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New Euro hypertension guidelines target most adults to less than 130/80 mm Hg
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
MUNICH – The European Society of Cardiology joined other international cardiology groups in endorsing lower targets for blood pressure treatment and lower pressure thresholds for starting drug treatment in its revised hypertension diagnosis and management guidelines released in August during the Society’s annual congress here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Provided that treatment is well tolerated, treated blood pressure should be targeted to 130/80 mm Hg or lower in most patients,” Giuseppe Mancia, MD, said as he and his colleagues presented the new guidelines at the annual congress of the European Society of Cardiology.
Although the new European guidelines further buttress this more aggressive approach to blood pressure management that first appeared almost a year ago in U.S. guidelines from the American College of Cardiology and the American Heart Association, an approach that remains controversial among U.S. primary care physicians, the European strategy (Eur Heart J. 2018 Sep 1;39[33]:3021-104) was generally more cautious than the broader endorsement of lower blood pressure goals advanced by the U.S. recommendations (J Am Coll Cardiol. 2018 May;71[19]:e127-e248).
In the European approach, “the first objective is to treat to less than 140/90 mm Hg. If this is well tolerated, then treat to less than 130/80 mm Hg in most patients,” said Dr. Mancia, cochair of the European writing panel. Further pressure reductions to less than 130/80 mm Hg are usually harder, the incremental benefit from further reduction is less than when pressures first fall below 140/90 mm Hg, and the evidence for incremental benefit of any size from further pressure reduction is less strong for certain key patient subgroups: people at least 80 years old, and patients with diabetes, chronic kidney disease, or coronary artery disease, said Dr. Mancia, an emeritus professor at the University of Milan.
“The consistency between two major guidelines is important, but there are differences that may look subtle but are not subtle,” he said in a video interview. “If a patient gets to less than 140 mm Hg, the doctor should not think that’s a failure; it’s a very important result.”
One striking example of how the two guidelines differ on treatment targets is for people at least 80 years old. The overall blood pressure threshold for starting drug treatment in patients this age in the European guidelines is 160/90 mm Hg, although it remains at 140/90 for people aged 65-79 years old “provided that treatment is well tolerated” and the patients are “fit.” The 2017 U.S. guidelines, by contrast, say that considering drug treatment for everyone with a pressure at or above 130/80 mm Hg is a class I recommendation regardless of age as long as the person is “noninstitutionalized, ambulatory, [and] community-dwelling.” Once an older patient of any age, 65 years or older, starts drug treatment to reduce blood pressure, the European guidelines allow for treating to a target systolic blood pressure of 130-139 mm Hg as long as the regimen is well tolerated, and the guidelines say that a diastolic pressure target of less than 80 mm Hg should be considered for all adults regardless of age.
The new European guidelines also define adults with an untreated pressure of 130-139/85-89 mm Hg as “high normal,” rather than the “stage 1 hypertension” designation given to people with pressures of 130-139/80-89 mm Hg in the U.S. guidelines. Robert M. Carey, MD, vice chair of the U.S. guidelines panel, minimized this as a “semantic” difference, and he highlighted that management of people with pressures in this range is roughly similar in the two sets of recommendations. “The name is different, but treatment is the same,” Dr. Carey said.
The European guidelines call for initial lifestyle interventions, followed by drug treatment “that may be considered” for patients who have “very-high” cardiovascular risk because of established cardiovascular disease, especially coronary artery disease, and detail the specific clinical conditions that fall into the very-high-risk category. The U.S. guidelines say that stage 1 hypertension patients should get lifestyle interventions, followed by drug treatment for the roughly 30% of patients in this category who score at least a 10% 10-year risk on the American College of Cardiology’s Atherosclerotic Cardiovascular Disease Risk Estimator Plus.The new European guidelines are a “validation” of the ACC/AHA 2017 guidelines, commented Dr. Carey, a professor of medicine at the University of Virginia in Charlottesville. “Overall, we’re delighted to have these two major groups” agree, he said in an interview. “There is a tremendous amount of concurrence.”
Other areas of agreement between the two guidelines include their emphasis on careful and repeated blood pressure measurement, including out-of-office measurement, before settling on a diagnosis of hypertension; systematic assessment of possible masked or white-coat hypertension in selected people; and frequent use of combined drug treatment including initiation of a dual-drug, single-pill regimen when starting drug treatment and aggressive follow-up by adding a third drug when needed. However, in another divergence the U.S. guidelines give a much stronger endorsement to starting treatment with monotherapy, a strategy the European guidelines scrapped.
Dr. Carey also noted that the European endorsement of three antihypertensives formulated into a single pill for patients who need more than two drugs would be difficult for American clinicians to follow as virtually no such formulations are approved for U.S. use.
Dr. Mancini has received honoraria from Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini, Merck, Novartis, Recordati, and Servier. Dr. Williams has been a consultant to Novartis, Relypsa, and Vascular Dynamics, and he has spoken on behalf of Boehringer Ingelheim, Daiichi Sankyo, Novartis, and Servier. Dr. Carey and Dr. Whelton had no commercial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
REPORTING FROM THE ESC CONGRESS 2018
Updated AHA recommendations favor nonstatin therapy for cholesterol control
Importance
While statins remain the foundation for treating high cholesterol in order to reduce cardiovascular risk, new evidence has lead to important revisions in the American Heart Association’s recommendations for treatment of hypercholesterolemia in patients at very high cardiovascular risk (secondary prevention) with the addition of specific nonstatin agents. We will briefly review the AHA 2013 guideline recommendations, the relevant new information, and the updated AHA recommendations.
American Heart Association 2013 guidelines
The 2013 American College of Cardiology/AHA cholesterol guidelines recommend either high- or moderate-intensity statin therapy for patients in the four statin benefit groups:
1. Adult patients older than 21 years of age with clinical atherosclerotic cardiovascular disease (ASCVD).
2. Adults older than 21 years of age with low-density lipoprotein cholesterol (LDL-C) above 190 mg/dL.
3. Adults aged 40-75 years without ASCVD but with diabetes and with LDL-C 70-189 mg/dL.
4. Adults aged 40-75 years without either ASCVD or diabetes, with LDL-C 70-189 mg/dL and an estimated 10-year risk for ASCVD of over 7.5% as determined by the Pooled Cohort Equations.
At the time of the 2013 guidelines, there was little evidence to recommend the use of medications other than statins.
Recent evidence
The IMPROVE-IT trial1 was a double-blind, randomized trial involving 18,144 men and women who were older than 50 years and hospitalized for an acute coronary syndrome within the preceding 10 days. They were randomized to either simvastatin plus ezetimibe or simvastatin plus placebo. The primary endpoints were a composite of death from cardiovascular disease, a major coronary event (nonfatal MI, unstable angina requiring admission, or coronary revascularization), or nonfatal stroke. At 1 year, the mean LDL was 69.9 mg/dL in the simvastatin-monotherapy group and 53.2 mg/dL in the simvastatin-ezetimibe group (P under .001), representing a 24% decrease in LDL between the two groups. The rate of the primary endpoints was significantly lower in the simvastatin plus ezetimibe group with a hazard ratio of 0.936 (P = .016). The risk of MI was significantly decreased with an HR of 0.87 (P = .002), and the risk of ischemic stroke significantly decreased with an HR of 0.79 (P = .008). Prespecified safety endpoints showed no significant difference between the two groups.
The FOURIER trial2 examined the PCSK-9 inhibitor, evolocumab. FOURIER was a randomized, double-blind, placebo-controlled study involving 27,564 patients with atherosclerotic cardiovascular disease and LDL levels of 70 mg/dL or higher who were receiving statin therapy (at least atorvastatin 20 mg or equivalent with/without ezetimibe). Patients were between 45 and 80 years old with a history of history of MI, nonhemorrhagic stroke, or symptomatic peripheral artery disease. Patients were randomized to receive subcutaneous injections of evolocumab or matching placebo. The primary endpoints were similar to that of IMPROVE-IT: a composite of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, and coronary revascularization. The median LDL on entry was 92 mg/dL for both groups. At 48 weeks, the evolocumab group showed a 59% decrease in LDL, compared with placebo, with a decrease in median LDL from 92 mg/dL to 30 mg/dL. The primary endpoint occurred in 9.8% of the evolocumab group and 11.3% in the placebo group for a hazard ratio of 0.85 (P less than .001) representing a total risk reduction of 13.2%. The risk of MI or stroke and need for revascularization were significantly lower values in the evolocumab group, compared with placebo. Cardiovascular death did not show significant changes. There was no significant difference in rate of serious events.
The ODYSSEY trial3 reported on another PCSK-9 inhibitor, alirocumab, in a randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an ACS in the prior 12 months. At the median follow-up (2.8 years), the LDL of the alirocumab group was 53.3 mg/dL, compared with 101.4 mg/dL in the placebo group. The primary endpoints for cardiovascular risks were similar to those in the FOURIER trial: a risk of 9.5% in the alirocumab group and 11.1% in the placebo group for a total risk reduction of 14.4%. This suggests the class of PCSK-9 inhibitors have a strong correlation with reducing LDL levels 54%-59% and reducing major cardiac adverse events by 13%-15%.
Recommendations
The American College of Cardiology released a focused update that integrated the new evidence regarding the use of nonstatin therapy. The current focused update recommends an overall 50% or greater reduction in LDL for patients with clinical ASCVD. If this reduction is not achieved, ACC suggests that one consider the addition of nonstatin therapy with either ezetimibe or a PCSK-9 inhibitor.4 If a patient requires less than 25% additional LDL reduction, consider ezetimibe; if a patient requires more than 25% additional LDL reduction, consider a PCSK-9 inhibitor. Specifically, the guideline states: “If the patient still has less than 50% reduction in LDL-C (and may consider LDL-C above 70 mg/dL or non–HDL-C above 100 mg/dL), the patient and clinician should enter into a discussion focused on shared decision making regarding the addition of a nonstatin medication to the current regimen.”
The other group that is mentioned in the recommendations, with an acknowledgment that the evidence for benefit in primary prevention is not available, is individuals who have an LDL above 190 mg/dL even while compliant with a maximally effective statin regimen. The guidelines make further but less strong recommendations about a number of risk groups, but the largest and strongest change, based on strong evidence, is the recommendation to consider nonstatin therapy in individuals with established ASCVD, as described above.
Bottom line
Recent trials show significant reductions in LDL, leading to significant reductions in cardiovascular endpoints with ezetimibe and PCSK-9 inhibitors. This has led to an additional ACC recommendation to consider the use of nonstatin therapy in addition to maximal statin therapy in selected patients with established cardiovascular disease.
References
1. Cannon C et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-97.
2. Sabatine M et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22.
3. ODYSSEY Outcomes: Results suggest use of PCSK9 inhibitor reduces CV events, LDL-C in ACS patients. Article from American College of Cardiology. ACC News Story. 2018 Mar 10.
4. Lloyd-Jones DM et al. 2017 Focused update of the 2016 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785-1822. Epub 2017 Sep 5.
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 (Pa.) Jefferson Health. Dr. Plako is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.
Importance
While statins remain the foundation for treating high cholesterol in order to reduce cardiovascular risk, new evidence has lead to important revisions in the American Heart Association’s recommendations for treatment of hypercholesterolemia in patients at very high cardiovascular risk (secondary prevention) with the addition of specific nonstatin agents. We will briefly review the AHA 2013 guideline recommendations, the relevant new information, and the updated AHA recommendations.
American Heart Association 2013 guidelines
The 2013 American College of Cardiology/AHA cholesterol guidelines recommend either high- or moderate-intensity statin therapy for patients in the four statin benefit groups:
1. Adult patients older than 21 years of age with clinical atherosclerotic cardiovascular disease (ASCVD).
2. Adults older than 21 years of age with low-density lipoprotein cholesterol (LDL-C) above 190 mg/dL.
3. Adults aged 40-75 years without ASCVD but with diabetes and with LDL-C 70-189 mg/dL.
4. Adults aged 40-75 years without either ASCVD or diabetes, with LDL-C 70-189 mg/dL and an estimated 10-year risk for ASCVD of over 7.5% as determined by the Pooled Cohort Equations.
At the time of the 2013 guidelines, there was little evidence to recommend the use of medications other than statins.
Recent evidence
The IMPROVE-IT trial1 was a double-blind, randomized trial involving 18,144 men and women who were older than 50 years and hospitalized for an acute coronary syndrome within the preceding 10 days. They were randomized to either simvastatin plus ezetimibe or simvastatin plus placebo. The primary endpoints were a composite of death from cardiovascular disease, a major coronary event (nonfatal MI, unstable angina requiring admission, or coronary revascularization), or nonfatal stroke. At 1 year, the mean LDL was 69.9 mg/dL in the simvastatin-monotherapy group and 53.2 mg/dL in the simvastatin-ezetimibe group (P under .001), representing a 24% decrease in LDL between the two groups. The rate of the primary endpoints was significantly lower in the simvastatin plus ezetimibe group with a hazard ratio of 0.936 (P = .016). The risk of MI was significantly decreased with an HR of 0.87 (P = .002), and the risk of ischemic stroke significantly decreased with an HR of 0.79 (P = .008). Prespecified safety endpoints showed no significant difference between the two groups.
The FOURIER trial2 examined the PCSK-9 inhibitor, evolocumab. FOURIER was a randomized, double-blind, placebo-controlled study involving 27,564 patients with atherosclerotic cardiovascular disease and LDL levels of 70 mg/dL or higher who were receiving statin therapy (at least atorvastatin 20 mg or equivalent with/without ezetimibe). Patients were between 45 and 80 years old with a history of history of MI, nonhemorrhagic stroke, or symptomatic peripheral artery disease. Patients were randomized to receive subcutaneous injections of evolocumab or matching placebo. The primary endpoints were similar to that of IMPROVE-IT: a composite of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, and coronary revascularization. The median LDL on entry was 92 mg/dL for both groups. At 48 weeks, the evolocumab group showed a 59% decrease in LDL, compared with placebo, with a decrease in median LDL from 92 mg/dL to 30 mg/dL. The primary endpoint occurred in 9.8% of the evolocumab group and 11.3% in the placebo group for a hazard ratio of 0.85 (P less than .001) representing a total risk reduction of 13.2%. The risk of MI or stroke and need for revascularization were significantly lower values in the evolocumab group, compared with placebo. Cardiovascular death did not show significant changes. There was no significant difference in rate of serious events.
The ODYSSEY trial3 reported on another PCSK-9 inhibitor, alirocumab, in a randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an ACS in the prior 12 months. At the median follow-up (2.8 years), the LDL of the alirocumab group was 53.3 mg/dL, compared with 101.4 mg/dL in the placebo group. The primary endpoints for cardiovascular risks were similar to those in the FOURIER trial: a risk of 9.5% in the alirocumab group and 11.1% in the placebo group for a total risk reduction of 14.4%. This suggests the class of PCSK-9 inhibitors have a strong correlation with reducing LDL levels 54%-59% and reducing major cardiac adverse events by 13%-15%.
Recommendations
The American College of Cardiology released a focused update that integrated the new evidence regarding the use of nonstatin therapy. The current focused update recommends an overall 50% or greater reduction in LDL for patients with clinical ASCVD. If this reduction is not achieved, ACC suggests that one consider the addition of nonstatin therapy with either ezetimibe or a PCSK-9 inhibitor.4 If a patient requires less than 25% additional LDL reduction, consider ezetimibe; if a patient requires more than 25% additional LDL reduction, consider a PCSK-9 inhibitor. Specifically, the guideline states: “If the patient still has less than 50% reduction in LDL-C (and may consider LDL-C above 70 mg/dL or non–HDL-C above 100 mg/dL), the patient and clinician should enter into a discussion focused on shared decision making regarding the addition of a nonstatin medication to the current regimen.”
The other group that is mentioned in the recommendations, with an acknowledgment that the evidence for benefit in primary prevention is not available, is individuals who have an LDL above 190 mg/dL even while compliant with a maximally effective statin regimen. The guidelines make further but less strong recommendations about a number of risk groups, but the largest and strongest change, based on strong evidence, is the recommendation to consider nonstatin therapy in individuals with established ASCVD, as described above.
Bottom line
Recent trials show significant reductions in LDL, leading to significant reductions in cardiovascular endpoints with ezetimibe and PCSK-9 inhibitors. This has led to an additional ACC recommendation to consider the use of nonstatin therapy in addition to maximal statin therapy in selected patients with established cardiovascular disease.
References
1. Cannon C et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-97.
2. Sabatine M et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22.
3. ODYSSEY Outcomes: Results suggest use of PCSK9 inhibitor reduces CV events, LDL-C in ACS patients. Article from American College of Cardiology. ACC News Story. 2018 Mar 10.
4. Lloyd-Jones DM et al. 2017 Focused update of the 2016 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785-1822. Epub 2017 Sep 5.
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 (Pa.) Jefferson Health. Dr. Plako is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.
Importance
While statins remain the foundation for treating high cholesterol in order to reduce cardiovascular risk, new evidence has lead to important revisions in the American Heart Association’s recommendations for treatment of hypercholesterolemia in patients at very high cardiovascular risk (secondary prevention) with the addition of specific nonstatin agents. We will briefly review the AHA 2013 guideline recommendations, the relevant new information, and the updated AHA recommendations.
American Heart Association 2013 guidelines
The 2013 American College of Cardiology/AHA cholesterol guidelines recommend either high- or moderate-intensity statin therapy for patients in the four statin benefit groups:
1. Adult patients older than 21 years of age with clinical atherosclerotic cardiovascular disease (ASCVD).
2. Adults older than 21 years of age with low-density lipoprotein cholesterol (LDL-C) above 190 mg/dL.
3. Adults aged 40-75 years without ASCVD but with diabetes and with LDL-C 70-189 mg/dL.
4. Adults aged 40-75 years without either ASCVD or diabetes, with LDL-C 70-189 mg/dL and an estimated 10-year risk for ASCVD of over 7.5% as determined by the Pooled Cohort Equations.
At the time of the 2013 guidelines, there was little evidence to recommend the use of medications other than statins.
Recent evidence
The IMPROVE-IT trial1 was a double-blind, randomized trial involving 18,144 men and women who were older than 50 years and hospitalized for an acute coronary syndrome within the preceding 10 days. They were randomized to either simvastatin plus ezetimibe or simvastatin plus placebo. The primary endpoints were a composite of death from cardiovascular disease, a major coronary event (nonfatal MI, unstable angina requiring admission, or coronary revascularization), or nonfatal stroke. At 1 year, the mean LDL was 69.9 mg/dL in the simvastatin-monotherapy group and 53.2 mg/dL in the simvastatin-ezetimibe group (P under .001), representing a 24% decrease in LDL between the two groups. The rate of the primary endpoints was significantly lower in the simvastatin plus ezetimibe group with a hazard ratio of 0.936 (P = .016). The risk of MI was significantly decreased with an HR of 0.87 (P = .002), and the risk of ischemic stroke significantly decreased with an HR of 0.79 (P = .008). Prespecified safety endpoints showed no significant difference between the two groups.
The FOURIER trial2 examined the PCSK-9 inhibitor, evolocumab. FOURIER was a randomized, double-blind, placebo-controlled study involving 27,564 patients with atherosclerotic cardiovascular disease and LDL levels of 70 mg/dL or higher who were receiving statin therapy (at least atorvastatin 20 mg or equivalent with/without ezetimibe). Patients were between 45 and 80 years old with a history of history of MI, nonhemorrhagic stroke, or symptomatic peripheral artery disease. Patients were randomized to receive subcutaneous injections of evolocumab or matching placebo. The primary endpoints were similar to that of IMPROVE-IT: a composite of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, and coronary revascularization. The median LDL on entry was 92 mg/dL for both groups. At 48 weeks, the evolocumab group showed a 59% decrease in LDL, compared with placebo, with a decrease in median LDL from 92 mg/dL to 30 mg/dL. The primary endpoint occurred in 9.8% of the evolocumab group and 11.3% in the placebo group for a hazard ratio of 0.85 (P less than .001) representing a total risk reduction of 13.2%. The risk of MI or stroke and need for revascularization were significantly lower values in the evolocumab group, compared with placebo. Cardiovascular death did not show significant changes. There was no significant difference in rate of serious events.
The ODYSSEY trial3 reported on another PCSK-9 inhibitor, alirocumab, in a randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an ACS in the prior 12 months. At the median follow-up (2.8 years), the LDL of the alirocumab group was 53.3 mg/dL, compared with 101.4 mg/dL in the placebo group. The primary endpoints for cardiovascular risks were similar to those in the FOURIER trial: a risk of 9.5% in the alirocumab group and 11.1% in the placebo group for a total risk reduction of 14.4%. This suggests the class of PCSK-9 inhibitors have a strong correlation with reducing LDL levels 54%-59% and reducing major cardiac adverse events by 13%-15%.
Recommendations
The American College of Cardiology released a focused update that integrated the new evidence regarding the use of nonstatin therapy. The current focused update recommends an overall 50% or greater reduction in LDL for patients with clinical ASCVD. If this reduction is not achieved, ACC suggests that one consider the addition of nonstatin therapy with either ezetimibe or a PCSK-9 inhibitor.4 If a patient requires less than 25% additional LDL reduction, consider ezetimibe; if a patient requires more than 25% additional LDL reduction, consider a PCSK-9 inhibitor. Specifically, the guideline states: “If the patient still has less than 50% reduction in LDL-C (and may consider LDL-C above 70 mg/dL or non–HDL-C above 100 mg/dL), the patient and clinician should enter into a discussion focused on shared decision making regarding the addition of a nonstatin medication to the current regimen.”
The other group that is mentioned in the recommendations, with an acknowledgment that the evidence for benefit in primary prevention is not available, is individuals who have an LDL above 190 mg/dL even while compliant with a maximally effective statin regimen. The guidelines make further but less strong recommendations about a number of risk groups, but the largest and strongest change, based on strong evidence, is the recommendation to consider nonstatin therapy in individuals with established ASCVD, as described above.
Bottom line
Recent trials show significant reductions in LDL, leading to significant reductions in cardiovascular endpoints with ezetimibe and PCSK-9 inhibitors. This has led to an additional ACC recommendation to consider the use of nonstatin therapy in addition to maximal statin therapy in selected patients with established cardiovascular disease.
References
1. Cannon C et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-97.
2. Sabatine M et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22.
3. ODYSSEY Outcomes: Results suggest use of PCSK9 inhibitor reduces CV events, LDL-C in ACS patients. Article from American College of Cardiology. ACC News Story. 2018 Mar 10.
4. Lloyd-Jones DM et al. 2017 Focused update of the 2016 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology task force on expert consensus decision pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785-1822. Epub 2017 Sep 5.
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 (Pa.) Jefferson Health. Dr. Plako is a second-year resident in the family medicine residency program at Abington Jefferson Hospital.
Updated IPF guideline refines diagnostic criteria with HRCT
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
AAP guidelines emphasize gender-affirmative care
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
FROM PEDATRICS
How to screen for, manage FASD in a medical home
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
providing early intervention and accessing community resources, according to a clinical report from the American Academy of Pediatrics.
After the AAP released its guidelines on fetal alcohol spectrum disorder (FASD) in 2015, some pediatricians asked for further guidance on how to care for patients with FASD within the medical home, as many had a knowledge gap on how to best manage these patients.
“For some pediatricians, it can seem like a daunting task to care for an individual with an FASD, but there are aspects of integrated care and providing a medical home that can be instituted as with all children with complex medical diagnoses,” wrote Renee M. Turchi, MD, MPH, of the department of pediatrics at St. Christopher’s Hospital for Children and Drexel Dornsife School of Public Health in Philadelphia, and her colleagues on the AAP Committee on Substance Abuse and the Council on Children with Disabilities. Their report is in Pediatrics. “In addition, not recognizing an FASD can lead to inadequate treatment and less-than-optimal outcomes for the patient and family.”
Dr. Turchi and her colleagues released the FASD clinical report with “strategies to support families who are interacting with early intervention services, the educational system, the behavioral and/or mental health system, other community resources, and the transition to adult-oriented heath care systems when appropriate.” They noted the prevalence of FASD is increasing, with 1 in 10 pregnant women using alcohol within the past 30 days and 1 in 33 pregnant women reporting binge drinking in the past 30 days. They reaffirmed the AAP’s endorsement from the 2015 clinical report on FASD regarding abstinence of alcohol for pregnant women, emphasizing that there is no amount or kind of alcohol that is risk free during pregnancy, nor is there a time in pregnancy when drinking alcohol is risk free.
Providers in a medical home should communicate any prenatal alcohol exposure (PAE) to obstetric providers so they can review risk factors, optimize screening, and monitor children, Dr. Turchi and her colleagues said. They also should understand the diagnostic criteria and classifications for FASDs, including physical features such as low weight, short palpebral features, smooth philtrum, a thin upper lip, abnormalities in the central nervous system, and any alcohol use during pregnancy. Any child – regardless of age – is a candidate for universal PAE screening at initial visits or when “additional cognitive and behavioral concerns arise.”
The federal Child Abuse Prevention and Treatment Act “does not require clinicians to report to child protective services if a child has been exposed prenatally to alcohol (i.e., for a positive PAE screening result). Referral to child protective services is required if the child has been diagnosed with an FASD in the period between birth and 3 years. The intent of this referral is to develop safe care and possible treatment plans for the infant and caregiver if needed, not to initiate punitive actions,” according to the report. States have their own definitions about child abuse and neglect, so the report encourages providers to know the mandates and reporting laws in the states where they practice.
Monitoring children in a medical home for the signs and symptoms of FASD is important, the authors said, because research has shown an increased chance at reducing adverse life outcomes if a child is diagnosed before age 6 and is in a stable home with access to support services.
Management of children with FASD is individual, as symptoms for each child will uniquely present not just in terms of physical issues such as growth or congenital defects affecting the heart, eyes, kidneys, or bones, but also as developmental, cognitive, and behavioral problems. Children with FASD also may receive a concomitant diagnosis when evaluated, such as ADHD or depression, that will require additional accommodation. The use of evidence-based diagnostic and standard screening approaches and referring when necessary will help reevaluate whether a child has a condition such as ADHD, oppositional defiant disorder, or another diagnosis, or is displaying symptoms of FASD such as a receptive or expressive language disorder.
Pediatricians must work together with the families, educational professionals, the mental health community, and therapists to help manage FASD in children. In cases where a child is in foster care, partnering with the foster care partners and child welfare agencies to gain access to the medical information of the biological parents is important to determine whether there is parental history of substance abuse and to provide appropriate treatment and interventions.
“Given the complex array of systems and services requiring navigation and coordination for children with an FASD and their families, a high-quality primary care medical home with partnerships with families, specialists, therapists, mental and/or behavioral health professionals, and community partners is critical, as it is for all children with special health care needs,” Dr. Turchi and her colleagues said.
The authors reported no relevant conflicts of interest.
SOURCE: Turchi RM et al. Pediatrics. 2018 Sept 10. doi:10.1542/peds.2018-2333.
FROM PEDIATRICS
New stroke intervention guidelines stress volume
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
FROM THE JOURNAL OF NEUROINTERVENTIONAL SURGERY
Guidelines released for perimenopausal depression
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
FROM THE JOURNAL OF WOMEN’S HEALTH
ASCO updates guidance on prophylaxis for adults with cancer-related immunosuppression
Fluoroquinolones are recommended for adults with cancer-related immunosuppression if they are at high risk of infection, according to an updated clinical practice guideline on antimicrobial prophylaxis.
By contrast, patients with solid tumors are not routinely recommended to receive antibiotic prophylaxis, according to the guideline, developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA).
The guideline includes antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions such as hand hygiene that may reduce infection risk.
Released in the Journal of Clinical Oncology, the updated guidelines were developed by an expert panel cochaired by Christopher R. Flowers, MD of Emory University, Atlanta, and Randy A. Taplitz, MD of the University of California, San Diego, Health.
For the most part, the panel endorsed the previous ASCO recommendations, published in 2013. However, the panel considered six new high-quality studies and six new or updated meta-analyses to make modifications and add some new recommendations.
Fluoroquinolones, in the 2013 guideline, were recommended over trimethoprim-sulfamethoxazole because of fewer adverse events leading to treatment discontinuation. Panelists for the new guidelines said they continued to support that recommendation, based on an updated literature review.
That review showed significant reductions in both febrile neutropenia incidence and all-cause mortality, not only for patients at high risk of febrile neutropenia or profound, protracted neutropenia but also for lower-risk patients with solid tumors, they said.
However, the benefits did not sufficiently outweigh the harms to justify recommending fluoroquinolone prophylaxis for all patients with solid tumors or lymphoma, according to the report from the expert panel.
Those harms could include antibiotic-associated adverse effects, emergence of resistance, and Clostridium difficile infections, they said.
Accordingly, they recommended fluoroquinolone prophylaxis for the high-risk patients, including most patients with acute myeloid leukemia/myelodysplastic syndromes (AML/MDS) or those undergoing hematopoietic stem-cell transplantation (HSCT).
Similarly, the panel recommended that high-risk patients should receive antifungal prophylaxis with an oral triazole or parenteral echinocandin, while prophylaxis would not be routinely recommended for solid tumor patients.
By contrast, all patients undergoing chemotherapy for malignancy should receive yearly influenza vaccination with an inactivated quadrivalent vaccine, the panel said in its antiviral prophylaxis recommendations.
Family members, household contacts, and health care providers also should receive influenza vaccinations, said the panel, endorsing recommendations from the Centers for Disease Control and Prevention that were also cited in the 2013 ASCO guidelines.
Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce risk of pathogen transmission, the panel said, endorsing CDC recommendations cited in the previous guideline.
However, the panel said they recommend against interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks.
“Evidence of clinical benefit is lacking” for those interventions, they said.
Participants in the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.
SOURCE: Taplitz RA et al. J Clin Oncol. 2018 Sept 4. doi: 10.1200/JCO.18.00374.
Fluoroquinolones are recommended for adults with cancer-related immunosuppression if they are at high risk of infection, according to an updated clinical practice guideline on antimicrobial prophylaxis.
By contrast, patients with solid tumors are not routinely recommended to receive antibiotic prophylaxis, according to the guideline, developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA).
The guideline includes antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions such as hand hygiene that may reduce infection risk.
Released in the Journal of Clinical Oncology, the updated guidelines were developed by an expert panel cochaired by Christopher R. Flowers, MD of Emory University, Atlanta, and Randy A. Taplitz, MD of the University of California, San Diego, Health.
For the most part, the panel endorsed the previous ASCO recommendations, published in 2013. However, the panel considered six new high-quality studies and six new or updated meta-analyses to make modifications and add some new recommendations.
Fluoroquinolones, in the 2013 guideline, were recommended over trimethoprim-sulfamethoxazole because of fewer adverse events leading to treatment discontinuation. Panelists for the new guidelines said they continued to support that recommendation, based on an updated literature review.
That review showed significant reductions in both febrile neutropenia incidence and all-cause mortality, not only for patients at high risk of febrile neutropenia or profound, protracted neutropenia but also for lower-risk patients with solid tumors, they said.
However, the benefits did not sufficiently outweigh the harms to justify recommending fluoroquinolone prophylaxis for all patients with solid tumors or lymphoma, according to the report from the expert panel.
Those harms could include antibiotic-associated adverse effects, emergence of resistance, and Clostridium difficile infections, they said.
Accordingly, they recommended fluoroquinolone prophylaxis for the high-risk patients, including most patients with acute myeloid leukemia/myelodysplastic syndromes (AML/MDS) or those undergoing hematopoietic stem-cell transplantation (HSCT).
Similarly, the panel recommended that high-risk patients should receive antifungal prophylaxis with an oral triazole or parenteral echinocandin, while prophylaxis would not be routinely recommended for solid tumor patients.
By contrast, all patients undergoing chemotherapy for malignancy should receive yearly influenza vaccination with an inactivated quadrivalent vaccine, the panel said in its antiviral prophylaxis recommendations.
Family members, household contacts, and health care providers also should receive influenza vaccinations, said the panel, endorsing recommendations from the Centers for Disease Control and Prevention that were also cited in the 2013 ASCO guidelines.
Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce risk of pathogen transmission, the panel said, endorsing CDC recommendations cited in the previous guideline.
However, the panel said they recommend against interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks.
“Evidence of clinical benefit is lacking” for those interventions, they said.
Participants in the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.
SOURCE: Taplitz RA et al. J Clin Oncol. 2018 Sept 4. doi: 10.1200/JCO.18.00374.
Fluoroquinolones are recommended for adults with cancer-related immunosuppression if they are at high risk of infection, according to an updated clinical practice guideline on antimicrobial prophylaxis.
By contrast, patients with solid tumors are not routinely recommended to receive antibiotic prophylaxis, according to the guideline, developed by the American Society of Clinical Oncology (ASCO) with the Infectious Diseases Society of America (IDSA).
The guideline includes antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions such as hand hygiene that may reduce infection risk.
Released in the Journal of Clinical Oncology, the updated guidelines were developed by an expert panel cochaired by Christopher R. Flowers, MD of Emory University, Atlanta, and Randy A. Taplitz, MD of the University of California, San Diego, Health.
For the most part, the panel endorsed the previous ASCO recommendations, published in 2013. However, the panel considered six new high-quality studies and six new or updated meta-analyses to make modifications and add some new recommendations.
Fluoroquinolones, in the 2013 guideline, were recommended over trimethoprim-sulfamethoxazole because of fewer adverse events leading to treatment discontinuation. Panelists for the new guidelines said they continued to support that recommendation, based on an updated literature review.
That review showed significant reductions in both febrile neutropenia incidence and all-cause mortality, not only for patients at high risk of febrile neutropenia or profound, protracted neutropenia but also for lower-risk patients with solid tumors, they said.
However, the benefits did not sufficiently outweigh the harms to justify recommending fluoroquinolone prophylaxis for all patients with solid tumors or lymphoma, according to the report from the expert panel.
Those harms could include antibiotic-associated adverse effects, emergence of resistance, and Clostridium difficile infections, they said.
Accordingly, they recommended fluoroquinolone prophylaxis for the high-risk patients, including most patients with acute myeloid leukemia/myelodysplastic syndromes (AML/MDS) or those undergoing hematopoietic stem-cell transplantation (HSCT).
Similarly, the panel recommended that high-risk patients should receive antifungal prophylaxis with an oral triazole or parenteral echinocandin, while prophylaxis would not be routinely recommended for solid tumor patients.
By contrast, all patients undergoing chemotherapy for malignancy should receive yearly influenza vaccination with an inactivated quadrivalent vaccine, the panel said in its antiviral prophylaxis recommendations.
Family members, household contacts, and health care providers also should receive influenza vaccinations, said the panel, endorsing recommendations from the Centers for Disease Control and Prevention that were also cited in the 2013 ASCO guidelines.
Health care workers should follow hand hygiene and respiratory hygiene/cough etiquette to reduce risk of pathogen transmission, the panel said, endorsing CDC recommendations cited in the previous guideline.
However, the panel said they recommend against interventions such as neutropenic diet, footwear exchange, nutritional supplements, and surgical masks.
“Evidence of clinical benefit is lacking” for those interventions, they said.
Participants in the expert panel disclosed potential conflicts of interest related to Merck, Chimerix, GlyPharma Therapeutic, Pfizer, Cidara Therapeutics, Celgene, Astellas Pharma, Gilead Sciences, and Allergan, among other entities.
SOURCE: Taplitz RA et al. J Clin Oncol. 2018 Sept 4. doi: 10.1200/JCO.18.00374.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
CDC releases guidelines for pediatric mTBI
and should base management and prognostication on clinical decision-making tools and symptom rating scales, according to new practice guidelines issued by a working group of the Centers for Disease Control and Prevention (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2853.
The guidelines were released simultaneously with a systematic review, conducted by the same authors, of the existing literature regarding pediatric mTBI (JAMA Pediatrics 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2847). As the evaluators sorted through the literature to find high-quality studies for this population, the funnel rapidly narrowed: From an initial pool of over 15,000 studies conducted between 1990 and 2015, findings from just 75 studies were eventually included in the systematic review.
The review’s findings formed the basis for the guidelines and allowed Angela Lumba-Brown, MD, a pediatric emergency medicine physician at Stanford (Calif.) University, and her coauthors to ascribe a level of confidence in the inference from study data for a given recommendation. Recommendations also are categorized by strength and accordingly indicate that clinicians “should” or “may” follow them. Exceptions are carved out for practices, such as the use of hypertonic 3% saline solution for acute headache in the ED, that should not be used outside research settings.
In the end, the guidelines cover 19 main topics, sorted into guidance regarding the diagnosis, prognosis, and management and treatment of mTBI in children.
Diagnosis
The recommendations regarding mTBI diagnosis center around determining which children are at risk for significant intracranial injury (ICI). The guidelines recommend, with moderate confidence, that clinicians usually should not obtain a head CT for children with mTBI. Validated clinical decision rules should be used for risk stratification to determine which children can safely avoid imaging and which children should be considered for head CT, wrote Dr. Lumba-Brown and her coauthors. Magnetic resonance imaging is not recommended for initial evaluation of mTBI, nor should skull radiographs be ordered in the absence of clinical suspicion for skull fracture.
From the systematic review, Dr. Lumba-Brown and her colleagues found that several risk factors taken together may mean that significant ICI is more likely. These include patient age younger than 2 years; any vomiting, loss of consciousness, or amnesia; a severe mechanism of injury, severe or worsening headache, or nonfrontal scalp hematoma; a Glasgow Coma Scale (GCS) score of less than 15; and clinical suspicion for skull fracture. Clinicians should give consideration to the risks of ionizing radiation to the head, and balance this against their assessment of risk for severe – and perhaps actionable – injury.
A validated symptom rating scale, used in an age-appropriate way, should be used as part of the evaluation of children with mTBI. For children aged 6 and older, the Graded Symptom Checklist is an appropriate tool within 2 days after injury, while the Post Concussion Symptom Scale as part of computerized neurocognitive testing can differentiate which high school athletes have mTBI when used within 4 days of injury, according to the guidelines, which also identify other validated symptom rating scales.
The guidelines authors recommend, with high confidence, that serum biomarkers should not be used outside of research settings in the diagnosis of mTBI in children at present.
Prognosis
Families should be counseled that symptoms mostly resolve within 1-3 months for up to 80% of children with mTBI, but families also should know that “each child’s recovery from mTBI is unique and will follow its own trajectory,” wrote Dr. Lumba-Brown and her coauthors, in a moderate-strength recommendation.
Some factors have been associated with slower recovery from mTBI, and either upon evaluation for mTBI or in routine sports examinations, families should be told about this potential if risk factors are present, said the guidelines, although the evidence supporting the associations is of “varying strength,” wrote Dr. Lumba-Brown and her coauthors. Children with previous mTBIs and those with a history of premorbid neurologic and psychiatric problems, learning problems, or family and social stress all may have delayed recovery. For children with ICI, lower cognitive ability also is associated with delayed recovery.
Demographic factors such as lower socioeconomic status and being of Hispanic ethnicity also may increase the risk for delayed mTBI recovery. Older children and adolescents may recover more slowly. Those with more severe initial presentation and more symptoms in the immediate post-mTBI phase also may have a slower recovery course, said Dr. Lumba-Brown and her coauthors.
A validated prediction rule can be used in the ED to gather information about these discrete risk factors to guide family counseling, according to the guidelines, which note that research has found that “an empirically derived set of risk factors predicted the risk of persistent post-concussion symptoms at 28 days” for children seen in the ED with mTBI.
During the recovery phase, a combination of tools should be used to track recovery from mTBI; these can include validated symptom scales, validated cognitive testing, reaction time measures, and, in adolescent athletes, balance testing. Using a combination of tools is a valuable strategy, the researchers wrote. “No single assessment tool is strongly predictive of outcome in children with mTBI,” they noted.
When prognosis is poor, or recovery is not proceeding as expected, clinicians should have a low threshold for initiating other interventions and referrals.
Management and treatment
Although the guideline authors acknowledged significant knowledge gaps in all areas of pediatric mTBI diagnosis and management, evidence is especially scant for best practices for treatment, rest, and return to play and school after a child sustains mTBI, said Dr. Lumba-Brown and her coauthors.
However, families should be given information about warning signs for serious head injury and how to monitor symptoms, as well as information about mTBI and the expected recovery course. Other forward-looking instructions should cover the importance of preventing new head injuries, managing the gradual return to normal cognitive and physical activities, and clear instructions regarding return to school and recreational activities. The guideline authors made a strong recommendation to provide this information, with high confidence in the data.
However, little strong evidence points the way to a clear set of criteria for when children are ready for school, play, and athletic participation. These decisions must be customized to the individual child, and decision making, particularly about return to school and academic activities, should be a collaborative affair, with schools, clinicians, and families all communicating to make sure the pace of return to normal life is keeping pace with the child’s recovery. “Because postconcussive symptoms resolve at different rates in different children after mTBI, individualization of return-to-school programming is necessary,” wrote Dr. Lumba-Brown and her coauthors.
The guideline authors cite evidence that “suggests that early rest (within the first 3 days) may be beneficial but that inactivity beyond this period for most children may worsen their self-reported symptoms.”
Psychosocial support may be beneficial for certain children, wrote the researchers, drawing on evidence showing that such support is beneficial in frank TBI, and is probably beneficial in mTBI.
Active rehabilitation as tolerated is recommended after an initial period of rest, with exertion kept to a level that does not exacerbate symptoms. Children should not participate in contact activities until symptoms are fully resolved.
A posttraumatic headache that is severe or worsens in the ED should prompt consideration of emergent neuroimaging, according to the guidelines. In the postacute phase, however, children can have nonopioid analgesia, although parents should know about such risks as rebound headache. When chronic headache follows a mTBI, the guidelines recommend that clinicians refer patients for a multidisciplinary evaluation that can assess the many factors – including analgesic overuse – that can be contributors.
Drawing on the larger body of adult TBI research, the authors recommend that insufficient or disordered sleep be addressed, because “the maintenance of appropriate sleep and the management of disrupted sleep may be a critical target of treatment for the child with mTBI.”
Children who suffer a mTBI may experience cognitive dysfunction as a direct result of injury to the brain or secondary to the effects of other symptoms such as sleep disruptions, headache pain, fatigue, or low tolerance of frustration. Clinicians may want to perform or refer their patients for a neuropsychological evaluation to determine what is causing the cognitive dysfunction, the authors said.
Dr. Lumba-Brown and her coauthors, who formed the CDC’s Pediatric Mild Traumatic Brain Injury Guideline Workgroup, also recommended that clinicians use the term “mild traumatic brain injury” to describe head injuries that cause confusion or disorientation, without loss of consciousness, or loss of consciousness of up to 30 minutes or less, or posttraumatic amnesia of less than 24 hours duration, and that are associated with a GCS of 13-15 by 30 minutes after injury or at the time of initial medical assessment. This practice, they said, may reduce the risk of misinterpretation by medical professionals and the public that can occur when the terms “mTBI,” “concussion,” and “minor head injury” all may refer to the same injury.
The CDC has developed a suite of materials to assist both health care providers and the public in guideline implementation. The agency also is using its HEADS UP campaign to publicize the guidelines and related materials, and plans ongoing evaluation of the guidelines and implementation materials.
Many study authors, including Dr. Lumba-Brown, had relationships with medical device or pharmaceutical companies. The systematic review and guideline development were funded by the CDC.
A growing realization that mTBI can have persistent and significant deleterious effects has informed medical and public attitudes toward concussion in children, which now results in almost 1 million annual ED visits.
Progress at the laboratory bench has elucidated much of the neurometabolic cascade that occurs with the insult of mTBI, and has allowed researchers to document the path of brain healing after injury. Neuroimaging now can go beyond static images to trace neural networks and detect previously unseen and subtle functional deficits engendered by mTBI.
In particular, 21st century magnetic resonance imaging (MRI) has shown increased sensitivity over CT alone. In the TRACK-TBI study, over one in four patients whose CTs were read as normal had MRI findings consistent with trauma-induced pathology. Both multimodal MRI and serum biomarkers show promise, although more research regarding their utility is needed, particularly in the case of proteomic biomarkers.
Still, high-quality studies of pediatric mTBI are scant, and translation of burgeoning research into clinical practice is severely impeded by the numerous knowledge gaps that exist in the field.
Dr. Lumba-Brown and her colleagues have synthesized research that supports a neurobiopsychosocial model of mTBI in children that comes into play most prominently in the postacute phase, when non–injury-related factors such as demographics, socioeconomic status, and premorbid psychological conditions are strong mediators of the recovery trajectory.
With children as with adults, scant research guides the path forward for treatment and recovery from mTBI. For children, clinicians are still grappling with issues surrounding return to full participation in the academic and recreational activities of the school environment.
Data from two currently active studies should help light the way forward, however. The TRACK-TBI study, funded by the National Institutes of Health, will include almost 200 children among its 2,700 enrollees who have sustained all levels of TBI.
The Concussion Assessment, Research, and Education (CARE) Consortium is funded jointly by the National College Athletic Association and the Department of Defense. Between student athletes and military cadets, over 40,000 individuals are now part of the study.
The two studies’ testing modalities and methodologies align, offering the opportunity for a powerful pooled analysis that includes civilians, athletes, and those in the military.
Until then, these guidelines provide a way forward to an individualized approach to the best care for a child with mTBI.
Michael McCrea, PhD, is professor of neurology and neurosurgery, and director of brain injury research at the Medical College of Wisconsin, Milwaukee. Geoff Manley, MD, PhD, is professor of neurologic surgery at the University of California, San Francisco. Neither author reported conflicts of interest. These remarks were drawn from an editorial accompanying the guidelines and systematic review (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2846).
A growing realization that mTBI can have persistent and significant deleterious effects has informed medical and public attitudes toward concussion in children, which now results in almost 1 million annual ED visits.
Progress at the laboratory bench has elucidated much of the neurometabolic cascade that occurs with the insult of mTBI, and has allowed researchers to document the path of brain healing after injury. Neuroimaging now can go beyond static images to trace neural networks and detect previously unseen and subtle functional deficits engendered by mTBI.
In particular, 21st century magnetic resonance imaging (MRI) has shown increased sensitivity over CT alone. In the TRACK-TBI study, over one in four patients whose CTs were read as normal had MRI findings consistent with trauma-induced pathology. Both multimodal MRI and serum biomarkers show promise, although more research regarding their utility is needed, particularly in the case of proteomic biomarkers.
Still, high-quality studies of pediatric mTBI are scant, and translation of burgeoning research into clinical practice is severely impeded by the numerous knowledge gaps that exist in the field.
Dr. Lumba-Brown and her colleagues have synthesized research that supports a neurobiopsychosocial model of mTBI in children that comes into play most prominently in the postacute phase, when non–injury-related factors such as demographics, socioeconomic status, and premorbid psychological conditions are strong mediators of the recovery trajectory.
With children as with adults, scant research guides the path forward for treatment and recovery from mTBI. For children, clinicians are still grappling with issues surrounding return to full participation in the academic and recreational activities of the school environment.
Data from two currently active studies should help light the way forward, however. The TRACK-TBI study, funded by the National Institutes of Health, will include almost 200 children among its 2,700 enrollees who have sustained all levels of TBI.
The Concussion Assessment, Research, and Education (CARE) Consortium is funded jointly by the National College Athletic Association and the Department of Defense. Between student athletes and military cadets, over 40,000 individuals are now part of the study.
The two studies’ testing modalities and methodologies align, offering the opportunity for a powerful pooled analysis that includes civilians, athletes, and those in the military.
Until then, these guidelines provide a way forward to an individualized approach to the best care for a child with mTBI.
Michael McCrea, PhD, is professor of neurology and neurosurgery, and director of brain injury research at the Medical College of Wisconsin, Milwaukee. Geoff Manley, MD, PhD, is professor of neurologic surgery at the University of California, San Francisco. Neither author reported conflicts of interest. These remarks were drawn from an editorial accompanying the guidelines and systematic review (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2846).
A growing realization that mTBI can have persistent and significant deleterious effects has informed medical and public attitudes toward concussion in children, which now results in almost 1 million annual ED visits.
Progress at the laboratory bench has elucidated much of the neurometabolic cascade that occurs with the insult of mTBI, and has allowed researchers to document the path of brain healing after injury. Neuroimaging now can go beyond static images to trace neural networks and detect previously unseen and subtle functional deficits engendered by mTBI.
In particular, 21st century magnetic resonance imaging (MRI) has shown increased sensitivity over CT alone. In the TRACK-TBI study, over one in four patients whose CTs were read as normal had MRI findings consistent with trauma-induced pathology. Both multimodal MRI and serum biomarkers show promise, although more research regarding their utility is needed, particularly in the case of proteomic biomarkers.
Still, high-quality studies of pediatric mTBI are scant, and translation of burgeoning research into clinical practice is severely impeded by the numerous knowledge gaps that exist in the field.
Dr. Lumba-Brown and her colleagues have synthesized research that supports a neurobiopsychosocial model of mTBI in children that comes into play most prominently in the postacute phase, when non–injury-related factors such as demographics, socioeconomic status, and premorbid psychological conditions are strong mediators of the recovery trajectory.
With children as with adults, scant research guides the path forward for treatment and recovery from mTBI. For children, clinicians are still grappling with issues surrounding return to full participation in the academic and recreational activities of the school environment.
Data from two currently active studies should help light the way forward, however. The TRACK-TBI study, funded by the National Institutes of Health, will include almost 200 children among its 2,700 enrollees who have sustained all levels of TBI.
The Concussion Assessment, Research, and Education (CARE) Consortium is funded jointly by the National College Athletic Association and the Department of Defense. Between student athletes and military cadets, over 40,000 individuals are now part of the study.
The two studies’ testing modalities and methodologies align, offering the opportunity for a powerful pooled analysis that includes civilians, athletes, and those in the military.
Until then, these guidelines provide a way forward to an individualized approach to the best care for a child with mTBI.
Michael McCrea, PhD, is professor of neurology and neurosurgery, and director of brain injury research at the Medical College of Wisconsin, Milwaukee. Geoff Manley, MD, PhD, is professor of neurologic surgery at the University of California, San Francisco. Neither author reported conflicts of interest. These remarks were drawn from an editorial accompanying the guidelines and systematic review (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2846).
and should base management and prognostication on clinical decision-making tools and symptom rating scales, according to new practice guidelines issued by a working group of the Centers for Disease Control and Prevention (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2853.
The guidelines were released simultaneously with a systematic review, conducted by the same authors, of the existing literature regarding pediatric mTBI (JAMA Pediatrics 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2847). As the evaluators sorted through the literature to find high-quality studies for this population, the funnel rapidly narrowed: From an initial pool of over 15,000 studies conducted between 1990 and 2015, findings from just 75 studies were eventually included in the systematic review.
The review’s findings formed the basis for the guidelines and allowed Angela Lumba-Brown, MD, a pediatric emergency medicine physician at Stanford (Calif.) University, and her coauthors to ascribe a level of confidence in the inference from study data for a given recommendation. Recommendations also are categorized by strength and accordingly indicate that clinicians “should” or “may” follow them. Exceptions are carved out for practices, such as the use of hypertonic 3% saline solution for acute headache in the ED, that should not be used outside research settings.
In the end, the guidelines cover 19 main topics, sorted into guidance regarding the diagnosis, prognosis, and management and treatment of mTBI in children.
Diagnosis
The recommendations regarding mTBI diagnosis center around determining which children are at risk for significant intracranial injury (ICI). The guidelines recommend, with moderate confidence, that clinicians usually should not obtain a head CT for children with mTBI. Validated clinical decision rules should be used for risk stratification to determine which children can safely avoid imaging and which children should be considered for head CT, wrote Dr. Lumba-Brown and her coauthors. Magnetic resonance imaging is not recommended for initial evaluation of mTBI, nor should skull radiographs be ordered in the absence of clinical suspicion for skull fracture.
From the systematic review, Dr. Lumba-Brown and her colleagues found that several risk factors taken together may mean that significant ICI is more likely. These include patient age younger than 2 years; any vomiting, loss of consciousness, or amnesia; a severe mechanism of injury, severe or worsening headache, or nonfrontal scalp hematoma; a Glasgow Coma Scale (GCS) score of less than 15; and clinical suspicion for skull fracture. Clinicians should give consideration to the risks of ionizing radiation to the head, and balance this against their assessment of risk for severe – and perhaps actionable – injury.
A validated symptom rating scale, used in an age-appropriate way, should be used as part of the evaluation of children with mTBI. For children aged 6 and older, the Graded Symptom Checklist is an appropriate tool within 2 days after injury, while the Post Concussion Symptom Scale as part of computerized neurocognitive testing can differentiate which high school athletes have mTBI when used within 4 days of injury, according to the guidelines, which also identify other validated symptom rating scales.
The guidelines authors recommend, with high confidence, that serum biomarkers should not be used outside of research settings in the diagnosis of mTBI in children at present.
Prognosis
Families should be counseled that symptoms mostly resolve within 1-3 months for up to 80% of children with mTBI, but families also should know that “each child’s recovery from mTBI is unique and will follow its own trajectory,” wrote Dr. Lumba-Brown and her coauthors, in a moderate-strength recommendation.
Some factors have been associated with slower recovery from mTBI, and either upon evaluation for mTBI or in routine sports examinations, families should be told about this potential if risk factors are present, said the guidelines, although the evidence supporting the associations is of “varying strength,” wrote Dr. Lumba-Brown and her coauthors. Children with previous mTBIs and those with a history of premorbid neurologic and psychiatric problems, learning problems, or family and social stress all may have delayed recovery. For children with ICI, lower cognitive ability also is associated with delayed recovery.
Demographic factors such as lower socioeconomic status and being of Hispanic ethnicity also may increase the risk for delayed mTBI recovery. Older children and adolescents may recover more slowly. Those with more severe initial presentation and more symptoms in the immediate post-mTBI phase also may have a slower recovery course, said Dr. Lumba-Brown and her coauthors.
A validated prediction rule can be used in the ED to gather information about these discrete risk factors to guide family counseling, according to the guidelines, which note that research has found that “an empirically derived set of risk factors predicted the risk of persistent post-concussion symptoms at 28 days” for children seen in the ED with mTBI.
During the recovery phase, a combination of tools should be used to track recovery from mTBI; these can include validated symptom scales, validated cognitive testing, reaction time measures, and, in adolescent athletes, balance testing. Using a combination of tools is a valuable strategy, the researchers wrote. “No single assessment tool is strongly predictive of outcome in children with mTBI,” they noted.
When prognosis is poor, or recovery is not proceeding as expected, clinicians should have a low threshold for initiating other interventions and referrals.
Management and treatment
Although the guideline authors acknowledged significant knowledge gaps in all areas of pediatric mTBI diagnosis and management, evidence is especially scant for best practices for treatment, rest, and return to play and school after a child sustains mTBI, said Dr. Lumba-Brown and her coauthors.
However, families should be given information about warning signs for serious head injury and how to monitor symptoms, as well as information about mTBI and the expected recovery course. Other forward-looking instructions should cover the importance of preventing new head injuries, managing the gradual return to normal cognitive and physical activities, and clear instructions regarding return to school and recreational activities. The guideline authors made a strong recommendation to provide this information, with high confidence in the data.
However, little strong evidence points the way to a clear set of criteria for when children are ready for school, play, and athletic participation. These decisions must be customized to the individual child, and decision making, particularly about return to school and academic activities, should be a collaborative affair, with schools, clinicians, and families all communicating to make sure the pace of return to normal life is keeping pace with the child’s recovery. “Because postconcussive symptoms resolve at different rates in different children after mTBI, individualization of return-to-school programming is necessary,” wrote Dr. Lumba-Brown and her coauthors.
The guideline authors cite evidence that “suggests that early rest (within the first 3 days) may be beneficial but that inactivity beyond this period for most children may worsen their self-reported symptoms.”
Psychosocial support may be beneficial for certain children, wrote the researchers, drawing on evidence showing that such support is beneficial in frank TBI, and is probably beneficial in mTBI.
Active rehabilitation as tolerated is recommended after an initial period of rest, with exertion kept to a level that does not exacerbate symptoms. Children should not participate in contact activities until symptoms are fully resolved.
A posttraumatic headache that is severe or worsens in the ED should prompt consideration of emergent neuroimaging, according to the guidelines. In the postacute phase, however, children can have nonopioid analgesia, although parents should know about such risks as rebound headache. When chronic headache follows a mTBI, the guidelines recommend that clinicians refer patients for a multidisciplinary evaluation that can assess the many factors – including analgesic overuse – that can be contributors.
Drawing on the larger body of adult TBI research, the authors recommend that insufficient or disordered sleep be addressed, because “the maintenance of appropriate sleep and the management of disrupted sleep may be a critical target of treatment for the child with mTBI.”
Children who suffer a mTBI may experience cognitive dysfunction as a direct result of injury to the brain or secondary to the effects of other symptoms such as sleep disruptions, headache pain, fatigue, or low tolerance of frustration. Clinicians may want to perform or refer their patients for a neuropsychological evaluation to determine what is causing the cognitive dysfunction, the authors said.
Dr. Lumba-Brown and her coauthors, who formed the CDC’s Pediatric Mild Traumatic Brain Injury Guideline Workgroup, also recommended that clinicians use the term “mild traumatic brain injury” to describe head injuries that cause confusion or disorientation, without loss of consciousness, or loss of consciousness of up to 30 minutes or less, or posttraumatic amnesia of less than 24 hours duration, and that are associated with a GCS of 13-15 by 30 minutes after injury or at the time of initial medical assessment. This practice, they said, may reduce the risk of misinterpretation by medical professionals and the public that can occur when the terms “mTBI,” “concussion,” and “minor head injury” all may refer to the same injury.
The CDC has developed a suite of materials to assist both health care providers and the public in guideline implementation. The agency also is using its HEADS UP campaign to publicize the guidelines and related materials, and plans ongoing evaluation of the guidelines and implementation materials.
Many study authors, including Dr. Lumba-Brown, had relationships with medical device or pharmaceutical companies. The systematic review and guideline development were funded by the CDC.
and should base management and prognostication on clinical decision-making tools and symptom rating scales, according to new practice guidelines issued by a working group of the Centers for Disease Control and Prevention (JAMA Pediatrics. 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2853.
The guidelines were released simultaneously with a systematic review, conducted by the same authors, of the existing literature regarding pediatric mTBI (JAMA Pediatrics 2018 Sep 4. doi: 10.1001/jamapediatrics.2018.2847). As the evaluators sorted through the literature to find high-quality studies for this population, the funnel rapidly narrowed: From an initial pool of over 15,000 studies conducted between 1990 and 2015, findings from just 75 studies were eventually included in the systematic review.
The review’s findings formed the basis for the guidelines and allowed Angela Lumba-Brown, MD, a pediatric emergency medicine physician at Stanford (Calif.) University, and her coauthors to ascribe a level of confidence in the inference from study data for a given recommendation. Recommendations also are categorized by strength and accordingly indicate that clinicians “should” or “may” follow them. Exceptions are carved out for practices, such as the use of hypertonic 3% saline solution for acute headache in the ED, that should not be used outside research settings.
In the end, the guidelines cover 19 main topics, sorted into guidance regarding the diagnosis, prognosis, and management and treatment of mTBI in children.
Diagnosis
The recommendations regarding mTBI diagnosis center around determining which children are at risk for significant intracranial injury (ICI). The guidelines recommend, with moderate confidence, that clinicians usually should not obtain a head CT for children with mTBI. Validated clinical decision rules should be used for risk stratification to determine which children can safely avoid imaging and which children should be considered for head CT, wrote Dr. Lumba-Brown and her coauthors. Magnetic resonance imaging is not recommended for initial evaluation of mTBI, nor should skull radiographs be ordered in the absence of clinical suspicion for skull fracture.
From the systematic review, Dr. Lumba-Brown and her colleagues found that several risk factors taken together may mean that significant ICI is more likely. These include patient age younger than 2 years; any vomiting, loss of consciousness, or amnesia; a severe mechanism of injury, severe or worsening headache, or nonfrontal scalp hematoma; a Glasgow Coma Scale (GCS) score of less than 15; and clinical suspicion for skull fracture. Clinicians should give consideration to the risks of ionizing radiation to the head, and balance this against their assessment of risk for severe – and perhaps actionable – injury.
A validated symptom rating scale, used in an age-appropriate way, should be used as part of the evaluation of children with mTBI. For children aged 6 and older, the Graded Symptom Checklist is an appropriate tool within 2 days after injury, while the Post Concussion Symptom Scale as part of computerized neurocognitive testing can differentiate which high school athletes have mTBI when used within 4 days of injury, according to the guidelines, which also identify other validated symptom rating scales.
The guidelines authors recommend, with high confidence, that serum biomarkers should not be used outside of research settings in the diagnosis of mTBI in children at present.
Prognosis
Families should be counseled that symptoms mostly resolve within 1-3 months for up to 80% of children with mTBI, but families also should know that “each child’s recovery from mTBI is unique and will follow its own trajectory,” wrote Dr. Lumba-Brown and her coauthors, in a moderate-strength recommendation.
Some factors have been associated with slower recovery from mTBI, and either upon evaluation for mTBI or in routine sports examinations, families should be told about this potential if risk factors are present, said the guidelines, although the evidence supporting the associations is of “varying strength,” wrote Dr. Lumba-Brown and her coauthors. Children with previous mTBIs and those with a history of premorbid neurologic and psychiatric problems, learning problems, or family and social stress all may have delayed recovery. For children with ICI, lower cognitive ability also is associated with delayed recovery.
Demographic factors such as lower socioeconomic status and being of Hispanic ethnicity also may increase the risk for delayed mTBI recovery. Older children and adolescents may recover more slowly. Those with more severe initial presentation and more symptoms in the immediate post-mTBI phase also may have a slower recovery course, said Dr. Lumba-Brown and her coauthors.
A validated prediction rule can be used in the ED to gather information about these discrete risk factors to guide family counseling, according to the guidelines, which note that research has found that “an empirically derived set of risk factors predicted the risk of persistent post-concussion symptoms at 28 days” for children seen in the ED with mTBI.
During the recovery phase, a combination of tools should be used to track recovery from mTBI; these can include validated symptom scales, validated cognitive testing, reaction time measures, and, in adolescent athletes, balance testing. Using a combination of tools is a valuable strategy, the researchers wrote. “No single assessment tool is strongly predictive of outcome in children with mTBI,” they noted.
When prognosis is poor, or recovery is not proceeding as expected, clinicians should have a low threshold for initiating other interventions and referrals.
Management and treatment
Although the guideline authors acknowledged significant knowledge gaps in all areas of pediatric mTBI diagnosis and management, evidence is especially scant for best practices for treatment, rest, and return to play and school after a child sustains mTBI, said Dr. Lumba-Brown and her coauthors.
However, families should be given information about warning signs for serious head injury and how to monitor symptoms, as well as information about mTBI and the expected recovery course. Other forward-looking instructions should cover the importance of preventing new head injuries, managing the gradual return to normal cognitive and physical activities, and clear instructions regarding return to school and recreational activities. The guideline authors made a strong recommendation to provide this information, with high confidence in the data.
However, little strong evidence points the way to a clear set of criteria for when children are ready for school, play, and athletic participation. These decisions must be customized to the individual child, and decision making, particularly about return to school and academic activities, should be a collaborative affair, with schools, clinicians, and families all communicating to make sure the pace of return to normal life is keeping pace with the child’s recovery. “Because postconcussive symptoms resolve at different rates in different children after mTBI, individualization of return-to-school programming is necessary,” wrote Dr. Lumba-Brown and her coauthors.
The guideline authors cite evidence that “suggests that early rest (within the first 3 days) may be beneficial but that inactivity beyond this period for most children may worsen their self-reported symptoms.”
Psychosocial support may be beneficial for certain children, wrote the researchers, drawing on evidence showing that such support is beneficial in frank TBI, and is probably beneficial in mTBI.
Active rehabilitation as tolerated is recommended after an initial period of rest, with exertion kept to a level that does not exacerbate symptoms. Children should not participate in contact activities until symptoms are fully resolved.
A posttraumatic headache that is severe or worsens in the ED should prompt consideration of emergent neuroimaging, according to the guidelines. In the postacute phase, however, children can have nonopioid analgesia, although parents should know about such risks as rebound headache. When chronic headache follows a mTBI, the guidelines recommend that clinicians refer patients for a multidisciplinary evaluation that can assess the many factors – including analgesic overuse – that can be contributors.
Drawing on the larger body of adult TBI research, the authors recommend that insufficient or disordered sleep be addressed, because “the maintenance of appropriate sleep and the management of disrupted sleep may be a critical target of treatment for the child with mTBI.”
Children who suffer a mTBI may experience cognitive dysfunction as a direct result of injury to the brain or secondary to the effects of other symptoms such as sleep disruptions, headache pain, fatigue, or low tolerance of frustration. Clinicians may want to perform or refer their patients for a neuropsychological evaluation to determine what is causing the cognitive dysfunction, the authors said.
Dr. Lumba-Brown and her coauthors, who formed the CDC’s Pediatric Mild Traumatic Brain Injury Guideline Workgroup, also recommended that clinicians use the term “mild traumatic brain injury” to describe head injuries that cause confusion or disorientation, without loss of consciousness, or loss of consciousness of up to 30 minutes or less, or posttraumatic amnesia of less than 24 hours duration, and that are associated with a GCS of 13-15 by 30 minutes after injury or at the time of initial medical assessment. This practice, they said, may reduce the risk of misinterpretation by medical professionals and the public that can occur when the terms “mTBI,” “concussion,” and “minor head injury” all may refer to the same injury.
The CDC has developed a suite of materials to assist both health care providers and the public in guideline implementation. The agency also is using its HEADS UP campaign to publicize the guidelines and related materials, and plans ongoing evaluation of the guidelines and implementation materials.
Many study authors, including Dr. Lumba-Brown, had relationships with medical device or pharmaceutical companies. The systematic review and guideline development were funded by the CDC.
FROM JAMA PEDIATRICS
Updates to EULAR hand OA management recommendations reflect current evidence
Updated EULAR recommendations on the management of hand osteoarthritis include five overarching principles as well as two new recommendations that reflect new research in the field.
The task force, led by Margreet Kloppenburg, MD, PhD, of the department of rheumatology at Leiden (the Netherlands) University Medical Center, noted that a decade had passed since the first recommendations were published in 2007.
“It was timely to update the recommendations, as many new studies had emerged during this period. In light of this new evidence, many of the 2007 recommendations were modified and new recommendations were added,” wrote Dr. Kloppenburg and her colleagues. The recommendations were published online in Annals of the Rheumatic Diseases.
They noted that the recommendations were targeted to all health professionals across primary and secondary care but also aimed to inform patients about their disease to “support shared decision making.”
In line with other EULAR sets of management recommendations, the update included five overarching principles that cover treatment goals, information and education for patients, individualization of treatment, shared decision making between clinicians and patients, and the need to take into consideration a multidisciplinary and multimodal (pharmacologic and nonpharmacologic) treatment approach.
The authors noted that for a long time hand OA was a “forgotten disease” and this was reflected by the paucity of clinical trials in the area. As a direct consequence, previous recommendations were based on expert opinion rather than evidence.
However, new data allowed the task force to recommend not to treat patients with hand OA with conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). The recommendation achieved the strongest level of evidence and a high level of agreement from the 19-member expert panel, which included 2 patient research partners. The authors said the recommendation was based on newer studies that demonstrated a lack of efficacy of csDMARDs and bDMARDs.
The authors also advised adapting the long-term follow-up of patients with hand OA to individual needs, although they noted this was based on expert opinion alone and that in the absence of a disease-modifying treatment, the goal of follow-up differs from that of many other rheumatic diseases. Individual needs will dictate the degree of follow-up required, based on the severity of symptoms, presence of erosive disease, reevaluation of the use of pharmacologic therapy, and a patient’s wishes and expectations. They also noted that “for most patients, standard radiographic follow-up is not useful at this moment” and that “follow-up does not necessarily have to be performed by a rheumatologist.
“Follow-up will likely increase adherence to nonpharmacological therapies like exercise or orthoses, and provides an opportunity for reevaluation of treatment,” they wrote.
The recommendations advise offering education and training in ergonomic principles and exercises to patients to improve function and muscle strength, as well as considering the use of orthoses in some patients.
Treatment recommendations suggested preferring topical treatments over systemic treatments and that oral analgesics, particularly NSAIDs, should be considered for a limited duration. The authors advised that chondroitin sulfate may be used in patients for pain relief and improvement in functioning and that intra-articular glucocorticoids should not generally be used but may be considered in patients with painful interphalangeal joints. Surgery should be considered for patients with structural abnormalities when other treatment modalities have not been sufficiently effective in relieving pain.
The recommendations were funded by EULAR. Several of the authors reported receiving consultancy fees and/or honoraria as well as research funding from industry.
SOURCE: Kloppenburg M et al. Ann Rheum Dis. 2018 Aug 28. doi: 10.1136/annrheumdis-2018-213826.
EULAR has updated its 2007 guidelines for the management of hand osteoarthritis. I find the recommendations helpful, and I have no disagreements.
The authors performed a systematic literature review that was more complete than the original guidelines. In addition, the methodology in developing the guidelines was updated utilizing the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) system to guide the expert opinion. The manuscript presents recommendations that are carefully supported in the text. To understand guidelines, one really needs to read the text.
The update lists a set of research questions, similar to the 2007 recommendations.
The authors group their therapeutic recommendations according to nonpharmacologic, pharmacologic, and surgical approaches, as well as about the need for follow-up. The three nonpharmacologic recommendations include education and training, exercise and muscle strengthening, and the use of orthoses. The pharmacologic approach includes topical therapy as a first-line, oral NSAIDs and analgesics, chondroitin sulfate, and intra-articular injections. There is a negative recommendation for the use of biologics. The surgical recommendation is directed at the relief of pain. The last recommendation emphasizes the need for follow-up and individual care.
The differences between the recommendations include the removal of acetaminophen as a first-line therapy. Indeed, it seems to be barely recommended at all. In addition, there is an emphasis on topical therapy, particularly NSAIDs. The authors are equivocal on the recommendations for intra-articular therapy. Paraffin and local heat are no longer included. The recommendation against biologic therapy is new. They included agents used for rheumatoid arthritis, such as methotrexate, in this negative recommendation.
These new recommendations are an update of guidelines that are over 10 years old. They are practical and helpful. Unfortunately, more research is needed as the present day therapy is often inadequate.
Roy D. Altman, MD, is professor emeritus of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He is a consultant to Ferring, Flexion, GlaxoSmithKline, Novartis, Olatec, Pfizer, and Sorrento Therapeutics.
EULAR has updated its 2007 guidelines for the management of hand osteoarthritis. I find the recommendations helpful, and I have no disagreements.
The authors performed a systematic literature review that was more complete than the original guidelines. In addition, the methodology in developing the guidelines was updated utilizing the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) system to guide the expert opinion. The manuscript presents recommendations that are carefully supported in the text. To understand guidelines, one really needs to read the text.
The update lists a set of research questions, similar to the 2007 recommendations.
The authors group their therapeutic recommendations according to nonpharmacologic, pharmacologic, and surgical approaches, as well as about the need for follow-up. The three nonpharmacologic recommendations include education and training, exercise and muscle strengthening, and the use of orthoses. The pharmacologic approach includes topical therapy as a first-line, oral NSAIDs and analgesics, chondroitin sulfate, and intra-articular injections. There is a negative recommendation for the use of biologics. The surgical recommendation is directed at the relief of pain. The last recommendation emphasizes the need for follow-up and individual care.
The differences between the recommendations include the removal of acetaminophen as a first-line therapy. Indeed, it seems to be barely recommended at all. In addition, there is an emphasis on topical therapy, particularly NSAIDs. The authors are equivocal on the recommendations for intra-articular therapy. Paraffin and local heat are no longer included. The recommendation against biologic therapy is new. They included agents used for rheumatoid arthritis, such as methotrexate, in this negative recommendation.
These new recommendations are an update of guidelines that are over 10 years old. They are practical and helpful. Unfortunately, more research is needed as the present day therapy is often inadequate.
Roy D. Altman, MD, is professor emeritus of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He is a consultant to Ferring, Flexion, GlaxoSmithKline, Novartis, Olatec, Pfizer, and Sorrento Therapeutics.
EULAR has updated its 2007 guidelines for the management of hand osteoarthritis. I find the recommendations helpful, and I have no disagreements.
The authors performed a systematic literature review that was more complete than the original guidelines. In addition, the methodology in developing the guidelines was updated utilizing the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) system to guide the expert opinion. The manuscript presents recommendations that are carefully supported in the text. To understand guidelines, one really needs to read the text.
The update lists a set of research questions, similar to the 2007 recommendations.
The authors group their therapeutic recommendations according to nonpharmacologic, pharmacologic, and surgical approaches, as well as about the need for follow-up. The three nonpharmacologic recommendations include education and training, exercise and muscle strengthening, and the use of orthoses. The pharmacologic approach includes topical therapy as a first-line, oral NSAIDs and analgesics, chondroitin sulfate, and intra-articular injections. There is a negative recommendation for the use of biologics. The surgical recommendation is directed at the relief of pain. The last recommendation emphasizes the need for follow-up and individual care.
The differences between the recommendations include the removal of acetaminophen as a first-line therapy. Indeed, it seems to be barely recommended at all. In addition, there is an emphasis on topical therapy, particularly NSAIDs. The authors are equivocal on the recommendations for intra-articular therapy. Paraffin and local heat are no longer included. The recommendation against biologic therapy is new. They included agents used for rheumatoid arthritis, such as methotrexate, in this negative recommendation.
These new recommendations are an update of guidelines that are over 10 years old. They are practical and helpful. Unfortunately, more research is needed as the present day therapy is often inadequate.
Roy D. Altman, MD, is professor emeritus of medicine in the division of rheumatology and immunology at the University of California, Los Angeles. He is a consultant to Ferring, Flexion, GlaxoSmithKline, Novartis, Olatec, Pfizer, and Sorrento Therapeutics.
Updated EULAR recommendations on the management of hand osteoarthritis include five overarching principles as well as two new recommendations that reflect new research in the field.
The task force, led by Margreet Kloppenburg, MD, PhD, of the department of rheumatology at Leiden (the Netherlands) University Medical Center, noted that a decade had passed since the first recommendations were published in 2007.
“It was timely to update the recommendations, as many new studies had emerged during this period. In light of this new evidence, many of the 2007 recommendations were modified and new recommendations were added,” wrote Dr. Kloppenburg and her colleagues. The recommendations were published online in Annals of the Rheumatic Diseases.
They noted that the recommendations were targeted to all health professionals across primary and secondary care but also aimed to inform patients about their disease to “support shared decision making.”
In line with other EULAR sets of management recommendations, the update included five overarching principles that cover treatment goals, information and education for patients, individualization of treatment, shared decision making between clinicians and patients, and the need to take into consideration a multidisciplinary and multimodal (pharmacologic and nonpharmacologic) treatment approach.
The authors noted that for a long time hand OA was a “forgotten disease” and this was reflected by the paucity of clinical trials in the area. As a direct consequence, previous recommendations were based on expert opinion rather than evidence.
However, new data allowed the task force to recommend not to treat patients with hand OA with conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). The recommendation achieved the strongest level of evidence and a high level of agreement from the 19-member expert panel, which included 2 patient research partners. The authors said the recommendation was based on newer studies that demonstrated a lack of efficacy of csDMARDs and bDMARDs.
The authors also advised adapting the long-term follow-up of patients with hand OA to individual needs, although they noted this was based on expert opinion alone and that in the absence of a disease-modifying treatment, the goal of follow-up differs from that of many other rheumatic diseases. Individual needs will dictate the degree of follow-up required, based on the severity of symptoms, presence of erosive disease, reevaluation of the use of pharmacologic therapy, and a patient’s wishes and expectations. They also noted that “for most patients, standard radiographic follow-up is not useful at this moment” and that “follow-up does not necessarily have to be performed by a rheumatologist.
“Follow-up will likely increase adherence to nonpharmacological therapies like exercise or orthoses, and provides an opportunity for reevaluation of treatment,” they wrote.
The recommendations advise offering education and training in ergonomic principles and exercises to patients to improve function and muscle strength, as well as considering the use of orthoses in some patients.
Treatment recommendations suggested preferring topical treatments over systemic treatments and that oral analgesics, particularly NSAIDs, should be considered for a limited duration. The authors advised that chondroitin sulfate may be used in patients for pain relief and improvement in functioning and that intra-articular glucocorticoids should not generally be used but may be considered in patients with painful interphalangeal joints. Surgery should be considered for patients with structural abnormalities when other treatment modalities have not been sufficiently effective in relieving pain.
The recommendations were funded by EULAR. Several of the authors reported receiving consultancy fees and/or honoraria as well as research funding from industry.
SOURCE: Kloppenburg M et al. Ann Rheum Dis. 2018 Aug 28. doi: 10.1136/annrheumdis-2018-213826.
Updated EULAR recommendations on the management of hand osteoarthritis include five overarching principles as well as two new recommendations that reflect new research in the field.
The task force, led by Margreet Kloppenburg, MD, PhD, of the department of rheumatology at Leiden (the Netherlands) University Medical Center, noted that a decade had passed since the first recommendations were published in 2007.
“It was timely to update the recommendations, as many new studies had emerged during this period. In light of this new evidence, many of the 2007 recommendations were modified and new recommendations were added,” wrote Dr. Kloppenburg and her colleagues. The recommendations were published online in Annals of the Rheumatic Diseases.
They noted that the recommendations were targeted to all health professionals across primary and secondary care but also aimed to inform patients about their disease to “support shared decision making.”
In line with other EULAR sets of management recommendations, the update included five overarching principles that cover treatment goals, information and education for patients, individualization of treatment, shared decision making between clinicians and patients, and the need to take into consideration a multidisciplinary and multimodal (pharmacologic and nonpharmacologic) treatment approach.
The authors noted that for a long time hand OA was a “forgotten disease” and this was reflected by the paucity of clinical trials in the area. As a direct consequence, previous recommendations were based on expert opinion rather than evidence.
However, new data allowed the task force to recommend not to treat patients with hand OA with conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). The recommendation achieved the strongest level of evidence and a high level of agreement from the 19-member expert panel, which included 2 patient research partners. The authors said the recommendation was based on newer studies that demonstrated a lack of efficacy of csDMARDs and bDMARDs.
The authors also advised adapting the long-term follow-up of patients with hand OA to individual needs, although they noted this was based on expert opinion alone and that in the absence of a disease-modifying treatment, the goal of follow-up differs from that of many other rheumatic diseases. Individual needs will dictate the degree of follow-up required, based on the severity of symptoms, presence of erosive disease, reevaluation of the use of pharmacologic therapy, and a patient’s wishes and expectations. They also noted that “for most patients, standard radiographic follow-up is not useful at this moment” and that “follow-up does not necessarily have to be performed by a rheumatologist.
“Follow-up will likely increase adherence to nonpharmacological therapies like exercise or orthoses, and provides an opportunity for reevaluation of treatment,” they wrote.
The recommendations advise offering education and training in ergonomic principles and exercises to patients to improve function and muscle strength, as well as considering the use of orthoses in some patients.
Treatment recommendations suggested preferring topical treatments over systemic treatments and that oral analgesics, particularly NSAIDs, should be considered for a limited duration. The authors advised that chondroitin sulfate may be used in patients for pain relief and improvement in functioning and that intra-articular glucocorticoids should not generally be used but may be considered in patients with painful interphalangeal joints. Surgery should be considered for patients with structural abnormalities when other treatment modalities have not been sufficiently effective in relieving pain.
The recommendations were funded by EULAR. Several of the authors reported receiving consultancy fees and/or honoraria as well as research funding from industry.
SOURCE: Kloppenburg M et al. Ann Rheum Dis. 2018 Aug 28. doi: 10.1136/annrheumdis-2018-213826.
FROM ANNALS OF THE RHEUMATIC DISEASES