Clinical Guidelines Hub

Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).

About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.

AGA Institute

Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).

About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.

AGA Institute

Physicians should consistently rule out opioid therapy as the cause of gastrointestinal symptoms, states a new clinical practice update published in the September 2017 issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2017.05.014).

About 4% of Americans receive long-term opioid therapy, primarily for musculoskeletal, postsurgical, or vascular pain, as well as nonsurgical abdominal pain, writes Michael Camilleri, MD, AGAF, of Mayo Clinic in Rochester, Minn., and his associates. Because opioid receptors thickly populate the gastrointestinal tract, exogenous opioids can trigger a variety of gastrointestinal symptoms. Examples include achalasia, gastroparesis, nausea, postsurgical ileus, constipation, and narcotic bowel syndrome.

AGA Institute

New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).

The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.

The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.

From AADE: 10 standards

Diabetes self-management education and support service providers should:

• Adopt a mission statement and goals.

• Adopt ongoing input from stakeholders and experts to improve quality and participation.

• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.

• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.

• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).

• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.

• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.

• Provide options and resources for ongoing support that participants can choose.

• Monitor participants’ progress toward self-management goals and other outcomes.

• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.

New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).

The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.

The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.

From AADE: 10 standards

Diabetes self-management education and support service providers should:

• Adopt a mission statement and goals.

• Adopt ongoing input from stakeholders and experts to improve quality and participation.

• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.

• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.

• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).

• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.

• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.

• Provide options and resources for ongoing support that participants can choose.

• Monitor participants’ progress toward self-management goals and other outcomes.

• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.

New standards for diabetes self-management education and support outline 10 key evidence-based standards for services that meet the Medicare diabetes self-management training regulations, although they do not guarantee coverage. The standards, produced by the American Association of Diabetes Educators in association with the American Diabetes Association, are an update to a similar document produced in 2014. The 2017 revision of the standards is the first to combine support and education to reflect the value of ongoing counsel for improved diabetes self-care, according to an accompanying statement (Diab Care. 2017 Jul 28. doi: 10.2337/dci17-0025).

The new document is full of good recommendations, but they do not cover some important areas. “I don’t disagree with any of them,” said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City School of Medicine (UMKC) and associate program director of the UMKC Endocrine Fellowship. But he pointed out that the standards did not include any mention of integrating patient care with other teams. “I think that’s unfortunate. Certainly in our small diabetes practice, we have certified diabetes educators, and all of our patients see them at some point. I hope in subsequent documents they’ll talk about that more,” said Dr. Hellman.

The paper disclosed no sources of funding or conflict of interest information. Dr. Hellman reported having no financial disclosures.

From AADE: 10 standards

Diabetes self-management education and support service providers should:

• Adopt a mission statement and goals.

• Adopt ongoing input from stakeholders and experts to improve quality and participation.

• Analyze the needs of the communities they serve to ensure the best design, delivery method, and use of resources to meet their needs.

• Employ a quality coordinator to oversee services. This individual should be responsible for evidence-based practice, service design, evaluation, and continuous quality improvement.

• Include at least one registered nurse, registered dietitian nutritionist, or pharmacist with training and experience related to DSMES, or a health care professional with a certificate as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM).

• Employ a curriculum that follows current evidence and practice guidelines, including a means for evaluating outcomes. The specific elements of the curriculum required will depend on the individual participant’s needs.

• Identify the needs of individual participants and be led by the participant, supported by diabetes self-management education and support team members. They should cooperatively develop an individualized diabetes self-management education and support plan.

• Provide options and resources for ongoing support that participants can choose.

• Monitor participants’ progress toward self-management goals and other outcomes.

• Have their quality control coordinators measure the impact and effectiveness of the diabetes self-management education and support services and determine potential improvements by systematically evaluating process and outcome data.

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

Osteoporosis is defined by a clinically diagnosed fragility fracture or a bone mineral density (BMD) of at least 2.5 SD below the mean for young female adults, usually measured by dual-energy x-ray absorptiometry. Risk factors include age, female sex, post-menopause, hypogonadism or premature ovarian failure, history of cigarette smoking or alcohol consumption (3 or more drinks daily), rheumatoid arthritis, or medications including glucocorticoids, anticoagulants, anticonvulsants, and aromatase inhibitors.

This guideline update focuses on treatment with bisphosphonates (alendronate, risedronate, ibandronate, zoledronic acid) and denosumab. Denosumab, a human monoclonal antibody against RANK-ligand, approved by the Food and Drug Administration for treatment of osteoporosis, has been added to the list of allowed medications since publication of the 2008 guideline. Several therapies have been excluded from the update, including calcitonin, which is no longer widely used for osteoporosis treatment, and etidronate and pamidronate, neither of which are FDA-approved for the prevention of fractures or treatment of osteoporosis. It should be noted that the evidence continues to be insufficient regarding the effectiveness of therapies to prevent fractures or to treat osteoporosis in men.

Bottom line:

Clinicians should offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk of hip and vertebral fractures in women who have known osteoporosis diagnosed as a T score less than –2.5 or those with a fragility fracture. Pharmacologic therapy should be used for 5 years; however, high risk patients may benefit from longer treatment. There is no benefit to bone density monitoring during the 5-year pharmacologic treatment period. In addition, bisphosphonates should be considered in men who have clinically recognized osteoporosis.

Reference:

Qaseem, A, Forciea, MA, McLean RM, Denberg TD. Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians. Ann Int Med. 2017;166(11):818-39.
 

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Meizinger is a second year resident in the Family Medicine Residency Program at Abington Jefferson Health.

The international Dementia With Lewy Bodies Consortium has updated its guideline for diagnosing and treating this disease. “The updated clinical criteria and associated biomarkers hopefully will lead to earlier and more accurate diagnosis, and that is key to helping patients confront this challenging illness and maximize their quality of life,” said Bradley Boeve, MD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and a coauthor. The guideline was published online ahead of print June 7 in Neurology.

The new guideline is a refinement of the consortium’s previous guideline, which was published in December 2005. To develop the new document, the consortium solicited and reviewed reports from four multidisciplinary expert working groups. The consortium also held a meeting in which patients and caregivers participated.

The revised consensus criteria distinguish between the clinical features and diagnostic biomarkers of the disease. The core clinical features are fluctuation in cognition, attention, and arousal; visual hallucinations (eg, of people, children, or animals); parkinsonism; and REM sleep behavior disorder, according to the authors. The criteria now list hypersomnia and hyposmia as supportive clinical features.

Direct biomarker evidence of Lewy body pathology is not available, said the authors. Indicative indirect biomarkers include reduced dopamine transporter uptake in basal ganglia demonstrated by single-photon emission computerized tomography or PET imaging, reduced uptake on metaiodobenzylguanidine (MIBG) myocardial scintigraphy, and polysomnographic confirmation of REM sleep without atonia.

A neurologist can diagnose probable dementia with Lewy bodies if two or more of its core clinical features are present, with or without the presence of indicative biomarkers. This diagnosis also is warranted if only one core clinical feature is present, but one or more indicative biomarkers are present.

The document incorporates new information about previously reported aspects of dementia with Lewy bodies and gives greater diagnostic weight to REM sleep behavior disorder and 123iodine-MIBG myocardial scintigraphy. The authors describe the diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations. They recommend minor modifications to pathologic methods and criteria to take account of Alzheimer’s disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss.

Because the literature contains few randomized controlled trials, the guideline’s recommendations about clinical management are based on expert opinion. Cholinesterase inhibitors can improve cognition, global function, activities of living, and neuropsychiatric symptoms, according to the authors. Nonpharmacologic management strategies should be developed and tested, they added.

“There remains a pressing need to understand the underlying neurobiology and pathophysiology of dementia with Lewy bodies, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support,” the authors concluded.

—Erik Greb

Suggested Reading

McKeith IG, Boeve BF, Dickson DW, et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jun 7 [Epub ahead of print].

The international Dementia With Lewy Bodies Consortium has updated its guideline for diagnosing and treating this disease. “The updated clinical criteria and associated biomarkers hopefully will lead to earlier and more accurate diagnosis, and that is key to helping patients confront this challenging illness and maximize their quality of life,” said Bradley Boeve, MD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and a coauthor. The guideline was published online ahead of print June 7 in Neurology.

The new guideline is a refinement of the consortium’s previous guideline, which was published in December 2005. To develop the new document, the consortium solicited and reviewed reports from four multidisciplinary expert working groups. The consortium also held a meeting in which patients and caregivers participated.

The revised consensus criteria distinguish between the clinical features and diagnostic biomarkers of the disease. The core clinical features are fluctuation in cognition, attention, and arousal; visual hallucinations (eg, of people, children, or animals); parkinsonism; and REM sleep behavior disorder, according to the authors. The criteria now list hypersomnia and hyposmia as supportive clinical features.

Direct biomarker evidence of Lewy body pathology is not available, said the authors. Indicative indirect biomarkers include reduced dopamine transporter uptake in basal ganglia demonstrated by single-photon emission computerized tomography or PET imaging, reduced uptake on metaiodobenzylguanidine (MIBG) myocardial scintigraphy, and polysomnographic confirmation of REM sleep without atonia.

A neurologist can diagnose probable dementia with Lewy bodies if two or more of its core clinical features are present, with or without the presence of indicative biomarkers. This diagnosis also is warranted if only one core clinical feature is present, but one or more indicative biomarkers are present.

The document incorporates new information about previously reported aspects of dementia with Lewy bodies and gives greater diagnostic weight to REM sleep behavior disorder and 123iodine-MIBG myocardial scintigraphy. The authors describe the diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations. They recommend minor modifications to pathologic methods and criteria to take account of Alzheimer’s disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss.

Because the literature contains few randomized controlled trials, the guideline’s recommendations about clinical management are based on expert opinion. Cholinesterase inhibitors can improve cognition, global function, activities of living, and neuropsychiatric symptoms, according to the authors. Nonpharmacologic management strategies should be developed and tested, they added.

“There remains a pressing need to understand the underlying neurobiology and pathophysiology of dementia with Lewy bodies, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support,” the authors concluded.

—Erik Greb

Suggested Reading

McKeith IG, Boeve BF, Dickson DW, et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jun 7 [Epub ahead of print].

The international Dementia With Lewy Bodies Consortium has updated its guideline for diagnosing and treating this disease. “The updated clinical criteria and associated biomarkers hopefully will lead to earlier and more accurate diagnosis, and that is key to helping patients confront this challenging illness and maximize their quality of life,” said Bradley Boeve, MD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and a coauthor. The guideline was published online ahead of print June 7 in Neurology.

The new guideline is a refinement of the consortium’s previous guideline, which was published in December 2005. To develop the new document, the consortium solicited and reviewed reports from four multidisciplinary expert working groups. The consortium also held a meeting in which patients and caregivers participated.

The revised consensus criteria distinguish between the clinical features and diagnostic biomarkers of the disease. The core clinical features are fluctuation in cognition, attention, and arousal; visual hallucinations (eg, of people, children, or animals); parkinsonism; and REM sleep behavior disorder, according to the authors. The criteria now list hypersomnia and hyposmia as supportive clinical features.

Direct biomarker evidence of Lewy body pathology is not available, said the authors. Indicative indirect biomarkers include reduced dopamine transporter uptake in basal ganglia demonstrated by single-photon emission computerized tomography or PET imaging, reduced uptake on metaiodobenzylguanidine (MIBG) myocardial scintigraphy, and polysomnographic confirmation of REM sleep without atonia.

A neurologist can diagnose probable dementia with Lewy bodies if two or more of its core clinical features are present, with or without the presence of indicative biomarkers. This diagnosis also is warranted if only one core clinical feature is present, but one or more indicative biomarkers are present.

The document incorporates new information about previously reported aspects of dementia with Lewy bodies and gives greater diagnostic weight to REM sleep behavior disorder and 123iodine-MIBG myocardial scintigraphy. The authors describe the diagnostic role of other neuroimaging, electrophysiologic, and laboratory investigations. They recommend minor modifications to pathologic methods and criteria to take account of Alzheimer’s disease neuropathologic change, to add previously omitted Lewy-related pathology categories, and to include assessments for substantia nigra neuronal loss.

Because the literature contains few randomized controlled trials, the guideline’s recommendations about clinical management are based on expert opinion. Cholinesterase inhibitors can improve cognition, global function, activities of living, and neuropsychiatric symptoms, according to the authors. Nonpharmacologic management strategies should be developed and tested, they added.

“There remains a pressing need to understand the underlying neurobiology and pathophysiology of dementia with Lewy bodies, to develop and deliver clinical trials with both symptomatic and disease-modifying agents, and to help patients and carers worldwide to inform themselves about the disease, its prognosis, best available treatments, ongoing research, and how to get adequate support,” the authors concluded.

—Erik Greb

Suggested Reading

McKeith IG, Boeve BF, Dickson DW, et al. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jun 7 [Epub ahead of print].

Since publication of initial findings of the Women’s Health Initiative (WHI) in 2002, use of systemic menopausal hormone therapy (HT) has declined by some 80% among US women.¹ Against this backdrop, this year’s Menopause Update highlights the “hot off the press” updated position statement on menopausal HT from The North American Menopause Society (NAMS), summarized by Dr. JoAnn V. Pinkerton. Although this guidance is chock full of practical, evidence-based guidance, the take-home message that Dr. Pinkerton and I would like to leave readers of OBG Management with is that for women with bothersome menopausal symptoms aged in their 50s or within 10 years of the onset of menopause who are free of contraindications, use of systemic HT is appropriate.

Related Article:
Dr. Andrew M. Kaunitz on prescribing systemic HT to older women

Although menopausal vasomotor and related symptoms improve as women age, in untreated women, vulvovaginal atrophy (VVA, also known as genitourinary syndrome of menopause, or GSM) tends to progress, causing vaginal dryness and sexual dysfunction, among other symptoms. When symptomatic GSM represents the only indication for treatment, low-dose local vaginal estrogen, ospemifene, or dehydroepiandrosterone (DHEA; prasterone) is safe and effective. However, as with systemic HT, specific treatments for GSM are substantially underutilized.² The current package labeling for low-dose vaginal estrogen deters many appropriate candidates from using this safe, effective treatment. In this Update, Dr. JoAnn E. Manson reviews the rationale for updating this labeling as well as recent efforts to accomplish the task.

Read about updated NAMS guidelines on HT

Guidelines on HT have been updated by The North American Menopause Society

The 2017 hormone therapy position statement of The North American Menopause Society [published online ahead of print June 2017]. Menopause.

The North American Menopause Society Hormone Therapy (HT) Position Statement Advisory Panel, composed of more than 20 experts in menopausal women's HT, including clinicians, researchers, and epidemiologists, reviewed the 2012 HT Position Statement, evaluated prior and new literature and used levels of evidence to identify the quality of the evidence and strength of the recommendations and to find consensus for the guidelines. The following information comes from the NAMS 2017 Hormone Therapy Position Statement.³

What are the major findings?

HT is the most effective treatment for vasomotor symptoms (VMS) and GSM and has been shown to prevent bone loss and fracture. Risks of HT may differ for women depending on type, dose, duration, route of administration, and timing of initiation and whether or not a progestogen is needed. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation about benefits and risks of continuing or discontinuing HT.

For women who are younger than age 60 or within 10 years of menopause and have no contraindication, the clearest benefit of HT is for the treatment of VMS and prevention of bone loss in those at elevated risk.

The clinical guidelines were presented to NAMS audience at the 2016 annual clinical meeting, where NAMS recommended "determining the most appropriate type, dose, formulation, and duration of HT."⁴

When to initiate HT and duration of use

In its now-published 2017 guidelines on HT, NAMS affirms the safety and efficacy of HT for symptomatic menopausal women or those at high risk for bone loss who are under age 60 or within 10 years of menopause. NAMS encourages practitioners to employ shared decision making with their patients to find the appropriate type, dose, formulation, and duration of HT, making individualized decisions based on evidence-based information, the unique health risks of women, and with periodic reassessment.

In the clinical guidelines presented in the 2016 NAMS annual meeting,⁴ key recommendations taken from the 2017 Hormone Therapy Position Statement³ include the following: For women who are aged younger than 60 years or within 10 years of menopause and have no contraindications, the benefit/risk ratio appears favorable for treatment of bothersome VMS and in those at elevated risk for bone loss or fracture.

For women who initiate HT more than 10 years from menopause or after age 60, this benefit/risk ratio appears less favorable because of greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia.

What about extended use of hormone therapy? There is no evidence to support routine discontinuation of HT after age 65. Decisions about longer durations of HT should be individualized and considered for indications such as persistent VMS or bone loss, with shared decision making, documentation, and periodic reevaluation. Longer duration is more favorable for estrogen therapy than for estrogen-progestin therapy, based on the Women's Health Initiative (WHI) randomized controlled trials.⁵

What about only vaginal symptoms? For bothersome GSM not relieved with over-the-counter therapies and without indications for use of systemic HT, low-dose vaginal estrogen therapy or other therapies are recommended and can be continued as long as indicated since there is minimal systemic absorption of estrogen, with serum levels remaining within the normal postmenopausal range.^6,7 For women with estrogen sensitive cancer, oncologists should be included in decision making, particularly for women on aromatase inhibitors.

Considerations for special populations Early menopause. For women with hypoestrogenism, primary ovarian insufficiency, or premature surgical menopause without contraindications, HT is recommended until at least the median age of menopause (52 years), as studies suggest that benefits outweigh the risks for effects on bone, heart, cognition, GSM, sexual function, and mood.⁸

Family history of breast cancer. Observational evidence suggests that use of HT does not further alter the risk for breast cancer in women with a family history of breast cancer. Family history is one risk, among others, that should be assessed when counseling women regarding HT.

Women who are BRCA-positive without breast cancer. For women who are BRCA-positive (higher genetic risk of breast cancer, primarily estrogen-receptor-negative), and have undergone surgical menopause (bilateral salpingo-oophorectomy), the benefits of estrogen to decrease health risks caused by premature loss of estrogen need to be considered on an individual basis.⁹ On the basis of limited observational studies, consider offering systemic HT until the median age of menopause (52 years) with longer use individualized.³

Related Article:
Is menopausal hormone therapy safe when your patient carries a BRCA mutation?

Survivors of endometrial and breast cancer with bothersome VMS. For women with prior estrogen-sensitive cancers, non-HTs should be considered first, particularly those agents studied through randomized controlled trials in this population and found to be effective. If systemic estrogen is considered for persistent symptoms after non-HT or complementary options have been unsuccessful, decisions should be made for compelling reasons and after detailed counseling, with shared decision making and in conjunction with their oncologist.³ 

Bothersome GSM. On the basis of limited observational data, there appears to be minimal to no demonstrated elevation in risk for recurrence of endometrial or breast cancer using low-dose vaginal estrogen,^3,10 but decisions should be made in conjunction with an oncologist.

Related Article:
Focus on treating genital atrophy symptoms
 

The importance of relaying the new guidelines to patients

It is important for clinicians to talk to women about their menopausal symptoms and their options for relief of symptoms or prevention of bone loss. Discussion should take into account age and time from menopause, include evidence-based information^11-13 about benefits and risks of different types of therapy, and employ shared decision making to choose the most appropriate therapy to maximize benefits and minimize risks for the individual woman.

Following the WHI initial release in 2002, both women and providers became fearful of HT and believed media hype and celebrities that compounded bioidentical HT was safer than FDA-approved HTs. However, compounded products lack safety and efficacy data, are not monitored or regulated by the FDA, and have unique risks associated with compounding, including concerns about sterility, impurities, and overdosing or underdosing, which could increase cancer risk.³

Read about modifying low-dose vaginal estrogen’s black box warning

Physicians continue to underwhelmingly prescribe low-dose vaginal estrogen for GSM 

Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women's EMPOWER survey: identifying women's perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14(3):413-424.

GSM is seriously underrecognized and undertreated.^2,8,14 It has a major impact on women's lives--a silent epidemic affecting women's quality of life, sexual health, interpersonal relationships, and even physical health in terms of increased risk of urinary tract infections and urinary symptoms. Unfortunately, patients are reluctant to mention the problem to their clinicians, and they do not clearly recognize it as a medical condition that has available treatment options. Clinicians also rarely receive adequate training in the management of this condition and how to discuss it with their patients. Given busy schedules and time constraints, addressing this topic often falls through the cracks, representing a missed opportunity for helping our patients with safe and effective treatments. In a recent study by Kingsberg and colleagues, an astoundingly low percentageof women with GSM symptoms received treatment. 

Details of the study

The study authors evaluated women's perceptions of GSM and available treatment options. US women aged 45 and older who reported GSM symptoms were surveyed. Of 1,858 women with a median age of 58 (range, 45-90), the study authors found that 50% had never used any treatment; 25% used over-the-counter medications; 18% were former users of GSM treatments; and 7% currently used prescribed GSM therapies.

When GSM was discussed, women were more likely than their clinicians to initiate the conversation. The main reason for women not mentioning their symptoms was the perception that GSM symptoms were a natural and inevitable part of aging. Hormonal products were perceived by women as having several downsides, including risk of systemic absorption, messiness of local creams, and the need to reuse an applicator. Overall, clinicians recommended vaginal estrogen therapy to only 23% and oral HTs to 18% of women.

The results of the study are consistent with results of earlier surveys of menopausal women. Although the survey included nearly 2,000 women, it has the potential for selection biases inherent to most Internet-based surveys. In addition, the respondents tended to be white and have higher socieconomic status, with limited representation from other groups.

Calls for the current boxed warning to be revised

GSM is highly prevalent among postmenopausal women; the condition has adverse effects on quality of life and sexual health.^2,8,14 Safe and effective treatments are available but are underutilized.^1,8,15,16 A current boxed warning appears on low-dose vaginal estrogen--class labeling that appears on all medications in the class of estrogen or HT, regardless of dose or route of administration. These warnings are based on findings from the WHI and other studies of systemic estrogen or estrogen plus progestin, which demonstrated a complex pattern of risks and benefits of HT (including increased risk of venous thrombosis or pulmonary embolism, stroke, and breast cancer [with estrogen plus progestin]).

These findings, however, do not appear to be relevant to low-dose vaginal estrogen, given minimal if any systemic absorption and much lower blood levels of hormones than found with systemic HT. Blood levels of estradiol with low-dose vaginal estrogen remain in the normal postmenopausal range, compared to several-fold elevations in hormone levels with systemic HT.^8,15,16 Additionally, observational studies of low-dose vaginal estrogen, as well as short-term randomized clinical trials, show no evidence of an increased risk of venous thromboembolic events, heart disease, stroke, breast cancer, or dementia--the listed possible adverse effects in the boxed warning. The current warning is based on extrapolating findings from systemic HT, which is inappropriate and not evidence-based for low-dose vaginal estrogen.¹⁵

The inappropriate boxed warning contributes to the problem of undertreatment of GSM in women by discouraging clinicians from prescribing the medication and dissuading patients from taking it even after purchase. Testimonials from many clinicians caring for these women have underscored that women will fill their prescription, but after seeing the boxed warning will often become alarmed and decide not to take the medication. Clinicians reported that patients often say at their next appointment: "No, I never took it. I got very scared when I saw the boxed warning." As a result, clinicians often have to spend a great deal of time explaining the limitations of, and lack of evidence for, the boxed warning on low-dose vaginal estrogen.

Related Article:
2016 Update on menopause
 

Recommended label revisions

A modified label, without a boxed warning, would be safer for women because the key messages would not be obscured by the large amount of irrelevant information. Our Working Group recommended that the label explain that the listed risks were found in studies of systemic HT and their relevance to low-dose vaginal estrogen is unknown. The Group also recommended that warning text should be added in bold font to advise  patients to seek medical attention if they have vaginal bleeding or spotting while taking the medication. In addition, patients who have a history of breast cancer or other hormone-sensitive cancer should discuss the use of the medication with their oncologist.   

Status update on efforts to revise label. A citizen's petition was filed in the Spring of 2016, with signatures from more than 600 clinicians and patients and representatives of medical and professional organizations endorsing a more appropriate evidence-based label for low-dose vaginal estrogen. The FDA is continuing to review and deliberate on these issues but has not yet made a final decision.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Since publication of initial findings of the Women’s Health Initiative (WHI) in 2002, use of systemic menopausal hormone therapy (HT) has declined by some 80% among US women.¹ Against this backdrop, this year’s Menopause Update highlights the “hot off the press” updated position statement on menopausal HT from The North American Menopause Society (NAMS), summarized by Dr. JoAnn V. Pinkerton. Although this guidance is chock full of practical, evidence-based guidance, the take-home message that Dr. Pinkerton and I would like to leave readers of OBG Management with is that for women with bothersome menopausal symptoms aged in their 50s or within 10 years of the onset of menopause who are free of contraindications, use of systemic HT is appropriate.

Related Article:
Dr. Andrew M. Kaunitz on prescribing systemic HT to older women

Although menopausal vasomotor and related symptoms improve as women age, in untreated women, vulvovaginal atrophy (VVA, also known as genitourinary syndrome of menopause, or GSM) tends to progress, causing vaginal dryness and sexual dysfunction, among other symptoms. When symptomatic GSM represents the only indication for treatment, low-dose local vaginal estrogen, ospemifene, or dehydroepiandrosterone (DHEA; prasterone) is safe and effective. However, as with systemic HT, specific treatments for GSM are substantially underutilized.² The current package labeling for low-dose vaginal estrogen deters many appropriate candidates from using this safe, effective treatment. In this Update, Dr. JoAnn E. Manson reviews the rationale for updating this labeling as well as recent efforts to accomplish the task.

Read about updated NAMS guidelines on HT

Guidelines on HT have been updated by The North American Menopause Society

The 2017 hormone therapy position statement of The North American Menopause Society [published online ahead of print June 2017]. Menopause.

The North American Menopause Society Hormone Therapy (HT) Position Statement Advisory Panel, composed of more than 20 experts in menopausal women's HT, including clinicians, researchers, and epidemiologists, reviewed the 2012 HT Position Statement, evaluated prior and new literature and used levels of evidence to identify the quality of the evidence and strength of the recommendations and to find consensus for the guidelines. The following information comes from the NAMS 2017 Hormone Therapy Position Statement.³

What are the major findings?

HT is the most effective treatment for vasomotor symptoms (VMS) and GSM and has been shown to prevent bone loss and fracture. Risks of HT may differ for women depending on type, dose, duration, route of administration, and timing of initiation and whether or not a progestogen is needed. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation about benefits and risks of continuing or discontinuing HT.

For women who are younger than age 60 or within 10 years of menopause and have no contraindication, the clearest benefit of HT is for the treatment of VMS and prevention of bone loss in those at elevated risk.

The clinical guidelines were presented to NAMS audience at the 2016 annual clinical meeting, where NAMS recommended "determining the most appropriate type, dose, formulation, and duration of HT."⁴

When to initiate HT and duration of use

In its now-published 2017 guidelines on HT, NAMS affirms the safety and efficacy of HT for symptomatic menopausal women or those at high risk for bone loss who are under age 60 or within 10 years of menopause. NAMS encourages practitioners to employ shared decision making with their patients to find the appropriate type, dose, formulation, and duration of HT, making individualized decisions based on evidence-based information, the unique health risks of women, and with periodic reassessment.

In the clinical guidelines presented in the 2016 NAMS annual meeting,⁴ key recommendations taken from the 2017 Hormone Therapy Position Statement³ include the following: For women who are aged younger than 60 years or within 10 years of menopause and have no contraindications, the benefit/risk ratio appears favorable for treatment of bothersome VMS and in those at elevated risk for bone loss or fracture.

For women who initiate HT more than 10 years from menopause or after age 60, this benefit/risk ratio appears less favorable because of greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia.

What about extended use of hormone therapy? There is no evidence to support routine discontinuation of HT after age 65. Decisions about longer durations of HT should be individualized and considered for indications such as persistent VMS or bone loss, with shared decision making, documentation, and periodic reevaluation. Longer duration is more favorable for estrogen therapy than for estrogen-progestin therapy, based on the Women's Health Initiative (WHI) randomized controlled trials.⁵

What about only vaginal symptoms? For bothersome GSM not relieved with over-the-counter therapies and without indications for use of systemic HT, low-dose vaginal estrogen therapy or other therapies are recommended and can be continued as long as indicated since there is minimal systemic absorption of estrogen, with serum levels remaining within the normal postmenopausal range.^6,7 For women with estrogen sensitive cancer, oncologists should be included in decision making, particularly for women on aromatase inhibitors.

Considerations for special populations Early menopause. For women with hypoestrogenism, primary ovarian insufficiency, or premature surgical menopause without contraindications, HT is recommended until at least the median age of menopause (52 years), as studies suggest that benefits outweigh the risks for effects on bone, heart, cognition, GSM, sexual function, and mood.⁸

Family history of breast cancer. Observational evidence suggests that use of HT does not further alter the risk for breast cancer in women with a family history of breast cancer. Family history is one risk, among others, that should be assessed when counseling women regarding HT.

Women who are BRCA-positive without breast cancer. For women who are BRCA-positive (higher genetic risk of breast cancer, primarily estrogen-receptor-negative), and have undergone surgical menopause (bilateral salpingo-oophorectomy), the benefits of estrogen to decrease health risks caused by premature loss of estrogen need to be considered on an individual basis.⁹ On the basis of limited observational studies, consider offering systemic HT until the median age of menopause (52 years) with longer use individualized.³

Related Article:
Is menopausal hormone therapy safe when your patient carries a BRCA mutation?

Survivors of endometrial and breast cancer with bothersome VMS. For women with prior estrogen-sensitive cancers, non-HTs should be considered first, particularly those agents studied through randomized controlled trials in this population and found to be effective. If systemic estrogen is considered for persistent symptoms after non-HT or complementary options have been unsuccessful, decisions should be made for compelling reasons and after detailed counseling, with shared decision making and in conjunction with their oncologist.³ 

Bothersome GSM. On the basis of limited observational data, there appears to be minimal to no demonstrated elevation in risk for recurrence of endometrial or breast cancer using low-dose vaginal estrogen,^3,10 but decisions should be made in conjunction with an oncologist.

Related Article:
Focus on treating genital atrophy symptoms
 

The importance of relaying the new guidelines to patients

It is important for clinicians to talk to women about their menopausal symptoms and their options for relief of symptoms or prevention of bone loss. Discussion should take into account age and time from menopause, include evidence-based information^11-13 about benefits and risks of different types of therapy, and employ shared decision making to choose the most appropriate therapy to maximize benefits and minimize risks for the individual woman.

Following the WHI initial release in 2002, both women and providers became fearful of HT and believed media hype and celebrities that compounded bioidentical HT was safer than FDA-approved HTs. However, compounded products lack safety and efficacy data, are not monitored or regulated by the FDA, and have unique risks associated with compounding, including concerns about sterility, impurities, and overdosing or underdosing, which could increase cancer risk.³

Read about modifying low-dose vaginal estrogen’s black box warning

Physicians continue to underwhelmingly prescribe low-dose vaginal estrogen for GSM 

Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women's EMPOWER survey: identifying women's perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14(3):413-424.

GSM is seriously underrecognized and undertreated.^2,8,14 It has a major impact on women's lives--a silent epidemic affecting women's quality of life, sexual health, interpersonal relationships, and even physical health in terms of increased risk of urinary tract infections and urinary symptoms. Unfortunately, patients are reluctant to mention the problem to their clinicians, and they do not clearly recognize it as a medical condition that has available treatment options. Clinicians also rarely receive adequate training in the management of this condition and how to discuss it with their patients. Given busy schedules and time constraints, addressing this topic often falls through the cracks, representing a missed opportunity for helping our patients with safe and effective treatments. In a recent study by Kingsberg and colleagues, an astoundingly low percentageof women with GSM symptoms received treatment. 

Details of the study

The study authors evaluated women's perceptions of GSM and available treatment options. US women aged 45 and older who reported GSM symptoms were surveyed. Of 1,858 women with a median age of 58 (range, 45-90), the study authors found that 50% had never used any treatment; 25% used over-the-counter medications; 18% were former users of GSM treatments; and 7% currently used prescribed GSM therapies.

When GSM was discussed, women were more likely than their clinicians to initiate the conversation. The main reason for women not mentioning their symptoms was the perception that GSM symptoms were a natural and inevitable part of aging. Hormonal products were perceived by women as having several downsides, including risk of systemic absorption, messiness of local creams, and the need to reuse an applicator. Overall, clinicians recommended vaginal estrogen therapy to only 23% and oral HTs to 18% of women.

The results of the study are consistent with results of earlier surveys of menopausal women. Although the survey included nearly 2,000 women, it has the potential for selection biases inherent to most Internet-based surveys. In addition, the respondents tended to be white and have higher socieconomic status, with limited representation from other groups.

Calls for the current boxed warning to be revised

GSM is highly prevalent among postmenopausal women; the condition has adverse effects on quality of life and sexual health.^2,8,14 Safe and effective treatments are available but are underutilized.^1,8,15,16 A current boxed warning appears on low-dose vaginal estrogen--class labeling that appears on all medications in the class of estrogen or HT, regardless of dose or route of administration. These warnings are based on findings from the WHI and other studies of systemic estrogen or estrogen plus progestin, which demonstrated a complex pattern of risks and benefits of HT (including increased risk of venous thrombosis or pulmonary embolism, stroke, and breast cancer [with estrogen plus progestin]).

These findings, however, do not appear to be relevant to low-dose vaginal estrogen, given minimal if any systemic absorption and much lower blood levels of hormones than found with systemic HT. Blood levels of estradiol with low-dose vaginal estrogen remain in the normal postmenopausal range, compared to several-fold elevations in hormone levels with systemic HT.^8,15,16 Additionally, observational studies of low-dose vaginal estrogen, as well as short-term randomized clinical trials, show no evidence of an increased risk of venous thromboembolic events, heart disease, stroke, breast cancer, or dementia--the listed possible adverse effects in the boxed warning. The current warning is based on extrapolating findings from systemic HT, which is inappropriate and not evidence-based for low-dose vaginal estrogen.¹⁵

The inappropriate boxed warning contributes to the problem of undertreatment of GSM in women by discouraging clinicians from prescribing the medication and dissuading patients from taking it even after purchase. Testimonials from many clinicians caring for these women have underscored that women will fill their prescription, but after seeing the boxed warning will often become alarmed and decide not to take the medication. Clinicians reported that patients often say at their next appointment: "No, I never took it. I got very scared when I saw the boxed warning." As a result, clinicians often have to spend a great deal of time explaining the limitations of, and lack of evidence for, the boxed warning on low-dose vaginal estrogen.

Related Article:
2016 Update on menopause
 

Recommended label revisions

A modified label, without a boxed warning, would be safer for women because the key messages would not be obscured by the large amount of irrelevant information. Our Working Group recommended that the label explain that the listed risks were found in studies of systemic HT and their relevance to low-dose vaginal estrogen is unknown. The Group also recommended that warning text should be added in bold font to advise  patients to seek medical attention if they have vaginal bleeding or spotting while taking the medication. In addition, patients who have a history of breast cancer or other hormone-sensitive cancer should discuss the use of the medication with their oncologist.   

Status update on efforts to revise label. A citizen's petition was filed in the Spring of 2016, with signatures from more than 600 clinicians and patients and representatives of medical and professional organizations endorsing a more appropriate evidence-based label for low-dose vaginal estrogen. The FDA is continuing to review and deliberate on these issues but has not yet made a final decision.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Since publication of initial findings of the Women’s Health Initiative (WHI) in 2002, use of systemic menopausal hormone therapy (HT) has declined by some 80% among US women.¹ Against this backdrop, this year’s Menopause Update highlights the “hot off the press” updated position statement on menopausal HT from The North American Menopause Society (NAMS), summarized by Dr. JoAnn V. Pinkerton. Although this guidance is chock full of practical, evidence-based guidance, the take-home message that Dr. Pinkerton and I would like to leave readers of OBG Management with is that for women with bothersome menopausal symptoms aged in their 50s or within 10 years of the onset of menopause who are free of contraindications, use of systemic HT is appropriate.

Related Article:
Dr. Andrew M. Kaunitz on prescribing systemic HT to older women

Although menopausal vasomotor and related symptoms improve as women age, in untreated women, vulvovaginal atrophy (VVA, also known as genitourinary syndrome of menopause, or GSM) tends to progress, causing vaginal dryness and sexual dysfunction, among other symptoms. When symptomatic GSM represents the only indication for treatment, low-dose local vaginal estrogen, ospemifene, or dehydroepiandrosterone (DHEA; prasterone) is safe and effective. However, as with systemic HT, specific treatments for GSM are substantially underutilized.² The current package labeling for low-dose vaginal estrogen deters many appropriate candidates from using this safe, effective treatment. In this Update, Dr. JoAnn E. Manson reviews the rationale for updating this labeling as well as recent efforts to accomplish the task.

Read about updated NAMS guidelines on HT

Guidelines on HT have been updated by The North American Menopause Society

The 2017 hormone therapy position statement of The North American Menopause Society [published online ahead of print June 2017]. Menopause.

The North American Menopause Society Hormone Therapy (HT) Position Statement Advisory Panel, composed of more than 20 experts in menopausal women's HT, including clinicians, researchers, and epidemiologists, reviewed the 2012 HT Position Statement, evaluated prior and new literature and used levels of evidence to identify the quality of the evidence and strength of the recommendations and to find consensus for the guidelines. The following information comes from the NAMS 2017 Hormone Therapy Position Statement.³

What are the major findings?

HT is the most effective treatment for vasomotor symptoms (VMS) and GSM and has been shown to prevent bone loss and fracture. Risks of HT may differ for women depending on type, dose, duration, route of administration, and timing of initiation and whether or not a progestogen is needed. Treatment should be individualized using the best available evidence to maximize benefits and minimize risks, with periodic reevaluation about benefits and risks of continuing or discontinuing HT.

For women who are younger than age 60 or within 10 years of menopause and have no contraindication, the clearest benefit of HT is for the treatment of VMS and prevention of bone loss in those at elevated risk.

The clinical guidelines were presented to NAMS audience at the 2016 annual clinical meeting, where NAMS recommended "determining the most appropriate type, dose, formulation, and duration of HT."⁴

When to initiate HT and duration of use

In its now-published 2017 guidelines on HT, NAMS affirms the safety and efficacy of HT for symptomatic menopausal women or those at high risk for bone loss who are under age 60 or within 10 years of menopause. NAMS encourages practitioners to employ shared decision making with their patients to find the appropriate type, dose, formulation, and duration of HT, making individualized decisions based on evidence-based information, the unique health risks of women, and with periodic reassessment.

In the clinical guidelines presented in the 2016 NAMS annual meeting,⁴ key recommendations taken from the 2017 Hormone Therapy Position Statement³ include the following: For women who are aged younger than 60 years or within 10 years of menopause and have no contraindications, the benefit/risk ratio appears favorable for treatment of bothersome VMS and in those at elevated risk for bone loss or fracture.

For women who initiate HT more than 10 years from menopause or after age 60, this benefit/risk ratio appears less favorable because of greater absolute risks of coronary heart disease, stroke, venous thromboembolism, and dementia.

What about extended use of hormone therapy? There is no evidence to support routine discontinuation of HT after age 65. Decisions about longer durations of HT should be individualized and considered for indications such as persistent VMS or bone loss, with shared decision making, documentation, and periodic reevaluation. Longer duration is more favorable for estrogen therapy than for estrogen-progestin therapy, based on the Women's Health Initiative (WHI) randomized controlled trials.⁵

What about only vaginal symptoms? For bothersome GSM not relieved with over-the-counter therapies and without indications for use of systemic HT, low-dose vaginal estrogen therapy or other therapies are recommended and can be continued as long as indicated since there is minimal systemic absorption of estrogen, with serum levels remaining within the normal postmenopausal range.^6,7 For women with estrogen sensitive cancer, oncologists should be included in decision making, particularly for women on aromatase inhibitors.

Considerations for special populations Early menopause. For women with hypoestrogenism, primary ovarian insufficiency, or premature surgical menopause without contraindications, HT is recommended until at least the median age of menopause (52 years), as studies suggest that benefits outweigh the risks for effects on bone, heart, cognition, GSM, sexual function, and mood.⁸

Family history of breast cancer. Observational evidence suggests that use of HT does not further alter the risk for breast cancer in women with a family history of breast cancer. Family history is one risk, among others, that should be assessed when counseling women regarding HT.

Women who are BRCA-positive without breast cancer. For women who are BRCA-positive (higher genetic risk of breast cancer, primarily estrogen-receptor-negative), and have undergone surgical menopause (bilateral salpingo-oophorectomy), the benefits of estrogen to decrease health risks caused by premature loss of estrogen need to be considered on an individual basis.⁹ On the basis of limited observational studies, consider offering systemic HT until the median age of menopause (52 years) with longer use individualized.³

Related Article:
Is menopausal hormone therapy safe when your patient carries a BRCA mutation?

Survivors of endometrial and breast cancer with bothersome VMS. For women with prior estrogen-sensitive cancers, non-HTs should be considered first, particularly those agents studied through randomized controlled trials in this population and found to be effective. If systemic estrogen is considered for persistent symptoms after non-HT or complementary options have been unsuccessful, decisions should be made for compelling reasons and after detailed counseling, with shared decision making and in conjunction with their oncologist.³ 

Bothersome GSM. On the basis of limited observational data, there appears to be minimal to no demonstrated elevation in risk for recurrence of endometrial or breast cancer using low-dose vaginal estrogen,^3,10 but decisions should be made in conjunction with an oncologist.

Related Article:
Focus on treating genital atrophy symptoms
 

The importance of relaying the new guidelines to patients

It is important for clinicians to talk to women about their menopausal symptoms and their options for relief of symptoms or prevention of bone loss. Discussion should take into account age and time from menopause, include evidence-based information^11-13 about benefits and risks of different types of therapy, and employ shared decision making to choose the most appropriate therapy to maximize benefits and minimize risks for the individual woman.

Following the WHI initial release in 2002, both women and providers became fearful of HT and believed media hype and celebrities that compounded bioidentical HT was safer than FDA-approved HTs. However, compounded products lack safety and efficacy data, are not monitored or regulated by the FDA, and have unique risks associated with compounding, including concerns about sterility, impurities, and overdosing or underdosing, which could increase cancer risk.³

Read about modifying low-dose vaginal estrogen’s black box warning

Physicians continue to underwhelmingly prescribe low-dose vaginal estrogen for GSM 

Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women's EMPOWER survey: identifying women's perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14(3):413-424.

GSM is seriously underrecognized and undertreated.^2,8,14 It has a major impact on women's lives--a silent epidemic affecting women's quality of life, sexual health, interpersonal relationships, and even physical health in terms of increased risk of urinary tract infections and urinary symptoms. Unfortunately, patients are reluctant to mention the problem to their clinicians, and they do not clearly recognize it as a medical condition that has available treatment options. Clinicians also rarely receive adequate training in the management of this condition and how to discuss it with their patients. Given busy schedules and time constraints, addressing this topic often falls through the cracks, representing a missed opportunity for helping our patients with safe and effective treatments. In a recent study by Kingsberg and colleagues, an astoundingly low percentageof women with GSM symptoms received treatment. 

Details of the study

The study authors evaluated women's perceptions of GSM and available treatment options. US women aged 45 and older who reported GSM symptoms were surveyed. Of 1,858 women with a median age of 58 (range, 45-90), the study authors found that 50% had never used any treatment; 25% used over-the-counter medications; 18% were former users of GSM treatments; and 7% currently used prescribed GSM therapies.

When GSM was discussed, women were more likely than their clinicians to initiate the conversation. The main reason for women not mentioning their symptoms was the perception that GSM symptoms were a natural and inevitable part of aging. Hormonal products were perceived by women as having several downsides, including risk of systemic absorption, messiness of local creams, and the need to reuse an applicator. Overall, clinicians recommended vaginal estrogen therapy to only 23% and oral HTs to 18% of women.

The results of the study are consistent with results of earlier surveys of menopausal women. Although the survey included nearly 2,000 women, it has the potential for selection biases inherent to most Internet-based surveys. In addition, the respondents tended to be white and have higher socieconomic status, with limited representation from other groups.

Calls for the current boxed warning to be revised

GSM is highly prevalent among postmenopausal women; the condition has adverse effects on quality of life and sexual health.^2,8,14 Safe and effective treatments are available but are underutilized.^1,8,15,16 A current boxed warning appears on low-dose vaginal estrogen--class labeling that appears on all medications in the class of estrogen or HT, regardless of dose or route of administration. These warnings are based on findings from the WHI and other studies of systemic estrogen or estrogen plus progestin, which demonstrated a complex pattern of risks and benefits of HT (including increased risk of venous thrombosis or pulmonary embolism, stroke, and breast cancer [with estrogen plus progestin]).

These findings, however, do not appear to be relevant to low-dose vaginal estrogen, given minimal if any systemic absorption and much lower blood levels of hormones than found with systemic HT. Blood levels of estradiol with low-dose vaginal estrogen remain in the normal postmenopausal range, compared to several-fold elevations in hormone levels with systemic HT.^8,15,16 Additionally, observational studies of low-dose vaginal estrogen, as well as short-term randomized clinical trials, show no evidence of an increased risk of venous thromboembolic events, heart disease, stroke, breast cancer, or dementia--the listed possible adverse effects in the boxed warning. The current warning is based on extrapolating findings from systemic HT, which is inappropriate and not evidence-based for low-dose vaginal estrogen.¹⁵

The inappropriate boxed warning contributes to the problem of undertreatment of GSM in women by discouraging clinicians from prescribing the medication and dissuading patients from taking it even after purchase. Testimonials from many clinicians caring for these women have underscored that women will fill their prescription, but after seeing the boxed warning will often become alarmed and decide not to take the medication. Clinicians reported that patients often say at their next appointment: "No, I never took it. I got very scared when I saw the boxed warning." As a result, clinicians often have to spend a great deal of time explaining the limitations of, and lack of evidence for, the boxed warning on low-dose vaginal estrogen.

Related Article:
2016 Update on menopause
 

Recommended label revisions

A modified label, without a boxed warning, would be safer for women because the key messages would not be obscured by the large amount of irrelevant information. Our Working Group recommended that the label explain that the listed risks were found in studies of systemic HT and their relevance to low-dose vaginal estrogen is unknown. The Group also recommended that warning text should be added in bold font to advise  patients to seek medical attention if they have vaginal bleeding or spotting while taking the medication. In addition, patients who have a history of breast cancer or other hormone-sensitive cancer should discuss the use of the medication with their oncologist.   

Status update on efforts to revise label. A citizen's petition was filed in the Spring of 2016, with signatures from more than 600 clinicians and patients and representatives of medical and professional organizations endorsing a more appropriate evidence-based label for low-dose vaginal estrogen. The FDA is continuing to review and deliberate on these issues but has not yet made a final decision.  

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.

“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.

A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).

After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.

Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).

The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).

The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.

Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.

“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.

—Erica Tricarico

Suggested Reading

Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.

A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.

“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.

A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).

After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.

Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).

The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).

The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.

Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.

“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.

—Erica Tricarico

Suggested Reading

Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.

A new guideline codeveloped by the American Academy of Neurology and the American Epilepsy Society is intended to aid clinicians as they counsel patients about SUDEP. The practice guideline, published in the April 25 issue of Neurology, provides information about SUDEP incidence in different epilepsy populations, data about risk factors, and recommendations for patient care.

“Our guideline brings clarity to the [SUDEP] discussion, giving health care providers practical information they can use to help people with epilepsy reduce their risk,” said Cynthia Harden, MD, Director of Epilepsy Services for the Mount Sinai Health System in New York City.

A panel of experts searched the MEDLINE and Embase databases from the earliest available article to November 2010. An identical search was performed in April 2015 for articles published since November 2010. The keywords for both searches were “SUDEP” and other traditional medical subheadings for epilepsy (eg, “epilepsy/abnormalities,” “epilepsy/drug effects,” or “epilepsy/therapy”).

After reviewing more than 1,000 abstracts, the panel selected 70 relevant articles. The team then conducted a systematic review and developed conclusions using the modified Grading Recommendations Assessment, Development, and Evaluation process. All recommendations were made by consensus.

Incidence rates were based on 12 Class I studies. The systematic review found that SUDEP affects one in 4,500 children with epilepsy per year. Based on these findings, the experts recommend that clinicians inform parents or guardians about this low risk of SUDEP in children (Level B). In addition, the panel recommends that clinicians inform adult patients about the small risk of SUDEP, which typically affects one in 1,000 adults with epilepsy annually (Level B).

The panel also found that generalized tonic-clonic seizures, which involve convulsions and loss of consciousness, are a major risk factor for SUDEP. In addition, they noted that patients who have three or more of these seizures per year have a 15-fold increased risk of SUDEP. To reduce this risk, clinicians are advised to manage epilepsy therapies actively in these patients to reduce seizures (Level B).

The guideline also recommends nocturnal supervision or other nocturnal precautions for patients who experience frequent generalized tonic-clonic seizures and nocturnal seizures (Level C). Furthermore, the presence of an additional person age 10 or older in the bedroom is associated with a decreased SUDEP risk. If individualized epilepsy and psychosocial circumstances permit, such a person should be present, said the panel. Providing nighttime observation might be overly burdensome or intrusive for some patients, the authors added.

Finally, clinicians are advised to inform patients that seizure freedom, especially freedom from generalized tonic-clonic seizures, is strongly associated with a decreased risk of SUDEP (Level B). The panel also analyzed other SUDEP risk factors (eg, lamotrigine use in women, heart rate variability, and male gender), but too little evidence was available to support recommendations.

“Research to identify preventable risk factors should be supported and encouraged so that future clinical trials will be conducted to reduce SUDEP occurrence,” said Dr. Harden.

—Erica Tricarico

Suggested Reading

Harden C, Tomson T, Gloss D, et al. Practice guideline summary: Sudden unexpected death in epilepsy incidence rates and risk factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2017;88(17):1674-1680.

Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States¹ and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”² with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV₁₎/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV₁.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.

Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States¹ and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”² with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV₁₎/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV₁.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.

Chronic obstructive lung disease (COPD) is the third leading cause of death in the United States¹ and a major cause of mortality and morbidity around the world. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) released a new “2017 Report”² with modified recommendations for the diagnosis, management, and prevention of COPD. The report contains several changes that are relevant to the primary care provider that will be outlined below.

Redefining COPD

GOLD’s definition of COPD was changed in its 2017 Report: “COPD is a common, preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitations that are due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.” The report emphasizes that “COPD may be punctuated by periods of acute worsening of respiratory symptoms, called exacerbations.” Note that the terms “emphysema” and “chronic bronchitis” have been removed in favor of a more comprehensive description of the pathophysiology of COPD. Importantly, the report states that cough and sputum production for at least 3 months in each of 2 consecutive years, previously accepted as diagnostic criteria, are present in only a minority of patients. It is noted that chronic respiratory symptoms may exist without spirometric changes and many patients (usually smokers) have structural evidence of COPD without airflow limitation.

Changes to COPD initial assessment

The primary criterion for diagnosis is unchanged: post-bronchodilator forced expiratory volume in 1 second (FEV₁₎/forced vital capacity (FVC) less than 0.70. Spirometry remains important to confirm the diagnosis in those with classic symptoms of dyspnea, chronic cough, and/or sputum production with a history of exposure to noxious particles or gases.

The GOLD assessment system previously incorporated spirometry and included an “ABCD” system such that patients in group A are least severe. Spirometry has been progressively deemphasized in favor of symptom-based classification and the 2017 Report, for the first time, dissociates spirometric findings from severity classification.

The new system uses symptom severity and exacerbation risk to classify COPD. Two specific standardized COPD symptom measurement tools, The Modified British Medical Research Council (mMRC) questionnaire and COPD Assessment Test (CAT), are reported by GOLD as the most widely used. Low symptom severity is considered an mMRC less than or equal to 1 or CAT less than or equal to 9, high symptom severity is considered an mMRC greater than or equal to 2 or CAT greater than or equal to 10. Low risk of exacerbation is defined as no more than one exacerbation not resulting in hospital admission in the last 12 months; high risk of exacerbation is defined as at least two exacerbations or any exacerbations resulting in hospital admission in the last 12 months. Symptom severity and exacerbation risk is divided into four quadrants:
 

• GOLD group A: Low symptom severity, low exacerbation risk.

• GOLD group B: High symptom severity, low exacerbation risk.

• GOLD group C: Low symptom severity, high exacerbation risk.

• GOLD group D: High symptom severity, high exacerbation risk.

Changes to prevention and management of stable COPD

Smoking cessation remains important in the prevention of COPD. The 2017 Report reflects the U.S. Preventive Services Task Force’s guidelines for smoking cessation: Offer nicotine replacement, cessation counseling, and pharmacotherapy (varenicline, bupropion or nortriptyline). There is insufficient evidence to support the use of e-cigarettes. Influenza and pneumococcal vaccinations are recommended. Pulmonary rehabilitation remains important.

The 2017 Report includes an expanded discussion of COPD medications. The role of short-acting bronchodilators (SABD) in COPD remains prominent. Changes include a stronger recommendation to use combination short-acting beta-agonists and short-acting muscarinic antagonists (SABA/SAMA) as these seem to be superior to SABD monotherapy in improving symptoms and FEV₁.

There were several changes to the pharmacologic treatment algorithm. For the first time, GOLD proposes escalation strategies. Preference is given to LABA/LAMA (long-acting beta-agonist/long-acting muscarinic antagonists) combinations over LABA/ICS (long-acting beta-agonist/inhaled corticosteroid) combinations as a mainstay of treatment. The rationale for this change is that LABA/LAMAs give greater bronchodilation compared with LABA/ICS, and one study showed a decreased rate of exacerbations compared to LABA/ICS in patients with a history of exacerbations. In addition, patients with COPD who receive ICS appear to have a higher risk of developing pneumonia. GOLD recommendations are:

• Group A: Start with single bronchodilator (short- or long-acting), escalate to alternative class of bronchodilator if necessary.

• Group B: Start with LABA or LAMA, escalate to LABA/LAMA if symptoms persist.

• Group C: Start with LAMA, escalate to LABA/LAMA (preferred) or LABA/ICS if exacerbations continue.

• Group D: Start with LABA/LAMA (preferred) or LAMA monotherapy, escalate to LABA/LAMA/ICS (preferred) or try LABA/ICS before escalating to LAMA/LABA/ICS if symptoms persist or exacerbations continue; roflumilast and/or a macrolide may be considered if further exacerbations occur with LABA/LAMA/ICS.
 

Bottom line

1. GOLD classification of COPD severity is now based on clinical criteria alone: symptom assessment and risk for exacerbation.

2. SABA/SAMA combination therapy seems to be superior to either SABA or SAMA alone.

3. Patients in group A (milder symptoms, low exacerbation risk) may be initiated on either short- or long-acting bronchodilator therapy.

4. Patients in group B (milder symptoms, increased exacerbation risk) should be initiated on LAMA monotherapy.

5. LABA/LAMA combination therapy seems to be superior to LABA/ICS combination therapy and should be used when long-acting bronchodilator monotherapy fails to control symptoms or reduce exacerbations.

References

1. CDC MMWR 11/23/12

2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 at http://goldcopd.org (accessed 3/10/2017)
 

Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital. Dr. Lent is chief resident in the program.

Since the last Practice Alert update on the United States Preventive Services Task Force in May of 2016,¹ the Task Force has released 19 recommendations on 13 topics that include: the use of aspirin and statins for the prevention of cardiovascular disease (CVD); support for breastfeeding; use of folic acid during pregnancy; and screening for syphilis, latent tuberculosis (TB), herpes, chronic obstructive pulmonary disease (COPD), colorectal cancer (CRC), obstructive sleep apnea (OSA), celiac disease, and skin cancer. The Task Force also released a draft recommendation regarding prostate cancer screening in asymptomatic men (see “A change for prostate cancer screening?”) and addressed screening pelvic examinations in asymptomatic women, the subject of this month’s audiocast. (To listen, go to: http://bit.ly/2nIVoD5.)

Recommendations to implement

Recommendations from the past year that family physicians should put into practice are detailed below and in TABLE 1.^2-8

CRC: Screen all individuals ages 50 to 75, but 76 to 85 selectively. The Task Force reaffirmed its 2008 finding that screening for CRC in adults ages 50 to 75 years is substantially beneficial.² In contrast to the previous recommendation, however, the new one does not state which screening tests are preferred. The tests considered were 3 stool tests (fecal immunochemical test [FIT], FIT-tumor DNA testing [FIT-DNA], and guaiac-based fecal occult blood test [gFOBT]), as well as 3 direct visualization tests (colonoscopy, sigmoidoscopy, and CT colonoscopy). The Task Force assessed various testing frequencies of each test and some test combinations. While the Task Force does not recommend any one screening strategy, there are still significant unknowns about FIT-DNA and CT colonoscopy. The American Academy of Family Physicians does not recommend using these 2 tests for screening purposes at this time.⁹

CRC screening for adults ages 76 to 85 was given a “C” recommendation, which means the value of the service to the population overall is small, but that certain individuals may benefit from it. The Task Force advises selectively offering a “C” service to individuals based on professional judgment and patient preferences. Regarding CRC screening in individuals 76 years or older, the ones most likely to benefit are those who have never been screened and those without significant comorbidities that could limit life expectancy. All “C” recommendations from the past year are listed in TABLE 2.^2-4

CVD prevention: When aspirin or a statin is indicated. The Task Force released 2 recommendations for the prevention of CVD this past year. One pertained to the use of low-dose aspirin³ (which also helps to prevent CRC), and the other addressed the use of low- to moderate-dose statins.⁴ Each recommendation is fairly complicated and nuanced in terms of age and risk for CVD. A decision to use low-dose aspirin must also consider the risk of bleeding.

To calculate a patient’s risk for CVD, the Task Force recommends using the risk calculator developed by the American College of Cardiology and the American Heart Association (http://www.cvriskcalculator.com/).

Adults for whom low-dose aspirin and low- to moderate-dose statins are recommended are described in TABLE 1.^2-8 Patients for whom individual decision making is advised, rather than a generalized recommendation, are reviewed in TABLE 2.^2-4 There is insufficient evidence to make a recommendation for the use of aspirin before age 50 or at age 70 and older,³ and for the use of statins in adults age 76 and older who do not have a history of CVD⁴ (TABLE 3^3,4,10-14). The use of low-dose aspirin and low-to-moderate dose statins have been the subject of JFP audiocasts in May 2016 and January 2017. (See http://bit.ly/2oiun8d and http://bit.ly/2oqkohR.)

2 pregnancy-related recommendations. To prevent neural tube defects in newborns, the Task Force now recommends daily folic acid, 0.4 to 0.8 mg (400 to 800 mcg), for all women who are planning on or are capable of becoming pregnant.⁵ This is an update of a 2009 recommendation that was worded slightly differently, recommending the supplement for all women of childbearing age.

A new recommendation on breastfeeding recognizes its benefits for both mother and baby and finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.⁶ Interventions—provided to individuals or groups by professionals or peers or through formal education—include promoting the benefits of breastfeeding, giving practical advice and direct support on how to breastfeed, and offering psychological support.

Latent TB: Advantages of newer testing method. The recommendation on screening for latent tuberculosis (TB) is an update from the one made in 1996.⁷ At that time, screening for latent infection was performed using a tuberculin skin test (TST). Now a TST or interferon-gamma release assay (IGRA) can be used. Testing with IGRA may be the best option for those who have received a bacille Calmette–Guérin vaccination (because it can cause a false-positive TST) or for those who are not likely to return to have their TST read.

A new recommendation on breastfeeding finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.

Those at high risk for latent TB include people who were born or have resided in countries with a high TB prevalence, those who have lived in a correctional institution or homeless shelter, and anyone in a high-risk group based on local epidemiology of the disease. (Read more on TB in this month’s Case Report.) Others at high risk are those who are immune suppressed because of infection or medications, and those who work in health care or correctional facilities. Screening of these groups is usually conducted as part of occupational health or is considered part of routine health care.

Syphilis: Screen high-risk individuals in 2 steps. The recommendation on syphilis screening basically reaffirms the one from 2004.⁸ Those at high risk for syphilis include men who have sex with men (who now account for 90% of new cases), those who are HIV positive, and those who engage in commercial sex work. Other racial and demographic groups can be at high risk depending on the local epidemiology of the disease. In a separate recommendation, the Task Force advises screening all pregnant women for syphilis.

Screening for syphilis infection involves 2 steps: first, a nontreponemal test (Venereal Disease Research Laboratory [VDRL] or rapid plasma reagin [RPR] test); second, a confirmatory treponemal antibody detection test (fluorescent treponemal antibody absorption [FTA-ABS] or Treponema pallidum particle agglutination [TPPA] test). Treatment for syphilis remains benzathine penicillin with the number of injections depending on the stage of infection. The Centers for Disease Control and Prevention is the best source for current recommendations for treatment of all sexually transmitted infections.¹⁵

Screening tests to avoid

TABLE 4^16,17 lists screening tests the Task Force recommends against. While chronic obstructive pulmonary disease afflicts 14% of US adults ages 40 to 79 years and is the third leading cause of death in the country, the Task Force found that early detection in asymptomatic adults does not affect the course of the illness and is of no benefit.¹⁶

Genital herpes, also prevalent, infects an estimated one out of 6 individuals, ages 14 to 49. It causes little mortality, except in neonates, but those infected can have recurrent flares and suffer psychological harms from stigmatization. Most genital herpes is caused by herpes simplex virus-2, and there is a serological test to detect it. However, the Task Force recommends against using the test to screen asymptomatic adults and adolescents, including those who are pregnant. This recommendation is based on the test’s high false-positive rate, which can cause emotional harm, and on the lack of evidence that detection through screening improves outcomes.¹⁷

The evidence is lacking for these practices

The Task Force is one of only a few organizations that will not make a recommendation if evidence is lacking on benefits and harms. In addition to the ‘I’ statements regarding CVD and CRC mentioned earlier, the Task Force found insufficient evidence to recommend screening for lipid disorders in individuals ages 20 years or younger,¹⁰ performing a visual skin exam as a screening tool for skin cancer,¹¹ screening for celiac disease,¹² performing a periodic pelvic examination in asymptomatic women,¹³ and screening for obstructive sleep apnea using screening questionnaires¹⁴ (TABLE 3^3,4,10-14).

Since the last Practice Alert update on the United States Preventive Services Task Force in May of 2016,¹ the Task Force has released 19 recommendations on 13 topics that include: the use of aspirin and statins for the prevention of cardiovascular disease (CVD); support for breastfeeding; use of folic acid during pregnancy; and screening for syphilis, latent tuberculosis (TB), herpes, chronic obstructive pulmonary disease (COPD), colorectal cancer (CRC), obstructive sleep apnea (OSA), celiac disease, and skin cancer. The Task Force also released a draft recommendation regarding prostate cancer screening in asymptomatic men (see “A change for prostate cancer screening?”) and addressed screening pelvic examinations in asymptomatic women, the subject of this month’s audiocast. (To listen, go to: http://bit.ly/2nIVoD5.)

Recommendations to implement

Recommendations from the past year that family physicians should put into practice are detailed below and in TABLE 1.^2-8

CRC: Screen all individuals ages 50 to 75, but 76 to 85 selectively. The Task Force reaffirmed its 2008 finding that screening for CRC in adults ages 50 to 75 years is substantially beneficial.² In contrast to the previous recommendation, however, the new one does not state which screening tests are preferred. The tests considered were 3 stool tests (fecal immunochemical test [FIT], FIT-tumor DNA testing [FIT-DNA], and guaiac-based fecal occult blood test [gFOBT]), as well as 3 direct visualization tests (colonoscopy, sigmoidoscopy, and CT colonoscopy). The Task Force assessed various testing frequencies of each test and some test combinations. While the Task Force does not recommend any one screening strategy, there are still significant unknowns about FIT-DNA and CT colonoscopy. The American Academy of Family Physicians does not recommend using these 2 tests for screening purposes at this time.⁹

CRC screening for adults ages 76 to 85 was given a “C” recommendation, which means the value of the service to the population overall is small, but that certain individuals may benefit from it. The Task Force advises selectively offering a “C” service to individuals based on professional judgment and patient preferences. Regarding CRC screening in individuals 76 years or older, the ones most likely to benefit are those who have never been screened and those without significant comorbidities that could limit life expectancy. All “C” recommendations from the past year are listed in TABLE 2.^2-4

CVD prevention: When aspirin or a statin is indicated. The Task Force released 2 recommendations for the prevention of CVD this past year. One pertained to the use of low-dose aspirin³ (which also helps to prevent CRC), and the other addressed the use of low- to moderate-dose statins.⁴ Each recommendation is fairly complicated and nuanced in terms of age and risk for CVD. A decision to use low-dose aspirin must also consider the risk of bleeding.

To calculate a patient’s risk for CVD, the Task Force recommends using the risk calculator developed by the American College of Cardiology and the American Heart Association (http://www.cvriskcalculator.com/).

Adults for whom low-dose aspirin and low- to moderate-dose statins are recommended are described in TABLE 1.^2-8 Patients for whom individual decision making is advised, rather than a generalized recommendation, are reviewed in TABLE 2.^2-4 There is insufficient evidence to make a recommendation for the use of aspirin before age 50 or at age 70 and older,³ and for the use of statins in adults age 76 and older who do not have a history of CVD⁴ (TABLE 3^3,4,10-14). The use of low-dose aspirin and low-to-moderate dose statins have been the subject of JFP audiocasts in May 2016 and January 2017. (See http://bit.ly/2oiun8d and http://bit.ly/2oqkohR.)

2 pregnancy-related recommendations. To prevent neural tube defects in newborns, the Task Force now recommends daily folic acid, 0.4 to 0.8 mg (400 to 800 mcg), for all women who are planning on or are capable of becoming pregnant.⁵ This is an update of a 2009 recommendation that was worded slightly differently, recommending the supplement for all women of childbearing age.

A new recommendation on breastfeeding recognizes its benefits for both mother and baby and finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.⁶ Interventions—provided to individuals or groups by professionals or peers or through formal education—include promoting the benefits of breastfeeding, giving practical advice and direct support on how to breastfeed, and offering psychological support.

Latent TB: Advantages of newer testing method. The recommendation on screening for latent tuberculosis (TB) is an update from the one made in 1996.⁷ At that time, screening for latent infection was performed using a tuberculin skin test (TST). Now a TST or interferon-gamma release assay (IGRA) can be used. Testing with IGRA may be the best option for those who have received a bacille Calmette–Guérin vaccination (because it can cause a false-positive TST) or for those who are not likely to return to have their TST read.

A new recommendation on breastfeeding finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.

Those at high risk for latent TB include people who were born or have resided in countries with a high TB prevalence, those who have lived in a correctional institution or homeless shelter, and anyone in a high-risk group based on local epidemiology of the disease. (Read more on TB in this month’s Case Report.) Others at high risk are those who are immune suppressed because of infection or medications, and those who work in health care or correctional facilities. Screening of these groups is usually conducted as part of occupational health or is considered part of routine health care.

Syphilis: Screen high-risk individuals in 2 steps. The recommendation on syphilis screening basically reaffirms the one from 2004.⁸ Those at high risk for syphilis include men who have sex with men (who now account for 90% of new cases), those who are HIV positive, and those who engage in commercial sex work. Other racial and demographic groups can be at high risk depending on the local epidemiology of the disease. In a separate recommendation, the Task Force advises screening all pregnant women for syphilis.

Screening for syphilis infection involves 2 steps: first, a nontreponemal test (Venereal Disease Research Laboratory [VDRL] or rapid plasma reagin [RPR] test); second, a confirmatory treponemal antibody detection test (fluorescent treponemal antibody absorption [FTA-ABS] or Treponema pallidum particle agglutination [TPPA] test). Treatment for syphilis remains benzathine penicillin with the number of injections depending on the stage of infection. The Centers for Disease Control and Prevention is the best source for current recommendations for treatment of all sexually transmitted infections.¹⁵

Screening tests to avoid

TABLE 4^16,17 lists screening tests the Task Force recommends against. While chronic obstructive pulmonary disease afflicts 14% of US adults ages 40 to 79 years and is the third leading cause of death in the country, the Task Force found that early detection in asymptomatic adults does not affect the course of the illness and is of no benefit.¹⁶

Genital herpes, also prevalent, infects an estimated one out of 6 individuals, ages 14 to 49. It causes little mortality, except in neonates, but those infected can have recurrent flares and suffer psychological harms from stigmatization. Most genital herpes is caused by herpes simplex virus-2, and there is a serological test to detect it. However, the Task Force recommends against using the test to screen asymptomatic adults and adolescents, including those who are pregnant. This recommendation is based on the test’s high false-positive rate, which can cause emotional harm, and on the lack of evidence that detection through screening improves outcomes.¹⁷

The evidence is lacking for these practices

The Task Force is one of only a few organizations that will not make a recommendation if evidence is lacking on benefits and harms. In addition to the ‘I’ statements regarding CVD and CRC mentioned earlier, the Task Force found insufficient evidence to recommend screening for lipid disorders in individuals ages 20 years or younger,¹⁰ performing a visual skin exam as a screening tool for skin cancer,¹¹ screening for celiac disease,¹² performing a periodic pelvic examination in asymptomatic women,¹³ and screening for obstructive sleep apnea using screening questionnaires¹⁴ (TABLE 3^3,4,10-14).

Since the last Practice Alert update on the United States Preventive Services Task Force in May of 2016,¹ the Task Force has released 19 recommendations on 13 topics that include: the use of aspirin and statins for the prevention of cardiovascular disease (CVD); support for breastfeeding; use of folic acid during pregnancy; and screening for syphilis, latent tuberculosis (TB), herpes, chronic obstructive pulmonary disease (COPD), colorectal cancer (CRC), obstructive sleep apnea (OSA), celiac disease, and skin cancer. The Task Force also released a draft recommendation regarding prostate cancer screening in asymptomatic men (see “A change for prostate cancer screening?”) and addressed screening pelvic examinations in asymptomatic women, the subject of this month’s audiocast. (To listen, go to: http://bit.ly/2nIVoD5.)

Recommendations to implement

Recommendations from the past year that family physicians should put into practice are detailed below and in TABLE 1.^2-8

CRC: Screen all individuals ages 50 to 75, but 76 to 85 selectively. The Task Force reaffirmed its 2008 finding that screening for CRC in adults ages 50 to 75 years is substantially beneficial.² In contrast to the previous recommendation, however, the new one does not state which screening tests are preferred. The tests considered were 3 stool tests (fecal immunochemical test [FIT], FIT-tumor DNA testing [FIT-DNA], and guaiac-based fecal occult blood test [gFOBT]), as well as 3 direct visualization tests (colonoscopy, sigmoidoscopy, and CT colonoscopy). The Task Force assessed various testing frequencies of each test and some test combinations. While the Task Force does not recommend any one screening strategy, there are still significant unknowns about FIT-DNA and CT colonoscopy. The American Academy of Family Physicians does not recommend using these 2 tests for screening purposes at this time.⁹

CRC screening for adults ages 76 to 85 was given a “C” recommendation, which means the value of the service to the population overall is small, but that certain individuals may benefit from it. The Task Force advises selectively offering a “C” service to individuals based on professional judgment and patient preferences. Regarding CRC screening in individuals 76 years or older, the ones most likely to benefit are those who have never been screened and those without significant comorbidities that could limit life expectancy. All “C” recommendations from the past year are listed in TABLE 2.^2-4

CVD prevention: When aspirin or a statin is indicated. The Task Force released 2 recommendations for the prevention of CVD this past year. One pertained to the use of low-dose aspirin³ (which also helps to prevent CRC), and the other addressed the use of low- to moderate-dose statins.⁴ Each recommendation is fairly complicated and nuanced in terms of age and risk for CVD. A decision to use low-dose aspirin must also consider the risk of bleeding.

To calculate a patient’s risk for CVD, the Task Force recommends using the risk calculator developed by the American College of Cardiology and the American Heart Association (http://www.cvriskcalculator.com/).

Adults for whom low-dose aspirin and low- to moderate-dose statins are recommended are described in TABLE 1.^2-8 Patients for whom individual decision making is advised, rather than a generalized recommendation, are reviewed in TABLE 2.^2-4 There is insufficient evidence to make a recommendation for the use of aspirin before age 50 or at age 70 and older,³ and for the use of statins in adults age 76 and older who do not have a history of CVD⁴ (TABLE 3^3,4,10-14). The use of low-dose aspirin and low-to-moderate dose statins have been the subject of JFP audiocasts in May 2016 and January 2017. (See http://bit.ly/2oiun8d and http://bit.ly/2oqkohR.)

2 pregnancy-related recommendations. To prevent neural tube defects in newborns, the Task Force now recommends daily folic acid, 0.4 to 0.8 mg (400 to 800 mcg), for all women who are planning on or are capable of becoming pregnant.⁵ This is an update of a 2009 recommendation that was worded slightly differently, recommending the supplement for all women of childbearing age.

A new recommendation on breastfeeding recognizes its benefits for both mother and baby and finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.⁶ Interventions—provided to individuals or groups by professionals or peers or through formal education—include promoting the benefits of breastfeeding, giving practical advice and direct support on how to breastfeed, and offering psychological support.

Latent TB: Advantages of newer testing method. The recommendation on screening for latent tuberculosis (TB) is an update from the one made in 1996.⁷ At that time, screening for latent infection was performed using a tuberculin skin test (TST). Now a TST or interferon-gamma release assay (IGRA) can be used. Testing with IGRA may be the best option for those who have received a bacille Calmette–Guérin vaccination (because it can cause a false-positive TST) or for those who are not likely to return to have their TST read.

A new recommendation on breastfeeding finds that interventions to encourage breastfeeding increase the prevalence of this practice and its duration.

Those at high risk for latent TB include people who were born or have resided in countries with a high TB prevalence, those who have lived in a correctional institution or homeless shelter, and anyone in a high-risk group based on local epidemiology of the disease. (Read more on TB in this month’s Case Report.) Others at high risk are those who are immune suppressed because of infection or medications, and those who work in health care or correctional facilities. Screening of these groups is usually conducted as part of occupational health or is considered part of routine health care.

Syphilis: Screen high-risk individuals in 2 steps. The recommendation on syphilis screening basically reaffirms the one from 2004.⁸ Those at high risk for syphilis include men who have sex with men (who now account for 90% of new cases), those who are HIV positive, and those who engage in commercial sex work. Other racial and demographic groups can be at high risk depending on the local epidemiology of the disease. In a separate recommendation, the Task Force advises screening all pregnant women for syphilis.

Screening for syphilis infection involves 2 steps: first, a nontreponemal test (Venereal Disease Research Laboratory [VDRL] or rapid plasma reagin [RPR] test); second, a confirmatory treponemal antibody detection test (fluorescent treponemal antibody absorption [FTA-ABS] or Treponema pallidum particle agglutination [TPPA] test). Treatment for syphilis remains benzathine penicillin with the number of injections depending on the stage of infection. The Centers for Disease Control and Prevention is the best source for current recommendations for treatment of all sexually transmitted infections.¹⁵

Screening tests to avoid

TABLE 4^16,17 lists screening tests the Task Force recommends against. While chronic obstructive pulmonary disease afflicts 14% of US adults ages 40 to 79 years and is the third leading cause of death in the country, the Task Force found that early detection in asymptomatic adults does not affect the course of the illness and is of no benefit.¹⁶

Genital herpes, also prevalent, infects an estimated one out of 6 individuals, ages 14 to 49. It causes little mortality, except in neonates, but those infected can have recurrent flares and suffer psychological harms from stigmatization. Most genital herpes is caused by herpes simplex virus-2, and there is a serological test to detect it. However, the Task Force recommends against using the test to screen asymptomatic adults and adolescents, including those who are pregnant. This recommendation is based on the test’s high false-positive rate, which can cause emotional harm, and on the lack of evidence that detection through screening improves outcomes.¹⁷

The evidence is lacking for these practices

The Task Force is one of only a few organizations that will not make a recommendation if evidence is lacking on benefits and harms. In addition to the ‘I’ statements regarding CVD and CRC mentioned earlier, the Task Force found insufficient evidence to recommend screening for lipid disorders in individuals ages 20 years or younger,¹⁰ performing a visual skin exam as a screening tool for skin cancer,¹¹ screening for celiac disease,¹² performing a periodic pelvic examination in asymptomatic women,¹³ and screening for obstructive sleep apnea using screening questionnaires¹⁴ (TABLE 3^3,4,10-14).

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

However, magnetic resonance elastography (MRE) is somewhat more accurate for detecting cirrhosis in nonalcoholic fatty liver disease, wrote Joseph K. Lim, MD, AGAF, of Yale University in New Haven, Conn., with his associates from the Clinical Guidelines Committee of the AGA. VCTE is convenient but performs unevenly in some liver conditions and is especially unreliable in patients with acute hepatitis, alcohol abuse, food intake within 2-3 hours, congestive heart failure, or extrahepatic cholestasis, the guideline notes. Yet, VCTE remains the most common imaging tool for diagnosing fibrosis in the United States, and the guideline addresses “focused, clinically relevant questions” to guide its use.

When possible, clinicians should use VCTE instead of noninvasive serum tests for cirrhosis in patients with chronic hepatitis C, the guideline asserts. In pooled analyses of 62 studies, VCTE detected about 89% of cirrhosis cases (95% confidence interval, 84%-92%), Fibrosis-4 test (FIB-4) detected 87% (95% CI, 74%-94%), and aspartate aminotransferase to platelet ratio index (APRI) detected 77% (95% CI, 73%-81%). The specificity of VCTE (91%) also equaled or exceeded that of FIB-4 (91%) or APRI (78%), the guideline noted.

For chronic hepatitis C, MRE had “poorer specificity with higher false-positive rates, suggesting poorer diagnostic performance,” compared with VCTE. Lower cost and lower point-of-care availability make VCTE “an attractive solution compared to MRE,” the guideline adds. It conditionally recommends VCTE cutoffs of 12.5 kPa for cirrhosis and 9.5 kPa for advanced (F3-F4) liver fibrosis after patients have a sustained virologic response to therapy. The 9.5-kPa cutoff would misclassify only 1% of low-risk patients and 7% of high-risk patients, but noncirrhotic patients (less than 9.5 kPa) may reasonably choose to continue specialty care if they prioritize avoiding “the small risk” of hepatocellular carcinoma over the “inconvenience and risks of continued laboratory and fibrosis testing.”

For chronic hepatitis B, the guideline conditionally recommends VCTE with an 11.0-kPa cutoff over APRI or FIB-4. In a pooled analysis of 28 studies, VCTE detected cirrhosis with a sensitivity of 86% and a specificity of 85%, compared with 66% and 74%, respectively, for APRI, and 87% and 65%, respectively, for FIB-4. However, the overall diagnostic performance of VCTE resembled that of the serum tests, and clinicians should interpret VCTE in the context of other clinical cirrhosis data, the guideline states.

Among 17 studies of VCTE cutoffs in hepatitis B, an 11.0-kPa threshold diagnosed cirrhosis with a sensitivity of 81% and a specificity of 83%. This cutoff would miss cirrhosis in less than 1% of low-risk patients and about 5% of high-risk patients and would yield false positives in 10%-15% of patients. Thus, its cutoff minimizes false negatives, reflecting “a judgment that the harm of missing cirrhosis is greater than the harm of over diagnosis,” the authors write.

For chronic alcoholic liver disease, the AGA conditionally recommends VCTE with a cirrhosis cutoff of 12.5 kPa. In pooled analyses, this value had a sensitivity of 95% and a specificity of 71%. For suspected compensated cirrhosis, the guideline conditionally suggests a 19.5-kPa cutoff when assessing the need for esophagogastroduodenoscopy (EGD) to identify high-risk esophageal varices. Patients who fall below this cutoff can reasonably pursue screening endoscopy if they are concerned about the small risk of acute variceal hemorrhage, the guideline adds.

The guideline also conditionally recommends a 17-kPa cutoff to detect clinically significant portal hypertension in patients with suspected chronic liver disease who are undergoing elective nonhepatic surgeries. This cutoff will miss about 0.1% of very low-risk patients, 0.8% of low-risk patients, and 7% of high-risk patients. Because the failure to detect portal hypertension contributes to operative morbidity and mortality, higher-risk patients might “reasonably” pursue screening endoscopy even if their kPa is below the cutoff, the guideline states.

The guideline made no recommendation about VCTE versus APRI or FIB-4 in adults with nonalcoholic fatty liver disease (NAFLD), citing “unacceptable bias” in 12 studies that excluded obese patients, used per-protocol rather than intention-to-diagnose analyses, and ignored “unsuccessful or inadequate” liver stiffness measurements, which are relatively common in NAFLD, the guideline notes. It conditionally recommends MRE over VCTE in high-risk adults with NAFLD, including those who are older, diabetic, or obese (especially with central adiposity) or who have alanine levels more than twice the upper limit of normal. However, it cites insufficient evidence to extend this recommendation to low-risk patients who only have imaging evidence of fatty liver.

Overall, the guideline focuses on “routine clinical management issues, and [does] not address comparisons with proprietary serum fibrosis assays, other emerging imaging-based fibrosis assessment techniques, or combinations of more than one noninvasive fibrosis test,” the authors note. They also limited VCTE cutoffs to single thresholds that prioritized sensitivity over specificity. “Additional studies are needed to further define the role of VCTE, MRE, and emerging diagnostic studies in the assessment of liver fibrosis, for which a significant unmet medical need remains, particularly in conditions such as NAFLD/[nonalcoholic steatohepatitis],” they add. “In particular, defining the implications for serial liver stiffness measurements over time on management decisions is of great interest.”

Dr. Muir has served as a consultant for AbbVie, Bristol-Myers Squibb, Gilead, and Merck. Dr. Lim has served as a consultant for Bristol Myers-Squibb, Gilead, Merck, and Boehringer Ingelheim. Dr. Flamm has served as a consultant or received research support from Gilead, Bristol-Myers Squibb, AbbVie, Salix Pharmaceuticals, and Intercept Pharmaceuticals. Dr. Dieterich has presented lectures for Gilead and Merck products. The rest of the authors disclosed no conflicts related to the content of this guideline.

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

However, magnetic resonance elastography (MRE) is somewhat more accurate for detecting cirrhosis in nonalcoholic fatty liver disease, wrote Joseph K. Lim, MD, AGAF, of Yale University in New Haven, Conn., with his associates from the Clinical Guidelines Committee of the AGA. VCTE is convenient but performs unevenly in some liver conditions and is especially unreliable in patients with acute hepatitis, alcohol abuse, food intake within 2-3 hours, congestive heart failure, or extrahepatic cholestasis, the guideline notes. Yet, VCTE remains the most common imaging tool for diagnosing fibrosis in the United States, and the guideline addresses “focused, clinically relevant questions” to guide its use.

When possible, clinicians should use VCTE instead of noninvasive serum tests for cirrhosis in patients with chronic hepatitis C, the guideline asserts. In pooled analyses of 62 studies, VCTE detected about 89% of cirrhosis cases (95% confidence interval, 84%-92%), Fibrosis-4 test (FIB-4) detected 87% (95% CI, 74%-94%), and aspartate aminotransferase to platelet ratio index (APRI) detected 77% (95% CI, 73%-81%). The specificity of VCTE (91%) also equaled or exceeded that of FIB-4 (91%) or APRI (78%), the guideline noted.

For chronic hepatitis C, MRE had “poorer specificity with higher false-positive rates, suggesting poorer diagnostic performance,” compared with VCTE. Lower cost and lower point-of-care availability make VCTE “an attractive solution compared to MRE,” the guideline adds. It conditionally recommends VCTE cutoffs of 12.5 kPa for cirrhosis and 9.5 kPa for advanced (F3-F4) liver fibrosis after patients have a sustained virologic response to therapy. The 9.5-kPa cutoff would misclassify only 1% of low-risk patients and 7% of high-risk patients, but noncirrhotic patients (less than 9.5 kPa) may reasonably choose to continue specialty care if they prioritize avoiding “the small risk” of hepatocellular carcinoma over the “inconvenience and risks of continued laboratory and fibrosis testing.”

For chronic hepatitis B, the guideline conditionally recommends VCTE with an 11.0-kPa cutoff over APRI or FIB-4. In a pooled analysis of 28 studies, VCTE detected cirrhosis with a sensitivity of 86% and a specificity of 85%, compared with 66% and 74%, respectively, for APRI, and 87% and 65%, respectively, for FIB-4. However, the overall diagnostic performance of VCTE resembled that of the serum tests, and clinicians should interpret VCTE in the context of other clinical cirrhosis data, the guideline states.

Among 17 studies of VCTE cutoffs in hepatitis B, an 11.0-kPa threshold diagnosed cirrhosis with a sensitivity of 81% and a specificity of 83%. This cutoff would miss cirrhosis in less than 1% of low-risk patients and about 5% of high-risk patients and would yield false positives in 10%-15% of patients. Thus, its cutoff minimizes false negatives, reflecting “a judgment that the harm of missing cirrhosis is greater than the harm of over diagnosis,” the authors write.

For chronic alcoholic liver disease, the AGA conditionally recommends VCTE with a cirrhosis cutoff of 12.5 kPa. In pooled analyses, this value had a sensitivity of 95% and a specificity of 71%. For suspected compensated cirrhosis, the guideline conditionally suggests a 19.5-kPa cutoff when assessing the need for esophagogastroduodenoscopy (EGD) to identify high-risk esophageal varices. Patients who fall below this cutoff can reasonably pursue screening endoscopy if they are concerned about the small risk of acute variceal hemorrhage, the guideline adds.

The guideline also conditionally recommends a 17-kPa cutoff to detect clinically significant portal hypertension in patients with suspected chronic liver disease who are undergoing elective nonhepatic surgeries. This cutoff will miss about 0.1% of very low-risk patients, 0.8% of low-risk patients, and 7% of high-risk patients. Because the failure to detect portal hypertension contributes to operative morbidity and mortality, higher-risk patients might “reasonably” pursue screening endoscopy even if their kPa is below the cutoff, the guideline states.

The guideline made no recommendation about VCTE versus APRI or FIB-4 in adults with nonalcoholic fatty liver disease (NAFLD), citing “unacceptable bias” in 12 studies that excluded obese patients, used per-protocol rather than intention-to-diagnose analyses, and ignored “unsuccessful or inadequate” liver stiffness measurements, which are relatively common in NAFLD, the guideline notes. It conditionally recommends MRE over VCTE in high-risk adults with NAFLD, including those who are older, diabetic, or obese (especially with central adiposity) or who have alanine levels more than twice the upper limit of normal. However, it cites insufficient evidence to extend this recommendation to low-risk patients who only have imaging evidence of fatty liver.

Overall, the guideline focuses on “routine clinical management issues, and [does] not address comparisons with proprietary serum fibrosis assays, other emerging imaging-based fibrosis assessment techniques, or combinations of more than one noninvasive fibrosis test,” the authors note. They also limited VCTE cutoffs to single thresholds that prioritized sensitivity over specificity. “Additional studies are needed to further define the role of VCTE, MRE, and emerging diagnostic studies in the assessment of liver fibrosis, for which a significant unmet medical need remains, particularly in conditions such as NAFLD/[nonalcoholic steatohepatitis],” they add. “In particular, defining the implications for serial liver stiffness measurements over time on management decisions is of great interest.”

Dr. Muir has served as a consultant for AbbVie, Bristol-Myers Squibb, Gilead, and Merck. Dr. Lim has served as a consultant for Bristol Myers-Squibb, Gilead, Merck, and Boehringer Ingelheim. Dr. Flamm has served as a consultant or received research support from Gilead, Bristol-Myers Squibb, AbbVie, Salix Pharmaceuticals, and Intercept Pharmaceuticals. Dr. Dieterich has presented lectures for Gilead and Merck products. The rest of the authors disclosed no conflicts related to the content of this guideline.

Vibration-controlled transient elastography (VCTE) can accurately diagnose cirrhosis in most patients with chronic liver disease, particularly those with chronic hepatitis B or C, states a new guideline from the AGA Institute, published in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.017).

However, magnetic resonance elastography (MRE) is somewhat more accurate for detecting cirrhosis in nonalcoholic fatty liver disease, wrote Joseph K. Lim, MD, AGAF, of Yale University in New Haven, Conn., with his associates from the Clinical Guidelines Committee of the AGA. VCTE is convenient but performs unevenly in some liver conditions and is especially unreliable in patients with acute hepatitis, alcohol abuse, food intake within 2-3 hours, congestive heart failure, or extrahepatic cholestasis, the guideline notes. Yet, VCTE remains the most common imaging tool for diagnosing fibrosis in the United States, and the guideline addresses “focused, clinically relevant questions” to guide its use.

When possible, clinicians should use VCTE instead of noninvasive serum tests for cirrhosis in patients with chronic hepatitis C, the guideline asserts. In pooled analyses of 62 studies, VCTE detected about 89% of cirrhosis cases (95% confidence interval, 84%-92%), Fibrosis-4 test (FIB-4) detected 87% (95% CI, 74%-94%), and aspartate aminotransferase to platelet ratio index (APRI) detected 77% (95% CI, 73%-81%). The specificity of VCTE (91%) also equaled or exceeded that of FIB-4 (91%) or APRI (78%), the guideline noted.

For chronic hepatitis C, MRE had “poorer specificity with higher false-positive rates, suggesting poorer diagnostic performance,” compared with VCTE. Lower cost and lower point-of-care availability make VCTE “an attractive solution compared to MRE,” the guideline adds. It conditionally recommends VCTE cutoffs of 12.5 kPa for cirrhosis and 9.5 kPa for advanced (F3-F4) liver fibrosis after patients have a sustained virologic response to therapy. The 9.5-kPa cutoff would misclassify only 1% of low-risk patients and 7% of high-risk patients, but noncirrhotic patients (less than 9.5 kPa) may reasonably choose to continue specialty care if they prioritize avoiding “the small risk” of hepatocellular carcinoma over the “inconvenience and risks of continued laboratory and fibrosis testing.”

For chronic hepatitis B, the guideline conditionally recommends VCTE with an 11.0-kPa cutoff over APRI or FIB-4. In a pooled analysis of 28 studies, VCTE detected cirrhosis with a sensitivity of 86% and a specificity of 85%, compared with 66% and 74%, respectively, for APRI, and 87% and 65%, respectively, for FIB-4. However, the overall diagnostic performance of VCTE resembled that of the serum tests, and clinicians should interpret VCTE in the context of other clinical cirrhosis data, the guideline states.

Among 17 studies of VCTE cutoffs in hepatitis B, an 11.0-kPa threshold diagnosed cirrhosis with a sensitivity of 81% and a specificity of 83%. This cutoff would miss cirrhosis in less than 1% of low-risk patients and about 5% of high-risk patients and would yield false positives in 10%-15% of patients. Thus, its cutoff minimizes false negatives, reflecting “a judgment that the harm of missing cirrhosis is greater than the harm of over diagnosis,” the authors write.

For chronic alcoholic liver disease, the AGA conditionally recommends VCTE with a cirrhosis cutoff of 12.5 kPa. In pooled analyses, this value had a sensitivity of 95% and a specificity of 71%. For suspected compensated cirrhosis, the guideline conditionally suggests a 19.5-kPa cutoff when assessing the need for esophagogastroduodenoscopy (EGD) to identify high-risk esophageal varices. Patients who fall below this cutoff can reasonably pursue screening endoscopy if they are concerned about the small risk of acute variceal hemorrhage, the guideline adds.

The guideline also conditionally recommends a 17-kPa cutoff to detect clinically significant portal hypertension in patients with suspected chronic liver disease who are undergoing elective nonhepatic surgeries. This cutoff will miss about 0.1% of very low-risk patients, 0.8% of low-risk patients, and 7% of high-risk patients. Because the failure to detect portal hypertension contributes to operative morbidity and mortality, higher-risk patients might “reasonably” pursue screening endoscopy even if their kPa is below the cutoff, the guideline states.

The guideline made no recommendation about VCTE versus APRI or FIB-4 in adults with nonalcoholic fatty liver disease (NAFLD), citing “unacceptable bias” in 12 studies that excluded obese patients, used per-protocol rather than intention-to-diagnose analyses, and ignored “unsuccessful or inadequate” liver stiffness measurements, which are relatively common in NAFLD, the guideline notes. It conditionally recommends MRE over VCTE in high-risk adults with NAFLD, including those who are older, diabetic, or obese (especially with central adiposity) or who have alanine levels more than twice the upper limit of normal. However, it cites insufficient evidence to extend this recommendation to low-risk patients who only have imaging evidence of fatty liver.

Overall, the guideline focuses on “routine clinical management issues, and [does] not address comparisons with proprietary serum fibrosis assays, other emerging imaging-based fibrosis assessment techniques, or combinations of more than one noninvasive fibrosis test,” the authors note. They also limited VCTE cutoffs to single thresholds that prioritized sensitivity over specificity. “Additional studies are needed to further define the role of VCTE, MRE, and emerging diagnostic studies in the assessment of liver fibrosis, for which a significant unmet medical need remains, particularly in conditions such as NAFLD/[nonalcoholic steatohepatitis],” they add. “In particular, defining the implications for serial liver stiffness measurements over time on management decisions is of great interest.”

Dr. Muir has served as a consultant for AbbVie, Bristol-Myers Squibb, Gilead, and Merck. Dr. Lim has served as a consultant for Bristol Myers-Squibb, Gilead, Merck, and Boehringer Ingelheim. Dr. Flamm has served as a consultant or received research support from Gilead, Bristol-Myers Squibb, AbbVie, Salix Pharmaceuticals, and Intercept Pharmaceuticals. Dr. Dieterich has presented lectures for Gilead and Merck products. The rest of the authors disclosed no conflicts related to the content of this guideline.

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.

The AGA Institute issued a clinical practice update for managing hepatitis C virus–infected patients who achieve a sustained virologic response after antiviral therapy, who still require ongoing care for their liver disease. The expert review appears in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2017.03.018).

Even though direct-acting antiviral regimens have produced remarkably high sustained virologic response (SVR) rates and it appears that fewer than 1% of patients relapse, and even though liver fibrosis and cirrhosis may regress with this therapy, continued surveillance and even intervention may be needed “to reduce complications arising from liver damage that has already accrued by the time SVR was attained,” said Ira M. Jacobson, MD, AGAF, chair of the department of medicine, Mount Sinai Beth Israel Medical Center, New York, and his associates.