Christine Kilgore

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a Webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information [from medical records],” he said.

The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” making it likely that many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses the issue of corrections to medical records, saying that “patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

The physicians who attended the NIH session reviewed a case in which a patient presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he also reported symptoms of severe depression and a history of drug use.

The day after the social worker evaluated the 37-year-old unemployed man, he requested that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that if he were the provider faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

Overall, physicians “take the record too seriously” and, although questions remain, they are going to have to be more willing to consider patient requests to alter the medical records, Mr. Annas told this newspaper.

Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he said.

“It makes sense that when you take a history, you should go over it with the patient and ask, 'Is this what you tell me? Is it right?'”

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a Webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information [from medical records],” he said.

The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” making it likely that many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses the issue of corrections to medical records, saying that “patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

The physicians who attended the NIH session reviewed a case in which a patient presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he also reported symptoms of severe depression and a history of drug use.

The day after the social worker evaluated the 37-year-old unemployed man, he requested that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that if he were the provider faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

Overall, physicians “take the record too seriously” and, although questions remain, they are going to have to be more willing to consider patient requests to alter the medical records, Mr. Annas told this newspaper.

Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he said.

“It makes sense that when you take a history, you should go over it with the patient and ask, 'Is this what you tell me? Is it right?'”

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a Webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information [from medical records],” he said.

The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” making it likely that many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses the issue of corrections to medical records, saying that “patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

The physicians who attended the NIH session reviewed a case in which a patient presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he also reported symptoms of severe depression and a history of drug use.

The day after the social worker evaluated the 37-year-old unemployed man, he requested that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that if he were the provider faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

Overall, physicians “take the record too seriously” and, although questions remain, they are going to have to be more willing to consider patient requests to alter the medical records, Mr. Annas told this newspaper.

Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he said.

“It makes sense that when you take a history, you should go over it with the patient and ask, 'Is this what you tell me? Is it right?'”

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper.

“First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation,” he said.

The new research reported in the Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601-7).

The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families. The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease. They found that 35 of 767 affected members of these families (5%)–in 20 of the 358 families–had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (Lancet 2005;365:410-2).

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (Lancet 2005;365:412-5).

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (Lancet 2005;365:415-6).

Each of the studies included large control populations; the mutation was absent from all the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same issue of the Lancet, called identification of the Gly2019Ser mutation “a major advance.” The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations–for instance, the extent and type of Lewy bodies–appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (Lancet 2005;365:363-4).

He and the investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Dr. Gilks' finding of the mutation in patients without any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease.

Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers–a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had less severe clinical symptoms despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he said.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he pointed out.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. “The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.”

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper.

“First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation,” he said.

The new research reported in the Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601-7).

The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families. The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease. They found that 35 of 767 affected members of these families (5%)–in 20 of the 358 families–had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (Lancet 2005;365:410-2).

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (Lancet 2005;365:412-5).

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (Lancet 2005;365:415-6).

Each of the studies included large control populations; the mutation was absent from all the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same issue of the Lancet, called identification of the Gly2019Ser mutation “a major advance.” The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations–for instance, the extent and type of Lewy bodies–appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (Lancet 2005;365:363-4).

He and the investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Dr. Gilks' finding of the mutation in patients without any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease.

Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers–a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had less severe clinical symptoms despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he said.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he pointed out.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. “The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.”

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper.

“First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation,” he said.

The new research reported in the Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601-7).

The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families. The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease. They found that 35 of 767 affected members of these families (5%)–in 20 of the 358 families–had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (Lancet 2005;365:410-2).

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (Lancet 2005;365:412-5).

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (Lancet 2005;365:415-6).

Each of the studies included large control populations; the mutation was absent from all the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same issue of the Lancet, called identification of the Gly2019Ser mutation “a major advance.” The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations–for instance, the extent and type of Lewy bodies–appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (Lancet 2005;365:363-4).

He and the investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Dr. Gilks' finding of the mutation in patients without any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease.

Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers–a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had less severe clinical symptoms despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he said.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he pointed out.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. “The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.”

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information” from medical records. The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” and thus many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses corrections to medical records. “Patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

Physicians at the NIH session reviewed a case in which a 37-year-old unemployed man presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he reported symptoms of severe depression and a history of drug use. The next day, he asked that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that, if faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

He offered his verdict on the case example after a free-ranging discussion in which some physicians voiced concern that a move from “physician's record” to “patient's record” would hinder communication among providers.

“You can't just delete things,” one physician said. “Or if there's going to be a patient medical record, maybe there needs to be another record [for providers],” she said.

It's true, Mr. Annas said, that “defense attorneys still say today that your best defense is a complete medical record.”

But overall, physicians “take the record too seriously.” They will have to be more willing to consider patient requests to alter the medical records, he told this newspaper. Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he added.

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information” from medical records. The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” and thus many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses corrections to medical records. “Patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

Physicians at the NIH session reviewed a case in which a 37-year-old unemployed man presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he reported symptoms of severe depression and a history of drug use. The next day, he asked that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that, if faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

He offered his verdict on the case example after a free-ranging discussion in which some physicians voiced concern that a move from “physician's record” to “patient's record” would hinder communication among providers.

“You can't just delete things,” one physician said. “Or if there's going to be a patient medical record, maybe there needs to be another record [for providers],” she said.

It's true, Mr. Annas said, that “defense attorneys still say today that your best defense is a complete medical record.”

But overall, physicians “take the record too seriously.” They will have to be more willing to consider patient requests to alter the medical records, he told this newspaper. Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he added.

The long-held perception that medical records should never be altered at a patient's request is quickly becoming erroneous, according to health lawyer and ethicist George Annas.

“We can delete (items from the record), as long as we note that something has been deleted and who did it,” said Mr. Annas, chairman of the department of health law, bioethics, and human rights at Boston University.

In a webcast sponsored by the National Institutes of Health, he braced physicians for a future in which patients will increasingly ask them to correct, delete, or change items in the medical record that are either errors or items that they are concerned may pose harm to them.

“The real reason patients don't ask to make deletions [now] is because most people don't look at their records,” he said. But with the advent of the Health Insurance Portability and Accountability Act (HIPAA), “now there's a federal right of access to medical records.”

Moreover, President Bush's current emphasis on electronic medical records (EMRs) embraces “the idea that patients should be in control,” and patients are generally much more concerned about the content of electronic records than paper records, said Mr. Annas, who is also professor of sociomedical sciences and community medicine at Boston University.

The Bush administration has not addressed, in the context of its EMR proposals, whether “a patient [should] be able to delete accurate, factual information” from medical records. The bottom line, however, is that “we're in the process of radically changing the medical record … into the patient's record,” Mr. Annas said.

There are “lots of mistakes in medical records,” and thus many changes made in the future will address actual errors. Debate about other types of alterations will ensue, but under this new climate “you could argue that patients should be able to change anything,” he told the physicians.

HIPAA addresses corrections to medical records. “Patients have a right to request corrections in the record, and if there's no response, they can write their own letter and have it added,” Mr. Annas explained.

Physicians at the NIH session reviewed a case in which a 37-year-old unemployed man presented at the National Institute of Neurological Diseases and Stroke to enroll in a sleep study. He had a chief complaint of insomnia but, during a visit with an NIH clinical social worker, he reported symptoms of severe depression and a history of drug use. The next day, he asked that the information entered in the computerized record be deleted. “He was vague in his request, but he was concerned that someone would illegally obtain access … and use [the information] against him,” said Elaine Chase, of the social work department at the NIH Clinical Center, Bethesda, Md.

Mr. Annas said that, if faced with this request, he would agree to delete the information most disconcerting to the patient. “And if he wanted it out of a paper record, I'd still say yes,” though, in the interest of research integrity, the patient should then be excluded from the NIH study, he said.

He offered his verdict on the case example after a free-ranging discussion in which some physicians voiced concern that a move from “physician's record” to “patient's record” would hinder communication among providers.

“You can't just delete things,” one physician said. “Or if there's going to be a patient medical record, maybe there needs to be another record [for providers],” she said.

It's true, Mr. Annas said, that “defense attorneys still say today that your best defense is a complete medical record.”

But overall, physicians “take the record too seriously.” They will have to be more willing to consider patient requests to alter the medical records, he told this newspaper. Theoretically, at least, the doctor and patient should review the content of the record before the visit ends, he added.

Prenatal exposure to combustion-related air pollution may cause chromosomal abnormalities in fetal tissue, according to a study of 60 New York City newborns.

In other populations, such abnormalities have been linked to an increased risk of leukemia and other cancers, said Kirsti A. Bocskay of the department of environmental health sciences at Columbia University, New York, and her colleagues.

The investigators monitored exposure to polycyclic aromatic hydrocarbons (PAHs)—found in emissions from vehicles, residential heating, power generation, and tobacco smoke—among nonsmoking African American and Dominican mothers in three low-income neighborhoods.

The mothers filled out questionnaires and wore air monitors for 48 hours in the third trimester. Chromosomal abnormalities were measured in umbilical cord blood at delivery.

The investigators found 4.7 chromosome abnormalities per 1,000 white blood cells in newborns from mothers with low exposure to PAHs and 7.2 abnormalities per 1,000 white blood cells in newborns from mothers with high exposure to PAHs.

The study finds a significant association between prenatal exposure to airborne carcinogenic PAHs and stable aberrations in cord blood at the relatively low environmental concentrations in New York, the researchers said (Cancer Epidemiol. Biomarkers Prev. 2005;14:506-11).

Prenatal exposure to combustion-related air pollution may cause chromosomal abnormalities in fetal tissue, according to a study of 60 New York City newborns.

In other populations, such abnormalities have been linked to an increased risk of leukemia and other cancers, said Kirsti A. Bocskay of the department of environmental health sciences at Columbia University, New York, and her colleagues.

The investigators monitored exposure to polycyclic aromatic hydrocarbons (PAHs)—found in emissions from vehicles, residential heating, power generation, and tobacco smoke—among nonsmoking African American and Dominican mothers in three low-income neighborhoods.

The mothers filled out questionnaires and wore air monitors for 48 hours in the third trimester. Chromosomal abnormalities were measured in umbilical cord blood at delivery.

The investigators found 4.7 chromosome abnormalities per 1,000 white blood cells in newborns from mothers with low exposure to PAHs and 7.2 abnormalities per 1,000 white blood cells in newborns from mothers with high exposure to PAHs.

The study finds a significant association between prenatal exposure to airborne carcinogenic PAHs and stable aberrations in cord blood at the relatively low environmental concentrations in New York, the researchers said (Cancer Epidemiol. Biomarkers Prev. 2005;14:506-11).

Prenatal exposure to combustion-related air pollution may cause chromosomal abnormalities in fetal tissue, according to a study of 60 New York City newborns.

In other populations, such abnormalities have been linked to an increased risk of leukemia and other cancers, said Kirsti A. Bocskay of the department of environmental health sciences at Columbia University, New York, and her colleagues.

The investigators monitored exposure to polycyclic aromatic hydrocarbons (PAHs)—found in emissions from vehicles, residential heating, power generation, and tobacco smoke—among nonsmoking African American and Dominican mothers in three low-income neighborhoods.

The mothers filled out questionnaires and wore air monitors for 48 hours in the third trimester. Chromosomal abnormalities were measured in umbilical cord blood at delivery.

The investigators found 4.7 chromosome abnormalities per 1,000 white blood cells in newborns from mothers with low exposure to PAHs and 7.2 abnormalities per 1,000 white blood cells in newborns from mothers with high exposure to PAHs.

The study finds a significant association between prenatal exposure to airborne carcinogenic PAHs and stable aberrations in cord blood at the relatively low environmental concentrations in New York, the researchers said (Cancer Epidemiol. Biomarkers Prev. 2005;14:506-11).

A recently reported 10% decline in the percentage of children and adolescents taking antidepressants last year is alarming but not surprising, given all the controversy and publicity leading up to the Food and Drug Administration's black box requirement for these drugs, leading experts say.

What is surprising, they say, is the finding that psychiatrists as well as primary care physicians might be writing fewer prescriptions.

The data were released last month by the pharmacy benefit manager Medco Health Systems Inc. Medco reported that antidepressant prescriptions for patients younger than 18 years fell 10% in 2004 after rising by almost the same percentage in 2003.

The steepest declines occurred in the second half of 2004, Medco said. In the third quarter, prescription use fell more than 19% from a year earlier. In the fourth quarter, prescription use fell by 16% from a year earlier.

Medco did not break down use patterns among specific antidepressants or diagnoses, nor did it release data on use by prescribing physicians. However, “we looked at both primary care physicians and psychiatric specialists, and we saw no difference in the drop-off rate [in prescribing],” said Ann Smith, a spokesperson for the company, which manages drug benefits for about 60 million Americans. “We're looking more at that [trend].”

The drop in antidepressant use among patients of primary care physicians is likely a physician-driven trend, but the drop among patients of psychiatrists is more likely a result of parents' concern, sources said.

“If that's the case [that psychiatrists are prescribing less], then that indicates to me that there's greater concern among parents… It's a result of the scare that has gone through the community and the misinterpretation that there's an increase in suicide [with use of the drugs],” said Darrel Regier, M.D., director of research for the American Psychiatric Association.

Like Dr. Regier, David Fassler, M.D., an American Medical Association delegate to the American Academy of Child and Adolescent Psychiatry, said he was surprised by Medco's report of cross-specialty declines.

“It was my impression that most of the change is taking place among [family physicians] and [pediatricians], both from my experience locally and from talking with physicians anecdotally,” said Dr. Fassler, also with the University of Vermont, Burlington.

Indeed, said Lynn Wegner, M.D., who chairs the American Academy of Pediatrics' section on developmental and behavioral pediatrics, said, “I think we've tapped into a segment of doctors who were uncomfortable [with prescribing the drugs], anyway. I think the [physicians] who have stopped are those who were leery to begin with or in very litigious areas.”

When the FDA announced last October its requirement for antidepressant labels to carry a black box warning about the risks of suicidal behavior, the APA immediately issued a statement of concern that the warning would have “a chilling effect on appropriate prescribing” for patients.

As expected, “this is a very significant change in prescribing patterns over a relatively short period of time,” Dr. Fassler said.

Just as alarming as the data from Medco, sources said, are anecdotal reports that primary care doctors renewing their malpractice insurance policies are being asked whether they prescribe antidepressants and are being told that they face higher premiums if they answer yes.

The APA has received such reports, Dr. Regier said, and “we're afraid this will have an additional chilling effect” on prescribing these drugs.

Adelaide Robb, M.D., medical director of inpatient psychiatry at Children's National Medical Center in Washington, said she has also heard of prescribers being told that their malpractice insurance premiums will rise.

Add this problem to primary care physicians' “feeling that they're not trained to handle suicidal ideation,” as well as the difficulty in complying with FDA recommendations for monitoring patients on antidepressants, and “I'm afraid the suicide rates will rise,” Dr. Robb said.

“New patients are going without care. It's getting harder and harder to see someone,” she said. “In our area, many pediatricians are now reluctant to initiate antidepressant drug treatment, whether for depression or other disorders. They're also reluctant to take stable patients.”

Dr. Regier said health insurers and managed behavioral health companies in particular “are going to have to loosen some of their restrictions on psychiatric disorder management” so that physicians can follow the FDA's guidelines for patient monitoring.

The black box says, “patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”

Dr. Regier said the APA hopes to learn more about “which groups of patients are most affected” by the declining prescriptions trend, and why.

In the next few months, the APA will also evaluate use of its Web site, www.ParentsMedGuide.org

A recently reported 10% decline in the percentage of children and adolescents taking antidepressants last year is alarming but not surprising, given all the controversy and publicity leading up to the Food and Drug Administration's black box requirement for these drugs, leading experts say.

What is surprising, they say, is the finding that psychiatrists as well as primary care physicians might be writing fewer prescriptions.

The data were released last month by the pharmacy benefit manager Medco Health Systems Inc. Medco reported that antidepressant prescriptions for patients younger than 18 years fell 10% in 2004 after rising by almost the same percentage in 2003.

The steepest declines occurred in the second half of 2004, Medco said. In the third quarter, prescription use fell more than 19% from a year earlier. In the fourth quarter, prescription use fell by 16% from a year earlier.

Medco did not break down use patterns among specific antidepressants or diagnoses, nor did it release data on use by prescribing physicians. However, “we looked at both primary care physicians and psychiatric specialists, and we saw no difference in the drop-off rate [in prescribing],” said Ann Smith, a spokesperson for the company, which manages drug benefits for about 60 million Americans. “We're looking more at that [trend].”

The drop in antidepressant use among patients of primary care physicians is likely a physician-driven trend, but the drop among patients of psychiatrists is more likely a result of parents' concern, sources said.

“If that's the case [that psychiatrists are prescribing less], then that indicates to me that there's greater concern among parents… It's a result of the scare that has gone through the community and the misinterpretation that there's an increase in suicide [with use of the drugs],” said Darrel Regier, M.D., director of research for the American Psychiatric Association.

Like Dr. Regier, David Fassler, M.D., an American Medical Association delegate to the American Academy of Child and Adolescent Psychiatry, said he was surprised by Medco's report of cross-specialty declines.

“It was my impression that most of the change is taking place among [family physicians] and [pediatricians], both from my experience locally and from talking with physicians anecdotally,” said Dr. Fassler, also with the University of Vermont, Burlington.

Indeed, said Lynn Wegner, M.D., who chairs the American Academy of Pediatrics' section on developmental and behavioral pediatrics, said, “I think we've tapped into a segment of doctors who were uncomfortable [with prescribing the drugs], anyway. I think the [physicians] who have stopped are those who were leery to begin with or in very litigious areas.”

When the FDA announced last October its requirement for antidepressant labels to carry a black box warning about the risks of suicidal behavior, the APA immediately issued a statement of concern that the warning would have “a chilling effect on appropriate prescribing” for patients.

As expected, “this is a very significant change in prescribing patterns over a relatively short period of time,” Dr. Fassler said.

Just as alarming as the data from Medco, sources said, are anecdotal reports that primary care doctors renewing their malpractice insurance policies are being asked whether they prescribe antidepressants and are being told that they face higher premiums if they answer yes.

The APA has received such reports, Dr. Regier said, and “we're afraid this will have an additional chilling effect” on prescribing these drugs.

Adelaide Robb, M.D., medical director of inpatient psychiatry at Children's National Medical Center in Washington, said she has also heard of prescribers being told that their malpractice insurance premiums will rise.

Add this problem to primary care physicians' “feeling that they're not trained to handle suicidal ideation,” as well as the difficulty in complying with FDA recommendations for monitoring patients on antidepressants, and “I'm afraid the suicide rates will rise,” Dr. Robb said.

“New patients are going without care. It's getting harder and harder to see someone,” she said. “In our area, many pediatricians are now reluctant to initiate antidepressant drug treatment, whether for depression or other disorders. They're also reluctant to take stable patients.”

Dr. Regier said health insurers and managed behavioral health companies in particular “are going to have to loosen some of their restrictions on psychiatric disorder management” so that physicians can follow the FDA's guidelines for patient monitoring.

The black box says, “patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”

Dr. Regier said the APA hopes to learn more about “which groups of patients are most affected” by the declining prescriptions trend, and why.

In the next few months, the APA will also evaluate use of its Web site, www.ParentsMedGuide.org

A recently reported 10% decline in the percentage of children and adolescents taking antidepressants last year is alarming but not surprising, given all the controversy and publicity leading up to the Food and Drug Administration's black box requirement for these drugs, leading experts say.

What is surprising, they say, is the finding that psychiatrists as well as primary care physicians might be writing fewer prescriptions.

The data were released last month by the pharmacy benefit manager Medco Health Systems Inc. Medco reported that antidepressant prescriptions for patients younger than 18 years fell 10% in 2004 after rising by almost the same percentage in 2003.

The steepest declines occurred in the second half of 2004, Medco said. In the third quarter, prescription use fell more than 19% from a year earlier. In the fourth quarter, prescription use fell by 16% from a year earlier.

Medco did not break down use patterns among specific antidepressants or diagnoses, nor did it release data on use by prescribing physicians. However, “we looked at both primary care physicians and psychiatric specialists, and we saw no difference in the drop-off rate [in prescribing],” said Ann Smith, a spokesperson for the company, which manages drug benefits for about 60 million Americans. “We're looking more at that [trend].”

The drop in antidepressant use among patients of primary care physicians is likely a physician-driven trend, but the drop among patients of psychiatrists is more likely a result of parents' concern, sources said.

“If that's the case [that psychiatrists are prescribing less], then that indicates to me that there's greater concern among parents… It's a result of the scare that has gone through the community and the misinterpretation that there's an increase in suicide [with use of the drugs],” said Darrel Regier, M.D., director of research for the American Psychiatric Association.

Like Dr. Regier, David Fassler, M.D., an American Medical Association delegate to the American Academy of Child and Adolescent Psychiatry, said he was surprised by Medco's report of cross-specialty declines.

“It was my impression that most of the change is taking place among [family physicians] and [pediatricians], both from my experience locally and from talking with physicians anecdotally,” said Dr. Fassler, also with the University of Vermont, Burlington.

Indeed, said Lynn Wegner, M.D., who chairs the American Academy of Pediatrics' section on developmental and behavioral pediatrics, said, “I think we've tapped into a segment of doctors who were uncomfortable [with prescribing the drugs], anyway. I think the [physicians] who have stopped are those who were leery to begin with or in very litigious areas.”

When the FDA announced last October its requirement for antidepressant labels to carry a black box warning about the risks of suicidal behavior, the APA immediately issued a statement of concern that the warning would have “a chilling effect on appropriate prescribing” for patients.

As expected, “this is a very significant change in prescribing patterns over a relatively short period of time,” Dr. Fassler said.

Just as alarming as the data from Medco, sources said, are anecdotal reports that primary care doctors renewing their malpractice insurance policies are being asked whether they prescribe antidepressants and are being told that they face higher premiums if they answer yes.

The APA has received such reports, Dr. Regier said, and “we're afraid this will have an additional chilling effect” on prescribing these drugs.

Adelaide Robb, M.D., medical director of inpatient psychiatry at Children's National Medical Center in Washington, said she has also heard of prescribers being told that their malpractice insurance premiums will rise.

Add this problem to primary care physicians' “feeling that they're not trained to handle suicidal ideation,” as well as the difficulty in complying with FDA recommendations for monitoring patients on antidepressants, and “I'm afraid the suicide rates will rise,” Dr. Robb said.

“New patients are going without care. It's getting harder and harder to see someone,” she said. “In our area, many pediatricians are now reluctant to initiate antidepressant drug treatment, whether for depression or other disorders. They're also reluctant to take stable patients.”

Dr. Regier said health insurers and managed behavioral health companies in particular “are going to have to loosen some of their restrictions on psychiatric disorder management” so that physicians can follow the FDA's guidelines for patient monitoring.

The black box says, “patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”

Dr. Regier said the APA hopes to learn more about “which groups of patients are most affected” by the declining prescriptions trend, and why.

In the next few months, the APA will also evaluate use of its Web site, www.ParentsMedGuide.org

The weight loss drug orlistat may prove to be a useful adjunct in the treatment of polycystic ovarian syndrome, according to findings from a small randomized study that compared the drug with metformin.

“[We've] demonstrated the therapeutic potential of orlistat in PCOS,” said Vijay Jayagopal, M.D., of the University of Hull (England) and his associates.

After a 12-week treatment period, 10 women treated with orlistat lost significantly more weight than 11 patients treated with metformin (a 4.7% vs. a 1% reduction) and had similar, statistically significant reductions in total serum testosterone (J. Clin. Endocrinol. Metab. 2005;90:729-33).

Neither drug produced significant reductions in fasting insulin, insulin resistance, sex hormone-binding globulin, or any of several lipid parameters studied.

In a written statement, Andrea E. Dunaif, M.D., president-elect of the Endocrine Society, said further research is needed to determine “where [weight-loss medications] will fit into the treatment of PCOS.”

The current study, however, “suggests that [the] medications may be an effective treatment option for not only the obesity but also the testosterone excess associated with PCOS,” said Dr. Dunaif of Northwestern University, Chicago.

Before drug treatment, all 21 patients—white women with PCOS—underwent an 8-week period of dietary modification (there were no significant changes in weight); they were then randomized to receive orlistat, which inhibits triglyceride and lipid absorption, or the insulin-sensitizing agent metformin.

Compared with baseline, a significant reduction in serum testosterone was observed after treatment in both the orlistat-treated group (approximately 94 ng/dL vs. 115 ng/dL) and the metformin-treated group (approximately 97 ng/dlL vs. 120 ng/dL).

Investigators noted that despite the lack of statistically significant improvements in many of the endocrine and metabolic parameters studied, the percentage changes from baseline were “more marked” in the orlistat group.

This may suggest that “the weight reduction had an overall stronger impact on these parameters than the insulin-sensitizing effect of metformin, the mechanism of which remains largely unknown,” they said.

Insulin resistance was calculated using the homeostasis model of assessment (HOMA-IR) method. The lack of statistically significant improvement in insulin resistance may be due in part to the large variability in HOMA-IR values in such a small group of patients, Dr. Jayagopal and his associates said.

The investigators did not collect information on menstrual change and ovulation, and the study was not powered to assess lipid changes. Such information is “clearly important” to acquire in larger studies, the investigators said.

In the meantime, Dr. Dunaif said, “we know that metformin is a proven and effective treatment for women with polycystic ovary syndrome.”

The weight loss drug orlistat may prove to be a useful adjunct in the treatment of polycystic ovarian syndrome, according to findings from a small randomized study that compared the drug with metformin.

“[We've] demonstrated the therapeutic potential of orlistat in PCOS,” said Vijay Jayagopal, M.D., of the University of Hull (England) and his associates.

After a 12-week treatment period, 10 women treated with orlistat lost significantly more weight than 11 patients treated with metformin (a 4.7% vs. a 1% reduction) and had similar, statistically significant reductions in total serum testosterone (J. Clin. Endocrinol. Metab. 2005;90:729-33).

Neither drug produced significant reductions in fasting insulin, insulin resistance, sex hormone-binding globulin, or any of several lipid parameters studied.

In a written statement, Andrea E. Dunaif, M.D., president-elect of the Endocrine Society, said further research is needed to determine “where [weight-loss medications] will fit into the treatment of PCOS.”

The current study, however, “suggests that [the] medications may be an effective treatment option for not only the obesity but also the testosterone excess associated with PCOS,” said Dr. Dunaif of Northwestern University, Chicago.

Before drug treatment, all 21 patients—white women with PCOS—underwent an 8-week period of dietary modification (there were no significant changes in weight); they were then randomized to receive orlistat, which inhibits triglyceride and lipid absorption, or the insulin-sensitizing agent metformin.

Compared with baseline, a significant reduction in serum testosterone was observed after treatment in both the orlistat-treated group (approximately 94 ng/dL vs. 115 ng/dL) and the metformin-treated group (approximately 97 ng/dlL vs. 120 ng/dL).

Investigators noted that despite the lack of statistically significant improvements in many of the endocrine and metabolic parameters studied, the percentage changes from baseline were “more marked” in the orlistat group.

This may suggest that “the weight reduction had an overall stronger impact on these parameters than the insulin-sensitizing effect of metformin, the mechanism of which remains largely unknown,” they said.

Insulin resistance was calculated using the homeostasis model of assessment (HOMA-IR) method. The lack of statistically significant improvement in insulin resistance may be due in part to the large variability in HOMA-IR values in such a small group of patients, Dr. Jayagopal and his associates said.

The investigators did not collect information on menstrual change and ovulation, and the study was not powered to assess lipid changes. Such information is “clearly important” to acquire in larger studies, the investigators said.

In the meantime, Dr. Dunaif said, “we know that metformin is a proven and effective treatment for women with polycystic ovary syndrome.”

The weight loss drug orlistat may prove to be a useful adjunct in the treatment of polycystic ovarian syndrome, according to findings from a small randomized study that compared the drug with metformin.

“[We've] demonstrated the therapeutic potential of orlistat in PCOS,” said Vijay Jayagopal, M.D., of the University of Hull (England) and his associates.

After a 12-week treatment period, 10 women treated with orlistat lost significantly more weight than 11 patients treated with metformin (a 4.7% vs. a 1% reduction) and had similar, statistically significant reductions in total serum testosterone (J. Clin. Endocrinol. Metab. 2005;90:729-33).

Neither drug produced significant reductions in fasting insulin, insulin resistance, sex hormone-binding globulin, or any of several lipid parameters studied.

In a written statement, Andrea E. Dunaif, M.D., president-elect of the Endocrine Society, said further research is needed to determine “where [weight-loss medications] will fit into the treatment of PCOS.”

The current study, however, “suggests that [the] medications may be an effective treatment option for not only the obesity but also the testosterone excess associated with PCOS,” said Dr. Dunaif of Northwestern University, Chicago.

Before drug treatment, all 21 patients—white women with PCOS—underwent an 8-week period of dietary modification (there were no significant changes in weight); they were then randomized to receive orlistat, which inhibits triglyceride and lipid absorption, or the insulin-sensitizing agent metformin.

Compared with baseline, a significant reduction in serum testosterone was observed after treatment in both the orlistat-treated group (approximately 94 ng/dL vs. 115 ng/dL) and the metformin-treated group (approximately 97 ng/dlL vs. 120 ng/dL).

Investigators noted that despite the lack of statistically significant improvements in many of the endocrine and metabolic parameters studied, the percentage changes from baseline were “more marked” in the orlistat group.

This may suggest that “the weight reduction had an overall stronger impact on these parameters than the insulin-sensitizing effect of metformin, the mechanism of which remains largely unknown,” they said.

Insulin resistance was calculated using the homeostasis model of assessment (HOMA-IR) method. The lack of statistically significant improvement in insulin resistance may be due in part to the large variability in HOMA-IR values in such a small group of patients, Dr. Jayagopal and his associates said.

The investigators did not collect information on menstrual change and ovulation, and the study was not powered to assess lipid changes. Such information is “clearly important” to acquire in larger studies, the investigators said.

In the meantime, Dr. Dunaif said, “we know that metformin is a proven and effective treatment for women with polycystic ovary syndrome.”

Nulliparous women who request pain relief early in labor may be better off receiving neuraxial analgesia than systemic opioid analgesia, according to investigators of a recently published, randomized trial.

Of 728 women who had spontaneous labor or spontaneous rupture of membranes, those who received intrathecal fentanyl when cervical dilation was less than 4 cm did not face an increased risk of having a cesarean section and had a shorter duration of labor, compared with those who received systemic hydromorphone early in labor.

Women who received neuraxial analgesia also reported better pain control, according to Cynthia A Wong, M.D., and her colleagues at Northwestern University in Chicago.

The findings show women who request pain relief early in spontaneous labor “can receive neuraxial analgesia at that time without adverse consequences,” the researchers said.

Women who request analgesia early in labor frequently receive systemic opioid analgesia, in keeping with the American College of Obstetricians and Gynecologists recommendation that epidural anesthesia be delayed, when feasible, until cervical dilation is at least 4-5 cm; other forms of analgesia should be used until that time.

Systemic opioid analgesia is often incomplete, however, and has potential maternal and fetal side effects, including neonatal and maternal respiratory depression (N. Engl. J. Med. 2005;352:655-65).

Laura Goetzl, M.D., who helped write ACOG's 2002 Practice Bulletin on Obstetric Analgesia and Anesthesia, said in an interview that the new findings present “another option” for prolonging the time to epidural.

“This is saying, instead of giving a higher dose of [systemic] narcotics to get women further along [until epidural administration], we can give them a smaller dose right into the spinal cord,” said Dr. Goetzl of the Medical University of South Carolina, Charleston.

The investigators studied the analgesia techniques at Northwestern's Prentice Women's Hospital from November 2000 to December 2003. Patients who requested analgesia when cervical dilation was less than 4 cm were randomized (nonblinded) to intrathecal or systemic analgesia.

The median dilation for both groups at the first analgesia request was 2 cm.

Analgesia in the intrathecal group was initiated using a combined spinal-epidural technique. Intrathecal fentanyl (25 mcg) was injected, an epidural catheter sited, and an epidural test dose administered.

When the patients in the intrathecal group made a second request for pain control, epidural analgesia was initiated.

Patients in the systemic group received 1 mg hydromorphone IM and 1 mg IV. Epidural analgesia was initiated in patients who were at least 4 cm dilated at their second request for pain control (otherwise hydromorphone was repeated), or at their third analgesia request—regardless of dilation.

Epidural analgesia was maintained in both groups until delivery, the investigators said.

The cesarean rate was not significantly different between the two groups (18% in the intrathecal group and 21% in the systemic group); nor was there a significant difference in the rate of instrumental vaginal delivery.

The median time from initial analgesia to complete dilation was significantly shorter after intrathecal analgesia than after systemic analgesia (295 vs. 385 minutes), even after investigators adjusted for cervical dilation at the time of initial anesthesia.

Women who received intrathecal analgesia also had a shorter time to vaginal delivery (398 vs. 479 minutes) and significantly lower average pain scores between the first and second analgesia requests. The incidence of 1-minute Apgar scores below 7 also was significantly lower in this group (17% vs. 24%).

Fetal deceleration occurred more commonly within 30 minutes of intrathecal opioid analgesia than after systemic analgesia. However, the incidence of nonreassuring fetal heart rate “was low, did not differ between groups, and did not result in any adverse neonatal outcome,” the investigators said.

Nulliparous women who request pain relief early in labor may be better off receiving neuraxial analgesia than systemic opioid analgesia, according to investigators of a recently published, randomized trial.

Of 728 women who had spontaneous labor or spontaneous rupture of membranes, those who received intrathecal fentanyl when cervical dilation was less than 4 cm did not face an increased risk of having a cesarean section and had a shorter duration of labor, compared with those who received systemic hydromorphone early in labor.

Women who received neuraxial analgesia also reported better pain control, according to Cynthia A Wong, M.D., and her colleagues at Northwestern University in Chicago.

The findings show women who request pain relief early in spontaneous labor “can receive neuraxial analgesia at that time without adverse consequences,” the researchers said.

Women who request analgesia early in labor frequently receive systemic opioid analgesia, in keeping with the American College of Obstetricians and Gynecologists recommendation that epidural anesthesia be delayed, when feasible, until cervical dilation is at least 4-5 cm; other forms of analgesia should be used until that time.

Systemic opioid analgesia is often incomplete, however, and has potential maternal and fetal side effects, including neonatal and maternal respiratory depression (N. Engl. J. Med. 2005;352:655-65).

Laura Goetzl, M.D., who helped write ACOG's 2002 Practice Bulletin on Obstetric Analgesia and Anesthesia, said in an interview that the new findings present “another option” for prolonging the time to epidural.

“This is saying, instead of giving a higher dose of [systemic] narcotics to get women further along [until epidural administration], we can give them a smaller dose right into the spinal cord,” said Dr. Goetzl of the Medical University of South Carolina, Charleston.

The investigators studied the analgesia techniques at Northwestern's Prentice Women's Hospital from November 2000 to December 2003. Patients who requested analgesia when cervical dilation was less than 4 cm were randomized (nonblinded) to intrathecal or systemic analgesia.

The median dilation for both groups at the first analgesia request was 2 cm.

Analgesia in the intrathecal group was initiated using a combined spinal-epidural technique. Intrathecal fentanyl (25 mcg) was injected, an epidural catheter sited, and an epidural test dose administered.

When the patients in the intrathecal group made a second request for pain control, epidural analgesia was initiated.

Patients in the systemic group received 1 mg hydromorphone IM and 1 mg IV. Epidural analgesia was initiated in patients who were at least 4 cm dilated at their second request for pain control (otherwise hydromorphone was repeated), or at their third analgesia request—regardless of dilation.

Epidural analgesia was maintained in both groups until delivery, the investigators said.

The cesarean rate was not significantly different between the two groups (18% in the intrathecal group and 21% in the systemic group); nor was there a significant difference in the rate of instrumental vaginal delivery.

The median time from initial analgesia to complete dilation was significantly shorter after intrathecal analgesia than after systemic analgesia (295 vs. 385 minutes), even after investigators adjusted for cervical dilation at the time of initial anesthesia.

Women who received intrathecal analgesia also had a shorter time to vaginal delivery (398 vs. 479 minutes) and significantly lower average pain scores between the first and second analgesia requests. The incidence of 1-minute Apgar scores below 7 also was significantly lower in this group (17% vs. 24%).

Fetal deceleration occurred more commonly within 30 minutes of intrathecal opioid analgesia than after systemic analgesia. However, the incidence of nonreassuring fetal heart rate “was low, did not differ between groups, and did not result in any adverse neonatal outcome,” the investigators said.

Nulliparous women who request pain relief early in labor may be better off receiving neuraxial analgesia than systemic opioid analgesia, according to investigators of a recently published, randomized trial.

Of 728 women who had spontaneous labor or spontaneous rupture of membranes, those who received intrathecal fentanyl when cervical dilation was less than 4 cm did not face an increased risk of having a cesarean section and had a shorter duration of labor, compared with those who received systemic hydromorphone early in labor.

Women who received neuraxial analgesia also reported better pain control, according to Cynthia A Wong, M.D., and her colleagues at Northwestern University in Chicago.

The findings show women who request pain relief early in spontaneous labor “can receive neuraxial analgesia at that time without adverse consequences,” the researchers said.

Women who request analgesia early in labor frequently receive systemic opioid analgesia, in keeping with the American College of Obstetricians and Gynecologists recommendation that epidural anesthesia be delayed, when feasible, until cervical dilation is at least 4-5 cm; other forms of analgesia should be used until that time.

Systemic opioid analgesia is often incomplete, however, and has potential maternal and fetal side effects, including neonatal and maternal respiratory depression (N. Engl. J. Med. 2005;352:655-65).

Laura Goetzl, M.D., who helped write ACOG's 2002 Practice Bulletin on Obstetric Analgesia and Anesthesia, said in an interview that the new findings present “another option” for prolonging the time to epidural.

“This is saying, instead of giving a higher dose of [systemic] narcotics to get women further along [until epidural administration], we can give them a smaller dose right into the spinal cord,” said Dr. Goetzl of the Medical University of South Carolina, Charleston.

The investigators studied the analgesia techniques at Northwestern's Prentice Women's Hospital from November 2000 to December 2003. Patients who requested analgesia when cervical dilation was less than 4 cm were randomized (nonblinded) to intrathecal or systemic analgesia.

The median dilation for both groups at the first analgesia request was 2 cm.

Analgesia in the intrathecal group was initiated using a combined spinal-epidural technique. Intrathecal fentanyl (25 mcg) was injected, an epidural catheter sited, and an epidural test dose administered.

When the patients in the intrathecal group made a second request for pain control, epidural analgesia was initiated.

Patients in the systemic group received 1 mg hydromorphone IM and 1 mg IV. Epidural analgesia was initiated in patients who were at least 4 cm dilated at their second request for pain control (otherwise hydromorphone was repeated), or at their third analgesia request—regardless of dilation.

Epidural analgesia was maintained in both groups until delivery, the investigators said.

The cesarean rate was not significantly different between the two groups (18% in the intrathecal group and 21% in the systemic group); nor was there a significant difference in the rate of instrumental vaginal delivery.

The median time from initial analgesia to complete dilation was significantly shorter after intrathecal analgesia than after systemic analgesia (295 vs. 385 minutes), even after investigators adjusted for cervical dilation at the time of initial anesthesia.

Women who received intrathecal analgesia also had a shorter time to vaginal delivery (398 vs. 479 minutes) and significantly lower average pain scores between the first and second analgesia requests. The incidence of 1-minute Apgar scores below 7 also was significantly lower in this group (17% vs. 24%).

Fetal deceleration occurred more commonly within 30 minutes of intrathecal opioid analgesia than after systemic analgesia. However, the incidence of nonreassuring fetal heart rate “was low, did not differ between groups, and did not result in any adverse neonatal outcome,” the investigators said.

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper. “First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation.”

The new research reported in The Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601–7). The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families.

The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease.

They found that 35 of 767 affected members of these families (5%)—in 20 of the 358 families—had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (The Lancet [online] http://image.thelancet.com/extras/04let12014web.pdf

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (The Lancet [online] http://image.thelancet.com/extras/04let12084web.pdf

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (The Lancet [online] http://image.thelancet.com/extras/04let12032web.pdf

Each of the studies included large control populations; the mutation was absent from all of the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same online issue of The Lancet, called identification of the Gly2019Ser mutation “a major advance.”

The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said in an editorial.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations—for instance, the extent and type of Lewy bodies—appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (The Lancet [online] http://image.thelancet.com/extras/04cmt455web.pdf

He and the study's investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Mr. Gilks' finding of the mutation in patients who did not have any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease. Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers—a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had clinical symptoms that were less severe, despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he commented.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he said.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper. “First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation.”

The new research reported in The Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601–7). The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families.

The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease.

They found that 35 of 767 affected members of these families (5%)—in 20 of the 358 families—had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (The Lancet [online] http://image.thelancet.com/extras/04let12014web.pdf

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (The Lancet [online] http://image.thelancet.com/extras/04let12084web.pdf

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (The Lancet [online] http://image.thelancet.com/extras/04let12032web.pdf

Each of the studies included large control populations; the mutation was absent from all of the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same online issue of The Lancet, called identification of the Gly2019Ser mutation “a major advance.”

The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said in an editorial.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations—for instance, the extent and type of Lewy bodies—appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (The Lancet [online] http://image.thelancet.com/extras/04cmt455web.pdf

He and the study's investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Mr. Gilks' finding of the mutation in patients who did not have any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease. Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers—a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had clinical symptoms that were less severe, despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he commented.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he said.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.

Screening for a recently identified mutation shown to cause approximately 5%-6% of familial and 1%-2% of apparently sporadic cases of Parkinson's disease will likely become an important component of genetic testing and counseling for this disease, according to investigators involved in the research.

“No other single mutation identified so far … has occurred with such high frequency” in patients with Parkinson's disease, said William C. Nichols, Ph.D., of Cincinnati Children's Hospital Medical Center, and his associates. Their report was one of three on the mutation published online in the Lancet.

However, two issues need to be resolved before genetic testing for Parkinson's disease can fulfill its potential, Dr. Nichols told this newspaper. “First, there is nothing which can be done for patients carrying the genetic mutation and thus might be predisposed to developing Parkinson's disease. And … [w]e can't yet predict what an individual's chances of developing the disease are, given they carry a predisposing mutation.”

The new research reported in The Lancet builds on findings published last year showing that mutations in the gene termed LRRK2 (for leucine-rich repeat kinase 2) cause some forms of autosomal dominant Parkinson's disease (Neuron 2004;44:601–7). The gene codes for the protein dardarin, which is the first kinase to be implicated in the disease.

In research completed since then, a specific mutation in the LRRK2 gene, Gly2019Ser, was identified in several families.

The investigators of the just-published studies sought to investigate the frequency of this mutation and its role in susceptibility to Parkinson's disease.

Dr. Nichols and his colleagues analyzed 358 North American families with at least one pair of siblings with Parkinson's disease.

They found that 35 of 767 affected members of these families (5%)—in 20 of the 358 families—had at least one copy of the mutated gene.

One of these 35 patients was homozygous for the mutation, they reported (The Lancet [online] http://image.thelancet.com/extras/04let12014web.pdf

Alessio Di Fonzo, M.D., of the University of Milan, and his colleagues, also detected the mutation in 4 of 61 families (7%) with Parkinson's disease and apparent autosomal dominant inheritance. The families were from Italy, Portugal, and Brazil (The Lancet [online] http://image.thelancet.com/extras/04let12084web.pdf

And William P. Gilks, of the Institute of Neurology and National Hospital for Neurology and Neurosurgery in London, and his associates, detected heterozygous Gly2019Ser mutations in 8 (2%) of 482 apparently sporadic cases, predominantly from the southeast of England.

Three of the patients turned out to have positive family histories (two involved first-degree relatives, and one involved a second-degree relative), Mr. Gilks and his colleagues reported (The Lancet [online] http://image.thelancet.com/extras/04let12032web.pdf

Each of the studies included large control populations; the mutation was absent from all of the control populations tested.

Alexis Brice, M.D., who commented on the studies in the same online issue of The Lancet, called identification of the Gly2019Ser mutation “a major advance.”

The mutation “accounts for a surprisingly high proportion of both familial and isolated cases (of the disease),” he said in an editorial.

Still, there is much to learn, he said. Patients with the Gly2019Ser mutation have typical clinical features of Parkinson's disease, for instance, but the associated clinical spectrum “must be better established,” he said.

Pathologic markers also must be better understood; the neuropathology in patients with the mutations—for instance, the extent and type of Lewy bodies—appears to vary considerably, even within the same family, noted Dr. Brice of Université Pierre et Marie Curie in Paris (The Lancet [online] http://image.thelancet.com/extras/04cmt455web.pdf

He and the study's investigators also cited the need to know more about the precise penetrance of the mutation before the new results are translated into practice.

In addition to Mr. Gilks' finding of the mutation in patients who did not have any family history of Parkinson's disease, Dr. Nichols found that “despite the apparent autosomal dominant effect (of the mutation),” only 13 (37%) of the siblings with a mutation reported having a parent with Parkinson's disease. Dr. Di Fonzo and his colleagues also identified some asymptomatic carriers—a finding that suggests penetrance was reduced or was age dependent.

Dr. Nichols, moreover, pointed out that, in his study, carriers of the mutation also had clinical symptoms that were less severe, despite having had the disease for a longer time, which suggests that “the mutation is associated with slowed disease progression,” he commented.

Despite the unanswered questions, now that the Gly2019Ser mutation has been identified, “there will be requests for presymptomatic testing by offspring of carriers,” Dr. Brice said in his commentary.

This “raises ethical issues similar to those for Huntington's disease” since, without a preventive treatment, “testing offers no direct medical benefit,” he said.

Dr. Nichols, in his remarks to this newspaper, noted: “I would not be surprised if there were not some company that will soon offer genetic testing for Parkinson's disease, maybe even at the prenatal level, because people are willing to pay for it.”

Dr. Brice noted that identification of the gene and the mutation should lead to a better understanding of the pathologic mechanism underlying Parkinson's disease, which will “hopefully lead to new treatments,” he said. The last page on the genetic basis of Parkinson's disease is yet to be written, and it promises to be very exciting.

Vaginal rather than abdominal hysterectomy should be performed “whenever technically feasible” to reduce potential complications and to speed hospital discharge and patients' return to normal activities, according to a new review of randomized controlled trials that have compared hysterectomy techniques.

“The many advantages demonstrated from avoiding abdominal hysterectomy … suggest that [it] should be avoided if it is possible and safe to do so,” wrote Neil Johnson, M.D., of the University of Auckland in New Zealand, and his colleagues.

The investigators also concluded that when vaginal hysterectomy is not possible, laparoscopic hysterectomy has advantages over abdominal hysterectomy, including a speedier recovery.

These advantages can be “offset,” however, by longer operating times and more urinary tract injuries, the investigators said.

The “systematic evidence review” of surgical approach to hysterectomy for benign gynecologic disease was conducted by the Cochrane Collaboration, an international organization that evaluates medical research and draws evidence-based conclusions about medical practice.

Leading experts in the United States predicted that—no matter how significant and informative—the conclusions of the metaanalysis will likely fall flat at home, particularly as they concern the issue of vaginal versus abdominal hysterectomy.

Physicians' choice of approach for hysterectomy is so tightly tied with experience and with physicians' “comfort” level that the predominance of the abdominal approach in the United States is unlikely to change, they said.

“I don't think there's ever been an economic incentive for one route over another. It's a training and comfort issue,” said Thomas Stovall, M.D., president of the Society of Gynecologic Surgeons. “I think we'll continue to see [choices] based on practice patterns and training.”

According to a 2002 report on hysterectomy issued by the Centers for Disease Control and Prevention—the most recent surveillance conducted—more than 60% of hysterectomies performed in the United States between 1994 and 1999 were abdominal. “I don't think the figures are that much different today,” Dr. Stovall said.

The Cochrane investigators searched Medline and numerous other registries and reviewed data from 27 randomized controlled trials that compared hysterectomy approaches in almost 3,650 women, the majority of whom were 41-50 years of age.

All but 7 of the trials were single-center trials (including two from the United States), and the majority of the 27 trials compared various types of laparoscopic surgery with either vaginal or abdominal hysterectomy. Three trials compared all three approaches, and two trials (published in 2002 and 2003) compared vaginal with abdominal hysterectomy.

The investigators found that, compared with abdominal surgery, vaginal hysterectomy meant a shorter stay in the hospital (by approximately 1 day), a quicker return to normal activities (10 vs. 13 days), and fewer infections and febrile episodes (odds ratio 0.42).

Laparoscopic hysterectomy (various types of laparoscopic surgery were pooled together) also had advantages over abdominal hysterectomy: less intraoperative blood loss, a smaller drop in hemoglobin level, a similarly shorter hospital stay and quicker return to normal activity, fewer wound or abdominal wall infections, and fewer unspecified infections or febrile episodes.

Laparoscopic operations were more likely than abdominal hysterectomies to result in urinary tract injuries, however (OR 2.61). And in general, they were longer operations (14 vs. 11 minutes). (The exception was laparoscopically assisted vaginal hysterectomy without uterine artery ligation; these operations were significantly shorter than abdominal hysterectomy.)

When compared with traditional vaginal hysterectomy, laparoscopic approaches fell short in the metaanalysis, leaving unanswered the question of whether laparoscopic procedures should be performed when vaginal hysterectomies are achievable, the investigators said (Cochrane Database Syst. Rev. 2005 [1]:CD003677.DOI:10.1002/14651858. CD003677.pub2).

There were no apparent benefits of laparoscopic hysterectomy over the vaginal approach; the speed of patient recovery and other issues were similar, and there was no statistically significant difference in the rate of urinary tract injuries. Laparoscopic procedures took longer (49 vs. 42 minutes), however.

The introduction of laparoscopic techniques into gynecologic training has been beneficial in that it has increased “surgeons' confidence and skill with vaginal surgery, thus making vaginal hysterectomy a more feasible option for many,” they said.

Such a happening has yet to play out in the United States, however, said Alan Johns, M.D., past president of the Society of Reproductive Surgeons and the American Association of Gynecologic Laparoscopists.

“The skill level of the gynecologic surgeon has actually dropped dramatically,” said Dr. Johns, who practices in Fort Worth, Tex. “The average graduate has not done enough vaginal hysterectomy … and laparoscopic skills are not taught in the vast majority of residency programs.” Patients also don't demand alternatives to traditional abdominal surgery, he said.

According to the 2002 CDC study, rates of laparoscopically assisted vaginal hysterectomies more than doubled between 1994 and 1999, from 13% of all vaginal hysterectomies to 28%. The overall rate of vaginal hysterectomy remained stable, however.

David Barlow, M.D., a coinvestigator of the Cochrane review and executive dean of medicine at the University of Glasgow in Scotland, said that most surgeons in the United Kingdom, who are paid the same regardless of which approach is employed, perform abdominal hysterectomies and that “few” surgeons are specially trained in laparoscopic approaches.

The risk of urinary tract injury during laparoscopic operations was “not surprising” and, although it was statistically significant, “it was not that high.” Dr. Barlow added, that these findings need to be conclusively proven through more study and trial data.

It's also still unclear whether total laparoscopic hysterectomy has any benefits or harms over other forms of laparoscopic hysterectomy, he and his coinvestigators said in the review.

Data on long-term outcomes were “sparse” in the trials that were included in the review, said Dr. Barlow and Dr. Johns and their colleagues in the review.

Future trials should report on outcomes such as long-term urinary, bowel, and sexual function, as well as the occurrence of fistulae, they added.

Dr. Stovall, clinical professor of obstetrics and gynecology at the University of Tennessee in Memphis, said that interpreting the review is difficult because trials to date have not set and adequately controlled for indications and criteria for various approaches to hysterectomy.

“It all comes down to the issue of patient selection, indications, and inclusion and exclusion criteria” for particular approaches, he said.

“These are somewhat subjective decisions” in clinical practice, but ideally, investigators would control for these factors in future trials, Dr. Stovall added.

With long-term follow-up, “I don't think we'll see any difference in outcomes for one approach versus another.”

Dr. Barlow emphasized, however, the importance of short-term patient recovery.

“What this paper is saying—a main message—is that patients are home a day earlier on average [with vaginal hysterectomy] and return to normal quicker. Patients like speedier recoveries,” he said.

In this preoperative view, the uterus and ovaries are completely encased in adhesions from prior surgeries; only the fundus and anterior uterus are visible.

Using laparoscopic techniques, the uterus and ovaries have been dissected free, allowing the uterus to be removed vaginally.

The laparoscopic-assisted vaginal hysterectomy has been completed, and the ovaries have been left in place. Photos courtesy Dr. Alan Johns

Vaginal rather than abdominal hysterectomy should be performed “whenever technically feasible” to reduce potential complications and to speed hospital discharge and patients' return to normal activities, according to a new review of randomized controlled trials that have compared hysterectomy techniques.

“The many advantages demonstrated from avoiding abdominal hysterectomy … suggest that [it] should be avoided if it is possible and safe to do so,” wrote Neil Johnson, M.D., of the University of Auckland in New Zealand, and his colleagues.

The investigators also concluded that when vaginal hysterectomy is not possible, laparoscopic hysterectomy has advantages over abdominal hysterectomy, including a speedier recovery.

These advantages can be “offset,” however, by longer operating times and more urinary tract injuries, the investigators said.

The “systematic evidence review” of surgical approach to hysterectomy for benign gynecologic disease was conducted by the Cochrane Collaboration, an international organization that evaluates medical research and draws evidence-based conclusions about medical practice.

Leading experts in the United States predicted that—no matter how significant and informative—the conclusions of the metaanalysis will likely fall flat at home, particularly as they concern the issue of vaginal versus abdominal hysterectomy.

Physicians' choice of approach for hysterectomy is so tightly tied with experience and with physicians' “comfort” level that the predominance of the abdominal approach in the United States is unlikely to change, they said.

“I don't think there's ever been an economic incentive for one route over another. It's a training and comfort issue,” said Thomas Stovall, M.D., president of the Society of Gynecologic Surgeons. “I think we'll continue to see [choices] based on practice patterns and training.”

According to a 2002 report on hysterectomy issued by the Centers for Disease Control and Prevention—the most recent surveillance conducted—more than 60% of hysterectomies performed in the United States between 1994 and 1999 were abdominal. “I don't think the figures are that much different today,” Dr. Stovall said.

The Cochrane investigators searched Medline and numerous other registries and reviewed data from 27 randomized controlled trials that compared hysterectomy approaches in almost 3,650 women, the majority of whom were 41-50 years of age.

All but 7 of the trials were single-center trials (including two from the United States), and the majority of the 27 trials compared various types of laparoscopic surgery with either vaginal or abdominal hysterectomy. Three trials compared all three approaches, and two trials (published in 2002 and 2003) compared vaginal with abdominal hysterectomy.

The investigators found that, compared with abdominal surgery, vaginal hysterectomy meant a shorter stay in the hospital (by approximately 1 day), a quicker return to normal activities (10 vs. 13 days), and fewer infections and febrile episodes (odds ratio 0.42).

Laparoscopic hysterectomy (various types of laparoscopic surgery were pooled together) also had advantages over abdominal hysterectomy: less intraoperative blood loss, a smaller drop in hemoglobin level, a similarly shorter hospital stay and quicker return to normal activity, fewer wound or abdominal wall infections, and fewer unspecified infections or febrile episodes.

Laparoscopic operations were more likely than abdominal hysterectomies to result in urinary tract injuries, however (OR 2.61). And in general, they were longer operations (14 vs. 11 minutes). (The exception was laparoscopically assisted vaginal hysterectomy without uterine artery ligation; these operations were significantly shorter than abdominal hysterectomy.)

When compared with traditional vaginal hysterectomy, laparoscopic approaches fell short in the metaanalysis, leaving unanswered the question of whether laparoscopic procedures should be performed when vaginal hysterectomies are achievable, the investigators said (Cochrane Database Syst. Rev. 2005 [1]:CD003677.DOI:10.1002/14651858. CD003677.pub2).

There were no apparent benefits of laparoscopic hysterectomy over the vaginal approach; the speed of patient recovery and other issues were similar, and there was no statistically significant difference in the rate of urinary tract injuries. Laparoscopic procedures took longer (49 vs. 42 minutes), however.

The introduction of laparoscopic techniques into gynecologic training has been beneficial in that it has increased “surgeons' confidence and skill with vaginal surgery, thus making vaginal hysterectomy a more feasible option for many,” they said.

Such a happening has yet to play out in the United States, however, said Alan Johns, M.D., past president of the Society of Reproductive Surgeons and the American Association of Gynecologic Laparoscopists.

“The skill level of the gynecologic surgeon has actually dropped dramatically,” said Dr. Johns, who practices in Fort Worth, Tex. “The average graduate has not done enough vaginal hysterectomy … and laparoscopic skills are not taught in the vast majority of residency programs.” Patients also don't demand alternatives to traditional abdominal surgery, he said.

According to the 2002 CDC study, rates of laparoscopically assisted vaginal hysterectomies more than doubled between 1994 and 1999, from 13% of all vaginal hysterectomies to 28%. The overall rate of vaginal hysterectomy remained stable, however.

David Barlow, M.D., a coinvestigator of the Cochrane review and executive dean of medicine at the University of Glasgow in Scotland, said that most surgeons in the United Kingdom, who are paid the same regardless of which approach is employed, perform abdominal hysterectomies and that “few” surgeons are specially trained in laparoscopic approaches.

The risk of urinary tract injury during laparoscopic operations was “not surprising” and, although it was statistically significant, “it was not that high.” Dr. Barlow added, that these findings need to be conclusively proven through more study and trial data.

It's also still unclear whether total laparoscopic hysterectomy has any benefits or harms over other forms of laparoscopic hysterectomy, he and his coinvestigators said in the review.

Data on long-term outcomes were “sparse” in the trials that were included in the review, said Dr. Barlow and Dr. Johns and their colleagues in the review.

Future trials should report on outcomes such as long-term urinary, bowel, and sexual function, as well as the occurrence of fistulae, they added.

Dr. Stovall, clinical professor of obstetrics and gynecology at the University of Tennessee in Memphis, said that interpreting the review is difficult because trials to date have not set and adequately controlled for indications and criteria for various approaches to hysterectomy.

“It all comes down to the issue of patient selection, indications, and inclusion and exclusion criteria” for particular approaches, he said.

“These are somewhat subjective decisions” in clinical practice, but ideally, investigators would control for these factors in future trials, Dr. Stovall added.

With long-term follow-up, “I don't think we'll see any difference in outcomes for one approach versus another.”

Dr. Barlow emphasized, however, the importance of short-term patient recovery.

“What this paper is saying—a main message—is that patients are home a day earlier on average [with vaginal hysterectomy] and return to normal quicker. Patients like speedier recoveries,” he said.

In this preoperative view, the uterus and ovaries are completely encased in adhesions from prior surgeries; only the fundus and anterior uterus are visible.

Using laparoscopic techniques, the uterus and ovaries have been dissected free, allowing the uterus to be removed vaginally.

The laparoscopic-assisted vaginal hysterectomy has been completed, and the ovaries have been left in place. Photos courtesy Dr. Alan Johns

Vaginal rather than abdominal hysterectomy should be performed “whenever technically feasible” to reduce potential complications and to speed hospital discharge and patients' return to normal activities, according to a new review of randomized controlled trials that have compared hysterectomy techniques.

“The many advantages demonstrated from avoiding abdominal hysterectomy … suggest that [it] should be avoided if it is possible and safe to do so,” wrote Neil Johnson, M.D., of the University of Auckland in New Zealand, and his colleagues.

The investigators also concluded that when vaginal hysterectomy is not possible, laparoscopic hysterectomy has advantages over abdominal hysterectomy, including a speedier recovery.

These advantages can be “offset,” however, by longer operating times and more urinary tract injuries, the investigators said.

The “systematic evidence review” of surgical approach to hysterectomy for benign gynecologic disease was conducted by the Cochrane Collaboration, an international organization that evaluates medical research and draws evidence-based conclusions about medical practice.

Leading experts in the United States predicted that—no matter how significant and informative—the conclusions of the metaanalysis will likely fall flat at home, particularly as they concern the issue of vaginal versus abdominal hysterectomy.

Physicians' choice of approach for hysterectomy is so tightly tied with experience and with physicians' “comfort” level that the predominance of the abdominal approach in the United States is unlikely to change, they said.

“I don't think there's ever been an economic incentive for one route over another. It's a training and comfort issue,” said Thomas Stovall, M.D., president of the Society of Gynecologic Surgeons. “I think we'll continue to see [choices] based on practice patterns and training.”

According to a 2002 report on hysterectomy issued by the Centers for Disease Control and Prevention—the most recent surveillance conducted—more than 60% of hysterectomies performed in the United States between 1994 and 1999 were abdominal. “I don't think the figures are that much different today,” Dr. Stovall said.

The Cochrane investigators searched Medline and numerous other registries and reviewed data from 27 randomized controlled trials that compared hysterectomy approaches in almost 3,650 women, the majority of whom were 41-50 years of age.

All but 7 of the trials were single-center trials (including two from the United States), and the majority of the 27 trials compared various types of laparoscopic surgery with either vaginal or abdominal hysterectomy. Three trials compared all three approaches, and two trials (published in 2002 and 2003) compared vaginal with abdominal hysterectomy.

The investigators found that, compared with abdominal surgery, vaginal hysterectomy meant a shorter stay in the hospital (by approximately 1 day), a quicker return to normal activities (10 vs. 13 days), and fewer infections and febrile episodes (odds ratio 0.42).

Laparoscopic hysterectomy (various types of laparoscopic surgery were pooled together) also had advantages over abdominal hysterectomy: less intraoperative blood loss, a smaller drop in hemoglobin level, a similarly shorter hospital stay and quicker return to normal activity, fewer wound or abdominal wall infections, and fewer unspecified infections or febrile episodes.

Laparoscopic operations were more likely than abdominal hysterectomies to result in urinary tract injuries, however (OR 2.61). And in general, they were longer operations (14 vs. 11 minutes). (The exception was laparoscopically assisted vaginal hysterectomy without uterine artery ligation; these operations were significantly shorter than abdominal hysterectomy.)

When compared with traditional vaginal hysterectomy, laparoscopic approaches fell short in the metaanalysis, leaving unanswered the question of whether laparoscopic procedures should be performed when vaginal hysterectomies are achievable, the investigators said (Cochrane Database Syst. Rev. 2005 [1]:CD003677.DOI:10.1002/14651858. CD003677.pub2).

There were no apparent benefits of laparoscopic hysterectomy over the vaginal approach; the speed of patient recovery and other issues were similar, and there was no statistically significant difference in the rate of urinary tract injuries. Laparoscopic procedures took longer (49 vs. 42 minutes), however.

The introduction of laparoscopic techniques into gynecologic training has been beneficial in that it has increased “surgeons' confidence and skill with vaginal surgery, thus making vaginal hysterectomy a more feasible option for many,” they said.

Such a happening has yet to play out in the United States, however, said Alan Johns, M.D., past president of the Society of Reproductive Surgeons and the American Association of Gynecologic Laparoscopists.

“The skill level of the gynecologic surgeon has actually dropped dramatically,” said Dr. Johns, who practices in Fort Worth, Tex. “The average graduate has not done enough vaginal hysterectomy … and laparoscopic skills are not taught in the vast majority of residency programs.” Patients also don't demand alternatives to traditional abdominal surgery, he said.

According to the 2002 CDC study, rates of laparoscopically assisted vaginal hysterectomies more than doubled between 1994 and 1999, from 13% of all vaginal hysterectomies to 28%. The overall rate of vaginal hysterectomy remained stable, however.

David Barlow, M.D., a coinvestigator of the Cochrane review and executive dean of medicine at the University of Glasgow in Scotland, said that most surgeons in the United Kingdom, who are paid the same regardless of which approach is employed, perform abdominal hysterectomies and that “few” surgeons are specially trained in laparoscopic approaches.

The risk of urinary tract injury during laparoscopic operations was “not surprising” and, although it was statistically significant, “it was not that high.” Dr. Barlow added, that these findings need to be conclusively proven through more study and trial data.

It's also still unclear whether total laparoscopic hysterectomy has any benefits or harms over other forms of laparoscopic hysterectomy, he and his coinvestigators said in the review.

Data on long-term outcomes were “sparse” in the trials that were included in the review, said Dr. Barlow and Dr. Johns and their colleagues in the review.

Future trials should report on outcomes such as long-term urinary, bowel, and sexual function, as well as the occurrence of fistulae, they added.

Dr. Stovall, clinical professor of obstetrics and gynecology at the University of Tennessee in Memphis, said that interpreting the review is difficult because trials to date have not set and adequately controlled for indications and criteria for various approaches to hysterectomy.

“It all comes down to the issue of patient selection, indications, and inclusion and exclusion criteria” for particular approaches, he said.

“These are somewhat subjective decisions” in clinical practice, but ideally, investigators would control for these factors in future trials, Dr. Stovall added.

With long-term follow-up, “I don't think we'll see any difference in outcomes for one approach versus another.”

Dr. Barlow emphasized, however, the importance of short-term patient recovery.

“What this paper is saying—a main message—is that patients are home a day earlier on average [with vaginal hysterectomy] and return to normal quicker. Patients like speedier recoveries,” he said.

In this preoperative view, the uterus and ovaries are completely encased in adhesions from prior surgeries; only the fundus and anterior uterus are visible.

Using laparoscopic techniques, the uterus and ovaries have been dissected free, allowing the uterus to be removed vaginally.

The laparoscopic-assisted vaginal hysterectomy has been completed, and the ovaries have been left in place. Photos courtesy Dr. Alan Johns

A program that sends nurses to visit economically disadvantaged, single mothers during pregnancy and for the child's first 2 years can have long-term benefits, recent data show.

The analysis, which was recently commissioned by the Washington state legislature, shows the largest cost savings of any home visit, child welfare, or early intervention program.

The home visitation program has been developed over 25 years and operates in 21 states and focuses on improving birth outcomes, parenting skills, and children's health and development. It also promotes economic self-sufficiency for families.

Each mother in the Nurse-Family Partnership develops a long-term relationship with one nurse who follows detailed guidelines and is trained in prenatal care and early child development.

The latest data, published in two articles in the journal Pediatrics, come from controlled, randomized trials that have been conducted in two settings: among low-income African American mothers in Memphis, and among an ethnically and racially diverse group of low-income women in Denver.

The women and children in Memphis were interviewed and evaluated 4 years after the program ended, near the child's sixth birthday. Those in Denver were evaluated 2 years after the program had ended.

“The effects of the program …increase the likelihood that nurse-visited children will adjust more effectively as they proceed through elementary school,” reported David L. Olds, Ph.D., of the department of pediatrics at the University of Colorado Health Sciences Center in Denver, and his associates (Pediatrics 2004;114:1550–9).

Of the 743 women in Memphis who were randomized to the nurse home visitation program or one of three other intervention groups, those enrolled in the nurse visitation program had fewer subsequent pregnancies and births (1 vs. 1.3 births), and longer intervals between births of their first and second children (34 vs. 30 months).

They also had longer relationships with their partners, used welfare and food stamps for fewer months, and were more likely to enroll their children in some form of preschool or licensed day care.

The children of these nurse-visited women had higher scores on tests of intellectual functioning and receptive language, and fewer behavioral problems in the borderline or clinical range (2% vs. 5%, based on the Achenbach Child Behavior Checklist).

Among children born to women with low psychological resources (limited intellectual functioning, mental health, and sense of control), those whose mothers met with the nurses had higher arithmetic achievement test scores and expressed less dysregulated aggression and incoherence when asked to respond to and finish story beginnings, the investigators said.

The program “is so effective [because] they've tested [and shown] the importance of using nurses instead of social workers,” said Steve Aos, associate director of the Washington State Institute for Public Policy, a nonpartisan organization that produced the analysis that is now gaining focus in Washington state.

“And especially since the program has gone national, Dr. Olds makes sure the program is done by the book. … [He appears to have] hit on a better theoretical model for intervention. But he's also a stickler for training and quality control,” Mr. Aos said.

Dr. Olds, who developed and has refined the program over the years, said he hopes to examine more the extent to which the program produces comparable effects across different populations.

Some effects—such as reductions in prenatal tobacco use and reductions in the rates and intervals of subsequent pregnancies—-seem to be fairly consistent. Other effects vary among populations.

The Denver data are particularly complex because that study involves a more diverse group of women who were enrolled in various public and private care settings, he noted.

The first trial of the program, which began about 20 years ago, involved low-income white families in rural New York. Researchers showing less alcohol use and better behavior among teenage children of nurse-visited mothers has been published, and the families are still being followed, Dr. Olds noted.

The evaluation done by Mr. Aos' organization at the request of the Washington state legislature showed that the Nurse-Family Partnership costs about $9,000 per family and had a record net benefit of more than $17,000 per child, in terms of welfare, criminal justice system, medical, and other cost savings.

Most of the 160 Nurse-Family Partnership programs across the country are administered through county health programs.

In the long term, however, “things will have to change—there just aren't enough funding streams,” said Matt Buhr-Vogel, manager of site development for the new Nurse-Family Partnership national office in Denver.

Hopefully, he said, the data suggesting improved school readiness will interest departments of education and other funders.

A program that sends nurses to visit economically disadvantaged, single mothers during pregnancy and for the child's first 2 years can have long-term benefits, recent data show.

The analysis, which was recently commissioned by the Washington state legislature, shows the largest cost savings of any home visit, child welfare, or early intervention program.

The home visitation program has been developed over 25 years and operates in 21 states and focuses on improving birth outcomes, parenting skills, and children's health and development. It also promotes economic self-sufficiency for families.

Each mother in the Nurse-Family Partnership develops a long-term relationship with one nurse who follows detailed guidelines and is trained in prenatal care and early child development.

The latest data, published in two articles in the journal Pediatrics, come from controlled, randomized trials that have been conducted in two settings: among low-income African American mothers in Memphis, and among an ethnically and racially diverse group of low-income women in Denver.

The women and children in Memphis were interviewed and evaluated 4 years after the program ended, near the child's sixth birthday. Those in Denver were evaluated 2 years after the program had ended.

“The effects of the program …increase the likelihood that nurse-visited children will adjust more effectively as they proceed through elementary school,” reported David L. Olds, Ph.D., of the department of pediatrics at the University of Colorado Health Sciences Center in Denver, and his associates (Pediatrics 2004;114:1550–9).

Of the 743 women in Memphis who were randomized to the nurse home visitation program or one of three other intervention groups, those enrolled in the nurse visitation program had fewer subsequent pregnancies and births (1 vs. 1.3 births), and longer intervals between births of their first and second children (34 vs. 30 months).

They also had longer relationships with their partners, used welfare and food stamps for fewer months, and were more likely to enroll their children in some form of preschool or licensed day care.

The children of these nurse-visited women had higher scores on tests of intellectual functioning and receptive language, and fewer behavioral problems in the borderline or clinical range (2% vs. 5%, based on the Achenbach Child Behavior Checklist).

Among children born to women with low psychological resources (limited intellectual functioning, mental health, and sense of control), those whose mothers met with the nurses had higher arithmetic achievement test scores and expressed less dysregulated aggression and incoherence when asked to respond to and finish story beginnings, the investigators said.

The program “is so effective [because] they've tested [and shown] the importance of using nurses instead of social workers,” said Steve Aos, associate director of the Washington State Institute for Public Policy, a nonpartisan organization that produced the analysis that is now gaining focus in Washington state.

“And especially since the program has gone national, Dr. Olds makes sure the program is done by the book. … [He appears to have] hit on a better theoretical model for intervention. But he's also a stickler for training and quality control,” Mr. Aos said.

Dr. Olds, who developed and has refined the program over the years, said he hopes to examine more the extent to which the program produces comparable effects across different populations.

Some effects—such as reductions in prenatal tobacco use and reductions in the rates and intervals of subsequent pregnancies—-seem to be fairly consistent. Other effects vary among populations.

The Denver data are particularly complex because that study involves a more diverse group of women who were enrolled in various public and private care settings, he noted.

The first trial of the program, which began about 20 years ago, involved low-income white families in rural New York. Researchers showing less alcohol use and better behavior among teenage children of nurse-visited mothers has been published, and the families are still being followed, Dr. Olds noted.

The evaluation done by Mr. Aos' organization at the request of the Washington state legislature showed that the Nurse-Family Partnership costs about $9,000 per family and had a record net benefit of more than $17,000 per child, in terms of welfare, criminal justice system, medical, and other cost savings.

Most of the 160 Nurse-Family Partnership programs across the country are administered through county health programs.

In the long term, however, “things will have to change—there just aren't enough funding streams,” said Matt Buhr-Vogel, manager of site development for the new Nurse-Family Partnership national office in Denver.

Hopefully, he said, the data suggesting improved school readiness will interest departments of education and other funders.

A program that sends nurses to visit economically disadvantaged, single mothers during pregnancy and for the child's first 2 years can have long-term benefits, recent data show.

The analysis, which was recently commissioned by the Washington state legislature, shows the largest cost savings of any home visit, child welfare, or early intervention program.

The home visitation program has been developed over 25 years and operates in 21 states and focuses on improving birth outcomes, parenting skills, and children's health and development. It also promotes economic self-sufficiency for families.

Each mother in the Nurse-Family Partnership develops a long-term relationship with one nurse who follows detailed guidelines and is trained in prenatal care and early child development.

The latest data, published in two articles in the journal Pediatrics, come from controlled, randomized trials that have been conducted in two settings: among low-income African American mothers in Memphis, and among an ethnically and racially diverse group of low-income women in Denver.

The women and children in Memphis were interviewed and evaluated 4 years after the program ended, near the child's sixth birthday. Those in Denver were evaluated 2 years after the program had ended.

“The effects of the program …increase the likelihood that nurse-visited children will adjust more effectively as they proceed through elementary school,” reported David L. Olds, Ph.D., of the department of pediatrics at the University of Colorado Health Sciences Center in Denver, and his associates (Pediatrics 2004;114:1550–9).

Of the 743 women in Memphis who were randomized to the nurse home visitation program or one of three other intervention groups, those enrolled in the nurse visitation program had fewer subsequent pregnancies and births (1 vs. 1.3 births), and longer intervals between births of their first and second children (34 vs. 30 months).

They also had longer relationships with their partners, used welfare and food stamps for fewer months, and were more likely to enroll their children in some form of preschool or licensed day care.

The children of these nurse-visited women had higher scores on tests of intellectual functioning and receptive language, and fewer behavioral problems in the borderline or clinical range (2% vs. 5%, based on the Achenbach Child Behavior Checklist).

Among children born to women with low psychological resources (limited intellectual functioning, mental health, and sense of control), those whose mothers met with the nurses had higher arithmetic achievement test scores and expressed less dysregulated aggression and incoherence when asked to respond to and finish story beginnings, the investigators said.

The program “is so effective [because] they've tested [and shown] the importance of using nurses instead of social workers,” said Steve Aos, associate director of the Washington State Institute for Public Policy, a nonpartisan organization that produced the analysis that is now gaining focus in Washington state.

“And especially since the program has gone national, Dr. Olds makes sure the program is done by the book. … [He appears to have] hit on a better theoretical model for intervention. But he's also a stickler for training and quality control,” Mr. Aos said.

Dr. Olds, who developed and has refined the program over the years, said he hopes to examine more the extent to which the program produces comparable effects across different populations.

Some effects—such as reductions in prenatal tobacco use and reductions in the rates and intervals of subsequent pregnancies—-seem to be fairly consistent. Other effects vary among populations.

The Denver data are particularly complex because that study involves a more diverse group of women who were enrolled in various public and private care settings, he noted.

The first trial of the program, which began about 20 years ago, involved low-income white families in rural New York. Researchers showing less alcohol use and better behavior among teenage children of nurse-visited mothers has been published, and the families are still being followed, Dr. Olds noted.

The evaluation done by Mr. Aos' organization at the request of the Washington state legislature showed that the Nurse-Family Partnership costs about $9,000 per family and had a record net benefit of more than $17,000 per child, in terms of welfare, criminal justice system, medical, and other cost savings.

Most of the 160 Nurse-Family Partnership programs across the country are administered through county health programs.

In the long term, however, “things will have to change—there just aren't enough funding streams,” said Matt Buhr-Vogel, manager of site development for the new Nurse-Family Partnership national office in Denver.

Hopefully, he said, the data suggesting improved school readiness will interest departments of education and other funders.