Christine Kilgore

With a new carotid registry on both carotid artery stenting and endarterectomy about to open, the American College of Cardiology is at the forefront of an intensifying national focus on the use of patient registries for measuring effectiveness of new treatments.

Officials at the Agency for Healthcare Research and Quality (AHRQ), the National Committee for Quality Assurance (NCQA), the Centers for Medicare and Medicaid Services (CMS), and other organizations increasingly view patient registries as a key component of outcomes research, benchmarking, and payment policy, including future pay-for-performance initiatives.

They also view carotid artery stenting (CAS) as a perfect example of a complex, high-risk procedure involving different specialists that must be systematically studied and analyzed after it has been unveiled in clinical practice—and one for which registries may be an ideal tool.

The collection of outcomes data on high-risk patients who undergo CAS is now a requirement for Medicare payment. When CMS expanded coverage of CAS a year ago to high-risk, symptomatic patients with carotid artery stenosis of at least 70% (treated outside the context of clinical trials), it stipulated that facilities must be certified by CMS to perform carotid stenting and that facilities must also collect data on all CAS procedures.

Data must be analyzed at least every 6 months and made available to CMS “upon request” and as part of the CMS process of recredentialing facilities. According to the CMS Web site, more than 800 hospitals are now certified and collecting data.

The ACC's carotid registry is expected to open officially this month or next. The Society for Vascular Surgery (SVS) has already opened a similar registry. Both registries will make it easier for facilities and physicians of all specialties to comply with CMS's payment requirements for CAS, leaders at the organizations say.

The registries also will allow them to collect long-term outcomes data on both CAS and carotid artery endarterectomy (CAE) and to benchmark their outcomes against those of other institutions.

The ACC's CAS registry has been in the works for some time, but the decision to include CAE was a more recent consideration, after it became evident that including it would make the registry an attractive option for surgeons as well as interventional cardiologists, said Dr. Kenneth Rosenfield, who led development of the registry.

Having a registry that is as multispecialty as possible has always been a goal of the ACC, Dr. Rosenfield said. “We're talking about optimizing patient safety across the board. We owe it to patients to collaborate.”

The ACC and SVS registries have their origins in a broader “Clinical Competence Statement on Carotid Stenting” that was published jointly by vascular surgery and interventional cardiology organizations last year.

The statement endorsed the creation of a national multispecialty carotid registry “for reporting of outcomes and assessment of institutional and individual operator competence.” It was issued by SVS, the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society for Vascular Medicine and Biology, and endorsed by the ACC.

Officials at ACC and SVS said that despite efforts to welcome all specialties, the two organizations decided to develop separate registries. However, officials at both organizations have also said in interviews that they are fully committed to sharing data elements and definitions.

“Both of our societies are committed to a process that will enable us to compare apples with apples,” said Dr. Rosenfield, director of the cardiac and vascular invasive service at Massachusetts General Hospital, Boston.

Officials at NCQA and AHRQ, in the meantime, are trying to anticipate and prepare for challenges in coordinating and analyzing data on carotid procedures from multiple patient registries.

The issue was discussed at a conference held late last year by NCQA and SCAI with funding from AHRQ, when experts discussed registries as evaluation tools and focused on CAS as a case study.

CMS, which anticipated and has supported the development of more than one carotid registry, also has told societies there should be as many common data elements as possible among the registries, that they should have “full transparency,” and that the registries should be accessible to the public.

ACC is adding the carotid registry to its larger Web-based National Cardiovascular Data Registry (NCDR), which houses two other registries—the CathPCI Registry, used by about 750 hospitals, and the ICD [implantable cardioverter defibrillator] Registry, which, starting this month, is the required registry for hospitals to receive Medicare coverage for the use of implantable cardioverter defibrillators for primary prevention of sudden cardiac death. (CMS contracted last fall with the ACC's NCDR to collect data on ICDs used for this indication. By this month, all hospitals must have transferred their current ICD data reporting activities to the ICD Registry.)

For carotid procedures, registry-level data are not enough, and randomized trials of CAS and CAE “need to be completed,” said Dr. Steve Phurrough, director of the Coverage and Analysis Group at CMS, in an interview. “With ICDs, we had lots of good-quality, high-volume data—with CAS we don't.”

Still, he said, registries are an important part of it all, especially because “comparing [and] risk-adjusting are better done in larger databases.”

The collection of data as a condition of coverage “will become more and more prevalent, especially [in light of recent cases in which] the risks of drugs and devices weren't known until a few years out,” he said.

Dr. Rosenfield said he believed the ACC registry is “a bit more robust” than the SVS registry, particularly with respect to preprocedural history, including neurologic history, and neurologic end points.

Dr. Ralph G. Brindis, chairman and chief medical officer of the ACC-NCDR, said the new registry would benefit from the NCDR's multifaceted strategy for auditing registry data to ensure it is complete and accurate.

“The biggest Achilles' heel [for registries] is the ability of [outsiders] to feel comfortable with the validity of the data,” he said.

With a new carotid registry on both carotid artery stenting and endarterectomy about to open, the American College of Cardiology is at the forefront of an intensifying national focus on the use of patient registries for measuring effectiveness of new treatments.

Officials at the Agency for Healthcare Research and Quality (AHRQ), the National Committee for Quality Assurance (NCQA), the Centers for Medicare and Medicaid Services (CMS), and other organizations increasingly view patient registries as a key component of outcomes research, benchmarking, and payment policy, including future pay-for-performance initiatives.

They also view carotid artery stenting (CAS) as a perfect example of a complex, high-risk procedure involving different specialists that must be systematically studied and analyzed after it has been unveiled in clinical practice—and one for which registries may be an ideal tool.

The collection of outcomes data on high-risk patients who undergo CAS is now a requirement for Medicare payment. When CMS expanded coverage of CAS a year ago to high-risk, symptomatic patients with carotid artery stenosis of at least 70% (treated outside the context of clinical trials), it stipulated that facilities must be certified by CMS to perform carotid stenting and that facilities must also collect data on all CAS procedures.

Data must be analyzed at least every 6 months and made available to CMS “upon request” and as part of the CMS process of recredentialing facilities. According to the CMS Web site, more than 800 hospitals are now certified and collecting data.

The ACC's carotid registry is expected to open officially this month or next. The Society for Vascular Surgery (SVS) has already opened a similar registry. Both registries will make it easier for facilities and physicians of all specialties to comply with CMS's payment requirements for CAS, leaders at the organizations say.

The registries also will allow them to collect long-term outcomes data on both CAS and carotid artery endarterectomy (CAE) and to benchmark their outcomes against those of other institutions.

The ACC's CAS registry has been in the works for some time, but the decision to include CAE was a more recent consideration, after it became evident that including it would make the registry an attractive option for surgeons as well as interventional cardiologists, said Dr. Kenneth Rosenfield, who led development of the registry.

Having a registry that is as multispecialty as possible has always been a goal of the ACC, Dr. Rosenfield said. “We're talking about optimizing patient safety across the board. We owe it to patients to collaborate.”

The ACC and SVS registries have their origins in a broader “Clinical Competence Statement on Carotid Stenting” that was published jointly by vascular surgery and interventional cardiology organizations last year.

The statement endorsed the creation of a national multispecialty carotid registry “for reporting of outcomes and assessment of institutional and individual operator competence.” It was issued by SVS, the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society for Vascular Medicine and Biology, and endorsed by the ACC.

Officials at ACC and SVS said that despite efforts to welcome all specialties, the two organizations decided to develop separate registries. However, officials at both organizations have also said in interviews that they are fully committed to sharing data elements and definitions.

“Both of our societies are committed to a process that will enable us to compare apples with apples,” said Dr. Rosenfield, director of the cardiac and vascular invasive service at Massachusetts General Hospital, Boston.

Officials at NCQA and AHRQ, in the meantime, are trying to anticipate and prepare for challenges in coordinating and analyzing data on carotid procedures from multiple patient registries.

The issue was discussed at a conference held late last year by NCQA and SCAI with funding from AHRQ, when experts discussed registries as evaluation tools and focused on CAS as a case study.

CMS, which anticipated and has supported the development of more than one carotid registry, also has told societies there should be as many common data elements as possible among the registries, that they should have “full transparency,” and that the registries should be accessible to the public.

ACC is adding the carotid registry to its larger Web-based National Cardiovascular Data Registry (NCDR), which houses two other registries—the CathPCI Registry, used by about 750 hospitals, and the ICD [implantable cardioverter defibrillator] Registry, which, starting this month, is the required registry for hospitals to receive Medicare coverage for the use of implantable cardioverter defibrillators for primary prevention of sudden cardiac death. (CMS contracted last fall with the ACC's NCDR to collect data on ICDs used for this indication. By this month, all hospitals must have transferred their current ICD data reporting activities to the ICD Registry.)

For carotid procedures, registry-level data are not enough, and randomized trials of CAS and CAE “need to be completed,” said Dr. Steve Phurrough, director of the Coverage and Analysis Group at CMS, in an interview. “With ICDs, we had lots of good-quality, high-volume data—with CAS we don't.”

Still, he said, registries are an important part of it all, especially because “comparing [and] risk-adjusting are better done in larger databases.”

The collection of data as a condition of coverage “will become more and more prevalent, especially [in light of recent cases in which] the risks of drugs and devices weren't known until a few years out,” he said.

Dr. Rosenfield said he believed the ACC registry is “a bit more robust” than the SVS registry, particularly with respect to preprocedural history, including neurologic history, and neurologic end points.

Dr. Ralph G. Brindis, chairman and chief medical officer of the ACC-NCDR, said the new registry would benefit from the NCDR's multifaceted strategy for auditing registry data to ensure it is complete and accurate.

“The biggest Achilles' heel [for registries] is the ability of [outsiders] to feel comfortable with the validity of the data,” he said.

With a new carotid registry on both carotid artery stenting and endarterectomy about to open, the American College of Cardiology is at the forefront of an intensifying national focus on the use of patient registries for measuring effectiveness of new treatments.

Officials at the Agency for Healthcare Research and Quality (AHRQ), the National Committee for Quality Assurance (NCQA), the Centers for Medicare and Medicaid Services (CMS), and other organizations increasingly view patient registries as a key component of outcomes research, benchmarking, and payment policy, including future pay-for-performance initiatives.

They also view carotid artery stenting (CAS) as a perfect example of a complex, high-risk procedure involving different specialists that must be systematically studied and analyzed after it has been unveiled in clinical practice—and one for which registries may be an ideal tool.

The collection of outcomes data on high-risk patients who undergo CAS is now a requirement for Medicare payment. When CMS expanded coverage of CAS a year ago to high-risk, symptomatic patients with carotid artery stenosis of at least 70% (treated outside the context of clinical trials), it stipulated that facilities must be certified by CMS to perform carotid stenting and that facilities must also collect data on all CAS procedures.

Data must be analyzed at least every 6 months and made available to CMS “upon request” and as part of the CMS process of recredentialing facilities. According to the CMS Web site, more than 800 hospitals are now certified and collecting data.

The ACC's carotid registry is expected to open officially this month or next. The Society for Vascular Surgery (SVS) has already opened a similar registry. Both registries will make it easier for facilities and physicians of all specialties to comply with CMS's payment requirements for CAS, leaders at the organizations say.

The registries also will allow them to collect long-term outcomes data on both CAS and carotid artery endarterectomy (CAE) and to benchmark their outcomes against those of other institutions.

The ACC's CAS registry has been in the works for some time, but the decision to include CAE was a more recent consideration, after it became evident that including it would make the registry an attractive option for surgeons as well as interventional cardiologists, said Dr. Kenneth Rosenfield, who led development of the registry.

Having a registry that is as multispecialty as possible has always been a goal of the ACC, Dr. Rosenfield said. “We're talking about optimizing patient safety across the board. We owe it to patients to collaborate.”

The ACC and SVS registries have their origins in a broader “Clinical Competence Statement on Carotid Stenting” that was published jointly by vascular surgery and interventional cardiology organizations last year.

The statement endorsed the creation of a national multispecialty carotid registry “for reporting of outcomes and assessment of institutional and individual operator competence.” It was issued by SVS, the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society for Vascular Medicine and Biology, and endorsed by the ACC.

Officials at ACC and SVS said that despite efforts to welcome all specialties, the two organizations decided to develop separate registries. However, officials at both organizations have also said in interviews that they are fully committed to sharing data elements and definitions.

“Both of our societies are committed to a process that will enable us to compare apples with apples,” said Dr. Rosenfield, director of the cardiac and vascular invasive service at Massachusetts General Hospital, Boston.

Officials at NCQA and AHRQ, in the meantime, are trying to anticipate and prepare for challenges in coordinating and analyzing data on carotid procedures from multiple patient registries.

The issue was discussed at a conference held late last year by NCQA and SCAI with funding from AHRQ, when experts discussed registries as evaluation tools and focused on CAS as a case study.

CMS, which anticipated and has supported the development of more than one carotid registry, also has told societies there should be as many common data elements as possible among the registries, that they should have “full transparency,” and that the registries should be accessible to the public.

ACC is adding the carotid registry to its larger Web-based National Cardiovascular Data Registry (NCDR), which houses two other registries—the CathPCI Registry, used by about 750 hospitals, and the ICD [implantable cardioverter defibrillator] Registry, which, starting this month, is the required registry for hospitals to receive Medicare coverage for the use of implantable cardioverter defibrillators for primary prevention of sudden cardiac death. (CMS contracted last fall with the ACC's NCDR to collect data on ICDs used for this indication. By this month, all hospitals must have transferred their current ICD data reporting activities to the ICD Registry.)

For carotid procedures, registry-level data are not enough, and randomized trials of CAS and CAE “need to be completed,” said Dr. Steve Phurrough, director of the Coverage and Analysis Group at CMS, in an interview. “With ICDs, we had lots of good-quality, high-volume data—with CAS we don't.”

Still, he said, registries are an important part of it all, especially because “comparing [and] risk-adjusting are better done in larger databases.”

The collection of data as a condition of coverage “will become more and more prevalent, especially [in light of recent cases in which] the risks of drugs and devices weren't known until a few years out,” he said.

Dr. Rosenfield said he believed the ACC registry is “a bit more robust” than the SVS registry, particularly with respect to preprocedural history, including neurologic history, and neurologic end points.

Dr. Ralph G. Brindis, chairman and chief medical officer of the ACC-NCDR, said the new registry would benefit from the NCDR's multifaceted strategy for auditing registry data to ensure it is complete and accurate.

“The biggest Achilles' heel [for registries] is the ability of [outsiders] to feel comfortable with the validity of the data,” he said.

Patients with early rheumatoid arthritis who are most likely to benefit from immediate introduction of infliximab plus high-dose methotrexate are those with high C-reactive protein levels, a high erythrocyte sedimentation rate, or persistent disease activity, as well as greater initial joint damage, according to a new analysis of trial data reported Dr. Josef S. Smolen, and his associates in Europe and the United States.

The 54-week trial showed that overall, combination therapy with methotrexate and infliximab provided greater clinical, radiographic, and functional benefits than treatment with methotrexate alone for patients with active, early-stage RA (Arthritis Rheum. 2006;54:702–10).

The new findings build on results from the ASPIRE study (Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset), the investigators reported.

Patients in the trial had RA for no longer than 3 years; the 1,049 patients were randomized to receive titrating doses of methotrexate up to 20 mg/wk plus placebo or infliximab at weeks 0, 2, and 6, and then every 8 weeks through week 46, Dr. Smolen, of the Medical University of Vienna, and his colleagues reported.

In the new analysis, the investigators looked for predictors of radiographic joint damage in order to identify subgroups of patients who would likely improve with methotrexate alone and those who would most benefit from the more expensive and potentially toxic combination therapy.

To do so, Dr. Smolen and his colleagues looked at the relationship between disease activity measures taken at baseline and at week 14, as well as those averaged over time, with changes in radiographic joint damage.

Radiographs were obtained within 4 weeks of the start of treatment and at weeks 30 and 54. Joint damage was assessed by changes in modified Sharp/van der Heijde scores (SHS).

The investigators found that methotrexate alone failed to prevent the progression of joint damage among patients with the highest C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and swollen joint counts, as well as the highest levels of joint damage at baseline.

Infliximab in combination with methotrexate, on the other hand, inhibited radiographic progression regardless of baseline and early disease activity or joint damage.

Patients in the highest baseline tertile of CRP (3 mg/dL or greater) and ESR (52 mm/hour or greater) who were treated only with methotrexate had mean increases in the SHS for joint damage of 5.62 and 5.89, respectively, from baseline to week 54. In patients who were treated with methotrexate plus infliximab, these changes were 0.73 and 1.12, respectively.

Also, patients receiving methotrexate alone who had persistently active disease—higher disease activity scores (DAS28)—at week 14 showed greater progression of joint damage from baseline to week 54 than those with lower DAS28 scores. Combination treatment led to significantly less joint damage regardless of disease activity at this time.

“This finding is of particular importance, since physicians generally prescribe [methotrexate] as initial [disease modifying-antirheumatic drug therapy] and then assess the adequacy of response [some] 3–6 months later,” the investigators said. The results “suggest that continuation of [methotrexate] alone in patients with a DAS28 of [greater than] 4.02 (or a simplified Disease Activity Index of [greater than] 23.8) at week 14 carries with it a significant risk of progressive joint damage.”

Overall, they said, the new analysis shows that “it is especially important to identify patients whose disease is rapidly advancing and who have the greatest potential to benefit from more intensive therapy.”

Patients with early rheumatoid arthritis who are most likely to benefit from immediate introduction of infliximab plus high-dose methotrexate are those with high C-reactive protein levels, a high erythrocyte sedimentation rate, or persistent disease activity, as well as greater initial joint damage, according to a new analysis of trial data reported Dr. Josef S. Smolen, and his associates in Europe and the United States.

The 54-week trial showed that overall, combination therapy with methotrexate and infliximab provided greater clinical, radiographic, and functional benefits than treatment with methotrexate alone for patients with active, early-stage RA (Arthritis Rheum. 2006;54:702–10).

The new findings build on results from the ASPIRE study (Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset), the investigators reported.

Patients in the trial had RA for no longer than 3 years; the 1,049 patients were randomized to receive titrating doses of methotrexate up to 20 mg/wk plus placebo or infliximab at weeks 0, 2, and 6, and then every 8 weeks through week 46, Dr. Smolen, of the Medical University of Vienna, and his colleagues reported.

In the new analysis, the investigators looked for predictors of radiographic joint damage in order to identify subgroups of patients who would likely improve with methotrexate alone and those who would most benefit from the more expensive and potentially toxic combination therapy.

To do so, Dr. Smolen and his colleagues looked at the relationship between disease activity measures taken at baseline and at week 14, as well as those averaged over time, with changes in radiographic joint damage.

Radiographs were obtained within 4 weeks of the start of treatment and at weeks 30 and 54. Joint damage was assessed by changes in modified Sharp/van der Heijde scores (SHS).

The investigators found that methotrexate alone failed to prevent the progression of joint damage among patients with the highest C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and swollen joint counts, as well as the highest levels of joint damage at baseline.

Infliximab in combination with methotrexate, on the other hand, inhibited radiographic progression regardless of baseline and early disease activity or joint damage.

Patients in the highest baseline tertile of CRP (3 mg/dL or greater) and ESR (52 mm/hour or greater) who were treated only with methotrexate had mean increases in the SHS for joint damage of 5.62 and 5.89, respectively, from baseline to week 54. In patients who were treated with methotrexate plus infliximab, these changes were 0.73 and 1.12, respectively.

Also, patients receiving methotrexate alone who had persistently active disease—higher disease activity scores (DAS28)—at week 14 showed greater progression of joint damage from baseline to week 54 than those with lower DAS28 scores. Combination treatment led to significantly less joint damage regardless of disease activity at this time.

“This finding is of particular importance, since physicians generally prescribe [methotrexate] as initial [disease modifying-antirheumatic drug therapy] and then assess the adequacy of response [some] 3–6 months later,” the investigators said. The results “suggest that continuation of [methotrexate] alone in patients with a DAS28 of [greater than] 4.02 (or a simplified Disease Activity Index of [greater than] 23.8) at week 14 carries with it a significant risk of progressive joint damage.”

Overall, they said, the new analysis shows that “it is especially important to identify patients whose disease is rapidly advancing and who have the greatest potential to benefit from more intensive therapy.”

Patients with early rheumatoid arthritis who are most likely to benefit from immediate introduction of infliximab plus high-dose methotrexate are those with high C-reactive protein levels, a high erythrocyte sedimentation rate, or persistent disease activity, as well as greater initial joint damage, according to a new analysis of trial data reported Dr. Josef S. Smolen, and his associates in Europe and the United States.

The 54-week trial showed that overall, combination therapy with methotrexate and infliximab provided greater clinical, radiographic, and functional benefits than treatment with methotrexate alone for patients with active, early-stage RA (Arthritis Rheum. 2006;54:702–10).

The new findings build on results from the ASPIRE study (Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset), the investigators reported.

Patients in the trial had RA for no longer than 3 years; the 1,049 patients were randomized to receive titrating doses of methotrexate up to 20 mg/wk plus placebo or infliximab at weeks 0, 2, and 6, and then every 8 weeks through week 46, Dr. Smolen, of the Medical University of Vienna, and his colleagues reported.

In the new analysis, the investigators looked for predictors of radiographic joint damage in order to identify subgroups of patients who would likely improve with methotrexate alone and those who would most benefit from the more expensive and potentially toxic combination therapy.

To do so, Dr. Smolen and his colleagues looked at the relationship between disease activity measures taken at baseline and at week 14, as well as those averaged over time, with changes in radiographic joint damage.

Radiographs were obtained within 4 weeks of the start of treatment and at weeks 30 and 54. Joint damage was assessed by changes in modified Sharp/van der Heijde scores (SHS).

The investigators found that methotrexate alone failed to prevent the progression of joint damage among patients with the highest C-reactive protein (CRP) levels, erythrocyte sedimentation rate (ESR), and swollen joint counts, as well as the highest levels of joint damage at baseline.

Infliximab in combination with methotrexate, on the other hand, inhibited radiographic progression regardless of baseline and early disease activity or joint damage.

Patients in the highest baseline tertile of CRP (3 mg/dL or greater) and ESR (52 mm/hour or greater) who were treated only with methotrexate had mean increases in the SHS for joint damage of 5.62 and 5.89, respectively, from baseline to week 54. In patients who were treated with methotrexate plus infliximab, these changes were 0.73 and 1.12, respectively.

Also, patients receiving methotrexate alone who had persistently active disease—higher disease activity scores (DAS28)—at week 14 showed greater progression of joint damage from baseline to week 54 than those with lower DAS28 scores. Combination treatment led to significantly less joint damage regardless of disease activity at this time.

“This finding is of particular importance, since physicians generally prescribe [methotrexate] as initial [disease modifying-antirheumatic drug therapy] and then assess the adequacy of response [some] 3–6 months later,” the investigators said. The results “suggest that continuation of [methotrexate] alone in patients with a DAS28 of [greater than] 4.02 (or a simplified Disease Activity Index of [greater than] 23.8) at week 14 carries with it a significant risk of progressive joint damage.”

Overall, they said, the new analysis shows that “it is especially important to identify patients whose disease is rapidly advancing and who have the greatest potential to benefit from more intensive therapy.”

Protein and energy supplementation can increase survival and reduce complications for hospitalized elderly patients who are undernourished at admission, but there is little or no evidence that it helps well-nourished patients who are hospitalized or older people who live in other settings, according to a review of 55 randomized controlled trials.

“Although the evidence is limited and generally of poor quality, we suggest that routine supplements should be considered” for undernourished elderly patients in the hospital, said Anne C. Milne, research fellow at the University of Aberdeen, Scotland, and her colleagues.

They used the methods of the international Cochrane Collaboration, an organization that evaluates medical research and draws evidence-based conclusions about medical practice, to conduct a metaanalysis of randomized or “quasirandomized trials” of oral protein and energy supplementation lasting at least 1 week in people older than 65 years. Supplementation included various commercial nutritional supplements, milk-based supplements, and fortification of normal food sources, but not special immunomodulatory supplements or supplements of specific amino acids.

The effects of supplementation on mortality and morbidity were statistically significant only in hospitalized patients who were deemed undernourished—and even then, the results were “borderline statistically significant,” the investigators said. Hospital stay was not reduced in patients who received supplements.

Supplementation may improve mortality in older patients in long-term care, but there's no evidence to suggest improvement in mortality and morbidity for older people at home or well-nourished older patients in any setting, they said (Ann. Intern. Med. 2006;144:37–48).

Protein and energy supplementation can increase survival and reduce complications for hospitalized elderly patients who are undernourished at admission, but there is little or no evidence that it helps well-nourished patients who are hospitalized or older people who live in other settings, according to a review of 55 randomized controlled trials.

“Although the evidence is limited and generally of poor quality, we suggest that routine supplements should be considered” for undernourished elderly patients in the hospital, said Anne C. Milne, research fellow at the University of Aberdeen, Scotland, and her colleagues.

They used the methods of the international Cochrane Collaboration, an organization that evaluates medical research and draws evidence-based conclusions about medical practice, to conduct a metaanalysis of randomized or “quasirandomized trials” of oral protein and energy supplementation lasting at least 1 week in people older than 65 years. Supplementation included various commercial nutritional supplements, milk-based supplements, and fortification of normal food sources, but not special immunomodulatory supplements or supplements of specific amino acids.

The effects of supplementation on mortality and morbidity were statistically significant only in hospitalized patients who were deemed undernourished—and even then, the results were “borderline statistically significant,” the investigators said. Hospital stay was not reduced in patients who received supplements.

Supplementation may improve mortality in older patients in long-term care, but there's no evidence to suggest improvement in mortality and morbidity for older people at home or well-nourished older patients in any setting, they said (Ann. Intern. Med. 2006;144:37–48).

Protein and energy supplementation can increase survival and reduce complications for hospitalized elderly patients who are undernourished at admission, but there is little or no evidence that it helps well-nourished patients who are hospitalized or older people who live in other settings, according to a review of 55 randomized controlled trials.

“Although the evidence is limited and generally of poor quality, we suggest that routine supplements should be considered” for undernourished elderly patients in the hospital, said Anne C. Milne, research fellow at the University of Aberdeen, Scotland, and her colleagues.

They used the methods of the international Cochrane Collaboration, an organization that evaluates medical research and draws evidence-based conclusions about medical practice, to conduct a metaanalysis of randomized or “quasirandomized trials” of oral protein and energy supplementation lasting at least 1 week in people older than 65 years. Supplementation included various commercial nutritional supplements, milk-based supplements, and fortification of normal food sources, but not special immunomodulatory supplements or supplements of specific amino acids.

The effects of supplementation on mortality and morbidity were statistically significant only in hospitalized patients who were deemed undernourished—and even then, the results were “borderline statistically significant,” the investigators said. Hospital stay was not reduced in patients who received supplements.

Supplementation may improve mortality in older patients in long-term care, but there's no evidence to suggest improvement in mortality and morbidity for older people at home or well-nourished older patients in any setting, they said (Ann. Intern. Med. 2006;144:37–48).

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause. It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published in February (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope and comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early. “The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement says that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination. Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests, such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, Dr. Strickberger said.

In general, however, the tilt table test provides little useful information, the statement points out. In patients who have no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis.”

In a patient who has an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause. It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published in February (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope and comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early. “The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement says that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination. Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests, such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, Dr. Strickberger said.

In general, however, the tilt table test provides little useful information, the statement points out. In patients who have no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis.”

In a patient who has an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause. It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published in February (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope and comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early. “The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement says that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination. Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests, such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, Dr. Strickberger said.

In general, however, the tilt table test provides little useful information, the statement points out. In patients who have no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis.”

In a patient who has an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)

Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)

Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)