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Revised U.S. cholesterol guidelines promote personalized risk assessment
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
New cholesterol guidelines expand options for primary care
CHICAGO – New U.S. cholesterol guidelines spell out the role for ezetimibe and PCSK9 inhibitors, expand the scope of individualized risk assessment, and cite the potential value of a coronary artery calcium score as an additional risk determinant.
Neil J. Stone MD, vice chair of the of the 2018 Cholesterol Guidelines Committee, sat down for an interview and detailed the research behind the guidelines and how new features can help guide treatment decisions for patients at risk for a cardiovascular event.
CHICAGO – New U.S. cholesterol guidelines spell out the role for ezetimibe and PCSK9 inhibitors, expand the scope of individualized risk assessment, and cite the potential value of a coronary artery calcium score as an additional risk determinant.
Neil J. Stone MD, vice chair of the of the 2018 Cholesterol Guidelines Committee, sat down for an interview and detailed the research behind the guidelines and how new features can help guide treatment decisions for patients at risk for a cardiovascular event.
CHICAGO – New U.S. cholesterol guidelines spell out the role for ezetimibe and PCSK9 inhibitors, expand the scope of individualized risk assessment, and cite the potential value of a coronary artery calcium score as an additional risk determinant.
Neil J. Stone MD, vice chair of the of the 2018 Cholesterol Guidelines Committee, sat down for an interview and detailed the research behind the guidelines and how new features can help guide treatment decisions for patients at risk for a cardiovascular event.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Bradycardia guideline sets new bar for shared decision-making in pacemaker placement
A new clinical practice guideline on the management of bradycardia and cardiac conduction system disorders in adults emphasizes the importance of patient-centered care and “shared decision-making” between patient and clinician, particularly with regard to patients who have indications for pacemaker implantation.
Shared decision-making extends to the end-of-life setting where “complex” informed consent and refusal of care decisions need to be patient-specific, and must involve all stakeholders, according to the new 2018 guidelines from the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS).
“Patients with decision-making capacity or his/her legally defined surrogate has the right to refuse or request withdrawal of pacemaker therapy, even if the patient is pacemaker dependent, which should be considered palliative, end-of-life care, and not physician-assisted suicide,” the guidelines read.
The guidelines additionally update the evaluation and treatment of sinus node dysfunction, atrioventricular block, and conduction disorders, based in part on a comprehensive evidence review conducted from January to September 2017. They supersede a 2008 guideline from the three societies on device-based therapy of cardiac rhythm abnormalities, and the focused update to that guideline published in 2012.
These guidelines will be useful not only to arrhythmia specialists, but also to internists and family physicians, cardiologists, surgeons, emergency physicians, and anesthesiologists, according to the guideline writing committee, which included representativens of ACC, AHA, HRS, and several other national organizations. The committee included cardiac electrophysiologists, cardiologists, surgeons, an anesthesiologist, and other clinicians, as well as a patient/lay representative, and was chaired by Fred M. Kusumoto, MD, of Mayo Clinic Florida in Jacksonville.
For sinus node dysfunction, no minimum heart rate or pause duration has been determined for which permanent pacing would be recommended, the guidelines state. To determine whether permanent pacing is necessary in those patients, clinicians should work to establish a temporal correlation bewteen bradycardia and symptoms, according to the guideline authors.
Left bundle branch block, when found on echocardiogram, greatly increases the chances of underlying structural heart disease and of a left ventricular systolic dysfunction diagnosis, according to the guidelines, which state that echocardiography is the most appropriate initial screening test for left ventricular systolic dysfunction and other structural heart disease.
Permanent pacing is recommended for certain types of atrioventricular (AV) block, according to the guidelines, which include high-grade AV block, acquired second-degree Mobitz type II AV block, and third-degree AV block not related to reversible or physiologic causes.
Treatment of sleep apnea can reduce frequency of nocturnal bradycardia and may provide a cardiovascular benefit, the guideline authors state. Patients with nocturnal bradycardias should be screened for sleep apnea, though authors cautioned that these arrhythmias are not, in and of themselves, an indication for permanent pacing.
“Treatment decisions are based not only on the best available evidence, but also on the patient’s goals of care and preferences,” Dr. Kusumoto said in a press release jointly issued by the ACC, AHA, and HRS. Toward that end, patients should receive “trusted material” to help them understand the consequences and risks of any proposed management decision.
Emerging pacing technologies such as His bundle pacing and transcatheter leadless pacing systems need more study to determine which patient populations will benefit most from them, the guidelines state.
“Regardless of technology, for the foreseeable future, pacing therapy requires implantation of a medical device,” Dr. Kusumoto said in the release. “Future studies are warranted to focus on the long-term implications associated with lifelong therapy.”
The 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay is now published in the Journal of the American College of Cardiology, and simultaneously in the journals Circulation and HeartRhythm.
Dr. Kusumoto reported no relationships with industry or other entities. Guideline co-authors provided disclosures related to Boston Scientific, Janssen Pharmaceuticals, Medtronic, Daiichi-Sankyo, Sanofi-Aventis, St. Jude Medical, and Abbott, among others.
SOURCE: Kusumoto FM, et al. J Am Coll Cardiol. 2018 Nov 6.
A new clinical practice guideline on the management of bradycardia and cardiac conduction system disorders in adults emphasizes the importance of patient-centered care and “shared decision-making” between patient and clinician, particularly with regard to patients who have indications for pacemaker implantation.
Shared decision-making extends to the end-of-life setting where “complex” informed consent and refusal of care decisions need to be patient-specific, and must involve all stakeholders, according to the new 2018 guidelines from the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS).
“Patients with decision-making capacity or his/her legally defined surrogate has the right to refuse or request withdrawal of pacemaker therapy, even if the patient is pacemaker dependent, which should be considered palliative, end-of-life care, and not physician-assisted suicide,” the guidelines read.
The guidelines additionally update the evaluation and treatment of sinus node dysfunction, atrioventricular block, and conduction disorders, based in part on a comprehensive evidence review conducted from January to September 2017. They supersede a 2008 guideline from the three societies on device-based therapy of cardiac rhythm abnormalities, and the focused update to that guideline published in 2012.
These guidelines will be useful not only to arrhythmia specialists, but also to internists and family physicians, cardiologists, surgeons, emergency physicians, and anesthesiologists, according to the guideline writing committee, which included representativens of ACC, AHA, HRS, and several other national organizations. The committee included cardiac electrophysiologists, cardiologists, surgeons, an anesthesiologist, and other clinicians, as well as a patient/lay representative, and was chaired by Fred M. Kusumoto, MD, of Mayo Clinic Florida in Jacksonville.
For sinus node dysfunction, no minimum heart rate or pause duration has been determined for which permanent pacing would be recommended, the guidelines state. To determine whether permanent pacing is necessary in those patients, clinicians should work to establish a temporal correlation bewteen bradycardia and symptoms, according to the guideline authors.
Left bundle branch block, when found on echocardiogram, greatly increases the chances of underlying structural heart disease and of a left ventricular systolic dysfunction diagnosis, according to the guidelines, which state that echocardiography is the most appropriate initial screening test for left ventricular systolic dysfunction and other structural heart disease.
Permanent pacing is recommended for certain types of atrioventricular (AV) block, according to the guidelines, which include high-grade AV block, acquired second-degree Mobitz type II AV block, and third-degree AV block not related to reversible or physiologic causes.
Treatment of sleep apnea can reduce frequency of nocturnal bradycardia and may provide a cardiovascular benefit, the guideline authors state. Patients with nocturnal bradycardias should be screened for sleep apnea, though authors cautioned that these arrhythmias are not, in and of themselves, an indication for permanent pacing.
“Treatment decisions are based not only on the best available evidence, but also on the patient’s goals of care and preferences,” Dr. Kusumoto said in a press release jointly issued by the ACC, AHA, and HRS. Toward that end, patients should receive “trusted material” to help them understand the consequences and risks of any proposed management decision.
Emerging pacing technologies such as His bundle pacing and transcatheter leadless pacing systems need more study to determine which patient populations will benefit most from them, the guidelines state.
“Regardless of technology, for the foreseeable future, pacing therapy requires implantation of a medical device,” Dr. Kusumoto said in the release. “Future studies are warranted to focus on the long-term implications associated with lifelong therapy.”
The 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay is now published in the Journal of the American College of Cardiology, and simultaneously in the journals Circulation and HeartRhythm.
Dr. Kusumoto reported no relationships with industry or other entities. Guideline co-authors provided disclosures related to Boston Scientific, Janssen Pharmaceuticals, Medtronic, Daiichi-Sankyo, Sanofi-Aventis, St. Jude Medical, and Abbott, among others.
SOURCE: Kusumoto FM, et al. J Am Coll Cardiol. 2018 Nov 6.
A new clinical practice guideline on the management of bradycardia and cardiac conduction system disorders in adults emphasizes the importance of patient-centered care and “shared decision-making” between patient and clinician, particularly with regard to patients who have indications for pacemaker implantation.
Shared decision-making extends to the end-of-life setting where “complex” informed consent and refusal of care decisions need to be patient-specific, and must involve all stakeholders, according to the new 2018 guidelines from the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS).
“Patients with decision-making capacity or his/her legally defined surrogate has the right to refuse or request withdrawal of pacemaker therapy, even if the patient is pacemaker dependent, which should be considered palliative, end-of-life care, and not physician-assisted suicide,” the guidelines read.
The guidelines additionally update the evaluation and treatment of sinus node dysfunction, atrioventricular block, and conduction disorders, based in part on a comprehensive evidence review conducted from January to September 2017. They supersede a 2008 guideline from the three societies on device-based therapy of cardiac rhythm abnormalities, and the focused update to that guideline published in 2012.
These guidelines will be useful not only to arrhythmia specialists, but also to internists and family physicians, cardiologists, surgeons, emergency physicians, and anesthesiologists, according to the guideline writing committee, which included representativens of ACC, AHA, HRS, and several other national organizations. The committee included cardiac electrophysiologists, cardiologists, surgeons, an anesthesiologist, and other clinicians, as well as a patient/lay representative, and was chaired by Fred M. Kusumoto, MD, of Mayo Clinic Florida in Jacksonville.
For sinus node dysfunction, no minimum heart rate or pause duration has been determined for which permanent pacing would be recommended, the guidelines state. To determine whether permanent pacing is necessary in those patients, clinicians should work to establish a temporal correlation bewteen bradycardia and symptoms, according to the guideline authors.
Left bundle branch block, when found on echocardiogram, greatly increases the chances of underlying structural heart disease and of a left ventricular systolic dysfunction diagnosis, according to the guidelines, which state that echocardiography is the most appropriate initial screening test for left ventricular systolic dysfunction and other structural heart disease.
Permanent pacing is recommended for certain types of atrioventricular (AV) block, according to the guidelines, which include high-grade AV block, acquired second-degree Mobitz type II AV block, and third-degree AV block not related to reversible or physiologic causes.
Treatment of sleep apnea can reduce frequency of nocturnal bradycardia and may provide a cardiovascular benefit, the guideline authors state. Patients with nocturnal bradycardias should be screened for sleep apnea, though authors cautioned that these arrhythmias are not, in and of themselves, an indication for permanent pacing.
“Treatment decisions are based not only on the best available evidence, but also on the patient’s goals of care and preferences,” Dr. Kusumoto said in a press release jointly issued by the ACC, AHA, and HRS. Toward that end, patients should receive “trusted material” to help them understand the consequences and risks of any proposed management decision.
Emerging pacing technologies such as His bundle pacing and transcatheter leadless pacing systems need more study to determine which patient populations will benefit most from them, the guidelines state.
“Regardless of technology, for the foreseeable future, pacing therapy requires implantation of a medical device,” Dr. Kusumoto said in the release. “Future studies are warranted to focus on the long-term implications associated with lifelong therapy.”
The 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay is now published in the Journal of the American College of Cardiology, and simultaneously in the journals Circulation and HeartRhythm.
Dr. Kusumoto reported no relationships with industry or other entities. Guideline co-authors provided disclosures related to Boston Scientific, Janssen Pharmaceuticals, Medtronic, Daiichi-Sankyo, Sanofi-Aventis, St. Jude Medical, and Abbott, among others.
SOURCE: Kusumoto FM, et al. J Am Coll Cardiol. 2018 Nov 6.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
AAP: Pediatricians can mitigate conflict effects on children
Pediatricians have a central role in addressing the impact to children caused by armed conflict, including diagnosing and managing health conditions resulting from exposure to associated violence, according to a new American Academy of Pediatrics policy statement.
The recommendation, published in Pediatrics, emphasizes the need for child health professionals to understand the prevalence of armed conflict and its pervasive effects on children and to respond both domestically and globally to the problem. The AAP defines armed conflict as any organized dispute that involves the use of weapons, violence, or force, such as international wars, civil wars, ethnic conflicts, and violence associated with gangs and drug trafficking. Children effected by armed conflict may include refugees forcibly displaced from their countries, unaccompanied immigrant children, and former child combatants, known as child soldiers.
The policy details the various health effects triggered by armed conflict, including physical, mental, developmental, and behavioral health conditions in children as well as indirect effects through deprivation and toxic stress. Children affected by armed conflict, for example, are at increased risk for PTSD, depression, anxiety, and behavioral and psychosomatic problems, which can continue well into adulthood, according to the policy statement.
To address these effects, pediatricians should receive training on trauma-informed care that enables them to recognize the dynamics of traumatic life experiences among children exposed to armed conflict and provide optimal responses, the policy advises.
and can work to mitigate the effects of trauma, according to the policy. The AAP recommends that child health professionals be prepared to diagnose and offer initial management for conditions associated with exposure to armed conflict as well as partner with community mental and behavioral health providers to establish collaborative care networks, when possible. Other AAP recommendations in the policy statement include that child health professionals:
- Be trained to provide “culturally effective care,” defined as “the delivery of care within the context of appropriate physician knowledge, understanding, and appreciation of all cultural distinctions, leading to optimal health outcomes.”
- Collaborate with local refugee resettlement groups and other public and private sector organizations, such as schools, health systems, and social services, to “facilitate the integration of children and families into their communities and to help families meet unmet needs.”
- Receive special preparation before working with refugees in camps or in conflict settings to become familiar with recognized standards for child protection and to better manage the physical, sexual, and psychological injuries caused by armed conflict.
The policy statement goes on to offer recommendations for systems that serve children exposed to armed conflict, advising that such systems should protect exposed children from abuse and exploitation, and offer access to physical, mental, behavioral, developmental, oral, and rehabilitation health services.
Finally, the AAP stressed its support of policies that advance the health, development, well-being, and rights of children affected by armed conflict and displacement. The AAP states that children should not be separated from their families during displacement and resettlement, emphasizing that “an intact family is the optimal environment for children’s health and well-being” and that “in the event of separation, family reunification should be prioritized.”
In addition, the AAP strongly advocates that children affected by armed conflict have access to educational opportunities, noting that pediatricians can act as a voice toward this end.
“There is strong evidence to suggest that education for boys and girls at all levels reduces most forms of political violence,” the authors wrote. “However, education currently receives less than 2% of all humanitarian funding, and girls are more likely than boys to be excluded from education. Because education is a priority for many children and essential for their well-being, child health providers may advocate for their educational rights and access, especially during humanitarian emergencies.”
SOURCE: Shenoda S et al. Pediatrics. 2018 Nov 5. doi: 10.1542/peds.2018.2586.
The new policy by the American Academy of Pediatrics regarding the effects of armed conflict on children is an important and interesting statement. At first look, someone reading statements like “children should be protected from land mines” might easily conclude that what is contained here is simply common sense guidelines.
On an individual level, the statement also urges individual child health professionals to consider getting out of their comfort zone and become more involved in community organizations, advocacy, and public policy. It also directly states that child health professionals should be prepared to diagnose and treat several mental health conditions that many might not consider in their current scope of practice. This is an important point, especially considering that stigma surrounding mental health treatment in many developing countries is even worse than it is in the United States – which means that primary care plays a crucial role in identification and treatment of these conditions.
David C. Rettew, MD , is an associate professor of psychiatry and pediatrics and director of child and adolescent psychiatry at the University of Vermont’s Center for Children, Youth, and Families in Burlington, Vt. These comments were taken from an interview with Dr. Rettew for this article.
The new policy by the American Academy of Pediatrics regarding the effects of armed conflict on children is an important and interesting statement. At first look, someone reading statements like “children should be protected from land mines” might easily conclude that what is contained here is simply common sense guidelines.
On an individual level, the statement also urges individual child health professionals to consider getting out of their comfort zone and become more involved in community organizations, advocacy, and public policy. It also directly states that child health professionals should be prepared to diagnose and treat several mental health conditions that many might not consider in their current scope of practice. This is an important point, especially considering that stigma surrounding mental health treatment in many developing countries is even worse than it is in the United States – which means that primary care plays a crucial role in identification and treatment of these conditions.
David C. Rettew, MD , is an associate professor of psychiatry and pediatrics and director of child and adolescent psychiatry at the University of Vermont’s Center for Children, Youth, and Families in Burlington, Vt. These comments were taken from an interview with Dr. Rettew for this article.
The new policy by the American Academy of Pediatrics regarding the effects of armed conflict on children is an important and interesting statement. At first look, someone reading statements like “children should be protected from land mines” might easily conclude that what is contained here is simply common sense guidelines.
On an individual level, the statement also urges individual child health professionals to consider getting out of their comfort zone and become more involved in community organizations, advocacy, and public policy. It also directly states that child health professionals should be prepared to diagnose and treat several mental health conditions that many might not consider in their current scope of practice. This is an important point, especially considering that stigma surrounding mental health treatment in many developing countries is even worse than it is in the United States – which means that primary care plays a crucial role in identification and treatment of these conditions.
David C. Rettew, MD , is an associate professor of psychiatry and pediatrics and director of child and adolescent psychiatry at the University of Vermont’s Center for Children, Youth, and Families in Burlington, Vt. These comments were taken from an interview with Dr. Rettew for this article.
Pediatricians have a central role in addressing the impact to children caused by armed conflict, including diagnosing and managing health conditions resulting from exposure to associated violence, according to a new American Academy of Pediatrics policy statement.
The recommendation, published in Pediatrics, emphasizes the need for child health professionals to understand the prevalence of armed conflict and its pervasive effects on children and to respond both domestically and globally to the problem. The AAP defines armed conflict as any organized dispute that involves the use of weapons, violence, or force, such as international wars, civil wars, ethnic conflicts, and violence associated with gangs and drug trafficking. Children effected by armed conflict may include refugees forcibly displaced from their countries, unaccompanied immigrant children, and former child combatants, known as child soldiers.
The policy details the various health effects triggered by armed conflict, including physical, mental, developmental, and behavioral health conditions in children as well as indirect effects through deprivation and toxic stress. Children affected by armed conflict, for example, are at increased risk for PTSD, depression, anxiety, and behavioral and psychosomatic problems, which can continue well into adulthood, according to the policy statement.
To address these effects, pediatricians should receive training on trauma-informed care that enables them to recognize the dynamics of traumatic life experiences among children exposed to armed conflict and provide optimal responses, the policy advises.
and can work to mitigate the effects of trauma, according to the policy. The AAP recommends that child health professionals be prepared to diagnose and offer initial management for conditions associated with exposure to armed conflict as well as partner with community mental and behavioral health providers to establish collaborative care networks, when possible. Other AAP recommendations in the policy statement include that child health professionals:
- Be trained to provide “culturally effective care,” defined as “the delivery of care within the context of appropriate physician knowledge, understanding, and appreciation of all cultural distinctions, leading to optimal health outcomes.”
- Collaborate with local refugee resettlement groups and other public and private sector organizations, such as schools, health systems, and social services, to “facilitate the integration of children and families into their communities and to help families meet unmet needs.”
- Receive special preparation before working with refugees in camps or in conflict settings to become familiar with recognized standards for child protection and to better manage the physical, sexual, and psychological injuries caused by armed conflict.
The policy statement goes on to offer recommendations for systems that serve children exposed to armed conflict, advising that such systems should protect exposed children from abuse and exploitation, and offer access to physical, mental, behavioral, developmental, oral, and rehabilitation health services.
Finally, the AAP stressed its support of policies that advance the health, development, well-being, and rights of children affected by armed conflict and displacement. The AAP states that children should not be separated from their families during displacement and resettlement, emphasizing that “an intact family is the optimal environment for children’s health and well-being” and that “in the event of separation, family reunification should be prioritized.”
In addition, the AAP strongly advocates that children affected by armed conflict have access to educational opportunities, noting that pediatricians can act as a voice toward this end.
“There is strong evidence to suggest that education for boys and girls at all levels reduces most forms of political violence,” the authors wrote. “However, education currently receives less than 2% of all humanitarian funding, and girls are more likely than boys to be excluded from education. Because education is a priority for many children and essential for their well-being, child health providers may advocate for their educational rights and access, especially during humanitarian emergencies.”
SOURCE: Shenoda S et al. Pediatrics. 2018 Nov 5. doi: 10.1542/peds.2018.2586.
Pediatricians have a central role in addressing the impact to children caused by armed conflict, including diagnosing and managing health conditions resulting from exposure to associated violence, according to a new American Academy of Pediatrics policy statement.
The recommendation, published in Pediatrics, emphasizes the need for child health professionals to understand the prevalence of armed conflict and its pervasive effects on children and to respond both domestically and globally to the problem. The AAP defines armed conflict as any organized dispute that involves the use of weapons, violence, or force, such as international wars, civil wars, ethnic conflicts, and violence associated with gangs and drug trafficking. Children effected by armed conflict may include refugees forcibly displaced from their countries, unaccompanied immigrant children, and former child combatants, known as child soldiers.
The policy details the various health effects triggered by armed conflict, including physical, mental, developmental, and behavioral health conditions in children as well as indirect effects through deprivation and toxic stress. Children affected by armed conflict, for example, are at increased risk for PTSD, depression, anxiety, and behavioral and psychosomatic problems, which can continue well into adulthood, according to the policy statement.
To address these effects, pediatricians should receive training on trauma-informed care that enables them to recognize the dynamics of traumatic life experiences among children exposed to armed conflict and provide optimal responses, the policy advises.
and can work to mitigate the effects of trauma, according to the policy. The AAP recommends that child health professionals be prepared to diagnose and offer initial management for conditions associated with exposure to armed conflict as well as partner with community mental and behavioral health providers to establish collaborative care networks, when possible. Other AAP recommendations in the policy statement include that child health professionals:
- Be trained to provide “culturally effective care,” defined as “the delivery of care within the context of appropriate physician knowledge, understanding, and appreciation of all cultural distinctions, leading to optimal health outcomes.”
- Collaborate with local refugee resettlement groups and other public and private sector organizations, such as schools, health systems, and social services, to “facilitate the integration of children and families into their communities and to help families meet unmet needs.”
- Receive special preparation before working with refugees in camps or in conflict settings to become familiar with recognized standards for child protection and to better manage the physical, sexual, and psychological injuries caused by armed conflict.
The policy statement goes on to offer recommendations for systems that serve children exposed to armed conflict, advising that such systems should protect exposed children from abuse and exploitation, and offer access to physical, mental, behavioral, developmental, oral, and rehabilitation health services.
Finally, the AAP stressed its support of policies that advance the health, development, well-being, and rights of children affected by armed conflict and displacement. The AAP states that children should not be separated from their families during displacement and resettlement, emphasizing that “an intact family is the optimal environment for children’s health and well-being” and that “in the event of separation, family reunification should be prioritized.”
In addition, the AAP strongly advocates that children affected by armed conflict have access to educational opportunities, noting that pediatricians can act as a voice toward this end.
“There is strong evidence to suggest that education for boys and girls at all levels reduces most forms of political violence,” the authors wrote. “However, education currently receives less than 2% of all humanitarian funding, and girls are more likely than boys to be excluded from education. Because education is a priority for many children and essential for their well-being, child health providers may advocate for their educational rights and access, especially during humanitarian emergencies.”
SOURCE: Shenoda S et al. Pediatrics. 2018 Nov 5. doi: 10.1542/peds.2018.2586.
FROM PEDIATRICS
Guideline authors inconsistently disclose conflicts
Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.
In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.
The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.
Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.
Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.
Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.
The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.
Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.
In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.
Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).
However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.
The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.
None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.
However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.
Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.
“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).
Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.
None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.
However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.
Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.
“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).
Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.
None of the guidelines included in either study was fully compliant with National Academy of Medicine standards, which include written disclosure, appointing committee chairs or cochairs with no conflicts of interest, and keeping committee members with conflicts to a minority of the committee membership, wrote Colette DeJong, MD, and Robert Steinbrook, MD, in an accompanying editorial. In the study by Khan et al., “Notably, 14 of the 18 panels had chairs with industry payments, and 10 had a majority of members with payments,” they wrote.
However, the federal government has so far shown no interest in supporting a fully independent entity to develop clinical practice guidelines, as occurs in the United Kingdom via the National Institute for Health and Care Excellence. “Preparation of guidelines by an independent public body with assured funding and independence could be an effective approach, not only for eliminating issues related to financial conflicts of interest but also for assuring the use of rigorous methodologies and avoiding the wasteful duplication of efforts by multiple committees,” they wrote.
Financial conflicts in clinical practice guidelines persist in the United States in part because many professional societies have financial conflicts with industry, the editorialists wrote.
“Robust, objective, and unbiased clinical practice guidelines support improvements in patient care; the best interests of patients are the paramount consideration,” they emphasized (JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4974).
Dr. DeJong is affiliated with the University of California, San Francisco; Dr. Steinbrook is Editor at Large for JAMA Internal Medicine. They had no financial conflicts to disclose.
Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.
In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.
The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.
Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.
Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.
Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.
The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.
Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.
In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.
Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).
However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.
The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.
Financial conflicts are often underreported by authors of clinical practice guidelines (CPGs) in several specialties including oncology, rheumatology, and gastroenterology, according to a pair of research letters published in JAMA Internal Medicine. The Institute of Medicine recommends that guideline authors include no more than 50% individuals with financial conflicts.
In one research letter, Rishad Khan, BSc, of the University of Toronto in Ontario and his colleagues reviewed data on undeclared financial conflicts of interest among authors of guidelines related to high-revenue medications.
The researchers identified CPGs via the National Guideline Clearinghouse and selected 18 CPGs for 10 high-revenue medications published between 2013 and 2017. Financial conflicts of interest were based on the Centers for Medicare & Medicaid Services Open Payments.
Of the 160 authors involved in the various guidelines, 79 (49.4%) disclosed a payment in the CPG or supplemental materials, and 50 (31.3%) disclosed payments from companies marketing 1 of the 10 high-revenue medications in the related guidelines.
Another 41 authors (25.6%) received but did not disclose payments from companies marketing 1 of the 10 high-revenue medications in CPGs.
Overall, 91 authors (56.9%) were found to have financial conflicts of interest that involved 1 of the 10 high-revenue medications, and “the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40,444) from two companies,” the researchers said.
The study findings were limited by several factors including “potential inaccuracies in CMS-OP reporting, which are rarely corrected, and lack of generalizability outside the United States” and by the limited time frame for data collection, which may have led to underestimation of conflicts for the guidelines, the researchers noted. In addition, “we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting,” they said.
Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals.
In a second research letter, half of the authors of gastroenterology guidelines received payments from industry, wrote Tyler Combs, BS, of Oklahoma State University, Tulsa, and his colleagues. Previous studies have reviewed the financial conflicts of interest in specialties including oncology, dermatology, and otolaryngology, but financial conflicts of interest among authors of gastroenterology guidelines have not been examined, the researchers said.
Mr. Combs and his colleagues identified 15 CPGs published by the American College of Gastroenterology between 2014 and 2016. They identified 83 authors, with an average of 4 authors for each guideline. Overall, 53% of the authors received industry payments, according to based on data from the 2014 to 2016 Centers for Medicare and Medicaid Services Open Payments database (OPD).
However, OPD information was not always consistent with information published with the guidelines, the researchers noted. They found that 16 (19%) of the 83 authors both disclosed financial conflicts of interests in the CPGs and had received payments according to OPD or had disclosed no financial conflicts of interest and had received no payments according to OPD. In addition, 49 (34%) of 146 cumulative financial conflicts of interest disclosed in the CPGs and 148 relationships identified on OPD were both disclosed as financial conflicts of interest and evidenced by OPD payment records. In this review, the median total payment was $1,000, with an interquartile range from $0 to $39,938.
The study findings were limited by a relatively short 12-month time frame, the researchers noted. However, “our finding that FCOI [financial conflicts of interest] disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG [American College of Gastroenterology] may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs,” they said.
The researchers had no financial conflicts to disclose.
SOURCE: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Financial conflicts of interest in the development of clinical guidelines persist in the United States.
Major finding: Approximately half of the committee members of guidelines in both studies had financial relationships; many were undisclosed and involved substantial payments.
Study details: The data come from two research letters, including 15 gastroenterology guidelines and 18 guidelines from multiple specialties.
Disclosures: Mr. Khan disclosed research funding from AbbVie and Ferring Pharmaceuticals. Mr. Combs had no financial conflicts to disclose.
Source: Combs T et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.4730. Khan R et al. JAMA Intern Med. 2018 Oct 29. doi: 10.1001/jamainternmed.2018.5106.
Palliative care update highlights role of nonspecialists
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
ACR readies first-ever guidelines on managing reproductive health in rheumatology
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
CHICAGO – Help is on the way for rheumatologists who may feel out of their depth regarding reproductive health issues in their patients.
for internal review in draft form. Lisa R. Sammaritano, MD, a leader of the expert panel that developed the evidence-based recommendations, shared highlights of the forthcoming guidelines at the annual meeting of the American College of Rheumatology.
“Our patients, fortunately, are pursuing pregnancy more often now than in years past. One of the key messages of the guidelines is that patients really do want to discuss these topics with their rheumatologist, even though that often does not happen now. What patients told us [in the guideline-development process] is their rheumatologist knows them better than their gynecologist or any of their other doctors because we have followed them for a long period of time and we understand their disease and their symptoms. They really want our input on questions about contraception, when to plan a pregnancy, and medication use,” said Dr. Sammaritano of the Hospital for Special Surgery and Cornell University in New York.
The guidelines were created over the course of a year and a half with extensive input from ob.gyns., as well as a patient panel. The project included a systematic review of more than 300 published studies in which guideline panelists attempt to find answers to an initial list of 370 questions. Dr. Sammaritano predicted that the guidelines will prove to be useful not only for rheumatologists, but for their colleagues in ob.gyn. as well. Just as rheumatologists likely haven’t kept up with the sea changes that have occurred in ob.gyn. since their medical school days, most ob.gyns. know little about rheumatic diseases.
“There’s room for education on both sides,” she observed in an interview. “I have had to write letters to gynecologists to get them to put my patients with antiphospholipid antibodies on a contraceptive that includes a progestin because the labeling says, ‘May increase risk of thrombosis.’ And yet if you look at the literature, most of the progestins do not increase the risk of thrombosis, even in patients who are already at increased risk because of a genetic prothrombotic abnormality. I practically had to sign my life away to get a gynecologist to put a progestin-containing IUD in my patient, whereas the risk of thrombosis to my patient with an unplanned pregnancy would have been 10-fold or 100-fold higher. Unplanned pregnancy is dangerous for patients with our diseases.”
And yet, she noted, half of all pregnancies in the United States are unplanned. Among women with rheumatic diseases, the proportion may well be even higher in light of their documented low rate of utilization of effective contraception.
A publication date for the guidelines won’t be set until the review is completed, but the plan is to issue three separate documents. One will address reproductive health outside of pregnancy, with key topics to include contraception, fertility preservation, menopause, and hormone replacement therapy. The second document will focus on pregnancy management, with special attention devoted to women with lupus or antiphospholipid antibodies because they are at particularly high risk of adverse pregnancy outcomes. The third document will be devoted to medications, covering issues including which medications can be continued during pregnancy and when to safely stop the ones that can’t. This section will address both maternal and paternal use of rheumatologic medications, the latter being a topic below the radar of ob.gyns.
The three medications whose paternal use in pregnancy generate the most questions in clinical practice are methotrexate, cyclophosphamide, and sulfasalazine.
“I cannot tell you how many times I’ve been asked whether male patients with rheumatic diseases need to stop their methotrexate before they plan to father a child – that’s been a big one. The answer is they don’t need to stop, but that’s a conditional recommendation because the product label still says to stop it 3 months before. But that’s based on theoretical concerns, and all the data support a lack of teratogenicity for men using methotrexate prior to and during pregnancy,” Dr. Sammaritano said.
Men on cyclophosphamide absolutely have to stop the drug 3 months before pregnancy because the drug causes DNA fragmentation in the sperm. Sulfasalazine is known to impair male fertility. The ACR guidelines will recommend that men continue the drug, but if pregnancy doesn’t occur within a reasonable time, then it’s appropriate to get a semen analysis rather than stopping sulfasalazine unnecessarily.
American College of Obstetricians and Gynecologists guidelines now recommend long-acting reversible contraception, including IUDs and progestin implants, as first-line contraception for all women. The ACR draft guidelines strongly recommend the same.
“That is new. The use of this form of contraception in women with rheumatic diseases is quite low. In general, our patients don’t use contraception as often as other women, and when they do, they don’t use effective contraception. There are many theories as to why that may be: perhaps it’s a focus on the more immediate issues of their rheumatic disease that doesn’t allow their rheumatologist to get to the point of discussing contraception,” according to Dr. Sammaritano.
Many rheumatologists will be pleasantly surprised to learn that the problem of increased risk of pelvic inflammatory disease associated with earlier-generation IUDs is no longer an issue with the current devices. And contrary to a misconception among some ob.gyns., autoimmune disease will not cause a woman to reject her IUD.
The ACR guidelines recommend continuing hydroxychloroquine in lupus patients during pregnancy – and considering starting the drug in those not already on it – because of strong evidence supporting both safety and benefit for mother and baby.
“We are recommending the use of low-dose aspirin for patients with lupus and antiphospholipid antibodies because those two conditions increase the risk for preeclampsia, and the ob.gyns. routinely use low-dose aspirin starting toward the end of the first trimester as preventive therapy. Large studies show that it reduces the risk,” she continued.
Dr. Sammaritano cautioned that the literature on the use of rheumatologic medications in pregnancy and breast feeding is generally weak – and in the case of the new oral small molecule JAK inhibitors, essentially nonexistent.
“A lot of our recommendations are conditional because we did not feel that the data support a strong recommendation. But you have to do something. As long as you communicate the idea that we’re doing the best we can with what information is available, I think patients will respond to that,” the rheumatologist said.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM THE ACR ANNUAL MEETING
Moderate hypofractionation preferred in new guideline for localized PC
Moderate hypofractionation is preferred over conventional fractionation in treatment of patients with localized prostate cancer who are candidates for external beam radiotherapy (EBRT), according to new a clinical practice guideline.
A meta-analysis of randomized clinical trials showed that moderate fractionation delivered the same efficacy as did conventional fractionation with a mild increase in gastrointestinal toxicity, reported lead author Scott C. Morgan, MD of OSF Medical Group in Bloomington, Illinois, and his colleagues. The drawback of toxicity is outweighed by distinct advantages in resource utilization and patient convenience, which make moderate hypofractionation the winning choice.
For many types of cancer, a shift toward fewer fractions of higher radiation is ongoing, driven largely by technological advances in radiation planning and delivery.
“Technical advances have permitted more precise and conformal delivery of escalated doses of radiation to the prostate, thereby improving the therapeutic ratio,” the authors wrote in the Journal of Clinical Oncology.
Fractionation is typically limited by adjacent tissue sensitivity, but prostate tumors are more sensitive to radiation than the rectum, allowing for higher doses of radiation without damaging healthy tissue. While conventional fractionation doses are between 180 and 200 cGy, moderate hypofractionation delivers doses of 240-340 cGy. Ultrahypofractionation is defined by doses equal to or greater than 500 cGy (the upper limit of the linear-quadratic model of cell survival).
The present guideline was developed through a 2-year, collaborative effort between the American Society of Radiation Oncology, the Society of Clinical Oncology, and the American Urological Association. Task force members included urologic surgeons and oncologists, medical physicists, and radiation oncologists from academic and nonacademic settings. A patient representative and radiation oncology resident also were involved. After completing a systematic literature review, the team developed recommendations with varying degrees of strength. Supporting evidence quality and level of consensus also were described.
Of note, the guideline calls for moderate hypofractionation for patients with localized prostate cancer regardless of urinary function, anatomy, comorbidity, or age, with or without radiation to the seminal vesicles. Along with this recommendation, clinicians should discuss with patients the small increased risk of acute gastrointestinal toxicity, compared with conventional fractionation and the limited follow-up time in most relevant clinical trials (often less than 5 years).
The guideline conveyed more skepticism regarding ultrahypofractionation because of a lack of supporting evidence and comparative trials. As such, the authors conditionally recommended ultrahypofractionation for low-risk and intermediate patients, the latter of whom should be encouraged to enter clinical trials.
“The conditional recommendations regarding ultrahypofractionation underscore the importance of shared decision making between clinicians and patients in this setting,” the authors wrote. “The decision to use ultrahypofractionated EBRT at this time should follow a detailed discussion of the existing uncertainties in the risk-benefit balance associated with this treatment approach and should be informed at all stages by the patient’s values and preferences.”
The authors reported financial affiliations with Amgen, GlaxoSmithKline, Bristol-Myers Squibb, and others.
SOURCE: Morgan et al. J Clin Oncol. 2018 Oct 11. doi: 10.1200/JCO.18.01097.
Moderate hypofractionation is preferred over conventional fractionation in treatment of patients with localized prostate cancer who are candidates for external beam radiotherapy (EBRT), according to new a clinical practice guideline.
A meta-analysis of randomized clinical trials showed that moderate fractionation delivered the same efficacy as did conventional fractionation with a mild increase in gastrointestinal toxicity, reported lead author Scott C. Morgan, MD of OSF Medical Group in Bloomington, Illinois, and his colleagues. The drawback of toxicity is outweighed by distinct advantages in resource utilization and patient convenience, which make moderate hypofractionation the winning choice.
For many types of cancer, a shift toward fewer fractions of higher radiation is ongoing, driven largely by technological advances in radiation planning and delivery.
“Technical advances have permitted more precise and conformal delivery of escalated doses of radiation to the prostate, thereby improving the therapeutic ratio,” the authors wrote in the Journal of Clinical Oncology.
Fractionation is typically limited by adjacent tissue sensitivity, but prostate tumors are more sensitive to radiation than the rectum, allowing for higher doses of radiation without damaging healthy tissue. While conventional fractionation doses are between 180 and 200 cGy, moderate hypofractionation delivers doses of 240-340 cGy. Ultrahypofractionation is defined by doses equal to or greater than 500 cGy (the upper limit of the linear-quadratic model of cell survival).
The present guideline was developed through a 2-year, collaborative effort between the American Society of Radiation Oncology, the Society of Clinical Oncology, and the American Urological Association. Task force members included urologic surgeons and oncologists, medical physicists, and radiation oncologists from academic and nonacademic settings. A patient representative and radiation oncology resident also were involved. After completing a systematic literature review, the team developed recommendations with varying degrees of strength. Supporting evidence quality and level of consensus also were described.
Of note, the guideline calls for moderate hypofractionation for patients with localized prostate cancer regardless of urinary function, anatomy, comorbidity, or age, with or without radiation to the seminal vesicles. Along with this recommendation, clinicians should discuss with patients the small increased risk of acute gastrointestinal toxicity, compared with conventional fractionation and the limited follow-up time in most relevant clinical trials (often less than 5 years).
The guideline conveyed more skepticism regarding ultrahypofractionation because of a lack of supporting evidence and comparative trials. As such, the authors conditionally recommended ultrahypofractionation for low-risk and intermediate patients, the latter of whom should be encouraged to enter clinical trials.
“The conditional recommendations regarding ultrahypofractionation underscore the importance of shared decision making between clinicians and patients in this setting,” the authors wrote. “The decision to use ultrahypofractionated EBRT at this time should follow a detailed discussion of the existing uncertainties in the risk-benefit balance associated with this treatment approach and should be informed at all stages by the patient’s values and preferences.”
The authors reported financial affiliations with Amgen, GlaxoSmithKline, Bristol-Myers Squibb, and others.
SOURCE: Morgan et al. J Clin Oncol. 2018 Oct 11. doi: 10.1200/JCO.18.01097.
Moderate hypofractionation is preferred over conventional fractionation in treatment of patients with localized prostate cancer who are candidates for external beam radiotherapy (EBRT), according to new a clinical practice guideline.
A meta-analysis of randomized clinical trials showed that moderate fractionation delivered the same efficacy as did conventional fractionation with a mild increase in gastrointestinal toxicity, reported lead author Scott C. Morgan, MD of OSF Medical Group in Bloomington, Illinois, and his colleagues. The drawback of toxicity is outweighed by distinct advantages in resource utilization and patient convenience, which make moderate hypofractionation the winning choice.
For many types of cancer, a shift toward fewer fractions of higher radiation is ongoing, driven largely by technological advances in radiation planning and delivery.
“Technical advances have permitted more precise and conformal delivery of escalated doses of radiation to the prostate, thereby improving the therapeutic ratio,” the authors wrote in the Journal of Clinical Oncology.
Fractionation is typically limited by adjacent tissue sensitivity, but prostate tumors are more sensitive to radiation than the rectum, allowing for higher doses of radiation without damaging healthy tissue. While conventional fractionation doses are between 180 and 200 cGy, moderate hypofractionation delivers doses of 240-340 cGy. Ultrahypofractionation is defined by doses equal to or greater than 500 cGy (the upper limit of the linear-quadratic model of cell survival).
The present guideline was developed through a 2-year, collaborative effort between the American Society of Radiation Oncology, the Society of Clinical Oncology, and the American Urological Association. Task force members included urologic surgeons and oncologists, medical physicists, and radiation oncologists from academic and nonacademic settings. A patient representative and radiation oncology resident also were involved. After completing a systematic literature review, the team developed recommendations with varying degrees of strength. Supporting evidence quality and level of consensus also were described.
Of note, the guideline calls for moderate hypofractionation for patients with localized prostate cancer regardless of urinary function, anatomy, comorbidity, or age, with or without radiation to the seminal vesicles. Along with this recommendation, clinicians should discuss with patients the small increased risk of acute gastrointestinal toxicity, compared with conventional fractionation and the limited follow-up time in most relevant clinical trials (often less than 5 years).
The guideline conveyed more skepticism regarding ultrahypofractionation because of a lack of supporting evidence and comparative trials. As such, the authors conditionally recommended ultrahypofractionation for low-risk and intermediate patients, the latter of whom should be encouraged to enter clinical trials.
“The conditional recommendations regarding ultrahypofractionation underscore the importance of shared decision making between clinicians and patients in this setting,” the authors wrote. “The decision to use ultrahypofractionated EBRT at this time should follow a detailed discussion of the existing uncertainties in the risk-benefit balance associated with this treatment approach and should be informed at all stages by the patient’s values and preferences.”
The authors reported financial affiliations with Amgen, GlaxoSmithKline, Bristol-Myers Squibb, and others.
SOURCE: Morgan et al. J Clin Oncol. 2018 Oct 11. doi: 10.1200/JCO.18.01097.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Moderate hypofractionation is preferred over conventional fractionation in treatment of patients with localized prostate cancer who are candidates for external beam radiotherapy (EBRT).
Major finding: The guideline panel reached a 94% consensus for the recommendation of moderate hypofractionation over conventional fractionation regardless of urinary function, anatomy, comorbidity, or age.
Study details: An evidence-based clinical practice guideline developed by the American Society of Radiation Oncology (ASTRO), the American Society of Clinical Oncology (ASCO), and the American Urological Association (AUA).
Disclosures: The authors reported financial affiliations with Amgen, GlaxoSmithKline, Bristol-Myers Squibb, and others.
Source: Morgan et al. J Clin Oncol. 2018 Oct 11. doi: 10.1200/JCO.18.01097.
Guidelines outline patient-centered approach to type 2 diabetes
issued jointly by the American Diabetes Association and the European Association for the Study of Diabetes.
The 2018 ADA/EASD Consensus Report also addresses clinical inertia and notes that medication adherence and persistence should be facilitated. All patients should be offered ongoing self-management education and support, Melanie J. Davies, MD, one of the two cochairs of the report-writing committee, said during a press conference at the annual meeting of the European Association for the Study of Diabetes.
The report also addresses preferred choices for glucose-lowering medications, largely based on recent findings of large-scale cardiovascular outcomes trials. There also is specific guidance on how to manage hyperglycemia in patients with atherosclerotic cardiovascular disease, chronic kidney disease, and heart failure.
“The consensus report focuses on not what an individual’s glycemic target should be or how to individualize goals but really addresses how each patient can achieve their individualized glycemic target,” Dr. Davies said.
Dr. Davies, who is professor of diabetes medicine at the University of Leicester (England) and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust also said that the report looked at taking patient factors and preferences into account but also considered “the ever-increasing complexity around the availability of glucose-lowering agents.”
Practical guide to managing patients
The consensus report, which was simultaneously published in the official journals of the ADA (Diabetes Care 2018 Sep; dci180033) and the EASD (Diabetologia. 2018 Sep. doi: 10.1007/s00125-018-4729-5) to coincide with its presentation at the EASD meeting, is much more visual and aims to be more of a practical aid than was the previous position statement from 2015 (Diabetologia. 2015 Mar;58:429-42; Diabetes Care 2015 Jan;38[1]:140-9), on which it was based, Dr. Davies said.
The patient has been placed firmly at the center of the decision cycle, she observed, which starts with assessment of patient characteristics and consideration of their lifestyle, comorbidities, and clinical parameters. Specific factors that may affect the choice of treatment, such as the individualized glycosylated hemoglobin (HbA1c) target or side effect profiles of medications, are included, as is working together with the patient to make, continually monitor, and reevaluate a shared decision plan.
In terms of lifestyle, one of the consensus recommendations is that “an individualized program of medical nutritional therapy should be offered to all patients,” with the more specific recommendation that those who are overweight or obese be advised of the health benefits of weight loss and be encouraged to participate in dietary modifications that may include food substitution. Increasing activity is also highly recommended based on long-established evidence that this can help reduce HbA1c level. Recommendations for when to consider bariatric surgery for weight management also are included.
Clarity on treating comorbidities
Previously discussed in June at the ADA’s annual meeting, the consensus report has undergone fine-tuning and multiple revisions. The report was based on a comprehensive and systematic review of the diabetes literature available from 2014 through February 2018. Overall, more than 6,000 randomized trials, reviews, and meta-analyses were considered and distilled down to a list of around 500 papers that were then thoroughly reviewed by an expert panel.
“I guarantee, there’s never been a paper that’s been more peer reviewed,” said John Buse, MD, PhD, the other cochair of the report’s writing committee. A total of 35 named individuals reviewed and provided more than 800 detailed comments among them, which were considered and reflected in the final version.
Dr. Buse is the Verne S. Caviness Distinguished Professor, chief of the division of endocrinology, and director of the diabetes center at the University of North Carolina at Chapel Hill.
“There’s much more clarity now,” added Dr. Davies, referring to the changes made to how patients with comorbidities are managed. If somebody does have atherosclerotic cardiovascular disease or chronic kidney disease, there is now clear direction on which glucose-lowering therapy should be considered first, and what to do if the HbA1c remains above target.
For example, in patients who have established atherosclerotic cardiovascular disease, the recommendation is, after metformin, to choose either a glucagonlike peptide–1 (GLP-1) receptor agonist or a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven cardiovascular benefit.
If heart failure or chronic kidney disease coexist, then an SGLT2 inhibitor shown to reduce their progression should be favored, or if contraindicated or not preferred, a GLP-1 receptor agonist with proven cardiovascular benefit should be given.
The main action, pros and cons of interventions, and the various medications are shown in tables to clearly guide clinicians in the decision-making process, Dr. Buse said.
First-line management
The first line recommended glucose-lowering therapy for hyperglycemia in type 2 diabetes remains metformin, together with comprehensive lifestyle advice, Dr. Buse observed.
“A huge controversy in the [diabetes] community asks, ‘Is metformin the first-line therapy because it’s cheap and was the first oral agent studied and has a long history?’ or is it something that really is based on medical evidence?” Dr. Buse acknowledged. Although combinations of glucose-lowering drugs have been proposed upfront, “the evidence for that is largely from small studies, in limited numbers of sites, such that, for now, we generally recommend starting on a single-agent medication if lifestyle management is not enough to control glucose.”
If there is a need to intensify treatment as the patient’s HbA1c remains above their individualized target, then other drugs may be added to step up the treatment. The consensus report then looks at which drugs might be best to add, based on the need to avoid hypoglycemia, promote weight loss, and/or if cost or availability is a major issue.
If patients need the greater glucose-lowering effects of an injectable medication, a GLP-1 receptor agonist – not insulin – is recommended, Dr. Buse observed. However, for patients with extreme and symptomatic hyperglycemia, insulin is then recommended.
There also is guidance on when to consider oral therapies in conjunction with injectable therapies, with the consensus recommendation stating: Patients who are unable to maintain glycemic targets on basal insulin in combination with oral medication can have treatment intensified with GLP-1 receptor agonists, SGLT2 inhibitors, or prandial insulin.
The ADA perspective
William T. Cefalu, MD, chief scientific, medical and mission officer of the ADA observed that the “ADA fully endorses the ADA/EASD Consensus Report” and had already added a statement on the recommendations into its Standards of Medical Care in Diabetes – 2018 as part of the organization’s Living Standards Update. This was a change made last year to allow real-time updates of practice recommendations based on new and evolving evidence released in between the annual process of updating the Society’s Standards.
“Much, if not all, of these recommendations from this paper will be incorporated into our Standards,” said Dr. Cefalu. “We applaud the authors of the consensus paper; we think this was an outstanding group, and we really feel that this is a paradigm change in diabetes management,” he added. “Instead of relying on the [HbA1c] number in an algorithm, this puts the patient at the center; patient-related factors, patient preferences, adherence, compliance, and more importantly, the underlying disease state … this really is a comprehensive approach to management.”
The stratification of patients by cardiovascular disease, kidney disease, or heart failure is a particularly noteworthy, as is the advice on which agent to choose if weight management is an issue. Finally, there are the considerations of costs of therapy, and what to do if there is the risk of hypoglycemia. “The consensus recommendations and approach to glycemic management in adults with type 2 diabetes presented within the report reflects the current view of the ADA,” Dr. Cefalu confirmed.
The EASD perspective
“The EASD was again delighted to go into cooperation with our colleagues and friends at the ADA because is it is so important to bring out a consensus on where we need to go in this forest of glucose-lowering therapies,” said Chantal Mathieu, MD, PhD, vice-president of the EASD.
“The fact that this consensus paper puts the patient front and center, and makes that an integral part of glucose-lowering therapy, and also that lifestyle is being accentuated again, together with education in every patient is crucial,” Dr. Mathieu, who is professor of medicine at the Katholieke Universiteit Leuven (Belgium), and a coauthor of the report, added.
“At EASD, we also believe that it is very important to bring this consensus paper to life,” she added, which is part of her role as the chair of postgraduate education at the EASD. Two of the EASD’s main remits is to ensure that the results of research and education are brought to the diabetes community at large, she said.
In every figure in the paper there is a highlight to say, “please avoid clinical inertia, reassess and modify treatment if necessary, at least every 3-6 months,” Dr. Mathieu noted during the EASD congress.
David Matthews, MD, professor of diabetic medicine at the University of Oxford (England) and president-elect of the EASD, commented on the 2018 ADA/EASD Consensus Report after its presentation at the EASD meeting. “The reality is that you’ve got to think extremely hard with your patients about what the balances between risks and benefits are,” Dr. Matthews said. “We encourage you to do this, what you have here is a wonderful handbook to guide you in your decision making.”
Dr. Davies reported receiving personal fees and/or grants from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, Intarcia Therapeutics/Servier, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabi, Novo Nordisk, Sanofi, and Takeda.
Dr. Buse disclosed acting as a consultant to and/or receiving research support from Adocia, AstraZeneca, Eli Lilly, GI Dynamics, Intarcia Therapeutics, MannKind, NovaTarg, Neurimmune, Novo Nordisk, Senseonics, and vTv Therapeutics with fees paid to the University of North Carolina. He holds stock options in Mellitus Health, PhaseBio and Stability Health.
Dr. Mathieu disclosed relationships with (advisory boards, speakers bureaus, and/or research support) from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Hanmi Pharmaceuticals, Intrexon, Janssen Pharmaceuticals, MannKind, Medtronic, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, Sanofi, and UCB.
Dr. Cefalu had no disclosures and Dr. Matthews had no relevant conflicts of interest other than becoming the EASD president-elect during the meeting.
issued jointly by the American Diabetes Association and the European Association for the Study of Diabetes.
The 2018 ADA/EASD Consensus Report also addresses clinical inertia and notes that medication adherence and persistence should be facilitated. All patients should be offered ongoing self-management education and support, Melanie J. Davies, MD, one of the two cochairs of the report-writing committee, said during a press conference at the annual meeting of the European Association for the Study of Diabetes.
The report also addresses preferred choices for glucose-lowering medications, largely based on recent findings of large-scale cardiovascular outcomes trials. There also is specific guidance on how to manage hyperglycemia in patients with atherosclerotic cardiovascular disease, chronic kidney disease, and heart failure.
“The consensus report focuses on not what an individual’s glycemic target should be or how to individualize goals but really addresses how each patient can achieve their individualized glycemic target,” Dr. Davies said.
Dr. Davies, who is professor of diabetes medicine at the University of Leicester (England) and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust also said that the report looked at taking patient factors and preferences into account but also considered “the ever-increasing complexity around the availability of glucose-lowering agents.”
Practical guide to managing patients
The consensus report, which was simultaneously published in the official journals of the ADA (Diabetes Care 2018 Sep; dci180033) and the EASD (Diabetologia. 2018 Sep. doi: 10.1007/s00125-018-4729-5) to coincide with its presentation at the EASD meeting, is much more visual and aims to be more of a practical aid than was the previous position statement from 2015 (Diabetologia. 2015 Mar;58:429-42; Diabetes Care 2015 Jan;38[1]:140-9), on which it was based, Dr. Davies said.
The patient has been placed firmly at the center of the decision cycle, she observed, which starts with assessment of patient characteristics and consideration of their lifestyle, comorbidities, and clinical parameters. Specific factors that may affect the choice of treatment, such as the individualized glycosylated hemoglobin (HbA1c) target or side effect profiles of medications, are included, as is working together with the patient to make, continually monitor, and reevaluate a shared decision plan.
In terms of lifestyle, one of the consensus recommendations is that “an individualized program of medical nutritional therapy should be offered to all patients,” with the more specific recommendation that those who are overweight or obese be advised of the health benefits of weight loss and be encouraged to participate in dietary modifications that may include food substitution. Increasing activity is also highly recommended based on long-established evidence that this can help reduce HbA1c level. Recommendations for when to consider bariatric surgery for weight management also are included.
Clarity on treating comorbidities
Previously discussed in June at the ADA’s annual meeting, the consensus report has undergone fine-tuning and multiple revisions. The report was based on a comprehensive and systematic review of the diabetes literature available from 2014 through February 2018. Overall, more than 6,000 randomized trials, reviews, and meta-analyses were considered and distilled down to a list of around 500 papers that were then thoroughly reviewed by an expert panel.
“I guarantee, there’s never been a paper that’s been more peer reviewed,” said John Buse, MD, PhD, the other cochair of the report’s writing committee. A total of 35 named individuals reviewed and provided more than 800 detailed comments among them, which were considered and reflected in the final version.
Dr. Buse is the Verne S. Caviness Distinguished Professor, chief of the division of endocrinology, and director of the diabetes center at the University of North Carolina at Chapel Hill.
“There’s much more clarity now,” added Dr. Davies, referring to the changes made to how patients with comorbidities are managed. If somebody does have atherosclerotic cardiovascular disease or chronic kidney disease, there is now clear direction on which glucose-lowering therapy should be considered first, and what to do if the HbA1c remains above target.
For example, in patients who have established atherosclerotic cardiovascular disease, the recommendation is, after metformin, to choose either a glucagonlike peptide–1 (GLP-1) receptor agonist or a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven cardiovascular benefit.
If heart failure or chronic kidney disease coexist, then an SGLT2 inhibitor shown to reduce their progression should be favored, or if contraindicated or not preferred, a GLP-1 receptor agonist with proven cardiovascular benefit should be given.
The main action, pros and cons of interventions, and the various medications are shown in tables to clearly guide clinicians in the decision-making process, Dr. Buse said.
First-line management
The first line recommended glucose-lowering therapy for hyperglycemia in type 2 diabetes remains metformin, together with comprehensive lifestyle advice, Dr. Buse observed.
“A huge controversy in the [diabetes] community asks, ‘Is metformin the first-line therapy because it’s cheap and was the first oral agent studied and has a long history?’ or is it something that really is based on medical evidence?” Dr. Buse acknowledged. Although combinations of glucose-lowering drugs have been proposed upfront, “the evidence for that is largely from small studies, in limited numbers of sites, such that, for now, we generally recommend starting on a single-agent medication if lifestyle management is not enough to control glucose.”
If there is a need to intensify treatment as the patient’s HbA1c remains above their individualized target, then other drugs may be added to step up the treatment. The consensus report then looks at which drugs might be best to add, based on the need to avoid hypoglycemia, promote weight loss, and/or if cost or availability is a major issue.
If patients need the greater glucose-lowering effects of an injectable medication, a GLP-1 receptor agonist – not insulin – is recommended, Dr. Buse observed. However, for patients with extreme and symptomatic hyperglycemia, insulin is then recommended.
There also is guidance on when to consider oral therapies in conjunction with injectable therapies, with the consensus recommendation stating: Patients who are unable to maintain glycemic targets on basal insulin in combination with oral medication can have treatment intensified with GLP-1 receptor agonists, SGLT2 inhibitors, or prandial insulin.
The ADA perspective
William T. Cefalu, MD, chief scientific, medical and mission officer of the ADA observed that the “ADA fully endorses the ADA/EASD Consensus Report” and had already added a statement on the recommendations into its Standards of Medical Care in Diabetes – 2018 as part of the organization’s Living Standards Update. This was a change made last year to allow real-time updates of practice recommendations based on new and evolving evidence released in between the annual process of updating the Society’s Standards.
“Much, if not all, of these recommendations from this paper will be incorporated into our Standards,” said Dr. Cefalu. “We applaud the authors of the consensus paper; we think this was an outstanding group, and we really feel that this is a paradigm change in diabetes management,” he added. “Instead of relying on the [HbA1c] number in an algorithm, this puts the patient at the center; patient-related factors, patient preferences, adherence, compliance, and more importantly, the underlying disease state … this really is a comprehensive approach to management.”
The stratification of patients by cardiovascular disease, kidney disease, or heart failure is a particularly noteworthy, as is the advice on which agent to choose if weight management is an issue. Finally, there are the considerations of costs of therapy, and what to do if there is the risk of hypoglycemia. “The consensus recommendations and approach to glycemic management in adults with type 2 diabetes presented within the report reflects the current view of the ADA,” Dr. Cefalu confirmed.
The EASD perspective
“The EASD was again delighted to go into cooperation with our colleagues and friends at the ADA because is it is so important to bring out a consensus on where we need to go in this forest of glucose-lowering therapies,” said Chantal Mathieu, MD, PhD, vice-president of the EASD.
“The fact that this consensus paper puts the patient front and center, and makes that an integral part of glucose-lowering therapy, and also that lifestyle is being accentuated again, together with education in every patient is crucial,” Dr. Mathieu, who is professor of medicine at the Katholieke Universiteit Leuven (Belgium), and a coauthor of the report, added.
“At EASD, we also believe that it is very important to bring this consensus paper to life,” she added, which is part of her role as the chair of postgraduate education at the EASD. Two of the EASD’s main remits is to ensure that the results of research and education are brought to the diabetes community at large, she said.
In every figure in the paper there is a highlight to say, “please avoid clinical inertia, reassess and modify treatment if necessary, at least every 3-6 months,” Dr. Mathieu noted during the EASD congress.
David Matthews, MD, professor of diabetic medicine at the University of Oxford (England) and president-elect of the EASD, commented on the 2018 ADA/EASD Consensus Report after its presentation at the EASD meeting. “The reality is that you’ve got to think extremely hard with your patients about what the balances between risks and benefits are,” Dr. Matthews said. “We encourage you to do this, what you have here is a wonderful handbook to guide you in your decision making.”
Dr. Davies reported receiving personal fees and/or grants from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, Intarcia Therapeutics/Servier, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabi, Novo Nordisk, Sanofi, and Takeda.
Dr. Buse disclosed acting as a consultant to and/or receiving research support from Adocia, AstraZeneca, Eli Lilly, GI Dynamics, Intarcia Therapeutics, MannKind, NovaTarg, Neurimmune, Novo Nordisk, Senseonics, and vTv Therapeutics with fees paid to the University of North Carolina. He holds stock options in Mellitus Health, PhaseBio and Stability Health.
Dr. Mathieu disclosed relationships with (advisory boards, speakers bureaus, and/or research support) from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Hanmi Pharmaceuticals, Intrexon, Janssen Pharmaceuticals, MannKind, Medtronic, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, Sanofi, and UCB.
Dr. Cefalu had no disclosures and Dr. Matthews had no relevant conflicts of interest other than becoming the EASD president-elect during the meeting.
issued jointly by the American Diabetes Association and the European Association for the Study of Diabetes.
The 2018 ADA/EASD Consensus Report also addresses clinical inertia and notes that medication adherence and persistence should be facilitated. All patients should be offered ongoing self-management education and support, Melanie J. Davies, MD, one of the two cochairs of the report-writing committee, said during a press conference at the annual meeting of the European Association for the Study of Diabetes.
The report also addresses preferred choices for glucose-lowering medications, largely based on recent findings of large-scale cardiovascular outcomes trials. There also is specific guidance on how to manage hyperglycemia in patients with atherosclerotic cardiovascular disease, chronic kidney disease, and heart failure.
“The consensus report focuses on not what an individual’s glycemic target should be or how to individualize goals but really addresses how each patient can achieve their individualized glycemic target,” Dr. Davies said.
Dr. Davies, who is professor of diabetes medicine at the University of Leicester (England) and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust also said that the report looked at taking patient factors and preferences into account but also considered “the ever-increasing complexity around the availability of glucose-lowering agents.”
Practical guide to managing patients
The consensus report, which was simultaneously published in the official journals of the ADA (Diabetes Care 2018 Sep; dci180033) and the EASD (Diabetologia. 2018 Sep. doi: 10.1007/s00125-018-4729-5) to coincide with its presentation at the EASD meeting, is much more visual and aims to be more of a practical aid than was the previous position statement from 2015 (Diabetologia. 2015 Mar;58:429-42; Diabetes Care 2015 Jan;38[1]:140-9), on which it was based, Dr. Davies said.
The patient has been placed firmly at the center of the decision cycle, she observed, which starts with assessment of patient characteristics and consideration of their lifestyle, comorbidities, and clinical parameters. Specific factors that may affect the choice of treatment, such as the individualized glycosylated hemoglobin (HbA1c) target or side effect profiles of medications, are included, as is working together with the patient to make, continually monitor, and reevaluate a shared decision plan.
In terms of lifestyle, one of the consensus recommendations is that “an individualized program of medical nutritional therapy should be offered to all patients,” with the more specific recommendation that those who are overweight or obese be advised of the health benefits of weight loss and be encouraged to participate in dietary modifications that may include food substitution. Increasing activity is also highly recommended based on long-established evidence that this can help reduce HbA1c level. Recommendations for when to consider bariatric surgery for weight management also are included.
Clarity on treating comorbidities
Previously discussed in June at the ADA’s annual meeting, the consensus report has undergone fine-tuning and multiple revisions. The report was based on a comprehensive and systematic review of the diabetes literature available from 2014 through February 2018. Overall, more than 6,000 randomized trials, reviews, and meta-analyses were considered and distilled down to a list of around 500 papers that were then thoroughly reviewed by an expert panel.
“I guarantee, there’s never been a paper that’s been more peer reviewed,” said John Buse, MD, PhD, the other cochair of the report’s writing committee. A total of 35 named individuals reviewed and provided more than 800 detailed comments among them, which were considered and reflected in the final version.
Dr. Buse is the Verne S. Caviness Distinguished Professor, chief of the division of endocrinology, and director of the diabetes center at the University of North Carolina at Chapel Hill.
“There’s much more clarity now,” added Dr. Davies, referring to the changes made to how patients with comorbidities are managed. If somebody does have atherosclerotic cardiovascular disease or chronic kidney disease, there is now clear direction on which glucose-lowering therapy should be considered first, and what to do if the HbA1c remains above target.
For example, in patients who have established atherosclerotic cardiovascular disease, the recommendation is, after metformin, to choose either a glucagonlike peptide–1 (GLP-1) receptor agonist or a sodium-glucose cotransporter 2 (SGLT2) inhibitor with proven cardiovascular benefit.
If heart failure or chronic kidney disease coexist, then an SGLT2 inhibitor shown to reduce their progression should be favored, or if contraindicated or not preferred, a GLP-1 receptor agonist with proven cardiovascular benefit should be given.
The main action, pros and cons of interventions, and the various medications are shown in tables to clearly guide clinicians in the decision-making process, Dr. Buse said.
First-line management
The first line recommended glucose-lowering therapy for hyperglycemia in type 2 diabetes remains metformin, together with comprehensive lifestyle advice, Dr. Buse observed.
“A huge controversy in the [diabetes] community asks, ‘Is metformin the first-line therapy because it’s cheap and was the first oral agent studied and has a long history?’ or is it something that really is based on medical evidence?” Dr. Buse acknowledged. Although combinations of glucose-lowering drugs have been proposed upfront, “the evidence for that is largely from small studies, in limited numbers of sites, such that, for now, we generally recommend starting on a single-agent medication if lifestyle management is not enough to control glucose.”
If there is a need to intensify treatment as the patient’s HbA1c remains above their individualized target, then other drugs may be added to step up the treatment. The consensus report then looks at which drugs might be best to add, based on the need to avoid hypoglycemia, promote weight loss, and/or if cost or availability is a major issue.
If patients need the greater glucose-lowering effects of an injectable medication, a GLP-1 receptor agonist – not insulin – is recommended, Dr. Buse observed. However, for patients with extreme and symptomatic hyperglycemia, insulin is then recommended.
There also is guidance on when to consider oral therapies in conjunction with injectable therapies, with the consensus recommendation stating: Patients who are unable to maintain glycemic targets on basal insulin in combination with oral medication can have treatment intensified with GLP-1 receptor agonists, SGLT2 inhibitors, or prandial insulin.
The ADA perspective
William T. Cefalu, MD, chief scientific, medical and mission officer of the ADA observed that the “ADA fully endorses the ADA/EASD Consensus Report” and had already added a statement on the recommendations into its Standards of Medical Care in Diabetes – 2018 as part of the organization’s Living Standards Update. This was a change made last year to allow real-time updates of practice recommendations based on new and evolving evidence released in between the annual process of updating the Society’s Standards.
“Much, if not all, of these recommendations from this paper will be incorporated into our Standards,” said Dr. Cefalu. “We applaud the authors of the consensus paper; we think this was an outstanding group, and we really feel that this is a paradigm change in diabetes management,” he added. “Instead of relying on the [HbA1c] number in an algorithm, this puts the patient at the center; patient-related factors, patient preferences, adherence, compliance, and more importantly, the underlying disease state … this really is a comprehensive approach to management.”
The stratification of patients by cardiovascular disease, kidney disease, or heart failure is a particularly noteworthy, as is the advice on which agent to choose if weight management is an issue. Finally, there are the considerations of costs of therapy, and what to do if there is the risk of hypoglycemia. “The consensus recommendations and approach to glycemic management in adults with type 2 diabetes presented within the report reflects the current view of the ADA,” Dr. Cefalu confirmed.
The EASD perspective
“The EASD was again delighted to go into cooperation with our colleagues and friends at the ADA because is it is so important to bring out a consensus on where we need to go in this forest of glucose-lowering therapies,” said Chantal Mathieu, MD, PhD, vice-president of the EASD.
“The fact that this consensus paper puts the patient front and center, and makes that an integral part of glucose-lowering therapy, and also that lifestyle is being accentuated again, together with education in every patient is crucial,” Dr. Mathieu, who is professor of medicine at the Katholieke Universiteit Leuven (Belgium), and a coauthor of the report, added.
“At EASD, we also believe that it is very important to bring this consensus paper to life,” she added, which is part of her role as the chair of postgraduate education at the EASD. Two of the EASD’s main remits is to ensure that the results of research and education are brought to the diabetes community at large, she said.
In every figure in the paper there is a highlight to say, “please avoid clinical inertia, reassess and modify treatment if necessary, at least every 3-6 months,” Dr. Mathieu noted during the EASD congress.
David Matthews, MD, professor of diabetic medicine at the University of Oxford (England) and president-elect of the EASD, commented on the 2018 ADA/EASD Consensus Report after its presentation at the EASD meeting. “The reality is that you’ve got to think extremely hard with your patients about what the balances between risks and benefits are,” Dr. Matthews said. “We encourage you to do this, what you have here is a wonderful handbook to guide you in your decision making.”
Dr. Davies reported receiving personal fees and/or grants from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead, Intarcia Therapeutics/Servier, Janssen, Merck Sharp & Dohme, Mitsubishi Tanabi, Novo Nordisk, Sanofi, and Takeda.
Dr. Buse disclosed acting as a consultant to and/or receiving research support from Adocia, AstraZeneca, Eli Lilly, GI Dynamics, Intarcia Therapeutics, MannKind, NovaTarg, Neurimmune, Novo Nordisk, Senseonics, and vTv Therapeutics with fees paid to the University of North Carolina. He holds stock options in Mellitus Health, PhaseBio and Stability Health.
Dr. Mathieu disclosed relationships with (advisory boards, speakers bureaus, and/or research support) from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Hanmi Pharmaceuticals, Intrexon, Janssen Pharmaceuticals, MannKind, Medtronic, MSD, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, Sanofi, and UCB.
Dr. Cefalu had no disclosures and Dr. Matthews had no relevant conflicts of interest other than becoming the EASD president-elect during the meeting.
REPORTING FROM EASD 2018
Endocrine Society updates guidelines for congenital adrenal hyperplasia
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
recently updated by the Endocrine Society.
The guidelines are an update to the 2010 Endocrine Society Clinical Practice Guideline on congenital adrenal hyperplasia (CAH) due to steroid 21-hydroxylase deficiency. They were published in The Journal of Clinical Endocrinology and Metabolism.
Richard J. Auchus, MD, PhD, of the University of Michigan, Ann Arbor, and coauthor of the 2018 guidelines, said many of the guidelines remain the same, such as use of neonatal screening. However, neonatal diagnosis methods should use gestational age and birth weight or liquid chromatography–tandem mass spectrometry for secondary screening. The authors also noted that the addition of commercially available serum 21-deoxycortisol measurements, while untested, could potentially help identify CAH carriers.
Changes in genital reconstructive surgery were also addressed in the new guidelines, and a recent systematic review and meta-analysis found a “favorable benefit to risk ratio” for both early and late genital reconstructive surgery. Dr. Auchus said the timing of the surgery remains controversial and that there were “downsides of both approaches.”
“I wish there was a straightforward and perfect solution, but I don’t think there is,” he said in an interview.
Dexamethasone for the prenatal treatment of CAH, and prenatal therapy in general is still regarded as experimental and is not recommended, Dr. Auchus said. The authors encouraged pregnant women who are considering prenatal treatment of CAH to go through Institutional Review Board–approved centers that can obtain outcomes. Pregnant women should not receive a glucocorticoid that traverses the placenta, such as dexamethasone.
Classical CAH should be treated with hydrocortisone maintenance therapy, while nonclassic CAH patients should receive glucocorticoid treatment, such as in cases of early onset and rapid progression of pubarche or bone age in children and overt virilization in adolescents.
Dr. Auchus said the new guidelines have been reorganized so information is easier to find, with recommendations beginning at birth before transitioning into recommendations for childhood and adulthood.
“I think the pediatric endocrinologists are familiar with the management of this disease, but I think a lot of the internal medicine endocrinologists don’t get much training in fellowships, and I think it will be easy for them now to find the information,” Dr. Auchus said. “[I]n the previous set of guidelines, it would’ve been difficult for them to find the information that’s scattered throughout.”
However, Dr. Auchus noted, the guidelines were careful to avoid recommendations of specific levels for analyzing biomarkers for monitoring treatment and specific doses. “[W]e gave some general ideas about ranges: that they should be low, they should be normal, they should be not very high, but it’s okay if it’s a little bit high,” he added.
Also, the evidence for the recommendations is limited to best practice guidelines because of a lack of randomized controlled trials, he noted.
“We certainly do need additional long-term data on these patients,” Dr. Auchus said. “[I]t’s our hope that with some of the networks that have been developed for studying adrenal diseases that we can collect that information in a minimally intrusive way for the benefit of all the current and future patients.”
The guidelines were funded by the Intramural Research Program of the National Institutes of Health. The authors report various personal and organizational financial interests in the form of paid consultancies, researcher support positions, advisory board memberships and investigator roles. See the full study for a complete list of disclosures.
SOURCE: Speiser PW et al. J Clin Endocrinol Metab. 2018 Sep 27. doi: 10.1210/jc.2018-01865.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM