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No benefit of EC/IC bypass versus meds in large-artery stroke
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA
No-biopsy approach to celiac disease diagnosis safe for some
TOPLINE:
For adults with suspected celiac disease who do not have immunoglobulin A (IgA) deficiency, diagnostic bowel biopsy can most likely be avoided if the serum antitissue transglutaminase IgA (tTG-IgA) level is high.
METHODOLOGY:
- Researchers evaluated the reliability of serum tests for diagnosing celiac disease, as defined by duodenal villous atrophy (Marsh type 3 or Corazza-Villanacci grade B).
- The main study cohort included 436 adults with suspected celiac disease who did not have IgA deficiency and who were not on a gluten-free diet (mean age, 40 years; 68% women). The patients were referred by 14 centers across four continents to undergo local endoscopic duodenal biopsy.
- Local serum tTG-IgA was measured with 14 test brands. Concentration was expressed as a multiple of each test’s upper limit of normal (ULN). Tests were defined as positive when they exceeded one times the ULN.
- Histology was assessed by the local pathologist, and discordant cases were reevaluated by a central pathologist.
TAKEAWAY:
- Positive serum tTG-IgA was detected in 363 (83%) participants; negative serum tTG-IgA was detected in 73 (17%).
- After local review, 341 of the participants with positive serum tTG-IgA had positive histology (true positives) and 22 had negative histology (false positives).
- Of the 73 participants with negative serum tTG-IgA, 66 had negative histology (true negatives) and 7 had positive histology (false negatives).
- Central reevaluation of duodenal histology was performed in 29 discordant cases, resulting in 348 true positive cases, 15 false positive cases, 66 true negative cases, and 7 false negative cases – the equivalent of a positive predictive value of 95.9%, a negative predictive value of 90.4%, a sensitivity of 98%, and a specificity of 81.5%.
- The positive predictive value of local serum tTG-IgA increased when the serologic threshold was defined at increasing multiples of the ULN. The test correctly diagnosed duodenal villous atrophy in 97.5% of patients with serum tTG-IgA concentrations greater than 10 times the ULN.
IN PRACTICE:
“The results of this multicentre prospective study indicate that a no-biopsy approach for the diagnosis of coeliac disease is safe and reliable in adult patients without IgA deficiency and with serum tTG-IgA greater than the assay-specific upper limit of normal,” the authors write. “We found no evidence that important comorbidities would be missed by adopting a no-biopsy strategy.”
SOURCE:
The study was led by Carolina Ciacci, Centre for Coeliac Disease, AOU San Giovanni Di Dio e Ruggi d’Aragona, Salerno, Italy, and was published online in The Lancet Gastroenterology and Hepatology.
LIMITATIONS:
Limitations include a lack of data on IgA-deficient participants, a low number of participants in some subgroup analyses, a lack of data for many ethnic groups, limited follow-up information, limited assessments in the central laboratory, and high pretest probability of celiac disease (low number of participants without duodenal villous atrophy).
DISCLOSURES:
The study had no specific funding. One coauthor is an employee of Werfen. The other authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
For adults with suspected celiac disease who do not have immunoglobulin A (IgA) deficiency, diagnostic bowel biopsy can most likely be avoided if the serum antitissue transglutaminase IgA (tTG-IgA) level is high.
METHODOLOGY:
- Researchers evaluated the reliability of serum tests for diagnosing celiac disease, as defined by duodenal villous atrophy (Marsh type 3 or Corazza-Villanacci grade B).
- The main study cohort included 436 adults with suspected celiac disease who did not have IgA deficiency and who were not on a gluten-free diet (mean age, 40 years; 68% women). The patients were referred by 14 centers across four continents to undergo local endoscopic duodenal biopsy.
- Local serum tTG-IgA was measured with 14 test brands. Concentration was expressed as a multiple of each test’s upper limit of normal (ULN). Tests were defined as positive when they exceeded one times the ULN.
- Histology was assessed by the local pathologist, and discordant cases were reevaluated by a central pathologist.
TAKEAWAY:
- Positive serum tTG-IgA was detected in 363 (83%) participants; negative serum tTG-IgA was detected in 73 (17%).
- After local review, 341 of the participants with positive serum tTG-IgA had positive histology (true positives) and 22 had negative histology (false positives).
- Of the 73 participants with negative serum tTG-IgA, 66 had negative histology (true negatives) and 7 had positive histology (false negatives).
- Central reevaluation of duodenal histology was performed in 29 discordant cases, resulting in 348 true positive cases, 15 false positive cases, 66 true negative cases, and 7 false negative cases – the equivalent of a positive predictive value of 95.9%, a negative predictive value of 90.4%, a sensitivity of 98%, and a specificity of 81.5%.
- The positive predictive value of local serum tTG-IgA increased when the serologic threshold was defined at increasing multiples of the ULN. The test correctly diagnosed duodenal villous atrophy in 97.5% of patients with serum tTG-IgA concentrations greater than 10 times the ULN.
IN PRACTICE:
“The results of this multicentre prospective study indicate that a no-biopsy approach for the diagnosis of coeliac disease is safe and reliable in adult patients without IgA deficiency and with serum tTG-IgA greater than the assay-specific upper limit of normal,” the authors write. “We found no evidence that important comorbidities would be missed by adopting a no-biopsy strategy.”
SOURCE:
The study was led by Carolina Ciacci, Centre for Coeliac Disease, AOU San Giovanni Di Dio e Ruggi d’Aragona, Salerno, Italy, and was published online in The Lancet Gastroenterology and Hepatology.
LIMITATIONS:
Limitations include a lack of data on IgA-deficient participants, a low number of participants in some subgroup analyses, a lack of data for many ethnic groups, limited follow-up information, limited assessments in the central laboratory, and high pretest probability of celiac disease (low number of participants without duodenal villous atrophy).
DISCLOSURES:
The study had no specific funding. One coauthor is an employee of Werfen. The other authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
For adults with suspected celiac disease who do not have immunoglobulin A (IgA) deficiency, diagnostic bowel biopsy can most likely be avoided if the serum antitissue transglutaminase IgA (tTG-IgA) level is high.
METHODOLOGY:
- Researchers evaluated the reliability of serum tests for diagnosing celiac disease, as defined by duodenal villous atrophy (Marsh type 3 or Corazza-Villanacci grade B).
- The main study cohort included 436 adults with suspected celiac disease who did not have IgA deficiency and who were not on a gluten-free diet (mean age, 40 years; 68% women). The patients were referred by 14 centers across four continents to undergo local endoscopic duodenal biopsy.
- Local serum tTG-IgA was measured with 14 test brands. Concentration was expressed as a multiple of each test’s upper limit of normal (ULN). Tests were defined as positive when they exceeded one times the ULN.
- Histology was assessed by the local pathologist, and discordant cases were reevaluated by a central pathologist.
TAKEAWAY:
- Positive serum tTG-IgA was detected in 363 (83%) participants; negative serum tTG-IgA was detected in 73 (17%).
- After local review, 341 of the participants with positive serum tTG-IgA had positive histology (true positives) and 22 had negative histology (false positives).
- Of the 73 participants with negative serum tTG-IgA, 66 had negative histology (true negatives) and 7 had positive histology (false negatives).
- Central reevaluation of duodenal histology was performed in 29 discordant cases, resulting in 348 true positive cases, 15 false positive cases, 66 true negative cases, and 7 false negative cases – the equivalent of a positive predictive value of 95.9%, a negative predictive value of 90.4%, a sensitivity of 98%, and a specificity of 81.5%.
- The positive predictive value of local serum tTG-IgA increased when the serologic threshold was defined at increasing multiples of the ULN. The test correctly diagnosed duodenal villous atrophy in 97.5% of patients with serum tTG-IgA concentrations greater than 10 times the ULN.
IN PRACTICE:
“The results of this multicentre prospective study indicate that a no-biopsy approach for the diagnosis of coeliac disease is safe and reliable in adult patients without IgA deficiency and with serum tTG-IgA greater than the assay-specific upper limit of normal,” the authors write. “We found no evidence that important comorbidities would be missed by adopting a no-biopsy strategy.”
SOURCE:
The study was led by Carolina Ciacci, Centre for Coeliac Disease, AOU San Giovanni Di Dio e Ruggi d’Aragona, Salerno, Italy, and was published online in The Lancet Gastroenterology and Hepatology.
LIMITATIONS:
Limitations include a lack of data on IgA-deficient participants, a low number of participants in some subgroup analyses, a lack of data for many ethnic groups, limited follow-up information, limited assessments in the central laboratory, and high pretest probability of celiac disease (low number of participants without duodenal villous atrophy).
DISCLOSURES:
The study had no specific funding. One coauthor is an employee of Werfen. The other authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Fish oil labels make health claims, despite lack of data
Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).
The authors say “additional regulation” of the claims may be needed to prevent consumer misinformation. Notably, 20% of adults older than 60 years take fish oil supplements for heart health despite the fact that multiple randomized trials show no cardiovascular benefit.
“Based on what I’ve seen personally in the grocery store and pharmacy, I was not surprised to find such high rates of health claims on fish oil supplements,” lead author Joanna Assadourian, BSA, of UT Southwestern Medical Center, Dallas, said in an interview. “What was surprising, though, was just how broad the types of claims being made were – from heart and brain health to joint health, eye health, and immune function.”
Principal author Ann Marie Navar, MD, PhD, also of UT Southwestern, added, “As a preventive cardiologist, I tell my patients that if they are taking fish oil to try to avoid heart disease, then they can stop taking it because it’s not helping them. Their money would be better spent on something that will actually prevent a heart attack, like more fresh vegetables, their blood pressure or cholesterol medication, or a gym membership.”
The study was published online in JAMA Cardiology.
‘Vague statements’
To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.
The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.
QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.
An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”
Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”
Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.
The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).
Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.
“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”
Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
Enthusiasm vs. evidence
“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.
“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.
The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.
A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.
Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.
Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”
No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).
The authors say “additional regulation” of the claims may be needed to prevent consumer misinformation. Notably, 20% of adults older than 60 years take fish oil supplements for heart health despite the fact that multiple randomized trials show no cardiovascular benefit.
“Based on what I’ve seen personally in the grocery store and pharmacy, I was not surprised to find such high rates of health claims on fish oil supplements,” lead author Joanna Assadourian, BSA, of UT Southwestern Medical Center, Dallas, said in an interview. “What was surprising, though, was just how broad the types of claims being made were – from heart and brain health to joint health, eye health, and immune function.”
Principal author Ann Marie Navar, MD, PhD, also of UT Southwestern, added, “As a preventive cardiologist, I tell my patients that if they are taking fish oil to try to avoid heart disease, then they can stop taking it because it’s not helping them. Their money would be better spent on something that will actually prevent a heart attack, like more fresh vegetables, their blood pressure or cholesterol medication, or a gym membership.”
The study was published online in JAMA Cardiology.
‘Vague statements’
To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.
The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.
QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.
An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”
Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”
Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.
The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).
Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.
“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”
Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
Enthusiasm vs. evidence
“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.
“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.
The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.
A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.
Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.
Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”
No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Overall, about 74% of more than 2,800 supplements that were examined had labels that made at least one health claim, and only 19% included a U.S. Food and Drug Administration–reviewed qualified health claim (QHC).
The authors say “additional regulation” of the claims may be needed to prevent consumer misinformation. Notably, 20% of adults older than 60 years take fish oil supplements for heart health despite the fact that multiple randomized trials show no cardiovascular benefit.
“Based on what I’ve seen personally in the grocery store and pharmacy, I was not surprised to find such high rates of health claims on fish oil supplements,” lead author Joanna Assadourian, BSA, of UT Southwestern Medical Center, Dallas, said in an interview. “What was surprising, though, was just how broad the types of claims being made were – from heart and brain health to joint health, eye health, and immune function.”
Principal author Ann Marie Navar, MD, PhD, also of UT Southwestern, added, “As a preventive cardiologist, I tell my patients that if they are taking fish oil to try to avoid heart disease, then they can stop taking it because it’s not helping them. Their money would be better spent on something that will actually prevent a heart attack, like more fresh vegetables, their blood pressure or cholesterol medication, or a gym membership.”
The study was published online in JAMA Cardiology.
‘Vague statements’
To evaluate health claims made on fish oil supplement labels in the United States and to examine doses of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in commonly available formulations, the investigators analyzed labels on supplements obtained from the National Institutes of Health Dietary Supplement Label Database.
The main outcomes were the frequency and types of health claims made on the labels, including use of an FDA-reviewed QHC versus a structure/function claim and the organ system referenced, as well as the total daily doses in combined EPA and DHA supplements from leading manufacturers and retailers.
QHCs are statements regarding a supplement’s or food’s potential to treatment or prevent disease. Such claims undergo evidence review by the FDA and include qualifying language that reflects lack of scientific consensus or uncertainty.
An example: “Consuming EPA and DHA combined may reduce the risk of CHD [coronary heart disease] by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
By contrast, structure/function claims “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” but do not state that the supplement prevents, treats, or cures any disease. Such a claim “does not require any mitigating language regarding potential scientific uncertainty of the statement.”
Structure/function claims commonly state that the supplement “maintains,” “supports,” or “promotes” the function of certain organs. Examples are “promotes heart health” and “supports heart, mind and mood.”
Among 2,819 fish oil supplements, 2,082 (73.9%) made at least one health claim. Of these, only 399 (19.2%) used a QHC; the rest made only structure/function claims. In addition to heart-health claims, many fish oil supplements also have labels that make claims implying benefit to other organ systems, such as brain/mental health, joint health, and eye health – despite a lack of data from randomized clinical trials that support benefit.
The dose analysis of 255 fish oil supplements across 16 major brands found “substantial variability” in the daily dose of EPA (median interquartile range, 340 [135-647] mg/d), DHA (median IQR, 270 [140-500] mg/d), and total EPA+DHA (median IQR, 600 [300-1,100] mg/d).
Twenty-four (9.4%) of the supplements contained a daily dose of 2 g or more EPA+DHA.
“Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements,” the authors conclude. “Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”
Dr. Navar added, “We now need to understand what consumers are taking away from vague statements like ‘promotes brain health’ or ‘supports joint function’ – and test what language we can use to accurately describe the state of the science around fish oil and heart health.”
Enthusiasm vs. evidence
“I agree with these concerns and think that the enthusiasm for these supplements outpaces the evidence from rigorous randomized clinical trials,” JoAnn E. Manson, MD, MPH, DrPH, chief of the Division of Preventive Medicine at Brigham and Women’s Hospital, Boston, said in an interview. “Results of the observational studies have tended to be much more favorable than the randomized clinical trials.
“The labels can be very misleading to the general public,” she noted. “People are confronted with a dizzying array of dietary supplements, many of which include structure/function claims that require minimal, if any, evidence of efficacy. Clinicians should emphasize with patients that a dietary supplement will never be a substitute for a heart-healthy diet and that many supplements are not helpful for people who already follow a healthy diet,” she said.
The VITAL trial, for which Dr. Manson was principal investigator, showed that supplementation with n-3 fatty acids did not lead to a lower incidence of major cardiovascular events or cancer, compared with placebo.
A subgroup analysis showed that 1 g/d conferred a 20% reduction in major events only for participants who ate less than 1.5 servings of fish per week, Dr. Manson said.
Regarding supplement labels, clinicians should recommend that patients look for a U.S. Pharmacopoeia seal or a seal from the National Science Foundation or ConsumerLab, she advised. These seals ensure that the product has been audited for purity and consistency of content and that the dose in the capsule is consistent with what is on the label.
Dr. Manson also would like to see labels explain that most of the products have not been reviewed by the FDA. “Many members of the general public are misled by these labels into thinking that they’re going to receive health benefits. They’re spending a lot of money on supplements that likely provide no benefit and may even be associated with increased risks.”
No funding for the study was reported. Dr. Navar has received grants from BMS, Esperion, Amgen, and Janssen and personal fees from AstraZeneca, Boehringer Ingelheim, Bayer, BMS, Esperion, Janssen, Eli Lilly, Merck, Silence Therapeutics, Novo Nordisk, Novartis, New Amsterdam, and Pfizer outside the submitted work and serves as deputy editor for equity, diversity, and inclusion at JAMA Cardiology.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
How to manage heartburn cost-effectively after PPI failure
TOPLINE:
, matching therapy to phenotype.
METHODOLOGY:
- Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
- Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
- All index testing was assumed to be done while patients were off PPI treatment.
TAKEAWAY:
- PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
- Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
- Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
- Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
- The findings support recent clinical practice guidelines from the American Gastroenterological Association and the
IN PRACTICE:
“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.
SOURCE:
Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.
LIMITATIONS:
Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.
DISCLOSURES:
The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
A version of this article appeared on Medscape.com.
TOPLINE:
, matching therapy to phenotype.
METHODOLOGY:
- Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
- Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
- All index testing was assumed to be done while patients were off PPI treatment.
TAKEAWAY:
- PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
- Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
- Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
- Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
- The findings support recent clinical practice guidelines from the American Gastroenterological Association and the
IN PRACTICE:
“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.
SOURCE:
Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.
LIMITATIONS:
Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.
DISCLOSURES:
The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
A version of this article appeared on Medscape.com.
TOPLINE:
, matching therapy to phenotype.
METHODOLOGY:
- Researchers compared the cost-effectiveness over 1 year of four strategies for managing patients in whom empirical PPI treatment failed.
- Strategies were PPI optimization without diagnostic testing; endoscopy with PPI optimization to identify erosive reflux disease; endoscopy with PPI discontinuation when no erosive reflux disease was found; and combined endoscopy/ambulatory reflux monitoring and PPI discontinuation as appropriate for the phenotype (i.e., erosive disease, nonerosive disease, or functional heartburn).
- All index testing was assumed to be done while patients were off PPI treatment.
TAKEAWAY:
- PPI optimization without testing cost insurers $3,784 a year and patients $3,128 a year owing to health care expenses and lower work productivity associated with suboptimal symptom relief, resulting in a loss of 40 healthy days over the course of the year.
- Endoscopy with PPI optimization lowered insurer costs by $1,020 a year and patient costs by $1,621 a year, compared with optimization without testing, and added 11 healthy days a year by identifying erosive reflux disease.
- Endoscopy with PPI discontinuation added 11 healthy days a year by identifying patients without erosive reflux disease who did not need PPI therapy.
- Endoscopy with ambulatory reflux monitoring and a trial of PPI discontinuation was the most effective strategy, optimizing phenotype-guided treatment, saving insurers $2,183 and patients $2,396 a year, and adding 22 healthy days a year.
- The findings support recent clinical practice guidelines from the American Gastroenterological Association and the
IN PRACTICE:
“[A]n algorithmic approach to comprehensively stratify erosive and non-erosive reflux disease from functional heartburn combined with a trial of PPI discontinuation for patients without erosive findings provides value to patients and insurers,” the authors wrote.
SOURCE:
Eric D. Shah, MD, MBA, division of gastroenterology and hepatology, Michigan Medicine, Ann Arbor, led the study, which was published online in Clinical Gastroenterology and Hepatology.
LIMITATIONS:
Centers may have limited capacity for routine ambulatory reflux monitoring or may not perform it at all. Single-center and older studies were used for model inputs when no other data were available.
DISCLOSURES:
The study had no specific funding. Dr. Shah is supported by a National Institutes of Health grant and disclosed that he has consulted for Salix, Mahana, Neuraxis, Phathom, Takeda, Ardelyx, Sanofi, and GI Supply. Other coauthors have consulted for pharmaceutical and/or biotech companies.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Turmeric may be as effective as omeprazole for dyspepsia
TOPLINE:
METHODOLOGY:
- The researchers randomly assigned 206 patients to receive curcumin – the active ingredient in turmeric – alone; omeprazole alone; or curcumin plus omeprazole for 28 days. A total of 151 patients completed the study.
- Doses were two 250-mg curcumin pills four times daily, plus one placebo pill; one 20-mg omeprazole pill daily, plus two placebo pills four times daily; or two 250-mg curcumin pills four times daily, plus one 20-mg omeprazole pill once daily.
- Symptoms of functional dyspepsia were assessed on days 28 and 56 using the Severity of Dyspepsia Assessment (SODA) score.
TAKEAWAY:
- In the combined group, the curcumin-alone group, and the omeprazole-alone group, SODA scores for pain severity declined significantly by day 28 (–4.83, –5.46, and –6.22, respectively), as did scores for severity of other symptoms (–2.22, –2.32, and –2.31, respectively).
- Symptom improvements were even stronger by day 56 for pain (–7.19, –8.07, –8.85) and other symptoms (–4.09, –4.12, –3.71) in the same groups.
- Curcumin was safe and well tolerated, but satisfaction scores did not change significantly over time among those taking it, suggesting the possible need for improvement in its taste or smell.
- There was no synergistic effect between omeprazole and curcumin.
IN PRACTICE:
“The new findings from our study may justify considering curcumin in clinical practice. This multicenter, randomized, controlled trial provides highly reliable evidence for the treatment of functional dyspepsia,” the authors wrote.
SOURCE:
Pradermchai Kongkam, MD, of Chulalongkorn University, Bangkok, and Wichittra Khongkha of Chao Phraya Abhaibhubejhr Hospital, Prachin Buri, Thailand, are joint first authors. The study was published online in BMJ Evidence-Based Medicine.
LIMITATIONS:
A small number of participants in each group were lost to follow-up, and the follow-up period was short (less than 2 months) for all.
DISCLOSURES:
The study was funded by the Thai Traditional and Alternative Medicine Fund. The authors have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The researchers randomly assigned 206 patients to receive curcumin – the active ingredient in turmeric – alone; omeprazole alone; or curcumin plus omeprazole for 28 days. A total of 151 patients completed the study.
- Doses were two 250-mg curcumin pills four times daily, plus one placebo pill; one 20-mg omeprazole pill daily, plus two placebo pills four times daily; or two 250-mg curcumin pills four times daily, plus one 20-mg omeprazole pill once daily.
- Symptoms of functional dyspepsia were assessed on days 28 and 56 using the Severity of Dyspepsia Assessment (SODA) score.
TAKEAWAY:
- In the combined group, the curcumin-alone group, and the omeprazole-alone group, SODA scores for pain severity declined significantly by day 28 (–4.83, –5.46, and –6.22, respectively), as did scores for severity of other symptoms (–2.22, –2.32, and –2.31, respectively).
- Symptom improvements were even stronger by day 56 for pain (–7.19, –8.07, –8.85) and other symptoms (–4.09, –4.12, –3.71) in the same groups.
- Curcumin was safe and well tolerated, but satisfaction scores did not change significantly over time among those taking it, suggesting the possible need for improvement in its taste or smell.
- There was no synergistic effect between omeprazole and curcumin.
IN PRACTICE:
“The new findings from our study may justify considering curcumin in clinical practice. This multicenter, randomized, controlled trial provides highly reliable evidence for the treatment of functional dyspepsia,” the authors wrote.
SOURCE:
Pradermchai Kongkam, MD, of Chulalongkorn University, Bangkok, and Wichittra Khongkha of Chao Phraya Abhaibhubejhr Hospital, Prachin Buri, Thailand, are joint first authors. The study was published online in BMJ Evidence-Based Medicine.
LIMITATIONS:
A small number of participants in each group were lost to follow-up, and the follow-up period was short (less than 2 months) for all.
DISCLOSURES:
The study was funded by the Thai Traditional and Alternative Medicine Fund. The authors have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The researchers randomly assigned 206 patients to receive curcumin – the active ingredient in turmeric – alone; omeprazole alone; or curcumin plus omeprazole for 28 days. A total of 151 patients completed the study.
- Doses were two 250-mg curcumin pills four times daily, plus one placebo pill; one 20-mg omeprazole pill daily, plus two placebo pills four times daily; or two 250-mg curcumin pills four times daily, plus one 20-mg omeprazole pill once daily.
- Symptoms of functional dyspepsia were assessed on days 28 and 56 using the Severity of Dyspepsia Assessment (SODA) score.
TAKEAWAY:
- In the combined group, the curcumin-alone group, and the omeprazole-alone group, SODA scores for pain severity declined significantly by day 28 (–4.83, –5.46, and –6.22, respectively), as did scores for severity of other symptoms (–2.22, –2.32, and –2.31, respectively).
- Symptom improvements were even stronger by day 56 for pain (–7.19, –8.07, –8.85) and other symptoms (–4.09, –4.12, –3.71) in the same groups.
- Curcumin was safe and well tolerated, but satisfaction scores did not change significantly over time among those taking it, suggesting the possible need for improvement in its taste or smell.
- There was no synergistic effect between omeprazole and curcumin.
IN PRACTICE:
“The new findings from our study may justify considering curcumin in clinical practice. This multicenter, randomized, controlled trial provides highly reliable evidence for the treatment of functional dyspepsia,” the authors wrote.
SOURCE:
Pradermchai Kongkam, MD, of Chulalongkorn University, Bangkok, and Wichittra Khongkha of Chao Phraya Abhaibhubejhr Hospital, Prachin Buri, Thailand, are joint first authors. The study was published online in BMJ Evidence-Based Medicine.
LIMITATIONS:
A small number of participants in each group were lost to follow-up, and the follow-up period was short (less than 2 months) for all.
DISCLOSURES:
The study was funded by the Thai Traditional and Alternative Medicine Fund. The authors have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM BMJ EVIDENCE-BASED MEDICINE
These four GI conditions may predict Parkinson’s disease
Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.
The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.
Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”
“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.
The study was published online in Gut.
Studies converge
To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.
First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.
Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.
All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.
In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.
Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.
To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.
Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.
Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).
Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.
“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.
However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”
His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
Body or brain?
The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”
The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.
Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.
“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”
“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”
No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.
The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.
Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”
“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.
The study was published online in Gut.
Studies converge
To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.
First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.
Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.
All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.
In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.
Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.
To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.
Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.
Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).
Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.
“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.
However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”
His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
Body or brain?
The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”
The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.
Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.
“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”
“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”
No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.
The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.
Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”
“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.
The study was published online in Gut.
Studies converge
To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.
First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.
Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.
All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.
In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.
Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.
To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.
Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.
Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).
Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.
“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.
However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”
His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
Body or brain?
The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”
The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.
Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.
“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”
“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”
No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM GUT
How to optimize in-hospital antimicrobial prescribing?
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.
In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.
Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.
Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.
“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’
“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”
The study was published online in the Canadian Medical Association Journal.
Antimicrobial reductions possible
The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.
The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).
They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.
Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.
The primary measure was days of therapy per 100 patient-days.
As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.
The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.
No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.
In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.
In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”
The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
Decision-making support
Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.
“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’
“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”
Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.
“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.
“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”
No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
How should muscle mass be measured in heart failure?
, research suggests.
In a single-center, retrospective study that included more than 800 patients, high MUAC (hazard ratio for combined events, 0.590) and high AMC (HR for combined events, 0.529) were associated with significantly better prognoses than low MUAC and low AMC.
The findings were “surprising,” Kentaro Kamiya, PT, PhD, and Shota Uchida, PT, PhD, of Kitasato University School of Allied Health Sciences in Kanagawa, Japan, said in an interview.
“These findings challenge the current recommendations found in sarcopenia guidelines,” they noted. The European Working Group on Sarcopenia in Older People and the Asian Working Group for Sarcopenia recommend SMI, as measured by bioelectrical impedance analysis (BIA), and CC as methods for screening skeletal muscle mass.
The study was published online in the Canadian Journal of Cardiology.
Arm measures prognostic
Sarcopenia, which is marked by a loss of skeletal muscle mass and strength, is associated with risks of adverse outcomes. Patients with heart failure have a high rate of sarcopenia, but assessing skeletal muscle mass in these patients is difficult because of the fluid retention they often have.
The investigators examined the association between skeletal muscle mass metrics, measured using bioelectrical impedance analysis, and anthropometric measures and prognosis in patients with heart failure.
SMI was calculated using the BIA by dividing appendicular skeletal muscle mass by height squared. MUAC and CC were measured to the nearest 1 mm using a plastic tape measure. AMC was calculated as follows: MUAC (cm) − (0.314 x triceps skinfold [TSF]). The TSF was measured to the nearest 2 mm with a skinfold caliper. The measuring spot for TSF was the same measuring spot for MUAC. MUAC, CC, and TSF were measured by trained physiotherapists or nurses.
The investigators identified 1,930 consecutive patients with heart failure who underwent cardiac rehabilitation during their hospitalization. They excluded from their analysis 1,013 patients who did not undergo a skeletal mass metrics evaluation and 48 who could not be followed up.
The analysis included 869 patients (median age, 73 years; 62% men). Patients were separated into three groups on the basis of the sex-specific tertiles of skeletal muscle mass. The study endpoint was all-cause death or readmission due to heart failure, and the median follow-up period was 1.24 years.
After the investigators adjusted the data for age, sex, New York Heart Association functional class III or IV, left ventricular ejection fraction (LVEF), ischemic etiology, prior heart failure, diabetes, chronic obstructive pulmonary disease, log-transformed B-type natriuretic peptide (BNP), and estimated glomerular filtration rate (eGFR), the high MUAC and high AMC groups were associated with significantly better prognoses than their respective low groups. By contrast, high SMI and high CC were not associated with better prognoses.
Subgroup analyses showed no interactions between MUAC and age, sex, LVEF, BNP, eGFR, prior heart failure, beta-blocker use, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker use. However, diuretic agents significantly interacted with AMC (P = .03).
“These results support the use of MUAC and AMC to determine the risk stratification of sarcopenia and a poor prognosis in patients with heart failure and suggest that they may be useful in developing treatment strategies in patients with heart failure,” wrote the authors.
“When caring for patients with heart failure, it seems that the often overlooked and simple measure of arm circumference might carry significant prognostic value,” said Dr. Kamiya and Dr. Uchida. “So, as you cuff the arm for routine blood pressure measurement, it might be worthwhile to also pay attention to arm girth.”
Although the findings provide valuable insights, they should be approached with caution, Dr. Kamiya and Dr. Uchida added. “Before considering them practice-changing, further research is needed to validate these results in diverse patient cohorts.”
Prospective study needed
Commenting on the study for this news organization, Jonathan H. Whiteson, MD, vice chair of clinical operations and medical director of cardiac and pulmonary rehabilitation at NYU Langone Health’s Rusk Rehabilitation in New York, expressed concerns about the study methodology.
Methodologic weaknesses include the retrospective, observational nature of the study and the fact that incomplete data collection led to the exclusion of more than half of the potential participants, he said. In addition, “anthropometric measurements are prone to inter-rater error. It is not clear if the same or different researchers conducted these measurements.
“Furthermore, hospitalized patients may not be clinically stable when discharged,” said Dr. Whiteson. “It is recommended that biometrics for muscle mass and fluid retention be done when patients are at an optimized clinical state: that is, stabilized outpatients.”
For now, Dr. Whiteson concluded, the findings should be considered “interesting and suggestive of further study.” What’s needed is “a prospective study including all patients admitted with heart failure, but measurements done when the patient is stabilized as an outpatient.”
The study was partially supported by the Japan Society for the Promotion of Science KAKENHI. Dr. Kamiya, Dr. Uchida, and Dr. Whiteson reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
, research suggests.
In a single-center, retrospective study that included more than 800 patients, high MUAC (hazard ratio for combined events, 0.590) and high AMC (HR for combined events, 0.529) were associated with significantly better prognoses than low MUAC and low AMC.
The findings were “surprising,” Kentaro Kamiya, PT, PhD, and Shota Uchida, PT, PhD, of Kitasato University School of Allied Health Sciences in Kanagawa, Japan, said in an interview.
“These findings challenge the current recommendations found in sarcopenia guidelines,” they noted. The European Working Group on Sarcopenia in Older People and the Asian Working Group for Sarcopenia recommend SMI, as measured by bioelectrical impedance analysis (BIA), and CC as methods for screening skeletal muscle mass.
The study was published online in the Canadian Journal of Cardiology.
Arm measures prognostic
Sarcopenia, which is marked by a loss of skeletal muscle mass and strength, is associated with risks of adverse outcomes. Patients with heart failure have a high rate of sarcopenia, but assessing skeletal muscle mass in these patients is difficult because of the fluid retention they often have.
The investigators examined the association between skeletal muscle mass metrics, measured using bioelectrical impedance analysis, and anthropometric measures and prognosis in patients with heart failure.
SMI was calculated using the BIA by dividing appendicular skeletal muscle mass by height squared. MUAC and CC were measured to the nearest 1 mm using a plastic tape measure. AMC was calculated as follows: MUAC (cm) − (0.314 x triceps skinfold [TSF]). The TSF was measured to the nearest 2 mm with a skinfold caliper. The measuring spot for TSF was the same measuring spot for MUAC. MUAC, CC, and TSF were measured by trained physiotherapists or nurses.
The investigators identified 1,930 consecutive patients with heart failure who underwent cardiac rehabilitation during their hospitalization. They excluded from their analysis 1,013 patients who did not undergo a skeletal mass metrics evaluation and 48 who could not be followed up.
The analysis included 869 patients (median age, 73 years; 62% men). Patients were separated into three groups on the basis of the sex-specific tertiles of skeletal muscle mass. The study endpoint was all-cause death or readmission due to heart failure, and the median follow-up period was 1.24 years.
After the investigators adjusted the data for age, sex, New York Heart Association functional class III or IV, left ventricular ejection fraction (LVEF), ischemic etiology, prior heart failure, diabetes, chronic obstructive pulmonary disease, log-transformed B-type natriuretic peptide (BNP), and estimated glomerular filtration rate (eGFR), the high MUAC and high AMC groups were associated with significantly better prognoses than their respective low groups. By contrast, high SMI and high CC were not associated with better prognoses.
Subgroup analyses showed no interactions between MUAC and age, sex, LVEF, BNP, eGFR, prior heart failure, beta-blocker use, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker use. However, diuretic agents significantly interacted with AMC (P = .03).
“These results support the use of MUAC and AMC to determine the risk stratification of sarcopenia and a poor prognosis in patients with heart failure and suggest that they may be useful in developing treatment strategies in patients with heart failure,” wrote the authors.
“When caring for patients with heart failure, it seems that the often overlooked and simple measure of arm circumference might carry significant prognostic value,” said Dr. Kamiya and Dr. Uchida. “So, as you cuff the arm for routine blood pressure measurement, it might be worthwhile to also pay attention to arm girth.”
Although the findings provide valuable insights, they should be approached with caution, Dr. Kamiya and Dr. Uchida added. “Before considering them practice-changing, further research is needed to validate these results in diverse patient cohorts.”
Prospective study needed
Commenting on the study for this news organization, Jonathan H. Whiteson, MD, vice chair of clinical operations and medical director of cardiac and pulmonary rehabilitation at NYU Langone Health’s Rusk Rehabilitation in New York, expressed concerns about the study methodology.
Methodologic weaknesses include the retrospective, observational nature of the study and the fact that incomplete data collection led to the exclusion of more than half of the potential participants, he said. In addition, “anthropometric measurements are prone to inter-rater error. It is not clear if the same or different researchers conducted these measurements.
“Furthermore, hospitalized patients may not be clinically stable when discharged,” said Dr. Whiteson. “It is recommended that biometrics for muscle mass and fluid retention be done when patients are at an optimized clinical state: that is, stabilized outpatients.”
For now, Dr. Whiteson concluded, the findings should be considered “interesting and suggestive of further study.” What’s needed is “a prospective study including all patients admitted with heart failure, but measurements done when the patient is stabilized as an outpatient.”
The study was partially supported by the Japan Society for the Promotion of Science KAKENHI. Dr. Kamiya, Dr. Uchida, and Dr. Whiteson reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
, research suggests.
In a single-center, retrospective study that included more than 800 patients, high MUAC (hazard ratio for combined events, 0.590) and high AMC (HR for combined events, 0.529) were associated with significantly better prognoses than low MUAC and low AMC.
The findings were “surprising,” Kentaro Kamiya, PT, PhD, and Shota Uchida, PT, PhD, of Kitasato University School of Allied Health Sciences in Kanagawa, Japan, said in an interview.
“These findings challenge the current recommendations found in sarcopenia guidelines,” they noted. The European Working Group on Sarcopenia in Older People and the Asian Working Group for Sarcopenia recommend SMI, as measured by bioelectrical impedance analysis (BIA), and CC as methods for screening skeletal muscle mass.
The study was published online in the Canadian Journal of Cardiology.
Arm measures prognostic
Sarcopenia, which is marked by a loss of skeletal muscle mass and strength, is associated with risks of adverse outcomes. Patients with heart failure have a high rate of sarcopenia, but assessing skeletal muscle mass in these patients is difficult because of the fluid retention they often have.
The investigators examined the association between skeletal muscle mass metrics, measured using bioelectrical impedance analysis, and anthropometric measures and prognosis in patients with heart failure.
SMI was calculated using the BIA by dividing appendicular skeletal muscle mass by height squared. MUAC and CC were measured to the nearest 1 mm using a plastic tape measure. AMC was calculated as follows: MUAC (cm) − (0.314 x triceps skinfold [TSF]). The TSF was measured to the nearest 2 mm with a skinfold caliper. The measuring spot for TSF was the same measuring spot for MUAC. MUAC, CC, and TSF were measured by trained physiotherapists or nurses.
The investigators identified 1,930 consecutive patients with heart failure who underwent cardiac rehabilitation during their hospitalization. They excluded from their analysis 1,013 patients who did not undergo a skeletal mass metrics evaluation and 48 who could not be followed up.
The analysis included 869 patients (median age, 73 years; 62% men). Patients were separated into three groups on the basis of the sex-specific tertiles of skeletal muscle mass. The study endpoint was all-cause death or readmission due to heart failure, and the median follow-up period was 1.24 years.
After the investigators adjusted the data for age, sex, New York Heart Association functional class III or IV, left ventricular ejection fraction (LVEF), ischemic etiology, prior heart failure, diabetes, chronic obstructive pulmonary disease, log-transformed B-type natriuretic peptide (BNP), and estimated glomerular filtration rate (eGFR), the high MUAC and high AMC groups were associated with significantly better prognoses than their respective low groups. By contrast, high SMI and high CC were not associated with better prognoses.
Subgroup analyses showed no interactions between MUAC and age, sex, LVEF, BNP, eGFR, prior heart failure, beta-blocker use, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker use. However, diuretic agents significantly interacted with AMC (P = .03).
“These results support the use of MUAC and AMC to determine the risk stratification of sarcopenia and a poor prognosis in patients with heart failure and suggest that they may be useful in developing treatment strategies in patients with heart failure,” wrote the authors.
“When caring for patients with heart failure, it seems that the often overlooked and simple measure of arm circumference might carry significant prognostic value,” said Dr. Kamiya and Dr. Uchida. “So, as you cuff the arm for routine blood pressure measurement, it might be worthwhile to also pay attention to arm girth.”
Although the findings provide valuable insights, they should be approached with caution, Dr. Kamiya and Dr. Uchida added. “Before considering them practice-changing, further research is needed to validate these results in diverse patient cohorts.”
Prospective study needed
Commenting on the study for this news organization, Jonathan H. Whiteson, MD, vice chair of clinical operations and medical director of cardiac and pulmonary rehabilitation at NYU Langone Health’s Rusk Rehabilitation in New York, expressed concerns about the study methodology.
Methodologic weaknesses include the retrospective, observational nature of the study and the fact that incomplete data collection led to the exclusion of more than half of the potential participants, he said. In addition, “anthropometric measurements are prone to inter-rater error. It is not clear if the same or different researchers conducted these measurements.
“Furthermore, hospitalized patients may not be clinically stable when discharged,” said Dr. Whiteson. “It is recommended that biometrics for muscle mass and fluid retention be done when patients are at an optimized clinical state: that is, stabilized outpatients.”
For now, Dr. Whiteson concluded, the findings should be considered “interesting and suggestive of further study.” What’s needed is “a prospective study including all patients admitted with heart failure, but measurements done when the patient is stabilized as an outpatient.”
The study was partially supported by the Japan Society for the Promotion of Science KAKENHI. Dr. Kamiya, Dr. Uchida, and Dr. Whiteson reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY
As MOC debate heats up, cardiology societies weigh in
It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.
MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.
Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
MOC ‘burdensome,’ ‘costly,’ ‘complex’
On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates.
As of August 22, the petition had garnered more than 18,000 signatures.
Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.
The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.
Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.
Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.
In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
SCAI and HRS weigh in
Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities.
The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.
SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”
The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.”
In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”
Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
MOC alternatives
The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”
Alternative options that are arguably less arduous are available.
In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option.
The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve.
In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.
She said that, to date, more than “6,400 learners” are enrolled in the CMP program.
Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”
A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance.
Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.
Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”
Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.
A version of this article first appeared on Medscape.com.
It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.
MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.
Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
MOC ‘burdensome,’ ‘costly,’ ‘complex’
On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates.
As of August 22, the petition had garnered more than 18,000 signatures.
Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.
The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.
Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.
Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.
In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
SCAI and HRS weigh in
Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities.
The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.
SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”
The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.”
In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”
Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
MOC alternatives
The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”
Alternative options that are arguably less arduous are available.
In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option.
The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve.
In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.
She said that, to date, more than “6,400 learners” are enrolled in the CMP program.
Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”
A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance.
Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.
Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”
Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.
A version of this article first appeared on Medscape.com.
It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.
MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.
Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
MOC ‘burdensome,’ ‘costly,’ ‘complex’
On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates.
As of August 22, the petition had garnered more than 18,000 signatures.
Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.
The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.
Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.
Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.
In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
SCAI and HRS weigh in
Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities.
The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.
SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”
The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.”
In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”
Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
MOC alternatives
The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”
Alternative options that are arguably less arduous are available.
In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option.
The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve.
In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.
She said that, to date, more than “6,400 learners” are enrolled in the CMP program.
Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”
A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance.
Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.
Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”
Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.
A version of this article first appeared on Medscape.com.
AHA advocates normothermia for most comatose OHCA patients
a new American Heart Association (AHA) scientific advisory suggests.
On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.
The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.
“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.
“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.
“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”
The advisory was published online in Circulation.
TTM2 key
The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.
Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.
No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.
Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.
By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.
Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.
“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”
Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”
Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”
No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.
A version of this article first appeared on Medscape.com.
a new American Heart Association (AHA) scientific advisory suggests.
On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.
The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.
“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.
“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.
“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”
The advisory was published online in Circulation.
TTM2 key
The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.
Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.
No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.
Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.
By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.
Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.
“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”
Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”
Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”
No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.
A version of this article first appeared on Medscape.com.
a new American Heart Association (AHA) scientific advisory suggests.
On the basis of data from recent trials, the International Liaison Committee on Resuscitation and other organizations have altered their treatment recommendations for temperature management after cardiac arrest.
The AHA will present guidelines on this topic in a focused update to be published later in the year. Meanwhile, AHA’s Emergency Cardiovascular Care Committee convened a writing group to review the Hypothermia Versus Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial in the context of other recent evidence and rendered an expert opinion on how the trial may influence clinical practice. These findings will be incorporated into the upcoming guidelines.
“Many centers have already moved toward controlled normothermia for post-arrest patients, so we think this guidance will be welcomed by many,” said Sarah Perman, MD, of the Yale University, and Kate Berg, MD, of Beth Israel Deaconess Medical Center, who are both members of the AHA Emergency Cardiovascular Care Committee that authored the advisory.
“For those who continue to favor temperatures in the 32° to 36° range for some or even all patients, the guidance that we have drafted leaves room for clinicians to make patient-centered decisions,” they told this news organization.
“Certainly, a finite guideline that recommends one temperature for all would be easier to apply,” the authors acknowledged. “However, cardiac arrest is a heterogeneous event and brain injury is variable, and definitive evidence that one temperature in the range of 32-37.5 is superior to another is lacking. We hope that clinicians find that this guidance supports and informs their practice.”
The advisory was published online in Circulation.
TTM2 key
The new guidance is based largely on findings from the TTM2 trial, a multicenter, randomized clinical trial of temperature management for neuroprotection after cardiac arrest that included 1,900 unresponsive adult patients successfully resuscitated from OHCA.
Patients were randomly assigned to receive hypothermia, defined as a target temperature of 33° C for 28 hours, followed by gradual rewarming to 37° C, or normothermia, defined as a target temperature < 37.8° C, with early treatment of fever.
No significant between-group difference was seen in the primary outcome of death at 6 months, nor were there any significant differences by subgroups of sex, age, time to return of spontaneous circulation, initial rhythm, or circulatory shock on admission.
Although it’s still not clear whether certain patients might benefit from lower target temperatures, the authors noted, major international organizations now suggest a target post–cardiac arrest temperature of less than 37.5° C.
By contrast, current AHA guidelines endorse targeting a temperature between 32° C and 36° C for 24 hours.
Between now and the forthcoming formal guidance in the “2023 American Heart Association Focused Update on Advanced Cardiovascular Life Support,” the scientific advisory writing group agreed: “For unresponsive post–cardiac arrest adult patients with characteristics similar to those of individuals included in the TTM2 trial (OHCA of cardiac or unknown cause, excluding those with unwitnessed asystole), controlling patient temperature to < 37.5° C is a reasonable and evidence-based approach.
“For the broader group of patients with in-hospital cardiac arrest or OHCA of noncardiac (other medical) cause, evidence for the ideal approach to temperature management after return of spontaneous circulation is less certain; whether some of these patients might benefit from temperature control at temperatures between 33° C and 37.5° C remains unclear.”
Unless a catastrophic brain injury results from OHCA, the group wrote, “strictly preventing fever with continuous temperature monitoring, providing comprehensive critical care support, and deploying multimodal evidence-based strategies for neuroprognostication at a minimum of 72 hours after normothermia remain essential ...”
Dr. Perman and Dr. Berg concluded, “We hope that this guidance continues to encourage aggressive post-arrest care that includes focus on temperature control as well as the other major contributors to post-arrest bundles of care including hemodynamic optimization and guideline concordant neuroprognostication.”
No funding was reported. Dr. Berg has received grant support from AHA/ILCOR, and Dr. Perman, from NIH/NHLBI.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION