of hypothyroidism. “The rate of decline in thyroid hormone secretion is slow, which is important to realize when you look at screening every 2 years versus annual screening,” Dr. DiMeglio said. “By doing TPO as an anticipatory measure and TSH as a point-in-time measure, it's unlikely that you'll miss kids who have developed severe hypothyroidism over the 2-year period.”

Endocrinologists at Riley Hospital now perform their first screening for TSH and TPO at the first visit after the diagnosis of type 1 diabetes. After TPO antibodies are detected, the endocrinologists are divided about whether to measure total or free T4 at annual testing for TSH and T4. “I prefer using a total T4, but some of my colleagues feel differently,” Dr. DiMeglio said.

Thyroid disease is difficult to diagnose clinically in diabetes. The presentation of hypothyroidism, in particular, can resemble that of nephropathy and neuropathy. And the symptoms of hyperthyroidism can be similar to those of poor glycemic control.

Hypothyroidism can directly affect the course of diabetes, reducing the insulin degradation rate and causing abnormalities in lipid metabolism such as elevated triglycerides and LDL cholesterol, Dr. DiMeglio said.

Hypothyroidism will affect 15%–30% of patients with diabetes over their lifetimes. As in the general population, thyroid disease is associated with increasing age, female gender, and white ethnicity.

Hyperthyroidism appears to affect people with diabetes at about the same rate as it does the general population, DiMeglio noted.

Although the TSH assay is the most reliable screening test for thyroid dysfunction of either type, “it's important to remember that it's not perfect,” and that poorly controlled diabetes can result in “inappropriately low” serum TSH concentrations, she said.