Susan Birk

CHICAGO – The inflammatory theory of schizophrenia first put forth more than 100 years ago has scientific validity, a study of 30 psychotic pediatric patients indicates.

The study found significantly elevated serum levels of several inflammatory markers implicated in disruption of the blood-brain barrier (BBB) in psychotic children, compared with controls. The finding provides evidence for a relationship between psychosis, inflammation, and BBB disruption, reported Dr. Tatiana Falcone and the cerebrovascular research team led by Dr. Damir Janigro of Cleveland Clinic in a poster at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

“If our hypothesis is correct, and a causal link between inflammation and psychosis exists, new treatment modalities may be identified to add as a coadjuvant treatment for schizophrenia,” Dr. Falcone said in an interview.

“Although there are some studies evaluating anti-inflammatory medications in patients with schizophrenia, the results are confounding. We believe this might be related to the timing of the intervention, with more hope for effectiveness in first-episode psychosis and/or early-onset schizophrenia,” she said.

Patients had a diagnosis of acute psychosis on admission to the child and adolescent psychiatric unit at Cleveland Clinic. In the control group, a preliminary interview ruled out psychosis, neurodegenerative disorders, fever, current infection, and current use of antibiotics.

Blood samples were taken from the psychotic children on admission. All subjects underwent serum analysis for several inflammatory markers, including S100-β, a neurotrophic protein; tumor necrosis factor (TNF)–α; interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, and IL-10; and C-reactive protein.

The S100-β levels in 85% of the psychotic children exceeded the recognized normal range. The psychiatric patients also had significantly higher levels of IL-1β, TNF-α, IL-5, IL-6, and IL-10 than did controls. “These inflammatory mediators are often directly involved in BBB disruption,” Dr. Falcone said.

CHICAGO – The inflammatory theory of schizophrenia first put forth more than 100 years ago has scientific validity, a study of 30 psychotic pediatric patients indicates.

The study found significantly elevated serum levels of several inflammatory markers implicated in disruption of the blood-brain barrier (BBB) in psychotic children, compared with controls. The finding provides evidence for a relationship between psychosis, inflammation, and BBB disruption, reported Dr. Tatiana Falcone and the cerebrovascular research team led by Dr. Damir Janigro of Cleveland Clinic in a poster at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

“If our hypothesis is correct, and a causal link between inflammation and psychosis exists, new treatment modalities may be identified to add as a coadjuvant treatment for schizophrenia,” Dr. Falcone said in an interview.

“Although there are some studies evaluating anti-inflammatory medications in patients with schizophrenia, the results are confounding. We believe this might be related to the timing of the intervention, with more hope for effectiveness in first-episode psychosis and/or early-onset schizophrenia,” she said.

Patients had a diagnosis of acute psychosis on admission to the child and adolescent psychiatric unit at Cleveland Clinic. In the control group, a preliminary interview ruled out psychosis, neurodegenerative disorders, fever, current infection, and current use of antibiotics.

Blood samples were taken from the psychotic children on admission. All subjects underwent serum analysis for several inflammatory markers, including S100-β, a neurotrophic protein; tumor necrosis factor (TNF)–α; interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, and IL-10; and C-reactive protein.

The S100-β levels in 85% of the psychotic children exceeded the recognized normal range. The psychiatric patients also had significantly higher levels of IL-1β, TNF-α, IL-5, IL-6, and IL-10 than did controls. “These inflammatory mediators are often directly involved in BBB disruption,” Dr. Falcone said.

CHICAGO – The inflammatory theory of schizophrenia first put forth more than 100 years ago has scientific validity, a study of 30 psychotic pediatric patients indicates.

The study found significantly elevated serum levels of several inflammatory markers implicated in disruption of the blood-brain barrier (BBB) in psychotic children, compared with controls. The finding provides evidence for a relationship between psychosis, inflammation, and BBB disruption, reported Dr. Tatiana Falcone and the cerebrovascular research team led by Dr. Damir Janigro of Cleveland Clinic in a poster at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

“If our hypothesis is correct, and a causal link between inflammation and psychosis exists, new treatment modalities may be identified to add as a coadjuvant treatment for schizophrenia,” Dr. Falcone said in an interview.

“Although there are some studies evaluating anti-inflammatory medications in patients with schizophrenia, the results are confounding. We believe this might be related to the timing of the intervention, with more hope for effectiveness in first-episode psychosis and/or early-onset schizophrenia,” she said.

Patients had a diagnosis of acute psychosis on admission to the child and adolescent psychiatric unit at Cleveland Clinic. In the control group, a preliminary interview ruled out psychosis, neurodegenerative disorders, fever, current infection, and current use of antibiotics.

Blood samples were taken from the psychotic children on admission. All subjects underwent serum analysis for several inflammatory markers, including S100-β, a neurotrophic protein; tumor necrosis factor (TNF)–α; interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, and IL-10; and C-reactive protein.

The S100-β levels in 85% of the psychotic children exceeded the recognized normal range. The psychiatric patients also had significantly higher levels of IL-1β, TNF-α, IL-5, IL-6, and IL-10 than did controls. “These inflammatory mediators are often directly involved in BBB disruption,” Dr. Falcone said.

CHICAGO – Volumetric reduction of the hippocampus has emerged as a promising noninvasive imaging biomarker for prodromal and early stages of Alzheimer's disease.

The hippocampus was the site of the most dramatic changes in patients with single-domain mild cognitive impairment (memory loss), compared with normal controls. This part of the brain is therefore one of the most significant regions of interest for the early diagnosis of Alzheimer's disease (AD), said Dr. David S. Karow of the University of California, San Diego (UCSD), Medical Center.

Dr. Karow, a radiology resident, and his colleagues analyzed baseline MRI and fluorodeoxyglucose positron emission tomography (FDG-PET) images of the cohort of patients. All the patients were participants in the multicenter Alzheimer's Disease Neuroimaging Initiative, which is funded by the National Institutes of Health and by industry.

The finding of hippocampal volume reductions could help pave the way for the development of an objective, noninvasive test for early AD that would enable physicians to prescribe medications sooner to slow the disease's progression, Dr. Karow said in an interview. “The data we have gives us confidence that hippocampal volume is very promising for the diagnosis of early AD.… If you were going to pick one region as a noninvasive biomarker, whether it's for mild AD, mild cognitive impairment, or single-domain cognitive impairment, it's likely that the hippocampus is the region to monitor.”

The study revealed significant metabolic as well as structural reductions in the hippocampus, but volumetric reductions were more pronounced, he said.

The findings support a model of AD characterized by a process of downstream deinnervation, in which volume loss in regions of the mesial temporal lobe–the hippocampus in particular–leads to loss of activity in other regions.

In this study, the posterior cingulate cortex surfaced as the region of greatest early metabolic change without structural change. “This region is not the initial site of pathology, but because it's linked neurochemically to the mesial temporal lobe, you'll see metabolic changes there first,” he said. According to the model of AD, once these regions have been deprived of chemical and electrical input, atrophy will ultimately follow, Dr. Karow said.

He noted that, to his knowledge, the study is the first in AD research to combine data from both PET and MRI images, and to look at the relationship between metabolic and structural changes using a region of interest (ROI)-based approach across the whole brain. He presented the findings at the annual meeting of the Radiological Society of North America, and won the Trainee Research Prize for this work.

The researchers analyzed data from PET and MRI images for 80 normal controls, 156 patients with mild cognitive impairment (MCI), 69 patients with single-domain mild cognitive impairment (SMCI), and 68 patients with AD. Forty-five regions of interest were identified using FreeSurfer, 3-D reconstruction and segmentation software that assessed average differences in the volume/thickness and metabolic activity of these regions. Effect sizes for each group of patients were then calculated for each region.

Hippocampal volume reductions in SMCI patients averaged 9.5%, compared with controls. This group of patients also exhibited mean morphometric reductions of 6.2% in the entorhinal cortex, 5.5% in the amygdala, and 4.1% in the parahippocampal cortex. Compared with controls, volumetric losses in these structures were greatest for patients with mild AD, followed by MCI and then SMCI patients.

The largest metabolic differences among SMCI patients were declines of 4.2% in the entorhinal cortex, 3.3% in the posterior cingulate cortex, and 3.1% in the hippocampus, compared with controls.

Although the study revealed regions of the brain with greater metabolic reductions than atrophy in the SMCI, MCI, and AD groups, the magnitude of these changes was not as dramatic as the structural changes taking place in the hippocampus, Dr. Karow said. In terms of effect size, ROIs in the mesial temporal lobe, including the entorhinal cortex, and, in particular, the hippocampus, stood out as the most important in all three groups of patients, compared with controls.

Dr. Karow reported that neuroradiologists at UCSD have used the findings to create an imaging protocol that employs a commercial version of the brain imaging software used in this study. The protocol generates an automated segmentation of the patient's brain and compares the volume size of the hippocampus and the temporal horn of the lateral ventricle against normal volumes.

Hippocampal volume in patients with AD is typically at least two standard deviations below normal, and volume of the temporal horn of the lateral ventricle is typically two standard deviations above normal, noted Dr. Karow.

He disclosed that he has no financial conflicts of interest related to this study. Dr. Karow's coinvestigators included his mentors Anders Dale, Ph.D., and Dr. Carl K. Hoh. Dr. Dale is a founder of CorTechs Labs Inc., which developed the commercial version of the FreeSurfer software, called NeuroQuant; he holds equity interest in the company and serves on its scientific advisory board. Dr. Karow said the terms of this arrangement were reviewed and approved by UCSD in accordance with its conflict of interest policies.

Dr. Karow, the FreeSurfer-based methods also hold potential for the diagnosis of different types of dementia and behavioral disorders, as well as for clinical evaluations of medications, including those designed to slow AD progression.

Maps show average differences in activity and thickness between the diagnostic groups.

Source Courtesy Dr. David S. Karow

CHICAGO – Volumetric reduction of the hippocampus has emerged as a promising noninvasive imaging biomarker for prodromal and early stages of Alzheimer's disease.

The hippocampus was the site of the most dramatic changes in patients with single-domain mild cognitive impairment (memory loss), compared with normal controls. This part of the brain is therefore one of the most significant regions of interest for the early diagnosis of Alzheimer's disease (AD), said Dr. David S. Karow of the University of California, San Diego (UCSD), Medical Center.

Dr. Karow, a radiology resident, and his colleagues analyzed baseline MRI and fluorodeoxyglucose positron emission tomography (FDG-PET) images of the cohort of patients. All the patients were participants in the multicenter Alzheimer's Disease Neuroimaging Initiative, which is funded by the National Institutes of Health and by industry.

The finding of hippocampal volume reductions could help pave the way for the development of an objective, noninvasive test for early AD that would enable physicians to prescribe medications sooner to slow the disease's progression, Dr. Karow said in an interview. “The data we have gives us confidence that hippocampal volume is very promising for the diagnosis of early AD.… If you were going to pick one region as a noninvasive biomarker, whether it's for mild AD, mild cognitive impairment, or single-domain cognitive impairment, it's likely that the hippocampus is the region to monitor.”

The study revealed significant metabolic as well as structural reductions in the hippocampus, but volumetric reductions were more pronounced, he said.

The findings support a model of AD characterized by a process of downstream deinnervation, in which volume loss in regions of the mesial temporal lobe–the hippocampus in particular–leads to loss of activity in other regions.

In this study, the posterior cingulate cortex surfaced as the region of greatest early metabolic change without structural change. “This region is not the initial site of pathology, but because it's linked neurochemically to the mesial temporal lobe, you'll see metabolic changes there first,” he said. According to the model of AD, once these regions have been deprived of chemical and electrical input, atrophy will ultimately follow, Dr. Karow said.

He noted that, to his knowledge, the study is the first in AD research to combine data from both PET and MRI images, and to look at the relationship between metabolic and structural changes using a region of interest (ROI)-based approach across the whole brain. He presented the findings at the annual meeting of the Radiological Society of North America, and won the Trainee Research Prize for this work.

The researchers analyzed data from PET and MRI images for 80 normal controls, 156 patients with mild cognitive impairment (MCI), 69 patients with single-domain mild cognitive impairment (SMCI), and 68 patients with AD. Forty-five regions of interest were identified using FreeSurfer, 3-D reconstruction and segmentation software that assessed average differences in the volume/thickness and metabolic activity of these regions. Effect sizes for each group of patients were then calculated for each region.

Hippocampal volume reductions in SMCI patients averaged 9.5%, compared with controls. This group of patients also exhibited mean morphometric reductions of 6.2% in the entorhinal cortex, 5.5% in the amygdala, and 4.1% in the parahippocampal cortex. Compared with controls, volumetric losses in these structures were greatest for patients with mild AD, followed by MCI and then SMCI patients.

The largest metabolic differences among SMCI patients were declines of 4.2% in the entorhinal cortex, 3.3% in the posterior cingulate cortex, and 3.1% in the hippocampus, compared with controls.

Although the study revealed regions of the brain with greater metabolic reductions than atrophy in the SMCI, MCI, and AD groups, the magnitude of these changes was not as dramatic as the structural changes taking place in the hippocampus, Dr. Karow said. In terms of effect size, ROIs in the mesial temporal lobe, including the entorhinal cortex, and, in particular, the hippocampus, stood out as the most important in all three groups of patients, compared with controls.

Dr. Karow reported that neuroradiologists at UCSD have used the findings to create an imaging protocol that employs a commercial version of the brain imaging software used in this study. The protocol generates an automated segmentation of the patient's brain and compares the volume size of the hippocampus and the temporal horn of the lateral ventricle against normal volumes.

Hippocampal volume in patients with AD is typically at least two standard deviations below normal, and volume of the temporal horn of the lateral ventricle is typically two standard deviations above normal, noted Dr. Karow.

He disclosed that he has no financial conflicts of interest related to this study. Dr. Karow's coinvestigators included his mentors Anders Dale, Ph.D., and Dr. Carl K. Hoh. Dr. Dale is a founder of CorTechs Labs Inc., which developed the commercial version of the FreeSurfer software, called NeuroQuant; he holds equity interest in the company and serves on its scientific advisory board. Dr. Karow said the terms of this arrangement were reviewed and approved by UCSD in accordance with its conflict of interest policies.

Dr. Karow, the FreeSurfer-based methods also hold potential for the diagnosis of different types of dementia and behavioral disorders, as well as for clinical evaluations of medications, including those designed to slow AD progression.

Maps show average differences in activity and thickness between the diagnostic groups.

Source Courtesy Dr. David S. Karow

CHICAGO – Volumetric reduction of the hippocampus has emerged as a promising noninvasive imaging biomarker for prodromal and early stages of Alzheimer's disease.

The hippocampus was the site of the most dramatic changes in patients with single-domain mild cognitive impairment (memory loss), compared with normal controls. This part of the brain is therefore one of the most significant regions of interest for the early diagnosis of Alzheimer's disease (AD), said Dr. David S. Karow of the University of California, San Diego (UCSD), Medical Center.

Dr. Karow, a radiology resident, and his colleagues analyzed baseline MRI and fluorodeoxyglucose positron emission tomography (FDG-PET) images of the cohort of patients. All the patients were participants in the multicenter Alzheimer's Disease Neuroimaging Initiative, which is funded by the National Institutes of Health and by industry.

The finding of hippocampal volume reductions could help pave the way for the development of an objective, noninvasive test for early AD that would enable physicians to prescribe medications sooner to slow the disease's progression, Dr. Karow said in an interview. “The data we have gives us confidence that hippocampal volume is very promising for the diagnosis of early AD.… If you were going to pick one region as a noninvasive biomarker, whether it's for mild AD, mild cognitive impairment, or single-domain cognitive impairment, it's likely that the hippocampus is the region to monitor.”

The study revealed significant metabolic as well as structural reductions in the hippocampus, but volumetric reductions were more pronounced, he said.

The findings support a model of AD characterized by a process of downstream deinnervation, in which volume loss in regions of the mesial temporal lobe–the hippocampus in particular–leads to loss of activity in other regions.

In this study, the posterior cingulate cortex surfaced as the region of greatest early metabolic change without structural change. “This region is not the initial site of pathology, but because it's linked neurochemically to the mesial temporal lobe, you'll see metabolic changes there first,” he said. According to the model of AD, once these regions have been deprived of chemical and electrical input, atrophy will ultimately follow, Dr. Karow said.

He noted that, to his knowledge, the study is the first in AD research to combine data from both PET and MRI images, and to look at the relationship between metabolic and structural changes using a region of interest (ROI)-based approach across the whole brain. He presented the findings at the annual meeting of the Radiological Society of North America, and won the Trainee Research Prize for this work.

The researchers analyzed data from PET and MRI images for 80 normal controls, 156 patients with mild cognitive impairment (MCI), 69 patients with single-domain mild cognitive impairment (SMCI), and 68 patients with AD. Forty-five regions of interest were identified using FreeSurfer, 3-D reconstruction and segmentation software that assessed average differences in the volume/thickness and metabolic activity of these regions. Effect sizes for each group of patients were then calculated for each region.

Hippocampal volume reductions in SMCI patients averaged 9.5%, compared with controls. This group of patients also exhibited mean morphometric reductions of 6.2% in the entorhinal cortex, 5.5% in the amygdala, and 4.1% in the parahippocampal cortex. Compared with controls, volumetric losses in these structures were greatest for patients with mild AD, followed by MCI and then SMCI patients.

The largest metabolic differences among SMCI patients were declines of 4.2% in the entorhinal cortex, 3.3% in the posterior cingulate cortex, and 3.1% in the hippocampus, compared with controls.

Although the study revealed regions of the brain with greater metabolic reductions than atrophy in the SMCI, MCI, and AD groups, the magnitude of these changes was not as dramatic as the structural changes taking place in the hippocampus, Dr. Karow said. In terms of effect size, ROIs in the mesial temporal lobe, including the entorhinal cortex, and, in particular, the hippocampus, stood out as the most important in all three groups of patients, compared with controls.

Dr. Karow reported that neuroradiologists at UCSD have used the findings to create an imaging protocol that employs a commercial version of the brain imaging software used in this study. The protocol generates an automated segmentation of the patient's brain and compares the volume size of the hippocampus and the temporal horn of the lateral ventricle against normal volumes.

Hippocampal volume in patients with AD is typically at least two standard deviations below normal, and volume of the temporal horn of the lateral ventricle is typically two standard deviations above normal, noted Dr. Karow.

He disclosed that he has no financial conflicts of interest related to this study. Dr. Karow's coinvestigators included his mentors Anders Dale, Ph.D., and Dr. Carl K. Hoh. Dr. Dale is a founder of CorTechs Labs Inc., which developed the commercial version of the FreeSurfer software, called NeuroQuant; he holds equity interest in the company and serves on its scientific advisory board. Dr. Karow said the terms of this arrangement were reviewed and approved by UCSD in accordance with its conflict of interest policies.

Dr. Karow, the FreeSurfer-based methods also hold potential for the diagnosis of different types of dementia and behavioral disorders, as well as for clinical evaluations of medications, including those designed to slow AD progression.

Maps show average differences in activity and thickness between the diagnostic groups.

Source Courtesy Dr. David S. Karow

ROSEMONT, ILL. — Despite major patient safety strides during the past decade, health care providers need to create more accountability for medical errors and patient safety lapses in order to continue improving, according to Dr. Robert M. Wachter, professor of medicine at the University of California, San Francisco.

At the Joint Commission national conference on quality and patient safety, Dr. Wachter offered his perspectives on the status of patient safety in health care 10 years after the publication of the first Institute of Medicine report, “To Err Is Human: Building a Safer Health System.” He and Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, published an editorial on the topic shortly after the conference (N. Engl. J. Med. 2009;361:1401-6).

Balancing a culture of “no blame” with a culture of accountability remains a key challenge for providers. Although it's true that “most errors are committed by caring, competent people trying hard to get it right … the system produces low-quality, unsafe, unreliable care partly because there's been no business case to do otherwise,” he said.

“'No blame' is the right response for innocent slips and mistakes, which turn out to be most errors. But there need to be clear demarcations of blameworthy acts—not just gross incompetence, not just disruptive behavior, but also failure to follow reasonable safety standards,” said Dr. Wachter, who edits two online publications for the Agency for Healthcare Research and Quality: WebM&M (www.webmm.ahrq.govwww.psnet.ahrq.gov

Dr. Wachter cited the fact that average hand washing compliance rates continue to hover at only about 50% as an example of the need for more accountability. “I don't believe that is fully a systems problem,” he said. Part of the problem is that “there have been no penalties for transgressions.”

Although accountability is essential, “my guess is it will go too far,” Dr. Wachter added. “We've created an environment where people don't want to have to talk about errors. We're probably going to have to go too far and then come up with a sweet spot.”

Dr. Wachter also commented on other aspects of patient safety:

▸ Regulation. Health care organizations need regulators to set standards, but the challenge is ensuring that these standards truly help organizations improve safety. Until the Joint Commission developed standards for reading back instructions, “virtually none of us thought of doing that on our own,” he said.

At the same time, “it is extraordinarily difficult to have a set of rules and standards that apply equally in nuanced areas to organizations that are incredibly different in the way they do business, their financial resources, and their capacity,” he added.

For that reason, regulation is useful to get people moving, “but it tends to run out of gas over time,” Dr. Wachter said. To illustrate, he cited the Joint Commission's recent decision to remove adherence to medication reconciliation standards as a requirement for accreditation because organizations struggled to develop appropriate processes.

However, having an “outside organization creating rules and standards we must abide by was extraordinarily important in the first 5 years” after the IOM report, he said. Despite some glitches, “the Joint Commission has improved its processes tremendously” and recently made an important step in the right direction with the creation of the Center for Transforming Healthcare.

▸ Reporting. “The admonition to report everything is silly,” Dr. Wachter said. “Our mistake here was to not be thoughtful about what we are going to do with all of these reports” before requiring them.

However, providers have learned from this experience and begun to think more critically about what should be reported and how the data should be used, he said.

State reporting requirements on the 27 “never events” put forth by the National Quality Forum have led to more focused patient safety efforts. “Until the state reporting system, our process [at UCSF] for doing root cause analysis was pretty haphazard,” he noted. Now the institution holds a weekly 2-hour root cause analysis meeting attended by the same group of leaders.

▸ Information technology. Health care providers have developed a more robust, less naive understanding of the role of health care information technology in patient safety and now realize that it is not a panacea. Improvement efforts are not nearly as effective “if we just do the computer piece but don't educate people,” Dr. Wachter said.

Still, “even though we've got plenty of room to go, I think we should all be proud” of what has been accomplished in the past 10 years, he said.

ROSEMONT, ILL. — Despite major patient safety strides during the past decade, health care providers need to create more accountability for medical errors and patient safety lapses in order to continue improving, according to Dr. Robert M. Wachter, professor of medicine at the University of California, San Francisco.

At the Joint Commission national conference on quality and patient safety, Dr. Wachter offered his perspectives on the status of patient safety in health care 10 years after the publication of the first Institute of Medicine report, “To Err Is Human: Building a Safer Health System.” He and Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, published an editorial on the topic shortly after the conference (N. Engl. J. Med. 2009;361:1401-6).

Balancing a culture of “no blame” with a culture of accountability remains a key challenge for providers. Although it's true that “most errors are committed by caring, competent people trying hard to get it right … the system produces low-quality, unsafe, unreliable care partly because there's been no business case to do otherwise,” he said.

“'No blame' is the right response for innocent slips and mistakes, which turn out to be most errors. But there need to be clear demarcations of blameworthy acts—not just gross incompetence, not just disruptive behavior, but also failure to follow reasonable safety standards,” said Dr. Wachter, who edits two online publications for the Agency for Healthcare Research and Quality: WebM&M (www.webmm.ahrq.govwww.psnet.ahrq.gov

Dr. Wachter cited the fact that average hand washing compliance rates continue to hover at only about 50% as an example of the need for more accountability. “I don't believe that is fully a systems problem,” he said. Part of the problem is that “there have been no penalties for transgressions.”

Although accountability is essential, “my guess is it will go too far,” Dr. Wachter added. “We've created an environment where people don't want to have to talk about errors. We're probably going to have to go too far and then come up with a sweet spot.”

Dr. Wachter also commented on other aspects of patient safety:

▸ Regulation. Health care organizations need regulators to set standards, but the challenge is ensuring that these standards truly help organizations improve safety. Until the Joint Commission developed standards for reading back instructions, “virtually none of us thought of doing that on our own,” he said.

At the same time, “it is extraordinarily difficult to have a set of rules and standards that apply equally in nuanced areas to organizations that are incredibly different in the way they do business, their financial resources, and their capacity,” he added.

For that reason, regulation is useful to get people moving, “but it tends to run out of gas over time,” Dr. Wachter said. To illustrate, he cited the Joint Commission's recent decision to remove adherence to medication reconciliation standards as a requirement for accreditation because organizations struggled to develop appropriate processes.

However, having an “outside organization creating rules and standards we must abide by was extraordinarily important in the first 5 years” after the IOM report, he said. Despite some glitches, “the Joint Commission has improved its processes tremendously” and recently made an important step in the right direction with the creation of the Center for Transforming Healthcare.

▸ Reporting. “The admonition to report everything is silly,” Dr. Wachter said. “Our mistake here was to not be thoughtful about what we are going to do with all of these reports” before requiring them.

However, providers have learned from this experience and begun to think more critically about what should be reported and how the data should be used, he said.

State reporting requirements on the 27 “never events” put forth by the National Quality Forum have led to more focused patient safety efforts. “Until the state reporting system, our process [at UCSF] for doing root cause analysis was pretty haphazard,” he noted. Now the institution holds a weekly 2-hour root cause analysis meeting attended by the same group of leaders.

▸ Information technology. Health care providers have developed a more robust, less naive understanding of the role of health care information technology in patient safety and now realize that it is not a panacea. Improvement efforts are not nearly as effective “if we just do the computer piece but don't educate people,” Dr. Wachter said.

Still, “even though we've got plenty of room to go, I think we should all be proud” of what has been accomplished in the past 10 years, he said.

ROSEMONT, ILL. — Despite major patient safety strides during the past decade, health care providers need to create more accountability for medical errors and patient safety lapses in order to continue improving, according to Dr. Robert M. Wachter, professor of medicine at the University of California, San Francisco.

At the Joint Commission national conference on quality and patient safety, Dr. Wachter offered his perspectives on the status of patient safety in health care 10 years after the publication of the first Institute of Medicine report, “To Err Is Human: Building a Safer Health System.” He and Dr. Peter J. Pronovost of Johns Hopkins University, Baltimore, published an editorial on the topic shortly after the conference (N. Engl. J. Med. 2009;361:1401-6).

Balancing a culture of “no blame” with a culture of accountability remains a key challenge for providers. Although it's true that “most errors are committed by caring, competent people trying hard to get it right … the system produces low-quality, unsafe, unreliable care partly because there's been no business case to do otherwise,” he said.

“'No blame' is the right response for innocent slips and mistakes, which turn out to be most errors. But there need to be clear demarcations of blameworthy acts—not just gross incompetence, not just disruptive behavior, but also failure to follow reasonable safety standards,” said Dr. Wachter, who edits two online publications for the Agency for Healthcare Research and Quality: WebM&M (www.webmm.ahrq.govwww.psnet.ahrq.gov

Dr. Wachter cited the fact that average hand washing compliance rates continue to hover at only about 50% as an example of the need for more accountability. “I don't believe that is fully a systems problem,” he said. Part of the problem is that “there have been no penalties for transgressions.”

Although accountability is essential, “my guess is it will go too far,” Dr. Wachter added. “We've created an environment where people don't want to have to talk about errors. We're probably going to have to go too far and then come up with a sweet spot.”

Dr. Wachter also commented on other aspects of patient safety:

▸ Regulation. Health care organizations need regulators to set standards, but the challenge is ensuring that these standards truly help organizations improve safety. Until the Joint Commission developed standards for reading back instructions, “virtually none of us thought of doing that on our own,” he said.

At the same time, “it is extraordinarily difficult to have a set of rules and standards that apply equally in nuanced areas to organizations that are incredibly different in the way they do business, their financial resources, and their capacity,” he added.

For that reason, regulation is useful to get people moving, “but it tends to run out of gas over time,” Dr. Wachter said. To illustrate, he cited the Joint Commission's recent decision to remove adherence to medication reconciliation standards as a requirement for accreditation because organizations struggled to develop appropriate processes.

However, having an “outside organization creating rules and standards we must abide by was extraordinarily important in the first 5 years” after the IOM report, he said. Despite some glitches, “the Joint Commission has improved its processes tremendously” and recently made an important step in the right direction with the creation of the Center for Transforming Healthcare.

▸ Reporting. “The admonition to report everything is silly,” Dr. Wachter said. “Our mistake here was to not be thoughtful about what we are going to do with all of these reports” before requiring them.

However, providers have learned from this experience and begun to think more critically about what should be reported and how the data should be used, he said.

State reporting requirements on the 27 “never events” put forth by the National Quality Forum have led to more focused patient safety efforts. “Until the state reporting system, our process [at UCSF] for doing root cause analysis was pretty haphazard,” he noted. Now the institution holds a weekly 2-hour root cause analysis meeting attended by the same group of leaders.

▸ Information technology. Health care providers have developed a more robust, less naive understanding of the role of health care information technology in patient safety and now realize that it is not a panacea. Improvement efforts are not nearly as effective “if we just do the computer piece but don't educate people,” Dr. Wachter said.

Still, “even though we've got plenty of room to go, I think we should all be proud” of what has been accomplished in the past 10 years, he said.

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other, or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who've been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor-in-chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort vs. 0.7% of controls were positive for antiendomysial antibodies (EMA) or tissue-transglutaminase antibodies (tTG), or both (odds ratio 2.94). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) vs. 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34). (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104 [supplement 1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[supplement 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients vs. controls, and the differences did not reach statistical significance in either study. However, the patient populations in these studies were relatively small.

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, said Dr. Chey. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized.

“It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients. They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said.

Celiac disease is three- to fourfold more prevalent in IBS patients than in the general population.

Source DR. CHEY

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other, or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who've been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor-in-chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort vs. 0.7% of controls were positive for antiendomysial antibodies (EMA) or tissue-transglutaminase antibodies (tTG), or both (odds ratio 2.94). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) vs. 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34). (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104 [supplement 1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[supplement 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients vs. controls, and the differences did not reach statistical significance in either study. However, the patient populations in these studies were relatively small.

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, said Dr. Chey. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized.

“It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients. They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said.

Celiac disease is three- to fourfold more prevalent in IBS patients than in the general population.

Source DR. CHEY

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other, or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who've been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor-in-chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort vs. 0.7% of controls were positive for antiendomysial antibodies (EMA) or tissue-transglutaminase antibodies (tTG), or both (odds ratio 2.94). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) vs. 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34). (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104 [supplement 1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[supplement 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients vs. controls, and the differences did not reach statistical significance in either study. However, the patient populations in these studies were relatively small.

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, said Dr. Chey. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized.

“It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients. They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said.

Celiac disease is three- to fourfold more prevalent in IBS patients than in the general population.

Source DR. CHEY

ROSEMONT, ILL. — Morbidity and mortality conferences can yield improvements more quickly than can any other quality or patient safety measure in a hospital, but only if all of the disciplines involved meet at the same table in a concerted effort to learn from errors and make lasting changes, according to Dr. Omar Lateef, director of the critical care safety program at Rush University Medical Center in Chicago.

“Currently, the 'M and M' model in most hospitals remains isolated by discipline, not geographic space,” with specialties such as medicine, surgery, cardiac surgery, and cardiology each holding separate conferences, Dr. Lateef said at the Joint Commission national conference on quality and patient safety.

This piecemeal approach of organizing conferences based on specialty fosters separatism, blocks communication, leaves other disciplines out of valuable learning experiences, and creates confusion that leads to errors, he said.

By way of example, he noted the patient with pneumonia who is placed in the cardiac intensive care unit and is given an aspirin before being given the appropriate initial antibiotic regimen, and the patient with a myocardial infarction who is placed in the medical ICU and is given antibiotics before receiving aspirin therapy.

These “cultural differences” based on specialty “aren't good when you're taking care of the same patients. If you don't talk to each other, then bad things are ultimately going to happen,” Dr. Lateef said, noting that it is common for medical ICU patients to receive care from six different services.

Dr. Raj Behal, associate chief medical officer at Rush, noted that “the important thing is that as we're looking at individual cases we're looking for patterns across cases, so if we have a medication error in the OR pharmacy, what is that telling us? It's probably no longer just about the error, it's pointing to a larger issue.” That larger issue is more likely to be identified when all disciplines participate together in the process.

Rush has begun to hold multidisciplinary M and M conferences to provide a forum for discussions of mistakes among different disciplines. A multidisciplinary M and M conference to tackle the treatment of massive pulmonary embolism, for example, revealed the lack of a clear protocol to guide care in the absence of an obvious best practice.

“Many specialties did not realize the abilities of the other specialties” involved in the treatment of massive pulmonary embolism, such as interventional radiology, interventional cardiology, and cardiac surgery. In this instance, “M and M acted as the recognition tool of a problem,” said Dr. Lateef, who is also medical director of the medical ICU. Rush's chief medical officer set up meetings to discuss expert opinions and data from a variety of disciplines. As a result, a protocol for massive pulmonary embolism was developed and has been used several times within the past year.

“The job of a good M and M conference is to ensure that those who have the ability to change hospital practice are aware of the key issues within the hospital,” Dr. Lateef added. At Rush, the chief medical officer is kept apprised of the results of all M and M conferences. “Administrators have the power to change things. They need to know what those things are.”

ROSEMONT, ILL. — Morbidity and mortality conferences can yield improvements more quickly than can any other quality or patient safety measure in a hospital, but only if all of the disciplines involved meet at the same table in a concerted effort to learn from errors and make lasting changes, according to Dr. Omar Lateef, director of the critical care safety program at Rush University Medical Center in Chicago.

“Currently, the 'M and M' model in most hospitals remains isolated by discipline, not geographic space,” with specialties such as medicine, surgery, cardiac surgery, and cardiology each holding separate conferences, Dr. Lateef said at the Joint Commission national conference on quality and patient safety.

This piecemeal approach of organizing conferences based on specialty fosters separatism, blocks communication, leaves other disciplines out of valuable learning experiences, and creates confusion that leads to errors, he said.

By way of example, he noted the patient with pneumonia who is placed in the cardiac intensive care unit and is given an aspirin before being given the appropriate initial antibiotic regimen, and the patient with a myocardial infarction who is placed in the medical ICU and is given antibiotics before receiving aspirin therapy.

These “cultural differences” based on specialty “aren't good when you're taking care of the same patients. If you don't talk to each other, then bad things are ultimately going to happen,” Dr. Lateef said, noting that it is common for medical ICU patients to receive care from six different services.

Dr. Raj Behal, associate chief medical officer at Rush, noted that “the important thing is that as we're looking at individual cases we're looking for patterns across cases, so if we have a medication error in the OR pharmacy, what is that telling us? It's probably no longer just about the error, it's pointing to a larger issue.” That larger issue is more likely to be identified when all disciplines participate together in the process.

Rush has begun to hold multidisciplinary M and M conferences to provide a forum for discussions of mistakes among different disciplines. A multidisciplinary M and M conference to tackle the treatment of massive pulmonary embolism, for example, revealed the lack of a clear protocol to guide care in the absence of an obvious best practice.

“Many specialties did not realize the abilities of the other specialties” involved in the treatment of massive pulmonary embolism, such as interventional radiology, interventional cardiology, and cardiac surgery. In this instance, “M and M acted as the recognition tool of a problem,” said Dr. Lateef, who is also medical director of the medical ICU. Rush's chief medical officer set up meetings to discuss expert opinions and data from a variety of disciplines. As a result, a protocol for massive pulmonary embolism was developed and has been used several times within the past year.

“The job of a good M and M conference is to ensure that those who have the ability to change hospital practice are aware of the key issues within the hospital,” Dr. Lateef added. At Rush, the chief medical officer is kept apprised of the results of all M and M conferences. “Administrators have the power to change things. They need to know what those things are.”

ROSEMONT, ILL. — Morbidity and mortality conferences can yield improvements more quickly than can any other quality or patient safety measure in a hospital, but only if all of the disciplines involved meet at the same table in a concerted effort to learn from errors and make lasting changes, according to Dr. Omar Lateef, director of the critical care safety program at Rush University Medical Center in Chicago.

“Currently, the 'M and M' model in most hospitals remains isolated by discipline, not geographic space,” with specialties such as medicine, surgery, cardiac surgery, and cardiology each holding separate conferences, Dr. Lateef said at the Joint Commission national conference on quality and patient safety.

This piecemeal approach of organizing conferences based on specialty fosters separatism, blocks communication, leaves other disciplines out of valuable learning experiences, and creates confusion that leads to errors, he said.

By way of example, he noted the patient with pneumonia who is placed in the cardiac intensive care unit and is given an aspirin before being given the appropriate initial antibiotic regimen, and the patient with a myocardial infarction who is placed in the medical ICU and is given antibiotics before receiving aspirin therapy.

These “cultural differences” based on specialty “aren't good when you're taking care of the same patients. If you don't talk to each other, then bad things are ultimately going to happen,” Dr. Lateef said, noting that it is common for medical ICU patients to receive care from six different services.

Dr. Raj Behal, associate chief medical officer at Rush, noted that “the important thing is that as we're looking at individual cases we're looking for patterns across cases, so if we have a medication error in the OR pharmacy, what is that telling us? It's probably no longer just about the error, it's pointing to a larger issue.” That larger issue is more likely to be identified when all disciplines participate together in the process.

Rush has begun to hold multidisciplinary M and M conferences to provide a forum for discussions of mistakes among different disciplines. A multidisciplinary M and M conference to tackle the treatment of massive pulmonary embolism, for example, revealed the lack of a clear protocol to guide care in the absence of an obvious best practice.

“Many specialties did not realize the abilities of the other specialties” involved in the treatment of massive pulmonary embolism, such as interventional radiology, interventional cardiology, and cardiac surgery. In this instance, “M and M acted as the recognition tool of a problem,” said Dr. Lateef, who is also medical director of the medical ICU. Rush's chief medical officer set up meetings to discuss expert opinions and data from a variety of disciplines. As a result, a protocol for massive pulmonary embolism was developed and has been used several times within the past year.

“The job of a good M and M conference is to ensure that those who have the ability to change hospital practice are aware of the key issues within the hospital,” Dr. Lateef added. At Rush, the chief medical officer is kept apprised of the results of all M and M conferences. “Administrators have the power to change things. They need to know what those things are.”

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who have been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor in chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort versus 0.7% of controls were positive for antiendomysial antibody (EMA), tissue-transglutaminase antibody (tTG), or both (odds ratio 2.94, 95% confidence interval 1.36-6.35). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) versus 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34, 95% CI, 1.78-10.6) (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104[suppl1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[suppl 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients versus controls, and the differences did not reach statistical significance in either study.

However, the patient populations in these studies were relatively small. “If we had a larger study, those differences probably would be significant. We had about 500 IBS patients [in the prospective study], but for those types of differences we would need an even larger study.”

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, Dr. Chey said. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized. “It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients.

They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said. “We didn't feel comfortable making a sweeping recommendation. It may be reasonable to screen in this population, but we need prospective data.” The guidelines have been published in the American Journal of Gastroenterology (2009;104 ([suppl 1]):S1-35).

Dr. Chey also reported recent findings regarding patients who develop gastrointestinal symptoms related to the ingestion of gluten who do not have celiac disease. Some of these patients have a sensitivity to gluten, but in many cases do not show the intestinal inflammation on biopsy that is the hallmark of celiac disease, or they have mild abnormalities on biopsy but totally normal serology.

“The days of dismissing patients who say they have reactions to certain foods in their diets—particularly gluten-containing foods—are over. There is this other condition out there, and we need to understand it,” said Dr. Chey, adding that the prevalence of gluten sensitivity could be three or four times that of celiac disease.

“This is a rapidly expanding area and there are groups starting to work hard on understanding gluten sensitivity,” he said.

'There are … profound health consequences for the patients who are incorrectly diagnosed and treated.'

Source DR. CHEY

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who have been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor in chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort versus 0.7% of controls were positive for antiendomysial antibody (EMA), tissue-transglutaminase antibody (tTG), or both (odds ratio 2.94, 95% confidence interval 1.36-6.35). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) versus 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34, 95% CI, 1.78-10.6) (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104[suppl1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[suppl 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients versus controls, and the differences did not reach statistical significance in either study.

However, the patient populations in these studies were relatively small. “If we had a larger study, those differences probably would be significant. We had about 500 IBS patients [in the prospective study], but for those types of differences we would need an even larger study.”

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, Dr. Chey said. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized. “It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients.

They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said. “We didn't feel comfortable making a sweeping recommendation. It may be reasonable to screen in this population, but we need prospective data.” The guidelines have been published in the American Journal of Gastroenterology (2009;104 ([suppl 1]):S1-35).

Dr. Chey also reported recent findings regarding patients who develop gastrointestinal symptoms related to the ingestion of gluten who do not have celiac disease. Some of these patients have a sensitivity to gluten, but in many cases do not show the intestinal inflammation on biopsy that is the hallmark of celiac disease, or they have mild abnormalities on biopsy but totally normal serology.

“The days of dismissing patients who say they have reactions to certain foods in their diets—particularly gluten-containing foods—are over. There is this other condition out there, and we need to understand it,” said Dr. Chey, adding that the prevalence of gluten sensitivity could be three or four times that of celiac disease.

“This is a rapidly expanding area and there are groups starting to work hard on understanding gluten sensitivity,” he said.

'There are … profound health consequences for the patients who are incorrectly diagnosed and treated.'

Source DR. CHEY

CHICAGO — All irritable bowel syndrome patients with the diarrhea and mixed diarrhea-constipation phenotypes should be screened for celiac disease, according to guidelines issued by the American College of Gastroenterology earlier this year.

The guidelines were developed in response to emerging evidence showing a three- to fourfold greater prevalence of celiac disease in IBS patients than in the general population, Dr. William D. Chey said at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Celiac disease and IBS can have virtually identical symptoms, and mistaking one for the other or not knowing that both are present, can lead to expensive, unnecessary tests, ineffective therapies, and pointless repeat visits, said Dr. Chey, professor of internal medicine and director of the gastrointestinal physiology laboratory at the University of Michigan, Ann Arbor.

“Most important, people with untreated celiac disease have higher mortality and are at higher risk of developing cancer, osteoporosis, and a variety of other metabolic abnormalities than people who have been treated. There are clear cost consequences of not doing this correctly, but there are even more profound health consequences for the patients who are incorrectly diagnosed and treated,” said Dr. Chey, co–editor in chief of the American Journal of Gastroenterology.

A systematic review by Dr. Chey and his colleagues of seven studies from around the world involving 2,978 people (1,052 with IBS) found that 3% of the IBS cohort versus 0.7% of controls were positive for antiendomysial antibody (EMA), tissue-transglutaminase antibody (tTG), or both (odds ratio 2.94, 95% confidence interval 1.36-6.35). In a separate analysis of five studies, 3.6% of IBS patients (34 of 952) versus 0.7% of controls (12 of 1,798) tested positive for EMA, antigliadin antibody, or tTG and showed small bowel biopsy evidence of celiac disease (OR 4.34, 95% CI, 1.78-10.6) (Arch. Intern. Med. 2009;169:651-8; Am. J. Gastroenterol. 2009;104[suppl1]:S1-35).

There are limited data on this issue from the United States. Dr. Chey cited a retrospective study (Am. J. Gastroenterol. 2008;103[suppl 1]:S472) and a prospective study (Gastroenterology 2007;132:A-147) that found only small absolute differences in celiac disease prevalence among IBS patients versus controls, and the differences did not reach statistical significance in either study.

However, the patient populations in these studies were relatively small. “If we had a larger study, those differences probably would be significant. We had about 500 IBS patients [in the prospective study], but for those types of differences we would need an even larger study.”

Two decision analytic models used as a basis for the ACG guidelines showed that serologic screening for celiac disease in the IBS patient population is cost effective, even though the disease's prevalence among IBS patients actually is low, Dr. Chey said. According to these models, screening is cost effective as long as disease prevalence exceeds 1%, and both the prospective and retrospective studies from the United States met that criterion.

“It sounds impressive to say there's a three- to fourfold increase, and that is true, but overall, the prevalence of celiac disease among IBS patients is still pretty low,” Dr. Chey emphasized. “It's really important for doctors to understand that they're only going to find celiac disease in 1 or 2 out of 100 patients.

They're going to do a lot of testing and not find a lot of celiac disease. However, the benefits to patients and the time and costs saved with an accurate diagnosis and appropriate care make this routine testing worthwhile,” he said.

At present, the ACG guidelines do not recommend screening for celiac disease in constipation-predominant IBS patients because there are “virtually no data” showing that these patients are at increased risk, Dr. Chey said. “We didn't feel comfortable making a sweeping recommendation. It may be reasonable to screen in this population, but we need prospective data.” The guidelines have been published in the American Journal of Gastroenterology (2009;104 ([suppl 1]):S1-35).

Dr. Chey also reported recent findings regarding patients who develop gastrointestinal symptoms related to the ingestion of gluten who do not have celiac disease. Some of these patients have a sensitivity to gluten, but in many cases do not show the intestinal inflammation on biopsy that is the hallmark of celiac disease, or they have mild abnormalities on biopsy but totally normal serology.

“The days of dismissing patients who say they have reactions to certain foods in their diets—particularly gluten-containing foods—are over. There is this other condition out there, and we need to understand it,” said Dr. Chey, adding that the prevalence of gluten sensitivity could be three or four times that of celiac disease.

“This is a rapidly expanding area and there are groups starting to work hard on understanding gluten sensitivity,” he said.

'There are … profound health consequences for the patients who are incorrectly diagnosed and treated.'

Source DR. CHEY

ROSEMONT. ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce “more change between the decade that began 3 years ago and 2015 than between 1965 and 2005…. The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Dallas.

▸ The increasing viability of remote medicine—for example, robotic devices at the patient's bedside, telepharmacy, and telemedicine—could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the possibility that by 2040 about half of the U.S. population will be people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.”

Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations). “We need technology to keep up with that information,” he said.

▸ Increased competition among health care providers could occur in a constrained market, where “the real issue is doing it right all the time as inexpensively as possible.”

A health care environment that is becoming one of “nonpayment for non-performance” means “we're not to do old things in new ways, we're to do new things in new ways,” he said, and that means integrated systems. The most effective organizations are “fully integrated, so that when someone needs information, they can get it,” he said.

Mr. Bauer advocated an approach to thinking about the future of health care that forecasts probabilities and possibilities rather than accepts predictions as inevitable outcomes.

“It's best for you to approach the future of health care in general and quality and safety in particular with the idea of looking at the factors that could make things better, the same, or worse and then imagine how you can intervene to promote the chances of things getting better,” he said.

ROSEMONT. ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce “more change between the decade that began 3 years ago and 2015 than between 1965 and 2005…. The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Dallas.

▸ The increasing viability of remote medicine—for example, robotic devices at the patient's bedside, telepharmacy, and telemedicine—could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the possibility that by 2040 about half of the U.S. population will be people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.”

Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations). “We need technology to keep up with that information,” he said.

▸ Increased competition among health care providers could occur in a constrained market, where “the real issue is doing it right all the time as inexpensively as possible.”

A health care environment that is becoming one of “nonpayment for non-performance” means “we're not to do old things in new ways, we're to do new things in new ways,” he said, and that means integrated systems. The most effective organizations are “fully integrated, so that when someone needs information, they can get it,” he said.

Mr. Bauer advocated an approach to thinking about the future of health care that forecasts probabilities and possibilities rather than accepts predictions as inevitable outcomes.

“It's best for you to approach the future of health care in general and quality and safety in particular with the idea of looking at the factors that could make things better, the same, or worse and then imagine how you can intervene to promote the chances of things getting better,” he said.

ROSEMONT. ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce “more change between the decade that began 3 years ago and 2015 than between 1965 and 2005…. The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Dallas.

▸ The increasing viability of remote medicine—for example, robotic devices at the patient's bedside, telepharmacy, and telemedicine—could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the possibility that by 2040 about half of the U.S. population will be people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.”

Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations). “We need technology to keep up with that information,” he said.

▸ Increased competition among health care providers could occur in a constrained market, where “the real issue is doing it right all the time as inexpensively as possible.”

A health care environment that is becoming one of “nonpayment for non-performance” means “we're not to do old things in new ways, we're to do new things in new ways,” he said, and that means integrated systems. The most effective organizations are “fully integrated, so that when someone needs information, they can get it,” he said.

Mr. Bauer advocated an approach to thinking about the future of health care that forecasts probabilities and possibilities rather than accepts predictions as inevitable outcomes.

“It's best for you to approach the future of health care in general and quality and safety in particular with the idea of looking at the factors that could make things better, the same, or worse and then imagine how you can intervene to promote the chances of things getting better,” he said.

CHICAGO — When testing patients for celiac disease, physicians can no longer rely on a single paradigm for both overtly symptomatic patients and asymptomatic but genetically at-risk patients, according to Dr. Edwin Liu.

These two categories of patients require different approaches, said Dr. Liu, who spoke at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Most symptomatic patients need only one antibody test, transglutaminase IgA (IgA-TGA) and an IgA antibody level to assess for celiac disease. But genetically at-risk patients may need multiple tests over time to screen for the presence of celiac autoimmunity and to determine if a biopsy is needed. Patients considered at risk for celiac disease include first-degree relatives of those with celiac disease or type 1 diabetes, and patients with type 1 diabetes.

The patient with classic symptoms and an abnormal TGA result usually can be biopsied immediately with a greater than 90% likelihood that intestinal lesions will be found, but TGA predicts disease in only about 75% of asymptomatic patients at genetic risk.

Patients with very elevated blood TGA levels are more likely to have more severe intestinal injury, so “in screening those at genetic risk, we have to understand our own lab tests well,” Dr. Liu noted in an interview.

Therefore, in deciding when a biopsy is needed, physicians should interpret tests in a quantitative fashion. This interpretation should consider changes in TGA values over time because a single positive result may not provide enough information to make a decision to proceed with biopsy.

“In the case of a symptomatic person, [a single positive result] is probably okay, because you are looking for the presence or absence of disease. However, in the case of a person who's at risk for celiac disease, multiple tests over time may be needed” due to the potential for disease. In addition, “we really need to understand what is a very high level,” he said, “because higher TGA levels are more likely to lead to findings of intestinal lesions.”

Complicating this diagnostic picture is the wide variability of currently available IgA-TGA assays, said Dr. Liu of the Barbara Davis Center for Childhood Diabetes and the Children's Hospital and the University of Colorado at Denver. The definition of what constitutes a high TGA value differs depending on the laboratory and the assay used. Until universal testing and reporting standards are developed, specialists “must become familiar with their particular assay's performance in the screening-identified population. They need to understand how their test behaves in order to optimize the way they make decisions about biopsying.”

Dr. Liu acknowledged, however, that “every hospital uses a different lab, and there are so many different assays out there. If we understood the behavior of each assay, then we would understand the best time to do biopsies on these patients,” but physicians can't realistically be expected to know the dynamics of all these tests, he said.

Asymptomatic individuals may need to be tested several times before deciding whether to proceed with biopsy. This is because a biopsy done too soon could produce normal histologic findings that suggest the absence of disease, but these normal findings do not necessarily rule out the possibility that disease will develop, Dr. Liu said.

He cited an example of the patient with type 1 diabetes who has an abnormal TGA and whose small intestine biopsy is normal. The finding is not necessarily a “false-positive” TGA level, but could be caused instead by the underlying biology of celiac disease.

“If we biopsy patients too early, they may not have had time to develop intestinal lesions,” he said. “If we believe that the paradigm for most autoimmunity also applies to celiac disease—that autoantibodies precede the development of actual disease—then performing intestinal biopsy in the early stages of autoimmunity might lead to findings of normal histology.”

Although some clinicians prefer to perform a biopsy at the first sign of abnormality on TGA because they do not want to miss a case of disease, Dr. Liu said the approach to diagnosis at his institution differs somewhat. “We don't want to biopsy more than once,” he said. He noted that the risks of waiting to diagnose celiac disease in the absence of symptoms are not known, “but it also hasn't been soundly established whether there are any benefits to treating these patients early, before there are any symptoms.”

Dr. Liu and his colleagues at the University of Colorado have been conducting autoantibody workshops and are working with the Centers for Disease Control and Prevention to develop standards for IgA-TGA tests and reporting mechanisms. “Assay dynamics and quality can be very different. We need to standardize the assays to make them easier for physicians to interpret,” he said.

CHICAGO — When testing patients for celiac disease, physicians can no longer rely on a single paradigm for both overtly symptomatic patients and asymptomatic but genetically at-risk patients, according to Dr. Edwin Liu.

These two categories of patients require different approaches, said Dr. Liu, who spoke at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Most symptomatic patients need only one antibody test, transglutaminase IgA (IgA-TGA) and an IgA antibody level to assess for celiac disease. But genetically at-risk patients may need multiple tests over time to screen for the presence of celiac autoimmunity and to determine if a biopsy is needed. Patients considered at risk for celiac disease include first-degree relatives of those with celiac disease or type 1 diabetes, and patients with type 1 diabetes.

The patient with classic symptoms and an abnormal TGA result usually can be biopsied immediately with a greater than 90% likelihood that intestinal lesions will be found, but TGA predicts disease in only about 75% of asymptomatic patients at genetic risk.

Patients with very elevated blood TGA levels are more likely to have more severe intestinal injury, so “in screening those at genetic risk, we have to understand our own lab tests well,” Dr. Liu noted in an interview.

Therefore, in deciding when a biopsy is needed, physicians should interpret tests in a quantitative fashion. This interpretation should consider changes in TGA values over time because a single positive result may not provide enough information to make a decision to proceed with biopsy.

“In the case of a symptomatic person, [a single positive result] is probably okay, because you are looking for the presence or absence of disease. However, in the case of a person who's at risk for celiac disease, multiple tests over time may be needed” due to the potential for disease. In addition, “we really need to understand what is a very high level,” he said, “because higher TGA levels are more likely to lead to findings of intestinal lesions.”

Complicating this diagnostic picture is the wide variability of currently available IgA-TGA assays, said Dr. Liu of the Barbara Davis Center for Childhood Diabetes and the Children's Hospital and the University of Colorado at Denver. The definition of what constitutes a high TGA value differs depending on the laboratory and the assay used. Until universal testing and reporting standards are developed, specialists “must become familiar with their particular assay's performance in the screening-identified population. They need to understand how their test behaves in order to optimize the way they make decisions about biopsying.”

Dr. Liu acknowledged, however, that “every hospital uses a different lab, and there are so many different assays out there. If we understood the behavior of each assay, then we would understand the best time to do biopsies on these patients,” but physicians can't realistically be expected to know the dynamics of all these tests, he said.

Asymptomatic individuals may need to be tested several times before deciding whether to proceed with biopsy. This is because a biopsy done too soon could produce normal histologic findings that suggest the absence of disease, but these normal findings do not necessarily rule out the possibility that disease will develop, Dr. Liu said.

He cited an example of the patient with type 1 diabetes who has an abnormal TGA and whose small intestine biopsy is normal. The finding is not necessarily a “false-positive” TGA level, but could be caused instead by the underlying biology of celiac disease.

“If we biopsy patients too early, they may not have had time to develop intestinal lesions,” he said. “If we believe that the paradigm for most autoimmunity also applies to celiac disease—that autoantibodies precede the development of actual disease—then performing intestinal biopsy in the early stages of autoimmunity might lead to findings of normal histology.”

Although some clinicians prefer to perform a biopsy at the first sign of abnormality on TGA because they do not want to miss a case of disease, Dr. Liu said the approach to diagnosis at his institution differs somewhat. “We don't want to biopsy more than once,” he said. He noted that the risks of waiting to diagnose celiac disease in the absence of symptoms are not known, “but it also hasn't been soundly established whether there are any benefits to treating these patients early, before there are any symptoms.”

Dr. Liu and his colleagues at the University of Colorado have been conducting autoantibody workshops and are working with the Centers for Disease Control and Prevention to develop standards for IgA-TGA tests and reporting mechanisms. “Assay dynamics and quality can be very different. We need to standardize the assays to make them easier for physicians to interpret,” he said.

CHICAGO — When testing patients for celiac disease, physicians can no longer rely on a single paradigm for both overtly symptomatic patients and asymptomatic but genetically at-risk patients, according to Dr. Edwin Liu.

These two categories of patients require different approaches, said Dr. Liu, who spoke at a meeting on celiac disease sponsored by the American Gastroenterological Association.

Most symptomatic patients need only one antibody test, transglutaminase IgA (IgA-TGA) and an IgA antibody level to assess for celiac disease. But genetically at-risk patients may need multiple tests over time to screen for the presence of celiac autoimmunity and to determine if a biopsy is needed. Patients considered at risk for celiac disease include first-degree relatives of those with celiac disease or type 1 diabetes, and patients with type 1 diabetes.

The patient with classic symptoms and an abnormal TGA result usually can be biopsied immediately with a greater than 90% likelihood that intestinal lesions will be found, but TGA predicts disease in only about 75% of asymptomatic patients at genetic risk.

Patients with very elevated blood TGA levels are more likely to have more severe intestinal injury, so “in screening those at genetic risk, we have to understand our own lab tests well,” Dr. Liu noted in an interview.

Therefore, in deciding when a biopsy is needed, physicians should interpret tests in a quantitative fashion. This interpretation should consider changes in TGA values over time because a single positive result may not provide enough information to make a decision to proceed with biopsy.

“In the case of a symptomatic person, [a single positive result] is probably okay, because you are looking for the presence or absence of disease. However, in the case of a person who's at risk for celiac disease, multiple tests over time may be needed” due to the potential for disease. In addition, “we really need to understand what is a very high level,” he said, “because higher TGA levels are more likely to lead to findings of intestinal lesions.”

Complicating this diagnostic picture is the wide variability of currently available IgA-TGA assays, said Dr. Liu of the Barbara Davis Center for Childhood Diabetes and the Children's Hospital and the University of Colorado at Denver. The definition of what constitutes a high TGA value differs depending on the laboratory and the assay used. Until universal testing and reporting standards are developed, specialists “must become familiar with their particular assay's performance in the screening-identified population. They need to understand how their test behaves in order to optimize the way they make decisions about biopsying.”

Dr. Liu acknowledged, however, that “every hospital uses a different lab, and there are so many different assays out there. If we understood the behavior of each assay, then we would understand the best time to do biopsies on these patients,” but physicians can't realistically be expected to know the dynamics of all these tests, he said.

Asymptomatic individuals may need to be tested several times before deciding whether to proceed with biopsy. This is because a biopsy done too soon could produce normal histologic findings that suggest the absence of disease, but these normal findings do not necessarily rule out the possibility that disease will develop, Dr. Liu said.

He cited an example of the patient with type 1 diabetes who has an abnormal TGA and whose small intestine biopsy is normal. The finding is not necessarily a “false-positive” TGA level, but could be caused instead by the underlying biology of celiac disease.

“If we biopsy patients too early, they may not have had time to develop intestinal lesions,” he said. “If we believe that the paradigm for most autoimmunity also applies to celiac disease—that autoantibodies precede the development of actual disease—then performing intestinal biopsy in the early stages of autoimmunity might lead to findings of normal histology.”

Although some clinicians prefer to perform a biopsy at the first sign of abnormality on TGA because they do not want to miss a case of disease, Dr. Liu said the approach to diagnosis at his institution differs somewhat. “We don't want to biopsy more than once,” he said. He noted that the risks of waiting to diagnose celiac disease in the absence of symptoms are not known, “but it also hasn't been soundly established whether there are any benefits to treating these patients early, before there are any symptoms.”

Dr. Liu and his colleagues at the University of Colorado have been conducting autoantibody workshops and are working with the Centers for Disease Control and Prevention to develop standards for IgA-TGA tests and reporting mechanisms. “Assay dynamics and quality can be very different. We need to standardize the assays to make them easier for physicians to interpret,” he said.

CHICAGO — In the fall of 2006, a vendor accidentally cut the wrong cable in the computer room at Children's Specialized Hospital, New Brunswick, N.J., leaving the large pediatric rehabilitation provider's eight facilities without computers or phones for 3 days.

Staff continued to care for patients with the semimanual systems that were still in place, and no adverse events occurred as a result of the extended power loss. But the sobering experience sparked a comprehensive overhaul of the organization's communications downtime policies and procedures using a Six Sigma risk-reduction tool known as FMEA (Failure Modes and Effects Analysis). The tool, widely used in manufacturing, involves rating the risks associated with various components in a process on a numerical scale and prioritizing corrective actions according to risk level. Six Sigma is a management system first created by Motorola Inc. that seeks to improve quality and efficiency.

A root cause analysis and a review of existing policies and procedures soon after the communications failure quickly revealed serious shortcomings, including gaps between the administrative policy and the emergency operations plan, inconsistencies across some departments, no policies and procedures at all in other departments, and critical steps that were missing, including a formal process for communicating to staff that systems were down.

“The staff was completely out of the loop,” said Lorraine Quatrone, medical administrator at Children's Specialized Hospital. “We thought we had a plan in place,” but “we were operating in silos,” she said at the Joint Commission national conference on quality and patient safety.

The hospital made some quick fixes, after which “we could've sat back and said we're prepared,” said Ms. Quatrone. Instead, the hospital decided to “drill down and look behind doors” using FMEA methodology.

The major shortcoming was evident when the staff needed to be alerted of a communications failure, and they needed to know what to do to ensure patient safety once they were informed.

To make that happen, the hospital developed a standard template for downtime policies and procedures for completion by every department. In addition to asking directors and managers what their departments needed in order to continue to function in the absence of computers and telephones, the hospital also asked them to look at their departments as suppliers of information to the organization and to indicate how they could help other departments. “We wanted to make this an organizationwide commitment to helping each other,” Ms. Quatrone said.

Facilities management, for example, is now responsible for immediately distributing two-way radios to patient areas, making hourly rounds to check for emergency issues, and monitoring the energy management system. All nursing units are required to immediately begin recording the administration of all medications on a written worksheet.

The hospital also covered procedures for how each department would continue to function after systems were working again, including how information from the interim paper process would get entered into the electronic system. Once the system is operational, for example, pharmacy staff are required to enter all new medication orders electronically.

Following the revision of policies and procedures, department directors and managers were asked to educate their staff and to decide with them which electronic forms would be needed in paper form and where information should be kept. Information on the emergency plan became an integral part of new employee orientations as well.

The hospital conducted a series of simulated downtime drills. Awareness “seemed pretty low at the beginning, but as time went on and we did drills to reinforce our commitment to the process, we started to see the results edge up,” Ms. Quatrone says.

CHICAGO — In the fall of 2006, a vendor accidentally cut the wrong cable in the computer room at Children's Specialized Hospital, New Brunswick, N.J., leaving the large pediatric rehabilitation provider's eight facilities without computers or phones for 3 days.

Staff continued to care for patients with the semimanual systems that were still in place, and no adverse events occurred as a result of the extended power loss. But the sobering experience sparked a comprehensive overhaul of the organization's communications downtime policies and procedures using a Six Sigma risk-reduction tool known as FMEA (Failure Modes and Effects Analysis). The tool, widely used in manufacturing, involves rating the risks associated with various components in a process on a numerical scale and prioritizing corrective actions according to risk level. Six Sigma is a management system first created by Motorola Inc. that seeks to improve quality and efficiency.

A root cause analysis and a review of existing policies and procedures soon after the communications failure quickly revealed serious shortcomings, including gaps between the administrative policy and the emergency operations plan, inconsistencies across some departments, no policies and procedures at all in other departments, and critical steps that were missing, including a formal process for communicating to staff that systems were down.

“The staff was completely out of the loop,” said Lorraine Quatrone, medical administrator at Children's Specialized Hospital. “We thought we had a plan in place,” but “we were operating in silos,” she said at the Joint Commission national conference on quality and patient safety.

The hospital made some quick fixes, after which “we could've sat back and said we're prepared,” said Ms. Quatrone. Instead, the hospital decided to “drill down and look behind doors” using FMEA methodology.

The major shortcoming was evident when the staff needed to be alerted of a communications failure, and they needed to know what to do to ensure patient safety once they were informed.

To make that happen, the hospital developed a standard template for downtime policies and procedures for completion by every department. In addition to asking directors and managers what their departments needed in order to continue to function in the absence of computers and telephones, the hospital also asked them to look at their departments as suppliers of information to the organization and to indicate how they could help other departments. “We wanted to make this an organizationwide commitment to helping each other,” Ms. Quatrone said.

Facilities management, for example, is now responsible for immediately distributing two-way radios to patient areas, making hourly rounds to check for emergency issues, and monitoring the energy management system. All nursing units are required to immediately begin recording the administration of all medications on a written worksheet.

The hospital also covered procedures for how each department would continue to function after systems were working again, including how information from the interim paper process would get entered into the electronic system. Once the system is operational, for example, pharmacy staff are required to enter all new medication orders electronically.

Following the revision of policies and procedures, department directors and managers were asked to educate their staff and to decide with them which electronic forms would be needed in paper form and where information should be kept. Information on the emergency plan became an integral part of new employee orientations as well.

The hospital conducted a series of simulated downtime drills. Awareness “seemed pretty low at the beginning, but as time went on and we did drills to reinforce our commitment to the process, we started to see the results edge up,” Ms. Quatrone says.

CHICAGO — In the fall of 2006, a vendor accidentally cut the wrong cable in the computer room at Children's Specialized Hospital, New Brunswick, N.J., leaving the large pediatric rehabilitation provider's eight facilities without computers or phones for 3 days.

Staff continued to care for patients with the semimanual systems that were still in place, and no adverse events occurred as a result of the extended power loss. But the sobering experience sparked a comprehensive overhaul of the organization's communications downtime policies and procedures using a Six Sigma risk-reduction tool known as FMEA (Failure Modes and Effects Analysis). The tool, widely used in manufacturing, involves rating the risks associated with various components in a process on a numerical scale and prioritizing corrective actions according to risk level. Six Sigma is a management system first created by Motorola Inc. that seeks to improve quality and efficiency.

A root cause analysis and a review of existing policies and procedures soon after the communications failure quickly revealed serious shortcomings, including gaps between the administrative policy and the emergency operations plan, inconsistencies across some departments, no policies and procedures at all in other departments, and critical steps that were missing, including a formal process for communicating to staff that systems were down.

“The staff was completely out of the loop,” said Lorraine Quatrone, medical administrator at Children's Specialized Hospital. “We thought we had a plan in place,” but “we were operating in silos,” she said at the Joint Commission national conference on quality and patient safety.

The hospital made some quick fixes, after which “we could've sat back and said we're prepared,” said Ms. Quatrone. Instead, the hospital decided to “drill down and look behind doors” using FMEA methodology.

The major shortcoming was evident when the staff needed to be alerted of a communications failure, and they needed to know what to do to ensure patient safety once they were informed.

To make that happen, the hospital developed a standard template for downtime policies and procedures for completion by every department. In addition to asking directors and managers what their departments needed in order to continue to function in the absence of computers and telephones, the hospital also asked them to look at their departments as suppliers of information to the organization and to indicate how they could help other departments. “We wanted to make this an organizationwide commitment to helping each other,” Ms. Quatrone said.

Facilities management, for example, is now responsible for immediately distributing two-way radios to patient areas, making hourly rounds to check for emergency issues, and monitoring the energy management system. All nursing units are required to immediately begin recording the administration of all medications on a written worksheet.

The hospital also covered procedures for how each department would continue to function after systems were working again, including how information from the interim paper process would get entered into the electronic system. Once the system is operational, for example, pharmacy staff are required to enter all new medication orders electronically.

Following the revision of policies and procedures, department directors and managers were asked to educate their staff and to decide with them which electronic forms would be needed in paper form and where information should be kept. Information on the emergency plan became an integral part of new employee orientations as well.

The hospital conducted a series of simulated downtime drills. Awareness “seemed pretty low at the beginning, but as time went on and we did drills to reinforce our commitment to the process, we started to see the results edge up,” Ms. Quatrone says.

ROSEMONT, ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce more change between 2005 and 2015 than between 1965 and 2005. “The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Inc., Dallas.

▸ The increasing viability of remote medicine could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists, and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the potential for about half the U.S. population by 2040 to be made up of people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.” Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations).

“We need technology to keep up with that information,” he said.

ROSEMONT, ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce more change between 2005 and 2015 than between 1965 and 2005. “The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Inc., Dallas.

▸ The increasing viability of remote medicine could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists, and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the potential for about half the U.S. population by 2040 to be made up of people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.” Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations).

“We need technology to keep up with that information,” he said.

ROSEMONT, ILL. — Health care providers' ability to continue to improve patient safety and quality hinges on their embrace of digital technology, according to medical economist Jeffrey C. Bauer, Ph.D.

“We've reached the limits of the human mind to process all the information that's out there, and we have absolutely passed the limits of the paper trail. I cannot see progress without moving to a total digital transformation,” Dr. Bauer said in a plenary session at the Joint Commission national conference on quality and patient safety.

He called diversification “the defining characteristic of U.S. health care in the foreseeable future” and predicted it would produce more change between 2005 and 2015 than between 1965 and 2005. “The only way we can deal with that complexity … is with data systems. Without the technologies, we won't get there; with the technologies, we can do some really exciting things.”

He noted the following trends as signs of health care diversification:

▸ The shift from “one size fits all” to personalized medicine based on the unparalleled pace of findings in molecular science, genetics, and other medical research.

As an example, Dr. Bauer cited the relatively new discovery that breast cancer is not a single disease but a group of molecularly distinct neoplasms. “We can't give safe, quality care if we can't begin to use all of this information to match the right patient to the right drug,” he said.

The growth of personalized medicine also brings the recognition that many chronic diseases are latent in a person's genetic composition and must be “managed throughout our lifetime, not only when they appear in an acute state,” said Dr. Bauer, who is a management consulting partner with Affiliated Computer Services, Inc., Dallas.

▸ The increasing viability of remote medicine could provide a workable answer to the growing shortage of health care professionals.

“We cannot produce physicians, nurses, respiratory therapists, and occupational therapists fast enough to meet the shortages we've got in this country,” he said. “What we need is the informatics and the digital transformation work processes that very much have to be tied to safe and appropriate care.”

▸ Demographic changes, including the potential for about half the U.S. population by 2040 to be made up of people born in other countries, could be accompanied by a “host of new genetic conditions and different cultural practices.” Rather than breaking down medical data merely by race, researchers and providers will need to understand the complex demographics of disease patterns within races (for example, differences in cancer incidence among Asian-American subgroups, such as Filipino, Chinese, Japanese, Korean, and Vietnamese populations).

“We need technology to keep up with that information,” he said.