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New hypertension guidelines would add 15.6 million new diagnoses
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.
Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.
In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.
The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.
“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”
The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.
Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.
That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.
“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.
Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.
Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale
An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.
The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.
“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.
The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.
Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.
In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.
Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)
In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.
Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.
“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.
The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.
Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.
SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357
This article was updated 7/19/18.
FROM THE BMJ
Key clinical point: The 2017 ACC/AHA hypertension guidelines could dramatically increase the number of individuals with hypertension and candidates for treatment.
Major finding: The number of individuals with untreated hypertension increased from 8.1 million to 15.6 million.
Study details: A cross-sectional study of adults in nationally representative databases in the United States (NHANES) and China (CHARLS).
Disclosures: Authors reported disclosures related to Medtronic, Johnson and Johnson (Janssen), the Food and Drug Administration, UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo.
Source: Khera R et al. BMJ 2018;362:k2357.
EULAR nears first recommendations for managing Sjögren’s syndrome
AMSTERDAM – , and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.
“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.
In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:
• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.
• Patients with sicca syndrome should receive symptomatic relief with topical treatments.
• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.
The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.
The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.
The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.
Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.
For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.
Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.
The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.
The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.
She had no disclosures.
SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.
AMSTERDAM – , and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.
“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.
In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:
• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.
• Patients with sicca syndrome should receive symptomatic relief with topical treatments.
• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.
The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.
The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.
The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.
Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.
For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.
Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.
The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.
The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.
She had no disclosures.
SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.
AMSTERDAM – , and they divide the treatment targets into sicca syndrome and systemic manifestations of the disease.
“In Sjögren’s, we always have two subtypes of patients: those who have sicca syndrome only, and those with sicca syndrome plus systemic disease,” explained Soledad Retamozo, MD, who presented the current version of the recommendations at the European Congress of Rheumatology. “We wanted to highlight that there are two types of patients,” said Dr. Retamozo, a rheumatologist at the University of Córdoba (Argentina). “It’s hard to treat patients with sicca syndrome plus fatigue and pain because there is no high-level evidence on how to do this; all we have is expert opinion,” Dr. Retamozo said in an interview.
In fact, roughly half of the recommendations have no supporting evidence base, as presented by Dr. Retamozo. That starts with all three general recommendations she presented:
• Patients with Sjögren’s should be managed at a center of expertise using a multidisciplinary approach, which she said should include ophthalmologists and dentists to help address the mouth and ocular manifestations of sicca syndrome.
• Patients with sicca syndrome should receive symptomatic relief with topical treatments.
• Systemic treatments – glucocorticoids, immunosuppressants, and biologicals – can be considered for patients with active systemic disease.
The statement’s specific recommendations start with managing oral dryness, an intervention that should begin by measuring salivary gland (SG) dysfunction. The document next recommends nonpharmacologic interventions for mild SG dysfunction, pharmacological stimulation for moderate SG dysfunction, and a saliva substitute for severe SG dysfunction. All three recommendations are evidence based, relying on results from either randomized trials or controlled studies.
The second target for topical treatments is ocular dryness, which starts with artificial tears, or ocular gels or ointments, recommendations based on randomized trials. Refractory or severe ocular dryness should receive eye drops that contain a nonsteroidal anti-inflammatory drug or a glucocorticoid, based on controlled study results, or autologous serum eye drops, a strategy tested in a randomized trial.
The recommendations then shift to dealing with systemic manifestations, starting with fatigue and pain, offering the expert recommendation to evaluate the contribution of comorbid diseases and assess their severity with tools such as the Eular Sjögren’s Syndrome Patient-Reported Index (ESSPRI) (Ann Rheum Dis. 2011 June;70[6]:968-72), the Profile of Fatigue, and the Brief Pain Inventory.
Using evidence from randomized trials, the recommendations tell clinicians to consider treatment with analgesics or pain-modifying agents for musculoskeletal pain by weighing the potential benefits and adverse effects from this treatment.
For other forms of systemic disease, the recommendations offer the expert opinion to tailor treatment to the organ-specific severity using the ESSPRI definitions. If using glucocorticoids to treat systemic disease, they should be given at the minimum effective dose and for the shortest period of time needed to control active systemic disease, a recommendation based on retrospective or descriptive studies. Expert opinion called for using immunosuppressive treatments as glucocorticoid-sparing options for systemic disease, and this recommendation added that no particular immunosuppressive agent stands out as best compared with all available agents. In more than 95% of reported cases of systemic disease treatment in Sjögren’s patients, clinicians used the immunosuppressive drugs in association with glucocorticoids, Dr. Retamozo noted.
Finally, for systemic disease the recommendations cited evidence from controlled studies that B-cell targeted therapies, such as rituximab (Rituxan) and belimumab (Benlysta), may be considered in patients with severe, refractory systemic disease. An additional expert opinion was that the systemic, organ-specific approach should sequence treatments by using glucocorticoids first, followed by immunosuppressants, and finally biological drugs.
The recommendations finish with an entry that treatment of B-cell lymphoma be individualized based on the specific histopathologic subtype involved and the level of disease extension, an approach based on results from retrospective or descriptive studies.
The recommendations must still undergo final EULAR review and endorsement, with publication on track to occur before the end of 2018, Dr. Retamozo said.
She had no disclosures.
SOURCE: Retamozo S al. Ann Rheum Dis. 2018;77(Suppl 2):42. Abstract SP0159.
REPORTING FROM THE EULAR 2018 CONGRESS
New pediatric hypertension guidelines increased hypertension prevalence
New clinical among at-risk youth, according to findings published in Pediatrics.
In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.
To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.
Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.
In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.
For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.
BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.
Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.
Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.
The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.
The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.
SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.
New clinical among at-risk youth, according to findings published in Pediatrics.
In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.
To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.
Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.
In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.
For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.
BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.
Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.
Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.
The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.
The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.
SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.
New clinical among at-risk youth, according to findings published in Pediatrics.
In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.
To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.
Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.
In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.
For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.
BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.
Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.
Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.
The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.
The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.
SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.
FROM PEDIATRICS
Key clinical point: New clinical guidelines for pediatric hypertension resulted in increased prevalence of the condition and improved sensitivity in detecting target organ damage.
Major finding: BP classification under the new guideline resulted in an increased hypertension prevalence of 13% versus 8% with the 2004 guideline (P = .007).
Study details: The impact of the new guidelines was evaluated using data on 364 patients aged 10-18 years in an obesity and type 2 diabetes mellitus trial.
Disclosures: The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures to report.
Source: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.
Preview of ADA/EASD statement on hyperglycemia
A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.
He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.
When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.
“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.
But it’s a good bet that ADA scientific sessions attendees will see a move toward more specific recommendations based on patient characteristics and fewer one-size-fits-all recommendations. Specific characteristics like obesity, cardiovascular disease, and chronic kidney disease will likely be addressed in the new consensus statement.
One aspect of patient care that will see more attention in the ultimate statement is personalized care. “We will certainly highlight the need to individualize all aspects of care in a patient-centered way, taking into account both specific patient attributes and preferences,” Dr. Buse said.
The draft statement will be presented on Tuesday, June 26, at 8:00 a.m., so it may be worth staying for that last day of the meeting.
The final draft of the new statement will be released in October at the EASD annual meeting in Berlin, noted Dr. Buse, also director of the diabetes center at the university.
A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.
He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.
When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.
“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.
But it’s a good bet that ADA scientific sessions attendees will see a move toward more specific recommendations based on patient characteristics and fewer one-size-fits-all recommendations. Specific characteristics like obesity, cardiovascular disease, and chronic kidney disease will likely be addressed in the new consensus statement.
One aspect of patient care that will see more attention in the ultimate statement is personalized care. “We will certainly highlight the need to individualize all aspects of care in a patient-centered way, taking into account both specific patient attributes and preferences,” Dr. Buse said.
The draft statement will be presented on Tuesday, June 26, at 8:00 a.m., so it may be worth staying for that last day of the meeting.
The final draft of the new statement will be released in October at the EASD annual meeting in Berlin, noted Dr. Buse, also director of the diabetes center at the university.
A move toward more individualized treatment of hyperglycemia is coming in the next American Diabetes Association/European Association for the Study of Diabetes Consensus Report, according to John B. Buse, MD, PhD, cochair of the committee writing the new consensus statement.
He will present a draft of the statement on the management of hyperglycemia in type 2 diabetes at the ADA’s annual scientific sessions in Orlando.
When finalized – after revisions based on comments and feedback from diabetes care providers – clinical researchers, patient groups, payers, regulators, and stakeholders – the statement will update the last revision, issued in 2015.
“We are taking a new look at hyperglycemia based on the many studies conducted since 2014, particularly the cardiovascular outcomes trials,” Dr. Buse, the Verne S. Caviness Distinguished Professor in the division of endocrinology and metabolism and chief of endocrinology at the University of North Carolina, Chapel Hill, said in a statement.
But it’s a good bet that ADA scientific sessions attendees will see a move toward more specific recommendations based on patient characteristics and fewer one-size-fits-all recommendations. Specific characteristics like obesity, cardiovascular disease, and chronic kidney disease will likely be addressed in the new consensus statement.
One aspect of patient care that will see more attention in the ultimate statement is personalized care. “We will certainly highlight the need to individualize all aspects of care in a patient-centered way, taking into account both specific patient attributes and preferences,” Dr. Buse said.
The draft statement will be presented on Tuesday, June 26, at 8:00 a.m., so it may be worth staying for that last day of the meeting.
The final draft of the new statement will be released in October at the EASD annual meeting in Berlin, noted Dr. Buse, also director of the diabetes center at the university.
USPSTF: Don’t add ECG for cardio risk assessment
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
FROM JAMA
Key clinical point:
Major finding: Two randomized controlled trials including 1,151 individuals found no significant improvement from additional exercise ECG.
Study details: Researchers reviewed data from 16 studies including 77,140 individuals.
Disclosures: The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health & Human Services. The researchers had no financial conflicts to disclose.
Sources: Jonas D et al. JAMA.2018;319[22]:2315-28; Curry S et al. JAMA.2018;319[22]:2308-14.
ACS: Start colorectal cancer screening at age 45
The American Cancer Society recommends all U.S. adults at average risk of colorectal cancer (CRC) undergo screening starting at age 45 years.
That update to ACS recommendations is based on an increasing burden of CRC in younger individuals, microsimulation modeling results, and a “reasonable expectation” that screening tests will perform as well in adults aged 45-49 years as they do in older adults, members of the ACS Guideline Development Group said in the guideline, which was published in CA: A Cancer Journal for Clinicians.
Starting screening at age 45 contrasts with recommendations from the U.S. Preventive Services Task Force (USPSTF), which in 2016 gave an “A” recommendation for CRC screening from 50 to 75 years of age. At the time, the USPSTF noted a modest increase in life-years gained by starting earlier, based on microsimulation modeling. But it concluded that available evidence best supported starting at age 50.
The updated ACS guidelines are based in part on a modeling study that the authors say extends the previous analysis conducted for the USPSTF.
“The recommendation places a high value on the potential years of life saved, addresses anticipated rising incidence going forward, and is expected to contribute to the reduction in disparities in incidence before age 50 years in some racial groups,” the ACS guideline authors added.
The recommendation to start screening at age 45 is a “qualified” recommendation, the authors said, given the limitations of the current evidence base. Most studies to date have been focused on older individuals, in keeping with long-standing recommendations to start screening at age 50.
The move downward in screening age recommendation acknowledges one of the most “significant and disturbing” developments in CRC, the guideline’s authors said: the marked increase in incidence among younger individuals.
While CRC incidence and mortality have been declining in adults aged 55 years and older, recent studies cited in the ACS guideline document show a 51% increase in incidence from 1994 to 2014 – and an 11% increase in mortality from 2005 to 2015 – for adults younger than 55 years.
The current age-specific incidence rate for adults 45-49 years is 31.4 per 100,000, compared with 58.4 per 100,000 in adults 50-54 years. However, the ACS guideline authors said the higher rate in the older cohort is partly influenced by more frequent screening. “The true underlying risk in adults aged 45-49 years is likely closer to the risk in adults aged 50-54 years than the most recent age-specific rates would suggest,” they wrote.
Since patients in this age range have not been routinely screened before, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most. Choices for screening include either a structural examination or a high-sensitivity stool-based test, according to the guideline, which doesn’t state a preference for any particular test.
The AGA, in their statement in response, noted that with CRC rates rising in people younger than age 50, it is appropriate to consider beginning routine screening at age 45. The statement continues “Since patients in this age range have not been previously routinely screened, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most.”
In addition to Dr. Wolf, members of the ACS Guideline Development Group received no compensation.
SOURCE: Wolf AMD et al. CA Cancer J Clin. 2018 May 30. doi: 10.3322/caac.21457.
The latest recommendations from the American Cancer Society added individuals 45 years and older to the population for whom CRC screeningshould be performed. The change from a start age of 50 was prompted by the increase in CRC reported in younger adults and was based on a computer simulation that predicted a greater number of life-years saved using an earlier age for initiation of screening among adults at average risk for development of colorectal cancer. It is likely that screening will reduce cancer mortality even in this younger age group; however, several issues should be considered when implementing this policy.
Differences in screening tests: The reason for the increase in CRC in younger adults is not known. Nor is it understood why this increase is far greater for rectal cancer than cancers more proximal in the colon. Based on this observation, however, it is possible that flexible sigmoidoscopy may be a more appropriate test than colonoscopy for younger adults. Conversely, we do not know if the precursor of early-age CRC is more likely to be a flat lesion that is more difficult to detect using endoscopy, or less likely to bleed that may make FIT less able to detect, or have a genetic mechanism different from proximal CRC that is not part of the current DNA stool testing.
Value is the benefit gained with screening compared with the resources required to implement screening. The value of screening is greater in older individuals than in younger individuals because the risk of CRC is increased and for this reason, population-based screening should focus on screening older adults who have not undergone screening. Unfortunately, U.S. population adherence to CRC screening remains below 70% with little improvement since 2010. Only after the older population is fully screened should our attention shift to younger populations.
Disparities: The individuals most likely to undergo screening are unlikely to be the individuals most likely to benefit. African Americans have a higher age-related incidence of CRC but have the lowest screening rates in the U.S. compared with other racial and ethnic groups. This relates to not only reduced access but also reduced utilization. It is a concern that, by increasing the pool of individuals recommended for screening, we may also reduce access to those who may benefit most.
The ACS recommendations to go low may reduce colorectal cancer mortality in younger adults; however, our lack of understanding about the biology of the cancer hampers our ability to recommend the optimal screening strategy, sacrifices value, and may increase disparities in cancer outcomes.
John M. Inadomi, MD, AGAF, is a Cyrus E. Rubin Professor of Medicine and head of the division of gastroenterology at the University of Washington School of Medicine, Seattle. He has no conflicts.
The latest recommendations from the American Cancer Society added individuals 45 years and older to the population for whom CRC screeningshould be performed. The change from a start age of 50 was prompted by the increase in CRC reported in younger adults and was based on a computer simulation that predicted a greater number of life-years saved using an earlier age for initiation of screening among adults at average risk for development of colorectal cancer. It is likely that screening will reduce cancer mortality even in this younger age group; however, several issues should be considered when implementing this policy.
Differences in screening tests: The reason for the increase in CRC in younger adults is not known. Nor is it understood why this increase is far greater for rectal cancer than cancers more proximal in the colon. Based on this observation, however, it is possible that flexible sigmoidoscopy may be a more appropriate test than colonoscopy for younger adults. Conversely, we do not know if the precursor of early-age CRC is more likely to be a flat lesion that is more difficult to detect using endoscopy, or less likely to bleed that may make FIT less able to detect, or have a genetic mechanism different from proximal CRC that is not part of the current DNA stool testing.
Value is the benefit gained with screening compared with the resources required to implement screening. The value of screening is greater in older individuals than in younger individuals because the risk of CRC is increased and for this reason, population-based screening should focus on screening older adults who have not undergone screening. Unfortunately, U.S. population adherence to CRC screening remains below 70% with little improvement since 2010. Only after the older population is fully screened should our attention shift to younger populations.
Disparities: The individuals most likely to undergo screening are unlikely to be the individuals most likely to benefit. African Americans have a higher age-related incidence of CRC but have the lowest screening rates in the U.S. compared with other racial and ethnic groups. This relates to not only reduced access but also reduced utilization. It is a concern that, by increasing the pool of individuals recommended for screening, we may also reduce access to those who may benefit most.
The ACS recommendations to go low may reduce colorectal cancer mortality in younger adults; however, our lack of understanding about the biology of the cancer hampers our ability to recommend the optimal screening strategy, sacrifices value, and may increase disparities in cancer outcomes.
John M. Inadomi, MD, AGAF, is a Cyrus E. Rubin Professor of Medicine and head of the division of gastroenterology at the University of Washington School of Medicine, Seattle. He has no conflicts.
The latest recommendations from the American Cancer Society added individuals 45 years and older to the population for whom CRC screeningshould be performed. The change from a start age of 50 was prompted by the increase in CRC reported in younger adults and was based on a computer simulation that predicted a greater number of life-years saved using an earlier age for initiation of screening among adults at average risk for development of colorectal cancer. It is likely that screening will reduce cancer mortality even in this younger age group; however, several issues should be considered when implementing this policy.
Differences in screening tests: The reason for the increase in CRC in younger adults is not known. Nor is it understood why this increase is far greater for rectal cancer than cancers more proximal in the colon. Based on this observation, however, it is possible that flexible sigmoidoscopy may be a more appropriate test than colonoscopy for younger adults. Conversely, we do not know if the precursor of early-age CRC is more likely to be a flat lesion that is more difficult to detect using endoscopy, or less likely to bleed that may make FIT less able to detect, or have a genetic mechanism different from proximal CRC that is not part of the current DNA stool testing.
Value is the benefit gained with screening compared with the resources required to implement screening. The value of screening is greater in older individuals than in younger individuals because the risk of CRC is increased and for this reason, population-based screening should focus on screening older adults who have not undergone screening. Unfortunately, U.S. population adherence to CRC screening remains below 70% with little improvement since 2010. Only after the older population is fully screened should our attention shift to younger populations.
Disparities: The individuals most likely to undergo screening are unlikely to be the individuals most likely to benefit. African Americans have a higher age-related incidence of CRC but have the lowest screening rates in the U.S. compared with other racial and ethnic groups. This relates to not only reduced access but also reduced utilization. It is a concern that, by increasing the pool of individuals recommended for screening, we may also reduce access to those who may benefit most.
The ACS recommendations to go low may reduce colorectal cancer mortality in younger adults; however, our lack of understanding about the biology of the cancer hampers our ability to recommend the optimal screening strategy, sacrifices value, and may increase disparities in cancer outcomes.
John M. Inadomi, MD, AGAF, is a Cyrus E. Rubin Professor of Medicine and head of the division of gastroenterology at the University of Washington School of Medicine, Seattle. He has no conflicts.
The American Cancer Society recommends all U.S. adults at average risk of colorectal cancer (CRC) undergo screening starting at age 45 years.
That update to ACS recommendations is based on an increasing burden of CRC in younger individuals, microsimulation modeling results, and a “reasonable expectation” that screening tests will perform as well in adults aged 45-49 years as they do in older adults, members of the ACS Guideline Development Group said in the guideline, which was published in CA: A Cancer Journal for Clinicians.
Starting screening at age 45 contrasts with recommendations from the U.S. Preventive Services Task Force (USPSTF), which in 2016 gave an “A” recommendation for CRC screening from 50 to 75 years of age. At the time, the USPSTF noted a modest increase in life-years gained by starting earlier, based on microsimulation modeling. But it concluded that available evidence best supported starting at age 50.
The updated ACS guidelines are based in part on a modeling study that the authors say extends the previous analysis conducted for the USPSTF.
“The recommendation places a high value on the potential years of life saved, addresses anticipated rising incidence going forward, and is expected to contribute to the reduction in disparities in incidence before age 50 years in some racial groups,” the ACS guideline authors added.
The recommendation to start screening at age 45 is a “qualified” recommendation, the authors said, given the limitations of the current evidence base. Most studies to date have been focused on older individuals, in keeping with long-standing recommendations to start screening at age 50.
The move downward in screening age recommendation acknowledges one of the most “significant and disturbing” developments in CRC, the guideline’s authors said: the marked increase in incidence among younger individuals.
While CRC incidence and mortality have been declining in adults aged 55 years and older, recent studies cited in the ACS guideline document show a 51% increase in incidence from 1994 to 2014 – and an 11% increase in mortality from 2005 to 2015 – for adults younger than 55 years.
The current age-specific incidence rate for adults 45-49 years is 31.4 per 100,000, compared with 58.4 per 100,000 in adults 50-54 years. However, the ACS guideline authors said the higher rate in the older cohort is partly influenced by more frequent screening. “The true underlying risk in adults aged 45-49 years is likely closer to the risk in adults aged 50-54 years than the most recent age-specific rates would suggest,” they wrote.
Since patients in this age range have not been routinely screened before, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most. Choices for screening include either a structural examination or a high-sensitivity stool-based test, according to the guideline, which doesn’t state a preference for any particular test.
The AGA, in their statement in response, noted that with CRC rates rising in people younger than age 50, it is appropriate to consider beginning routine screening at age 45. The statement continues “Since patients in this age range have not been previously routinely screened, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most.”
In addition to Dr. Wolf, members of the ACS Guideline Development Group received no compensation.
SOURCE: Wolf AMD et al. CA Cancer J Clin. 2018 May 30. doi: 10.3322/caac.21457.
The American Cancer Society recommends all U.S. adults at average risk of colorectal cancer (CRC) undergo screening starting at age 45 years.
That update to ACS recommendations is based on an increasing burden of CRC in younger individuals, microsimulation modeling results, and a “reasonable expectation” that screening tests will perform as well in adults aged 45-49 years as they do in older adults, members of the ACS Guideline Development Group said in the guideline, which was published in CA: A Cancer Journal for Clinicians.
Starting screening at age 45 contrasts with recommendations from the U.S. Preventive Services Task Force (USPSTF), which in 2016 gave an “A” recommendation for CRC screening from 50 to 75 years of age. At the time, the USPSTF noted a modest increase in life-years gained by starting earlier, based on microsimulation modeling. But it concluded that available evidence best supported starting at age 50.
The updated ACS guidelines are based in part on a modeling study that the authors say extends the previous analysis conducted for the USPSTF.
“The recommendation places a high value on the potential years of life saved, addresses anticipated rising incidence going forward, and is expected to contribute to the reduction in disparities in incidence before age 50 years in some racial groups,” the ACS guideline authors added.
The recommendation to start screening at age 45 is a “qualified” recommendation, the authors said, given the limitations of the current evidence base. Most studies to date have been focused on older individuals, in keeping with long-standing recommendations to start screening at age 50.
The move downward in screening age recommendation acknowledges one of the most “significant and disturbing” developments in CRC, the guideline’s authors said: the marked increase in incidence among younger individuals.
While CRC incidence and mortality have been declining in adults aged 55 years and older, recent studies cited in the ACS guideline document show a 51% increase in incidence from 1994 to 2014 – and an 11% increase in mortality from 2005 to 2015 – for adults younger than 55 years.
The current age-specific incidence rate for adults 45-49 years is 31.4 per 100,000, compared with 58.4 per 100,000 in adults 50-54 years. However, the ACS guideline authors said the higher rate in the older cohort is partly influenced by more frequent screening. “The true underlying risk in adults aged 45-49 years is likely closer to the risk in adults aged 50-54 years than the most recent age-specific rates would suggest,” they wrote.
Since patients in this age range have not been routinely screened before, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most. Choices for screening include either a structural examination or a high-sensitivity stool-based test, according to the guideline, which doesn’t state a preference for any particular test.
The AGA, in their statement in response, noted that with CRC rates rising in people younger than age 50, it is appropriate to consider beginning routine screening at age 45. The statement continues “Since patients in this age range have not been previously routinely screened, the ACS recommendation is based on modeling. Now we need to analyze the outcomes of early screening to identify which patients will benefit most.”
In addition to Dr. Wolf, members of the ACS Guideline Development Group received no compensation.
SOURCE: Wolf AMD et al. CA Cancer J Clin. 2018 May 30. doi: 10.3322/caac.21457.
FROM CA: A CANCER JOURNAL FOR CLINICIANS
USPSTF: Fall prevention in the elderly? Think exercise
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
Malignant pleural mesothelioma guidelines often are ignored
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
SAN DIEGO – National guidelines for the treatment of malignant pleural mesothelioma often are not followed, a new study showed, with fewer than one-third of patients receiving cancer-directed surgery.
Another 32% received no treatment, although that didn’t seem to have an impact on median months of survival.
Still, “there can be a wide variation in median survival time, depending on clinical factors and tumor characteristics,” said study coauthor Harmik Soukiasian, MD, of Cedars-Sinai Medical Center, Los Angeles. “Given the variation in prognosis, it is quite astonishing that over 30% of MPM patients are not receiving any form of treatment. As clinicians armed with these data, we need to investigate why that is.”
Dr. Soukiasian presented the study findings at the annual meeting of the American Association for Thoracic Surgery.
MPM, a rare cancer, is mainly linked to asbestos exposure. “MPM is almost always a fatal disease, and the prognosis can only be modestly influenced by oncological treatments,” according to the authors of guidelines released in 2013. “The diagnostic process can be complex, with highly specialized advice frequently required to arrive at a definite diagnosis. Treatment varies from therapeutic nihilism to radical combined-modality treatment approaches” (J Thorac Dis. 2013 Dec;5[6]:E254-E307).
Surgical resection is a controversial treatment for MPM, Dr. Soukiasian said. It is “based on the principle of macroscopic resection of solid tumor with adjuvant therapy to treat micrometastatic disease,” he explained. “Cancer-directed surgery for MPM is usually reserved for localized epithelial type histology and is associated with a 5-year survival rate of 15%.”
For the new study, the investigators tracked 3,834 patients in the National Cancer Database (2004-2014) diagnosed with MPM clinical stages I-III. Most had epithelioid MPM (69%), with sarcomatoid (17%) and mixed subtype (15%) making up the rest. They examined whether patient treatment complied with the National Comprehensive Cancer Network (NCCN) guidelines, which recommend surgery in resectable epithelioid MPM.
“Our study revealed significant lack of compliance with NCCN guidelines, as well as many disparities in the management of MPM,” Dr. Soukiasian said. “For the overall cohort, 32.3% of patients did not receive any treatment, 18.1% had surgery plus chemotherapy, 38.6% chemotherapy alone, and only 7% received trimodality therapy. In patients with epithelial histology, surgery was significantly underutilized, with only 30% of patients receiving cancer-directed surgery.”
In addition, he said, “our study reveals several disparities that affect compliance with NCCN guidelines. Treatment disparities were observed in women, octogenarians, the uninsured, the Medicaid-insured, and in patients with comorbidities. Guideline adherence was significantly increased in academic and high-volume hospitals with an associated increase in survival.”
But the study also found that median survival estimates were similar regardless of treatment: 10 months for no treatment, 15 months for chemotherapy only, 17 months for surgery only, and 22 months for surgery plus chemotherapy.
During the AATS presentation, an audience member asked about how performance status – a measure of a person’s ability to perform everyday activities – affects the eligibility for surgery.
“It’s quite common for low performance status to exclude someone from surgery,” the audience member said. “Some of these patients are very sick.”
Dr. Soukiasian acknowledged that performance status was not included in the data. The study was focused on the gap between guidelines and real-world practice, and generated questions of why and about the potential opportunity for improved treatment of these patients.
How do patient choices, cost, and quality of life factor in? “These are very important questions and concerns,” Dr. Soukiasian said. “Although our research does not provide data or conclusions on quality of life or cost, these topics will be important to address in follow-up studies to elucidate possible barriers in the treatment of MPM and the initiation of future educational opportunities for our patients.”
No disclosures and no study funding were reported.
SOURCE: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
REPORTING FROM THE AATS ANNUAL MEETING
Key clinical point:
Major finding: Guidelines recommend surgery in epithelioid MPM, but only 30% of patients received it.
Study details: Analysis of 3,834 patients diagnosed with MPM clinical stages I-III during 2004-2014.
Disclosures: No disclosures and no study funding were reported.
Source: Espinoza-Mercado F et al. General Thoracic Surgery Simultaneous Scientific Session. Abstract 18.
Suicide prevention gets ‘standard care’ recommendations
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
WASHINGTON – The National Action Alliance for Suicide Prevention released in April 2018 what the organization said was the first set of “standard care” recommendations for suicide prevention in people with suicide risk.
Care for people with a suicide risk in the United States “is not working very well. Evidence-based tools exist to detect and manage suicidality, but they are new and infrequently used” by many clinicians, including those seeing suicidal patients in primary care, emergency, or hospital settings, said Michael F. Hogan, PhD, during a session on the new standard-care recommendations at the annual conference of the American Association of Suicidology.
The Action Alliance seeks to have the standard care recommendations widely disseminated and hopes the document will receive endorsement from other organizations, said Dr. Hogan, a health policy consultant in Delmar, N.Y., and a member of the eight-person panel that wrote the recommendations.
These recommendations specify interventions for caregivers in four separate settings: primary care, outpatient behavioral health care (mental health and substance use treatment settings), emergency departments, and behavioral health inpatient care (hospital-level psychiatric or addiction treatment). For each setting, the recommendations highlight one or more core approaches, and then specify standards for identification and assessment, safety planning, means reduction, and follow-up contacts.
For example, within the primary care setting, the recommendations say the goals are to identify suicide risk, enhance the safety for those at risk, refer for specialized care, and provide “caring contacts.” The specifications note that this is achieved with standardized screening and assessment instruments (the recommendations cite eight screening tool options and also suggest three different possible assessment tools); referral as appropriate; a brief safety-planning intervention (the recommendations list five options for this) that includes lethality means reduction along with follow-up to be sure that lethal means have been removed; arranging for rapid follow-up with a mental health professional; and follow-up contact by the primary care clinician within the next 48 hours.
According to Dr. Hogan, a motivation for releasing these recommendations has been the growing U.S. incidence of suicide, rising from 10.4 deaths/100,000 in 2000 to 13.3/100,000 in 2015, a 28% relative increase during a period when the rates of the top killers in the United States – cancer, heart disease, and stroke – were falling. Other telling statistics are that most people who die from suicide had seen a primary care provider during the year before death, and nearly half had seen a primary care provider during the month before their death.
But often the indicators of impending suicide are missed or not acted on. a misperception that contributes to a “failure to ask about suicide risk” on the part of health care professionals, the recommendations said. The document also highlighted the idea that, “most health care professionals are not aware of newly developed brief interventions for suicide, leading to the assumption that they should not ask about suicide because there is nothing practical that can be done in ordinary health care settings.”
One limitation of the recommendations is that they might be interpreted as “standard of care” for medicolegal purposes, warned Alan L. Berman, PhD, during the session’s discussion period. In addition, the evidence base for some of the recommended procedures is not very strong, such as risk stratification, said Dr. Berman, a clinical psychologist and former executive director of the American Association of Suicidology.
Dr. Hogan, Dr. Andrews, and Dr. Berman had no disclosures.
REPORTING FROM THE AAS ANNUAL CONFERENCE
USPSTF advises against widespread prostate cancer screening
The USPSTF recommends that, to reduce the risk of false positives and unnecessary complications from prostate cancer screening and treatment, physicians and their male patients aged 55-69 years should review together the pros and cons.
Clinicians should not conduct prostate cancer screening in men aged 55-69 years who do not ask for it (level C recommendation), according to the USPSTF recommendations, published in JAMA, which also recommend against any prostate cancer screening for men aged 70 years and older (level D recommendation). The recommendations replace those from 2012, and upgrade the statement against routine screening from a D to a C.
“The change in recommendation grade further reflects new evidence about and increased use of active surveillance of low-risk prostate cancer, which may reduce the risk of subsequent harms from screening,” according to the USPSTF.
The recommendations apply to asymptomatic adult men in the general United States population with no previous diagnosis of prostate cancer, as well as those whose ethnicity or family history put them at increased risk of death from prostate cancer.
In the evidence report published in JAMA, Joshua J. Fenton, MD, professor in the department of family and community medicine of the University of California, Davis, Sacramento, and his colleagues reviewed 63 studies comprising 1,904,950 individuals. The researchers examined the findings for information including the effectiveness of PSA screening and the potential harms associated with both screening and cancer treatment if disease was identified.
Overdiagnosis of prostate cancer ranged from 21% to 50% for cancers detected by screening, and one randomized trial of more than 1,000 men found no significant reduction in mortality for prostatectomy or radiation therapy compared with active monitoring.
Overall, men randomized to PSA screening had no significant reduction in risk of prostate cancer mortality in trials from the United States or the United Kingdom, although data from a European trial showed a significant reduction. Complications requiring hospitalization occurred in 0.5%-1.6% of men who had biopsies after screening showed abnormal results.
The evidence review was limited by several factors including a lack of data on newer treatments such as cryotherapy and high-intensity focused ultrasound, the researchers noted.
However, the data support an individualized approach to PSA screening for prostate cancer, in which each man can weigh the potential risks and benefits of screening, according to the USPSTF.
The research was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
SOURCE: Fenton J et al. JAMA. 2018;319(18):1914-31. and JAMA. 2018;319(18):1901-13.
The new USPSTF guidelines take a thoughtful approach to assessing the pros and cons of PSA-based prostate cancer screening and highlight the importance of identifying subgroups who could most benefit from screening and treatment, H. Ballentine Carter, MD, wrote in an accompanying editorial.
“Patients, together with their physicians, should decide whether prostate cancer screening is right for the patient. In this regard, primary care physicians have an important role in reducing the harms associated with screening and could consider a number of factors in this decision process,” he said.
In particular, Dr. Carter noted that men aged 55-69 years without multiple comorbidities would reap the greatest benefits from screening, while those aged 70 years and older would be more susceptible to the harm associated with testing and treatment and should be screened rarely. He also endorsed a 2- to 4-year screening interval to help reduce false-positive test results and overdiagnosis.
“By virtue of their relationship with patients, primary care physicians are in a unique position to help ensure that men diagnosed with favorable-risk disease (Gleason score 6 cancer grade on biopsy, and PSA level less than 10 ng/mL) are presenting a balanced message regarding management options,” with active surveillance as the preferred choice, he said. (JAMA. 2018. May 8;319[18]:1866-8).
Dr. Carter is Bernard L. Schwartz distinguished professor of urologic oncology and professor of urology at Johns Hopkins University School of Medicine, Baltimore, and had no financial conflicts to disclose.
The new USPSTF guidelines take a thoughtful approach to assessing the pros and cons of PSA-based prostate cancer screening and highlight the importance of identifying subgroups who could most benefit from screening and treatment, H. Ballentine Carter, MD, wrote in an accompanying editorial.
“Patients, together with their physicians, should decide whether prostate cancer screening is right for the patient. In this regard, primary care physicians have an important role in reducing the harms associated with screening and could consider a number of factors in this decision process,” he said.
In particular, Dr. Carter noted that men aged 55-69 years without multiple comorbidities would reap the greatest benefits from screening, while those aged 70 years and older would be more susceptible to the harm associated with testing and treatment and should be screened rarely. He also endorsed a 2- to 4-year screening interval to help reduce false-positive test results and overdiagnosis.
“By virtue of their relationship with patients, primary care physicians are in a unique position to help ensure that men diagnosed with favorable-risk disease (Gleason score 6 cancer grade on biopsy, and PSA level less than 10 ng/mL) are presenting a balanced message regarding management options,” with active surveillance as the preferred choice, he said. (JAMA. 2018. May 8;319[18]:1866-8).
Dr. Carter is Bernard L. Schwartz distinguished professor of urologic oncology and professor of urology at Johns Hopkins University School of Medicine, Baltimore, and had no financial conflicts to disclose.
The new USPSTF guidelines take a thoughtful approach to assessing the pros and cons of PSA-based prostate cancer screening and highlight the importance of identifying subgroups who could most benefit from screening and treatment, H. Ballentine Carter, MD, wrote in an accompanying editorial.
“Patients, together with their physicians, should decide whether prostate cancer screening is right for the patient. In this regard, primary care physicians have an important role in reducing the harms associated with screening and could consider a number of factors in this decision process,” he said.
In particular, Dr. Carter noted that men aged 55-69 years without multiple comorbidities would reap the greatest benefits from screening, while those aged 70 years and older would be more susceptible to the harm associated with testing and treatment and should be screened rarely. He also endorsed a 2- to 4-year screening interval to help reduce false-positive test results and overdiagnosis.
“By virtue of their relationship with patients, primary care physicians are in a unique position to help ensure that men diagnosed with favorable-risk disease (Gleason score 6 cancer grade on biopsy, and PSA level less than 10 ng/mL) are presenting a balanced message regarding management options,” with active surveillance as the preferred choice, he said. (JAMA. 2018. May 8;319[18]:1866-8).
Dr. Carter is Bernard L. Schwartz distinguished professor of urologic oncology and professor of urology at Johns Hopkins University School of Medicine, Baltimore, and had no financial conflicts to disclose.
The USPSTF recommends that, to reduce the risk of false positives and unnecessary complications from prostate cancer screening and treatment, physicians and their male patients aged 55-69 years should review together the pros and cons.
Clinicians should not conduct prostate cancer screening in men aged 55-69 years who do not ask for it (level C recommendation), according to the USPSTF recommendations, published in JAMA, which also recommend against any prostate cancer screening for men aged 70 years and older (level D recommendation). The recommendations replace those from 2012, and upgrade the statement against routine screening from a D to a C.
“The change in recommendation grade further reflects new evidence about and increased use of active surveillance of low-risk prostate cancer, which may reduce the risk of subsequent harms from screening,” according to the USPSTF.
The recommendations apply to asymptomatic adult men in the general United States population with no previous diagnosis of prostate cancer, as well as those whose ethnicity or family history put them at increased risk of death from prostate cancer.
In the evidence report published in JAMA, Joshua J. Fenton, MD, professor in the department of family and community medicine of the University of California, Davis, Sacramento, and his colleagues reviewed 63 studies comprising 1,904,950 individuals. The researchers examined the findings for information including the effectiveness of PSA screening and the potential harms associated with both screening and cancer treatment if disease was identified.
Overdiagnosis of prostate cancer ranged from 21% to 50% for cancers detected by screening, and one randomized trial of more than 1,000 men found no significant reduction in mortality for prostatectomy or radiation therapy compared with active monitoring.
Overall, men randomized to PSA screening had no significant reduction in risk of prostate cancer mortality in trials from the United States or the United Kingdom, although data from a European trial showed a significant reduction. Complications requiring hospitalization occurred in 0.5%-1.6% of men who had biopsies after screening showed abnormal results.
The evidence review was limited by several factors including a lack of data on newer treatments such as cryotherapy and high-intensity focused ultrasound, the researchers noted.
However, the data support an individualized approach to PSA screening for prostate cancer, in which each man can weigh the potential risks and benefits of screening, according to the USPSTF.
The research was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
SOURCE: Fenton J et al. JAMA. 2018;319(18):1914-31. and JAMA. 2018;319(18):1901-13.
The USPSTF recommends that, to reduce the risk of false positives and unnecessary complications from prostate cancer screening and treatment, physicians and their male patients aged 55-69 years should review together the pros and cons.
Clinicians should not conduct prostate cancer screening in men aged 55-69 years who do not ask for it (level C recommendation), according to the USPSTF recommendations, published in JAMA, which also recommend against any prostate cancer screening for men aged 70 years and older (level D recommendation). The recommendations replace those from 2012, and upgrade the statement against routine screening from a D to a C.
“The change in recommendation grade further reflects new evidence about and increased use of active surveillance of low-risk prostate cancer, which may reduce the risk of subsequent harms from screening,” according to the USPSTF.
The recommendations apply to asymptomatic adult men in the general United States population with no previous diagnosis of prostate cancer, as well as those whose ethnicity or family history put them at increased risk of death from prostate cancer.
In the evidence report published in JAMA, Joshua J. Fenton, MD, professor in the department of family and community medicine of the University of California, Davis, Sacramento, and his colleagues reviewed 63 studies comprising 1,904,950 individuals. The researchers examined the findings for information including the effectiveness of PSA screening and the potential harms associated with both screening and cancer treatment if disease was identified.
Overdiagnosis of prostate cancer ranged from 21% to 50% for cancers detected by screening, and one randomized trial of more than 1,000 men found no significant reduction in mortality for prostatectomy or radiation therapy compared with active monitoring.
Overall, men randomized to PSA screening had no significant reduction in risk of prostate cancer mortality in trials from the United States or the United Kingdom, although data from a European trial showed a significant reduction. Complications requiring hospitalization occurred in 0.5%-1.6% of men who had biopsies after screening showed abnormal results.
The evidence review was limited by several factors including a lack of data on newer treatments such as cryotherapy and high-intensity focused ultrasound, the researchers noted.
However, the data support an individualized approach to PSA screening for prostate cancer, in which each man can weigh the potential risks and benefits of screening, according to the USPSTF.
The research was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
SOURCE: Fenton J et al. JAMA. 2018;319(18):1914-31. and JAMA. 2018;319(18):1901-13.
Key clinical point: PSA-based screening for prostate cancer in men aged 55-69 years has limited benefits and significant risks.
Major finding: Overdiagnosis occurred in approximately 21%-50% of cancers identified during PSA screening.
Study details: The evidence report was based on 63 studies including 1.9 million men.
Disclosures: The research was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
Source: JAMA. 2018;319(18):1901-13. Fenton J et al. JAMA. 2018;319(18):1914-31.