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AAD guidelines favor surgery for nonmelanoma skin cancers
, according to new practice guidelines issued by the American Academy of Dermatology.
Nonsurgical approaches such as cryotherapy, photodynamic therapy, and radiation may be considered for low-risk cancers if surgery is contraindicated, but these methods have lower cure rates, according to the guidelines. Christopher K. Bichakjian, MD, professor of dermatology, University of Michigan, Ann Arbor, and Murad Alam, MD, professor of dermatology, Northwestern University, Chicago, cochaired the work groups that developed the guidelines.
The guidelines for BCC and cSCC, published online in two separate papers (J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.006; J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.007), also discuss biopsy techniques, tumor staging, and prevention of recurrence of nonmelanoma skin cancers.
The most suitable stratification for localized BCC and cSCC is the framework provided by the National Comprehensive Cancer Network, the authors said in the guidelines.
For suspected BCC and cSCC, recommended biopsy techniques are punch biopsy, shave biopsy, and excisional biopsy. Biopsy technique is “contingent on the clinical characteristics of the suspected tumor, including morphology, expected histologic subtype and depth, natural history, and anatomic location; patient-specific factors, such as bleeding and wound healing diatheses; and patient preference and physician judgment,” the guidelines state. If the initial biopsy proves insufficient for diagnosis, a repeat biopsy may be considered.
For surgical treatment of BCC, curettage and electrodessication may be considered for low-risk tumors in nonterminal hair-bearing locations. Surgical excision with 4-mm clinical margins and histologic margin assessment is recommended for low-risk primary BCC. For high-risk BCC, Mohs micrographic surgery is recommended, the authors said.
Surgical options for cSCC also include curettage and electrodessication and standard excision for low-risk disease, and Mohs micrographic surgery for high-risk cSCC. In both BCC and cSCC, standard excision may be considered for high-risk tumors in some cases, but “strong caution is advised when selecting a treatment modality” for high-risk tumors “without complete margin assessment,” the guidelines state.
Nonsurgical therapies are generally not recommended as first-line treatment, especially in cSCC because of possible recurrence and metastasis. In cases where nonsurgical therapies are preferred, options may include cryosurgery, topical therapy, photodynamic therapy, radiation, or laser therapy, “with the understanding that the cure rate may be lower,” the authors wrote.
Patients with diagnosed nonmelanoma skin cancer should continue to undergo screening for new primary skin cancers (including BCC, cSCC, and melanoma) at least once per year, the guideline states. They should also be counseled on sun protection, tanning bed avoidance, and regular use of broad-spectrum sunscreen.
Although the new guidelines mainly “reaffirm common knowledge and current practice,” they offer a reminder of “alternative therapeutic or preventive options when insufficient evidence is available to support new therapies or previously dogmatic practice patterns,” the authors said.
These are the first guidelines of care for BCC and cSCC published by the AAD. Commonly used guidelines for the management of BCC and cSCC are published by the National Comprehensive Cancer Network, which are frequently referenced throughout the new AAD guidelines, Dr. Bichakjian said in an interview. While the aim of the cancer network is to develop multidisciplinary guidelines, reflected by the composition of the panel members, “AAD guidelines of care are established primarily by dermatologists for dermatologists,” he pointed out. “However, the work group recognizes that a variety of health care providers outside of dermatology take care of patients with BCC and cSCC, and acknowledges the importance of multidisciplinary care,” he added. “With these considerations in mind, reviewers from specialties outside of dermatology, including plastic surgery, otolaryngology/head and neck surgery, medical oncology, radiation oncology, and family medicine, were invited to critically review the current guidelines.”
The guidelines do not cover the management of actinic keratosis and cSCC in situ, he said. “The work group acknowledges the importance of appropriate management of premalignant and in situ lesions in the prevention of their potential progression to cSCC. However, additional data to provide comprehensive evidence-based recommendations were deemed too extensive to include in the current guidelines and will need to addressed separately.”
In an interview, David J. Leffell, MD, who was not an author of the guidelines, said that the new guidelines do an effective job of “highlighting where valid outcomes data exist and areas where they do not” for a wide range of therapies. They also “attempt to standardize approaches to diagnosis and care of nonmelanoma skin cancer and in general are consistent with established practice patterns,” he added. “Those contemporary approaches have developed in largely empirical fashion over many decades, but bear clarification and reinforcement,” said Dr. Leffell, professor of dermatology and surgery and chief of the section of dermatologic surgery and cutaneous oncology at Yale University, New Haven, Conn.
The guidelines “thoroughly summarize evidence-based recommendations for the entire spectrum of disease management,” Daniel D. Bennett, MD, of the department of dermatology at the University of Wisconsin – Madison, said in an interview. “While surgery remains the mainstay of treatment for BCC and cutaneous SCC, these guidelines include excellent reviews of nonsurgical management options,” he said.
Dr. Bichakjian, who is also chief of the division of cutaneous surgery and oncology at the University of Michigan, had no relevant financial disclosures to report. Dr. Alam, who is also chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern, disclosed relationships with Amway, OptMed, and 3M. Dr. Bennett and Dr. Leffell had no relevant disclosures.
, according to new practice guidelines issued by the American Academy of Dermatology.
Nonsurgical approaches such as cryotherapy, photodynamic therapy, and radiation may be considered for low-risk cancers if surgery is contraindicated, but these methods have lower cure rates, according to the guidelines. Christopher K. Bichakjian, MD, professor of dermatology, University of Michigan, Ann Arbor, and Murad Alam, MD, professor of dermatology, Northwestern University, Chicago, cochaired the work groups that developed the guidelines.
The guidelines for BCC and cSCC, published online in two separate papers (J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.006; J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.007), also discuss biopsy techniques, tumor staging, and prevention of recurrence of nonmelanoma skin cancers.
The most suitable stratification for localized BCC and cSCC is the framework provided by the National Comprehensive Cancer Network, the authors said in the guidelines.
For suspected BCC and cSCC, recommended biopsy techniques are punch biopsy, shave biopsy, and excisional biopsy. Biopsy technique is “contingent on the clinical characteristics of the suspected tumor, including morphology, expected histologic subtype and depth, natural history, and anatomic location; patient-specific factors, such as bleeding and wound healing diatheses; and patient preference and physician judgment,” the guidelines state. If the initial biopsy proves insufficient for diagnosis, a repeat biopsy may be considered.
For surgical treatment of BCC, curettage and electrodessication may be considered for low-risk tumors in nonterminal hair-bearing locations. Surgical excision with 4-mm clinical margins and histologic margin assessment is recommended for low-risk primary BCC. For high-risk BCC, Mohs micrographic surgery is recommended, the authors said.
Surgical options for cSCC also include curettage and electrodessication and standard excision for low-risk disease, and Mohs micrographic surgery for high-risk cSCC. In both BCC and cSCC, standard excision may be considered for high-risk tumors in some cases, but “strong caution is advised when selecting a treatment modality” for high-risk tumors “without complete margin assessment,” the guidelines state.
Nonsurgical therapies are generally not recommended as first-line treatment, especially in cSCC because of possible recurrence and metastasis. In cases where nonsurgical therapies are preferred, options may include cryosurgery, topical therapy, photodynamic therapy, radiation, or laser therapy, “with the understanding that the cure rate may be lower,” the authors wrote.
Patients with diagnosed nonmelanoma skin cancer should continue to undergo screening for new primary skin cancers (including BCC, cSCC, and melanoma) at least once per year, the guideline states. They should also be counseled on sun protection, tanning bed avoidance, and regular use of broad-spectrum sunscreen.
Although the new guidelines mainly “reaffirm common knowledge and current practice,” they offer a reminder of “alternative therapeutic or preventive options when insufficient evidence is available to support new therapies or previously dogmatic practice patterns,” the authors said.
These are the first guidelines of care for BCC and cSCC published by the AAD. Commonly used guidelines for the management of BCC and cSCC are published by the National Comprehensive Cancer Network, which are frequently referenced throughout the new AAD guidelines, Dr. Bichakjian said in an interview. While the aim of the cancer network is to develop multidisciplinary guidelines, reflected by the composition of the panel members, “AAD guidelines of care are established primarily by dermatologists for dermatologists,” he pointed out. “However, the work group recognizes that a variety of health care providers outside of dermatology take care of patients with BCC and cSCC, and acknowledges the importance of multidisciplinary care,” he added. “With these considerations in mind, reviewers from specialties outside of dermatology, including plastic surgery, otolaryngology/head and neck surgery, medical oncology, radiation oncology, and family medicine, were invited to critically review the current guidelines.”
The guidelines do not cover the management of actinic keratosis and cSCC in situ, he said. “The work group acknowledges the importance of appropriate management of premalignant and in situ lesions in the prevention of their potential progression to cSCC. However, additional data to provide comprehensive evidence-based recommendations were deemed too extensive to include in the current guidelines and will need to addressed separately.”
In an interview, David J. Leffell, MD, who was not an author of the guidelines, said that the new guidelines do an effective job of “highlighting where valid outcomes data exist and areas where they do not” for a wide range of therapies. They also “attempt to standardize approaches to diagnosis and care of nonmelanoma skin cancer and in general are consistent with established practice patterns,” he added. “Those contemporary approaches have developed in largely empirical fashion over many decades, but bear clarification and reinforcement,” said Dr. Leffell, professor of dermatology and surgery and chief of the section of dermatologic surgery and cutaneous oncology at Yale University, New Haven, Conn.
The guidelines “thoroughly summarize evidence-based recommendations for the entire spectrum of disease management,” Daniel D. Bennett, MD, of the department of dermatology at the University of Wisconsin – Madison, said in an interview. “While surgery remains the mainstay of treatment for BCC and cutaneous SCC, these guidelines include excellent reviews of nonsurgical management options,” he said.
Dr. Bichakjian, who is also chief of the division of cutaneous surgery and oncology at the University of Michigan, had no relevant financial disclosures to report. Dr. Alam, who is also chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern, disclosed relationships with Amway, OptMed, and 3M. Dr. Bennett and Dr. Leffell had no relevant disclosures.
, according to new practice guidelines issued by the American Academy of Dermatology.
Nonsurgical approaches such as cryotherapy, photodynamic therapy, and radiation may be considered for low-risk cancers if surgery is contraindicated, but these methods have lower cure rates, according to the guidelines. Christopher K. Bichakjian, MD, professor of dermatology, University of Michigan, Ann Arbor, and Murad Alam, MD, professor of dermatology, Northwestern University, Chicago, cochaired the work groups that developed the guidelines.
The guidelines for BCC and cSCC, published online in two separate papers (J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.006; J Am Acad Dermatol. 2018 Jan. 10. doi: 10.1016/j.jaad.2017.10.007), also discuss biopsy techniques, tumor staging, and prevention of recurrence of nonmelanoma skin cancers.
The most suitable stratification for localized BCC and cSCC is the framework provided by the National Comprehensive Cancer Network, the authors said in the guidelines.
For suspected BCC and cSCC, recommended biopsy techniques are punch biopsy, shave biopsy, and excisional biopsy. Biopsy technique is “contingent on the clinical characteristics of the suspected tumor, including morphology, expected histologic subtype and depth, natural history, and anatomic location; patient-specific factors, such as bleeding and wound healing diatheses; and patient preference and physician judgment,” the guidelines state. If the initial biopsy proves insufficient for diagnosis, a repeat biopsy may be considered.
For surgical treatment of BCC, curettage and electrodessication may be considered for low-risk tumors in nonterminal hair-bearing locations. Surgical excision with 4-mm clinical margins and histologic margin assessment is recommended for low-risk primary BCC. For high-risk BCC, Mohs micrographic surgery is recommended, the authors said.
Surgical options for cSCC also include curettage and electrodessication and standard excision for low-risk disease, and Mohs micrographic surgery for high-risk cSCC. In both BCC and cSCC, standard excision may be considered for high-risk tumors in some cases, but “strong caution is advised when selecting a treatment modality” for high-risk tumors “without complete margin assessment,” the guidelines state.
Nonsurgical therapies are generally not recommended as first-line treatment, especially in cSCC because of possible recurrence and metastasis. In cases where nonsurgical therapies are preferred, options may include cryosurgery, topical therapy, photodynamic therapy, radiation, or laser therapy, “with the understanding that the cure rate may be lower,” the authors wrote.
Patients with diagnosed nonmelanoma skin cancer should continue to undergo screening for new primary skin cancers (including BCC, cSCC, and melanoma) at least once per year, the guideline states. They should also be counseled on sun protection, tanning bed avoidance, and regular use of broad-spectrum sunscreen.
Although the new guidelines mainly “reaffirm common knowledge and current practice,” they offer a reminder of “alternative therapeutic or preventive options when insufficient evidence is available to support new therapies or previously dogmatic practice patterns,” the authors said.
These are the first guidelines of care for BCC and cSCC published by the AAD. Commonly used guidelines for the management of BCC and cSCC are published by the National Comprehensive Cancer Network, which are frequently referenced throughout the new AAD guidelines, Dr. Bichakjian said in an interview. While the aim of the cancer network is to develop multidisciplinary guidelines, reflected by the composition of the panel members, “AAD guidelines of care are established primarily by dermatologists for dermatologists,” he pointed out. “However, the work group recognizes that a variety of health care providers outside of dermatology take care of patients with BCC and cSCC, and acknowledges the importance of multidisciplinary care,” he added. “With these considerations in mind, reviewers from specialties outside of dermatology, including plastic surgery, otolaryngology/head and neck surgery, medical oncology, radiation oncology, and family medicine, were invited to critically review the current guidelines.”
The guidelines do not cover the management of actinic keratosis and cSCC in situ, he said. “The work group acknowledges the importance of appropriate management of premalignant and in situ lesions in the prevention of their potential progression to cSCC. However, additional data to provide comprehensive evidence-based recommendations were deemed too extensive to include in the current guidelines and will need to addressed separately.”
In an interview, David J. Leffell, MD, who was not an author of the guidelines, said that the new guidelines do an effective job of “highlighting where valid outcomes data exist and areas where they do not” for a wide range of therapies. They also “attempt to standardize approaches to diagnosis and care of nonmelanoma skin cancer and in general are consistent with established practice patterns,” he added. “Those contemporary approaches have developed in largely empirical fashion over many decades, but bear clarification and reinforcement,” said Dr. Leffell, professor of dermatology and surgery and chief of the section of dermatologic surgery and cutaneous oncology at Yale University, New Haven, Conn.
The guidelines “thoroughly summarize evidence-based recommendations for the entire spectrum of disease management,” Daniel D. Bennett, MD, of the department of dermatology at the University of Wisconsin – Madison, said in an interview. “While surgery remains the mainstay of treatment for BCC and cutaneous SCC, these guidelines include excellent reviews of nonsurgical management options,” he said.
Dr. Bichakjian, who is also chief of the division of cutaneous surgery and oncology at the University of Michigan, had no relevant financial disclosures to report. Dr. Alam, who is also chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern, disclosed relationships with Amway, OptMed, and 3M. Dr. Bennett and Dr. Leffell had no relevant disclosures.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
APA guideline backs naltrexone, acamprosate for alcohol use disorder
Naltrexone or acamprosate should be offered as first-line pharmacologic therapy to patients with moderate to severe alcohol use disorder (AUD) who do not respond to nonpharmacologic therapy alone, according to a practice guideline published by the American Psychiatric Association.
if naltrexone and acamprosate are not effective or well tolerated, the report said.
The APA guideline recommends against the use of antidepressants and benzodiazepines for patients with alcohol use disorder, except for situations where a co-occurring disorder requires treatment. In addition, the guideline recommends against the use of acamprosate in patients with renal impairment, and specifies that naltrexone should not be used by patients with acute hepatitis, hepatic failure, or opioid dependence.
“Naltrexone and acamprosate have the best available evidence as pharmacotherapy for patients with AUD,” wrote Victor I. Reus, MD, and his coauthors in the APA Guideline Writing Group, which formed the guideline using a systematic review of current literature in accordance with Institute of Medicine (now called the National Academy of Medicine) and Agency for Healthcare Research and Quality standards.
Naltrexone, an opioid receptor antagonist, is effective in treating both AUD and opioid use disorder. Studies have shown that it may decrease cravings, and is associated with fewer drinking days and a reduced likelihood of return to drinking, the authors reported. In patients with a history of renal impairment, serum creatinine should be measured, and results should be reviewed before initiating treatment with acamprosate – a synthetic amino acid.
Disulfiram breaks down acetaldehyde, an ethanol byproduct, and should be used only to treat patients with a goal of abstinence. It is not recommended as a first-line therapy because of the side effects of concurrent alcohol use, including tachycardia, flushing, headache, nausea, and vomiting, reported Dr. Reus of the psychiatry department at the University of California, San Francisco, and his coauthors.
“Patients should be fully informed of the physiological consequences of consuming alcohol while taking disulfiram and should agree to taking the medication,” the authors wrote. “They should be instructed to abstain from drinking alcohol for at least 12 hours before taking a dose of the medication and be advised that reactions with alcohol can occur up to 14 days after taking disulfiram.”
Lastly, topiramate and gabapentin may be used in patients for whom naltrexone and acamprosate are ineffective, though topiramate may have side effects of concern to the patient, including cognitive dysfunction and numbness, tingling, paresthesias, dizziness, taste abnormalities, and decreased appetite or weight loss, the report said.
Although the APA guideline acknowledges the importance of psychiatric evaluation and nonpharmacologic treatments such as cognitive-behavioral therapy and 12-step programs, it does not provide recommendations on those treatment options.
Further research on alcohol use disorder should include study of quantitative measures for longitudinal monitoring, co-occurring medical and psychiatric conditions, and the effectiveness of naltrexone versus combination therapy for patients with both AUD and opioid use disorder, the authors said.
“The overall goal of this guideline is to enhance the treatment of AUD for millions of affected individuals, thereby reducing the significant psychosocial and public health consequences of this important psychiatric condition,” the report concluded. An executive summary of the guideline was published in the American Journal of Psychiatry.
The guideline authors disclosed no conflicts of interest with their work on the guideline.
SOURCE: Reus VI et al. Am J Psychiatry. 2018;175:86-90.
Naltrexone or acamprosate should be offered as first-line pharmacologic therapy to patients with moderate to severe alcohol use disorder (AUD) who do not respond to nonpharmacologic therapy alone, according to a practice guideline published by the American Psychiatric Association.
if naltrexone and acamprosate are not effective or well tolerated, the report said.
The APA guideline recommends against the use of antidepressants and benzodiazepines for patients with alcohol use disorder, except for situations where a co-occurring disorder requires treatment. In addition, the guideline recommends against the use of acamprosate in patients with renal impairment, and specifies that naltrexone should not be used by patients with acute hepatitis, hepatic failure, or opioid dependence.
“Naltrexone and acamprosate have the best available evidence as pharmacotherapy for patients with AUD,” wrote Victor I. Reus, MD, and his coauthors in the APA Guideline Writing Group, which formed the guideline using a systematic review of current literature in accordance with Institute of Medicine (now called the National Academy of Medicine) and Agency for Healthcare Research and Quality standards.
Naltrexone, an opioid receptor antagonist, is effective in treating both AUD and opioid use disorder. Studies have shown that it may decrease cravings, and is associated with fewer drinking days and a reduced likelihood of return to drinking, the authors reported. In patients with a history of renal impairment, serum creatinine should be measured, and results should be reviewed before initiating treatment with acamprosate – a synthetic amino acid.
Disulfiram breaks down acetaldehyde, an ethanol byproduct, and should be used only to treat patients with a goal of abstinence. It is not recommended as a first-line therapy because of the side effects of concurrent alcohol use, including tachycardia, flushing, headache, nausea, and vomiting, reported Dr. Reus of the psychiatry department at the University of California, San Francisco, and his coauthors.
“Patients should be fully informed of the physiological consequences of consuming alcohol while taking disulfiram and should agree to taking the medication,” the authors wrote. “They should be instructed to abstain from drinking alcohol for at least 12 hours before taking a dose of the medication and be advised that reactions with alcohol can occur up to 14 days after taking disulfiram.”
Lastly, topiramate and gabapentin may be used in patients for whom naltrexone and acamprosate are ineffective, though topiramate may have side effects of concern to the patient, including cognitive dysfunction and numbness, tingling, paresthesias, dizziness, taste abnormalities, and decreased appetite or weight loss, the report said.
Although the APA guideline acknowledges the importance of psychiatric evaluation and nonpharmacologic treatments such as cognitive-behavioral therapy and 12-step programs, it does not provide recommendations on those treatment options.
Further research on alcohol use disorder should include study of quantitative measures for longitudinal monitoring, co-occurring medical and psychiatric conditions, and the effectiveness of naltrexone versus combination therapy for patients with both AUD and opioid use disorder, the authors said.
“The overall goal of this guideline is to enhance the treatment of AUD for millions of affected individuals, thereby reducing the significant psychosocial and public health consequences of this important psychiatric condition,” the report concluded. An executive summary of the guideline was published in the American Journal of Psychiatry.
The guideline authors disclosed no conflicts of interest with their work on the guideline.
SOURCE: Reus VI et al. Am J Psychiatry. 2018;175:86-90.
Naltrexone or acamprosate should be offered as first-line pharmacologic therapy to patients with moderate to severe alcohol use disorder (AUD) who do not respond to nonpharmacologic therapy alone, according to a practice guideline published by the American Psychiatric Association.
if naltrexone and acamprosate are not effective or well tolerated, the report said.
The APA guideline recommends against the use of antidepressants and benzodiazepines for patients with alcohol use disorder, except for situations where a co-occurring disorder requires treatment. In addition, the guideline recommends against the use of acamprosate in patients with renal impairment, and specifies that naltrexone should not be used by patients with acute hepatitis, hepatic failure, or opioid dependence.
“Naltrexone and acamprosate have the best available evidence as pharmacotherapy for patients with AUD,” wrote Victor I. Reus, MD, and his coauthors in the APA Guideline Writing Group, which formed the guideline using a systematic review of current literature in accordance with Institute of Medicine (now called the National Academy of Medicine) and Agency for Healthcare Research and Quality standards.
Naltrexone, an opioid receptor antagonist, is effective in treating both AUD and opioid use disorder. Studies have shown that it may decrease cravings, and is associated with fewer drinking days and a reduced likelihood of return to drinking, the authors reported. In patients with a history of renal impairment, serum creatinine should be measured, and results should be reviewed before initiating treatment with acamprosate – a synthetic amino acid.
Disulfiram breaks down acetaldehyde, an ethanol byproduct, and should be used only to treat patients with a goal of abstinence. It is not recommended as a first-line therapy because of the side effects of concurrent alcohol use, including tachycardia, flushing, headache, nausea, and vomiting, reported Dr. Reus of the psychiatry department at the University of California, San Francisco, and his coauthors.
“Patients should be fully informed of the physiological consequences of consuming alcohol while taking disulfiram and should agree to taking the medication,” the authors wrote. “They should be instructed to abstain from drinking alcohol for at least 12 hours before taking a dose of the medication and be advised that reactions with alcohol can occur up to 14 days after taking disulfiram.”
Lastly, topiramate and gabapentin may be used in patients for whom naltrexone and acamprosate are ineffective, though topiramate may have side effects of concern to the patient, including cognitive dysfunction and numbness, tingling, paresthesias, dizziness, taste abnormalities, and decreased appetite or weight loss, the report said.
Although the APA guideline acknowledges the importance of psychiatric evaluation and nonpharmacologic treatments such as cognitive-behavioral therapy and 12-step programs, it does not provide recommendations on those treatment options.
Further research on alcohol use disorder should include study of quantitative measures for longitudinal monitoring, co-occurring medical and psychiatric conditions, and the effectiveness of naltrexone versus combination therapy for patients with both AUD and opioid use disorder, the authors said.
“The overall goal of this guideline is to enhance the treatment of AUD for millions of affected individuals, thereby reducing the significant psychosocial and public health consequences of this important psychiatric condition,” the report concluded. An executive summary of the guideline was published in the American Journal of Psychiatry.
The guideline authors disclosed no conflicts of interest with their work on the guideline.
SOURCE: Reus VI et al. Am J Psychiatry. 2018;175:86-90.
FROM THE AMERICAN JOURNAL OF PSYCHIATRY
Bright Futures 4th Edition gets a clinical refresher
CHICAGO – Bracing his audience for a whirlwind tour of the many updates to the fourth edition of Bright Futures, Joseph F. Hagan Jr., MD, said that it’s still completely possible to fit Bright Futures visits into a clinic day.
“I practice primary care pediatrics,” said Dr. Hagan, a pediatrician in private practice and clinical professor of pediatrics at the University of Vermont, both in Burlington. “I said to my Bright Futures colleagues, if I didn’t think I could do this in 18 minutes, I wouldn’t ask you to do it.”
The Bright Futures framework, described by Dr. Hagan as the health prevention and disease prevention component of the medical home for children and youth, emerges in the Fourth Edition with a significant evidence-based refresher. The changes and updates are built within the existing framework and encompass surveillance and screening recommendations as well as anticipatory guidance. All content, including family handouts, has been updated, said Dr. Hagan, a coeditor of the Fourth Edition of Bright Futures. He spoke at the annual meeting of the American Academy of Pediatrics.
New clinical content
“What’s new? Maternal depression screening is new,” said Dr. Hagan, noting that the recommendation has long been under discussion. Now, supported by a 2016 United States Preventative Task Force (USPSTF) recommendation that carries a grade B level of evidence, all mothers should be screened for depression at the 1-, 2-, 4-, and 6-month Bright Futures visits.
However, he said, know your local regulations. “State mandates to do more might overrule this.” And conversely, “Just because we’re doing it universally until 6 months doesn’t mean you couldn’t selectively screen later if you have concerns.”
Safe sleep is another area with new clinical focus, he said. The new recommendation for the child to sleep in the parent’s room for “at least 6 months” draws on data from European studies showing lower mortality for children who share a room with parents during this period.
Clinicians should continue to recommend that parents not sleep with their infants in couches, chairs, or beds. As before, parents should be told not to have loose blankets, stuffed toys, or crib bumpers in their babies’ cribs. Another key message, said Dr. Hagan, is that “There is no such thing as safe ‘breast-sleeping.’ ”
Parents should be reminded not to swaddle at nap – or bedtime. The risk is that even a 2-month-old infant may be capable of wriggling over from back to front, and a swaddled infant whose hands are trapped may not be able to move to protect her airway once prone. “Swaddle for comfort, swaddle for crying, swaddle for nursing, but don’t swaddle for sleep” is the message, said Dr. Hagan.
For breast-fed babies, iron supplementation should begin at the 4-month visit. The notion is to prevent progression from iron deficiency to frank anemia, said Dr. Hagan. “We know that we screen for iron deficiency anemia … but we also know that before you’re iron deficient anemic, you’re iron deficient,” he said, and iron’s also critical to brain development. For convenience, switching from vitamin D alone to a multivitamin drop with iron at 4 months is a practical choice.
New dental health recommendations bring prevention to the pediatrician’s office. “Fluoride varnish? Do it!” said Dr. Hagan. Although the USPSTF made a 2014 grade B recommendation that primary care clinicians apply fluoride varnish to primary teeth as soon as they erupt, “It’s new to the Bright Futures periodicity schedule,” he said; parents can be assured that fluoride varnish does not cause fluorosis.
The good news for clinicians, he noted. “Once it hits the periodicity schedule, now, it’s a billable service that must be paid” under Affordable Care Act regulations, said Dr. Hagan. “Don’t let your insurer say, ‘That’s part of what you’re already being paid for.’ ” He recommends avoiding the pressure to bundle this important service. Use the discrete CPT code 99188, “Application of a fluoride varnish by a physician or other qualified health care professional.”
Although Bright Futures has updated recommendations for dyslipidemia blood screening, the USPSTF found insufficient evidence to back lipid screening for those younger than 20 years of age, citing an inability to assess the balance of benefits and harms for universal, rather than risk-based, screening. However, said Dr. Hagan, the American Academy of Pediatrics (AAP), and the National Heart, Lung, and Blood Institute (NHLBI) were looking at this issue at about the same time, and they “did a really good job of showing their work,” to show that if family history alone guided screening in the pediatric population, it “just wasn’t getting done.” And AAP and NHLBI did demonstrate evidence sufficient to support this recommendation.
Accordingly, Bright Futures recommends one screening between ages 9 and 11 years and an additional screening between ages 17 and 21. These windows are designed to bracket puberty, said Dr. Hagan, because values can be skewed during that period. “It’s billable, it’s not bundle-able, and I’d recommend that you do it,” he said.
Developmental surveillance and screening
What’s new with developmental surveillance and screening? “Well, we could argue that the milestones are something to think about, because the milestones are the cornerstone of developmental surveillance,” said Dr. Hagan. “You’re in the room with the child. You’re trained, you’re experienced, you’re smart, your gestalt tells you if their development is good or bad.” 
As important as surveillance is, though, he said, it is “nowhere near as important as screening.” Surveillance happens at every well-child visit, but there’s no substitute for formal developmental screening. For the Fourth Edition guidance and toolkit, gross motor milestones have been adjusted to reflect what’s really being seen as more parents adopt the Back to Sleep recommendations as well.
A standardized developmental screening tool is used at the 9-, 18-, and 30-month visits, and when parents or caregivers express concern about development. Autism-specific screening happens at 18 and 24 months.
“Remember this, if you remember nothing else: If the screening is positive, and you believe there’s a problem, you’re going to refer,” not just to the appropriate specialist but also for early intervention services, so time isn’t lost as the child is waiting for further evaluation and a formal diagnosis, said Dr. Hagan. This coordinated effort appropriately places the responsibility for early identification of developmental delays and disorders at the doorstep of the child’s medical home.
The federally-coordinated Birth to 5: Watch Me Thrive! effort has aggregated research-based screening tools, users’ guides targeted at a variety of audiences, and resources to help caregivers, said Dr. Hagan.
Four commonly-used tools to consider using during the visit are the Parents’ Evaluation of Developmental Status, the Ages and Stages Questionnaire, the Child Health and Development Interactive System, and the Survey of Wellbeing of Young Children. Of these, said Dr. Hagan, the latter is the only tool that’s in the public domain. However, he said, they are “all really good.”
Consider having parents fill out screening questionnaires in the waiting room before the visit, said Dr. Hagan. “I always tell my colleagues, ‘Have them start the visit without you, if you want to get it done in 18 minutes.’ ”
Two questionnaires per visit are available in the Bright Futures toolkit. One questionnaire asks developmental surveillance and risk assessment questions for selective screening. The second questionnaire asks prescreening questions to help with the anticipatory guidance part of the visit, he said. Having families do these ahead of time, said Dr. Hagan, “allows you to become more focused.”
Paying attention to practicalities can make all this go more smoothly, and maximize reimbursement as well. In his own practice, Dr. Hagan said, screening tools and questionnaires are integrated into the EHR system, so that appropriate paperwork prints automatically ahead of the visit.
It’s also worth reviewing billing practices to make sure that CPT code 96110 is used when administering screening with a standardized instrument and completing scoring and documentation. According to the Bright Futures periodicity schedule, this may be done at the 9-, 18-, and 30-month visits for developmental screening, as well as at 18 and 24 months for autism-specific screening.
Promoting lifelong health
Since the initial Bright Futures guidelines were published in the late 1990s, said Dr. Hagan, the focus has always been on seeing the child as part of the family, who, in turn, are part of the community, forming a framework that addresses the social components of child health. “If you’re not looking at the whole picture, you’re not promoting health,” he said. “It’s no big surprise that we now have a specific, called-out focus on promoting lifelong health.”
In the Fourth Edition, the theme of promoting lifelong health for families and communities is woven throughout, with social determinants of health being a specific visit priority. For example, questions about food insecurity have been drawn from the published literature and are included. Also, said Dr. Hagan, there’s specific anticipatory guidance content that’s clearly marked as addressing social determinants of health.
The fundamental importance of socioeconomic status as a social determinant of health was brought home by the Robert Wood Johnson Foundation’s Commission to Build a Healthier America, which demonstrated that, “Your ZIP code is more important to your health than your genetic code,” said Dr. Hagan. “So your work in health supervision is important, and you have been leaders in this effort.”
Research guides Bright Futures updates
The fourth edition of Bright Futures builds on health promotion themes to support the mental and physical health of children and adolescents, and has a robust framework of evidence underpinning the guidelines, said Dr. Hagan.
The goal is for clinicians to “use evidence to decide upon content of their own health supervision visits,” he explained.
The chapter of the Bright Futures guidelines that addresses the evidence and rationale for the guidelines has been expanded to better answer two questions, said Dr. Hagan: “What evidence grounds our recommendations?” and “What rationale did we use when evidence was insufficient or lacking?”
When possible, the editors of the guidelines used evidence-based sources such as recommendations from the USPSTF, the Centers for Disease Control Community Guide, and the Cochrane Collaboration.
There were many more evidence-based recommendations available to those working on the 4th edition than there had been when writing the previous edition, when, said Dr. Hagan, the USPSTF had exactly two recommendations for those under the age of 21 years. The current expanded number of USPSTF pediatric recommendations was due in part to the attention the AAP was able to bring regarding the need for evidence-based recommendations in pediatrics, he said.
When guidelines were not available, the editors also turned to high quality studies from peer reviewed publications. When such high quality evidence was lacking in a particular area, the guidelines make clear what rationale was used to formulate a given recommendation, and that some recommendations should be interpreted with a degree of caution.
And, said Dr. Hagan, even science-based guidelines will change as more data accumulates. “Don’t forget about peanuts!” he said. “It was really logical 15 years ago when we said don’t give peanut products until 1 year of age. And about 2 years ago, we found out that it really didn’t work.”
Although there are specific updates to clinical content, there also were changes made in broader strokes throughout the 4th edition. One of these shifts embeds social determinants of health in many visits. This adjustment acknowledges the growing body of knowledge that “strengths and protective factors make a difference, and risk factors make a difference” in pediatric outcomes.
A greater focus on lifelong physical and mental health is included under the general rubric of promoting lifelong health for families and communities. More emphasis is placed on promoting health for children and youth who have special health care needs as well.
Nuts-and-bolts changes in the updated 4th edition include updates for milestones of development and accompanying developmental surveillance questions, new clinical content and guidance for implementation that have been added based on strong evidence, and a variety of updates for adolescent screenings in particular.
The full 4th edition Bright Futures toolkit will be available for use in 2018.
Dr. Hagan was a coeditor of the Fourth Edition of Bright Futures.
*This article was updated on December 21, 2017
CHICAGO – Bracing his audience for a whirlwind tour of the many updates to the fourth edition of Bright Futures, Joseph F. Hagan Jr., MD, said that it’s still completely possible to fit Bright Futures visits into a clinic day.
“I practice primary care pediatrics,” said Dr. Hagan, a pediatrician in private practice and clinical professor of pediatrics at the University of Vermont, both in Burlington. “I said to my Bright Futures colleagues, if I didn’t think I could do this in 18 minutes, I wouldn’t ask you to do it.”
The Bright Futures framework, described by Dr. Hagan as the health prevention and disease prevention component of the medical home for children and youth, emerges in the Fourth Edition with a significant evidence-based refresher. The changes and updates are built within the existing framework and encompass surveillance and screening recommendations as well as anticipatory guidance. All content, including family handouts, has been updated, said Dr. Hagan, a coeditor of the Fourth Edition of Bright Futures. He spoke at the annual meeting of the American Academy of Pediatrics.
New clinical content
“What’s new? Maternal depression screening is new,” said Dr. Hagan, noting that the recommendation has long been under discussion. Now, supported by a 2016 United States Preventative Task Force (USPSTF) recommendation that carries a grade B level of evidence, all mothers should be screened for depression at the 1-, 2-, 4-, and 6-month Bright Futures visits.
However, he said, know your local regulations. “State mandates to do more might overrule this.” And conversely, “Just because we’re doing it universally until 6 months doesn’t mean you couldn’t selectively screen later if you have concerns.”
Safe sleep is another area with new clinical focus, he said. The new recommendation for the child to sleep in the parent’s room for “at least 6 months” draws on data from European studies showing lower mortality for children who share a room with parents during this period.
Clinicians should continue to recommend that parents not sleep with their infants in couches, chairs, or beds. As before, parents should be told not to have loose blankets, stuffed toys, or crib bumpers in their babies’ cribs. Another key message, said Dr. Hagan, is that “There is no such thing as safe ‘breast-sleeping.’ ”
Parents should be reminded not to swaddle at nap – or bedtime. The risk is that even a 2-month-old infant may be capable of wriggling over from back to front, and a swaddled infant whose hands are trapped may not be able to move to protect her airway once prone. “Swaddle for comfort, swaddle for crying, swaddle for nursing, but don’t swaddle for sleep” is the message, said Dr. Hagan.
For breast-fed babies, iron supplementation should begin at the 4-month visit. The notion is to prevent progression from iron deficiency to frank anemia, said Dr. Hagan. “We know that we screen for iron deficiency anemia … but we also know that before you’re iron deficient anemic, you’re iron deficient,” he said, and iron’s also critical to brain development. For convenience, switching from vitamin D alone to a multivitamin drop with iron at 4 months is a practical choice.
New dental health recommendations bring prevention to the pediatrician’s office. “Fluoride varnish? Do it!” said Dr. Hagan. Although the USPSTF made a 2014 grade B recommendation that primary care clinicians apply fluoride varnish to primary teeth as soon as they erupt, “It’s new to the Bright Futures periodicity schedule,” he said; parents can be assured that fluoride varnish does not cause fluorosis.
The good news for clinicians, he noted. “Once it hits the periodicity schedule, now, it’s a billable service that must be paid” under Affordable Care Act regulations, said Dr. Hagan. “Don’t let your insurer say, ‘That’s part of what you’re already being paid for.’ ” He recommends avoiding the pressure to bundle this important service. Use the discrete CPT code 99188, “Application of a fluoride varnish by a physician or other qualified health care professional.”
Although Bright Futures has updated recommendations for dyslipidemia blood screening, the USPSTF found insufficient evidence to back lipid screening for those younger than 20 years of age, citing an inability to assess the balance of benefits and harms for universal, rather than risk-based, screening. However, said Dr. Hagan, the American Academy of Pediatrics (AAP), and the National Heart, Lung, and Blood Institute (NHLBI) were looking at this issue at about the same time, and they “did a really good job of showing their work,” to show that if family history alone guided screening in the pediatric population, it “just wasn’t getting done.” And AAP and NHLBI did demonstrate evidence sufficient to support this recommendation.
Accordingly, Bright Futures recommends one screening between ages 9 and 11 years and an additional screening between ages 17 and 21. These windows are designed to bracket puberty, said Dr. Hagan, because values can be skewed during that period. “It’s billable, it’s not bundle-able, and I’d recommend that you do it,” he said.
Developmental surveillance and screening
What’s new with developmental surveillance and screening? “Well, we could argue that the milestones are something to think about, because the milestones are the cornerstone of developmental surveillance,” said Dr. Hagan. “You’re in the room with the child. You’re trained, you’re experienced, you’re smart, your gestalt tells you if their development is good or bad.”
As important as surveillance is, though, he said, it is “nowhere near as important as screening.” Surveillance happens at every well-child visit, but there’s no substitute for formal developmental screening. For the Fourth Edition guidance and toolkit, gross motor milestones have been adjusted to reflect what’s really being seen as more parents adopt the Back to Sleep recommendations as well.
A standardized developmental screening tool is used at the 9-, 18-, and 30-month visits, and when parents or caregivers express concern about development. Autism-specific screening happens at 18 and 24 months.
“Remember this, if you remember nothing else: If the screening is positive, and you believe there’s a problem, you’re going to refer,” not just to the appropriate specialist but also for early intervention services, so time isn’t lost as the child is waiting for further evaluation and a formal diagnosis, said Dr. Hagan. This coordinated effort appropriately places the responsibility for early identification of developmental delays and disorders at the doorstep of the child’s medical home.
The federally-coordinated Birth to 5: Watch Me Thrive! effort has aggregated research-based screening tools, users’ guides targeted at a variety of audiences, and resources to help caregivers, said Dr. Hagan.
Four commonly-used tools to consider using during the visit are the Parents’ Evaluation of Developmental Status, the Ages and Stages Questionnaire, the Child Health and Development Interactive System, and the Survey of Wellbeing of Young Children. Of these, said Dr. Hagan, the latter is the only tool that’s in the public domain. However, he said, they are “all really good.”
Consider having parents fill out screening questionnaires in the waiting room before the visit, said Dr. Hagan. “I always tell my colleagues, ‘Have them start the visit without you, if you want to get it done in 18 minutes.’ ”
Two questionnaires per visit are available in the Bright Futures toolkit. One questionnaire asks developmental surveillance and risk assessment questions for selective screening. The second questionnaire asks prescreening questions to help with the anticipatory guidance part of the visit, he said. Having families do these ahead of time, said Dr. Hagan, “allows you to become more focused.”
Paying attention to practicalities can make all this go more smoothly, and maximize reimbursement as well. In his own practice, Dr. Hagan said, screening tools and questionnaires are integrated into the EHR system, so that appropriate paperwork prints automatically ahead of the visit.
It’s also worth reviewing billing practices to make sure that CPT code 96110 is used when administering screening with a standardized instrument and completing scoring and documentation. According to the Bright Futures periodicity schedule, this may be done at the 9-, 18-, and 30-month visits for developmental screening, as well as at 18 and 24 months for autism-specific screening.
Promoting lifelong health
Since the initial Bright Futures guidelines were published in the late 1990s, said Dr. Hagan, the focus has always been on seeing the child as part of the family, who, in turn, are part of the community, forming a framework that addresses the social components of child health. “If you’re not looking at the whole picture, you’re not promoting health,” he said. “It’s no big surprise that we now have a specific, called-out focus on promoting lifelong health.”
In the Fourth Edition, the theme of promoting lifelong health for families and communities is woven throughout, with social determinants of health being a specific visit priority. For example, questions about food insecurity have been drawn from the published literature and are included. Also, said Dr. Hagan, there’s specific anticipatory guidance content that’s clearly marked as addressing social determinants of health.
The fundamental importance of socioeconomic status as a social determinant of health was brought home by the Robert Wood Johnson Foundation’s Commission to Build a Healthier America, which demonstrated that, “Your ZIP code is more important to your health than your genetic code,” said Dr. Hagan. “So your work in health supervision is important, and you have been leaders in this effort.”
Research guides Bright Futures updates
The fourth edition of Bright Futures builds on health promotion themes to support the mental and physical health of children and adolescents, and has a robust framework of evidence underpinning the guidelines, said Dr. Hagan.
The goal is for clinicians to “use evidence to decide upon content of their own health supervision visits,” he explained.
The chapter of the Bright Futures guidelines that addresses the evidence and rationale for the guidelines has been expanded to better answer two questions, said Dr. Hagan: “What evidence grounds our recommendations?” and “What rationale did we use when evidence was insufficient or lacking?”
When possible, the editors of the guidelines used evidence-based sources such as recommendations from the USPSTF, the Centers for Disease Control Community Guide, and the Cochrane Collaboration.
There were many more evidence-based recommendations available to those working on the 4th edition than there had been when writing the previous edition, when, said Dr. Hagan, the USPSTF had exactly two recommendations for those under the age of 21 years. The current expanded number of USPSTF pediatric recommendations was due in part to the attention the AAP was able to bring regarding the need for evidence-based recommendations in pediatrics, he said.
When guidelines were not available, the editors also turned to high quality studies from peer reviewed publications. When such high quality evidence was lacking in a particular area, the guidelines make clear what rationale was used to formulate a given recommendation, and that some recommendations should be interpreted with a degree of caution.
And, said Dr. Hagan, even science-based guidelines will change as more data accumulates. “Don’t forget about peanuts!” he said. “It was really logical 15 years ago when we said don’t give peanut products until 1 year of age. And about 2 years ago, we found out that it really didn’t work.”
Although there are specific updates to clinical content, there also were changes made in broader strokes throughout the 4th edition. One of these shifts embeds social determinants of health in many visits. This adjustment acknowledges the growing body of knowledge that “strengths and protective factors make a difference, and risk factors make a difference” in pediatric outcomes.
A greater focus on lifelong physical and mental health is included under the general rubric of promoting lifelong health for families and communities. More emphasis is placed on promoting health for children and youth who have special health care needs as well.
Nuts-and-bolts changes in the updated 4th edition include updates for milestones of development and accompanying developmental surveillance questions, new clinical content and guidance for implementation that have been added based on strong evidence, and a variety of updates for adolescent screenings in particular.
The full 4th edition Bright Futures toolkit will be available for use in 2018.
Dr. Hagan was a coeditor of the Fourth Edition of Bright Futures.
*This article was updated on December 21, 2017
CHICAGO – Bracing his audience for a whirlwind tour of the many updates to the fourth edition of Bright Futures, Joseph F. Hagan Jr., MD, said that it’s still completely possible to fit Bright Futures visits into a clinic day.
“I practice primary care pediatrics,” said Dr. Hagan, a pediatrician in private practice and clinical professor of pediatrics at the University of Vermont, both in Burlington. “I said to my Bright Futures colleagues, if I didn’t think I could do this in 18 minutes, I wouldn’t ask you to do it.”
The Bright Futures framework, described by Dr. Hagan as the health prevention and disease prevention component of the medical home for children and youth, emerges in the Fourth Edition with a significant evidence-based refresher. The changes and updates are built within the existing framework and encompass surveillance and screening recommendations as well as anticipatory guidance. All content, including family handouts, has been updated, said Dr. Hagan, a coeditor of the Fourth Edition of Bright Futures. He spoke at the annual meeting of the American Academy of Pediatrics.
New clinical content
“What’s new? Maternal depression screening is new,” said Dr. Hagan, noting that the recommendation has long been under discussion. Now, supported by a 2016 United States Preventative Task Force (USPSTF) recommendation that carries a grade B level of evidence, all mothers should be screened for depression at the 1-, 2-, 4-, and 6-month Bright Futures visits.
However, he said, know your local regulations. “State mandates to do more might overrule this.” And conversely, “Just because we’re doing it universally until 6 months doesn’t mean you couldn’t selectively screen later if you have concerns.”
Safe sleep is another area with new clinical focus, he said. The new recommendation for the child to sleep in the parent’s room for “at least 6 months” draws on data from European studies showing lower mortality for children who share a room with parents during this period.
Clinicians should continue to recommend that parents not sleep with their infants in couches, chairs, or beds. As before, parents should be told not to have loose blankets, stuffed toys, or crib bumpers in their babies’ cribs. Another key message, said Dr. Hagan, is that “There is no such thing as safe ‘breast-sleeping.’ ”
Parents should be reminded not to swaddle at nap – or bedtime. The risk is that even a 2-month-old infant may be capable of wriggling over from back to front, and a swaddled infant whose hands are trapped may not be able to move to protect her airway once prone. “Swaddle for comfort, swaddle for crying, swaddle for nursing, but don’t swaddle for sleep” is the message, said Dr. Hagan.
For breast-fed babies, iron supplementation should begin at the 4-month visit. The notion is to prevent progression from iron deficiency to frank anemia, said Dr. Hagan. “We know that we screen for iron deficiency anemia … but we also know that before you’re iron deficient anemic, you’re iron deficient,” he said, and iron’s also critical to brain development. For convenience, switching from vitamin D alone to a multivitamin drop with iron at 4 months is a practical choice.
New dental health recommendations bring prevention to the pediatrician’s office. “Fluoride varnish? Do it!” said Dr. Hagan. Although the USPSTF made a 2014 grade B recommendation that primary care clinicians apply fluoride varnish to primary teeth as soon as they erupt, “It’s new to the Bright Futures periodicity schedule,” he said; parents can be assured that fluoride varnish does not cause fluorosis.
The good news for clinicians, he noted. “Once it hits the periodicity schedule, now, it’s a billable service that must be paid” under Affordable Care Act regulations, said Dr. Hagan. “Don’t let your insurer say, ‘That’s part of what you’re already being paid for.’ ” He recommends avoiding the pressure to bundle this important service. Use the discrete CPT code 99188, “Application of a fluoride varnish by a physician or other qualified health care professional.”
Although Bright Futures has updated recommendations for dyslipidemia blood screening, the USPSTF found insufficient evidence to back lipid screening for those younger than 20 years of age, citing an inability to assess the balance of benefits and harms for universal, rather than risk-based, screening. However, said Dr. Hagan, the American Academy of Pediatrics (AAP), and the National Heart, Lung, and Blood Institute (NHLBI) were looking at this issue at about the same time, and they “did a really good job of showing their work,” to show that if family history alone guided screening in the pediatric population, it “just wasn’t getting done.” And AAP and NHLBI did demonstrate evidence sufficient to support this recommendation.
Accordingly, Bright Futures recommends one screening between ages 9 and 11 years and an additional screening between ages 17 and 21. These windows are designed to bracket puberty, said Dr. Hagan, because values can be skewed during that period. “It’s billable, it’s not bundle-able, and I’d recommend that you do it,” he said.
Developmental surveillance and screening
What’s new with developmental surveillance and screening? “Well, we could argue that the milestones are something to think about, because the milestones are the cornerstone of developmental surveillance,” said Dr. Hagan. “You’re in the room with the child. You’re trained, you’re experienced, you’re smart, your gestalt tells you if their development is good or bad.”
As important as surveillance is, though, he said, it is “nowhere near as important as screening.” Surveillance happens at every well-child visit, but there’s no substitute for formal developmental screening. For the Fourth Edition guidance and toolkit, gross motor milestones have been adjusted to reflect what’s really being seen as more parents adopt the Back to Sleep recommendations as well.
A standardized developmental screening tool is used at the 9-, 18-, and 30-month visits, and when parents or caregivers express concern about development. Autism-specific screening happens at 18 and 24 months.
“Remember this, if you remember nothing else: If the screening is positive, and you believe there’s a problem, you’re going to refer,” not just to the appropriate specialist but also for early intervention services, so time isn’t lost as the child is waiting for further evaluation and a formal diagnosis, said Dr. Hagan. This coordinated effort appropriately places the responsibility for early identification of developmental delays and disorders at the doorstep of the child’s medical home.
The federally-coordinated Birth to 5: Watch Me Thrive! effort has aggregated research-based screening tools, users’ guides targeted at a variety of audiences, and resources to help caregivers, said Dr. Hagan.
Four commonly-used tools to consider using during the visit are the Parents’ Evaluation of Developmental Status, the Ages and Stages Questionnaire, the Child Health and Development Interactive System, and the Survey of Wellbeing of Young Children. Of these, said Dr. Hagan, the latter is the only tool that’s in the public domain. However, he said, they are “all really good.”
Consider having parents fill out screening questionnaires in the waiting room before the visit, said Dr. Hagan. “I always tell my colleagues, ‘Have them start the visit without you, if you want to get it done in 18 minutes.’ ”
Two questionnaires per visit are available in the Bright Futures toolkit. One questionnaire asks developmental surveillance and risk assessment questions for selective screening. The second questionnaire asks prescreening questions to help with the anticipatory guidance part of the visit, he said. Having families do these ahead of time, said Dr. Hagan, “allows you to become more focused.”
Paying attention to practicalities can make all this go more smoothly, and maximize reimbursement as well. In his own practice, Dr. Hagan said, screening tools and questionnaires are integrated into the EHR system, so that appropriate paperwork prints automatically ahead of the visit.
It’s also worth reviewing billing practices to make sure that CPT code 96110 is used when administering screening with a standardized instrument and completing scoring and documentation. According to the Bright Futures periodicity schedule, this may be done at the 9-, 18-, and 30-month visits for developmental screening, as well as at 18 and 24 months for autism-specific screening.
Promoting lifelong health
Since the initial Bright Futures guidelines were published in the late 1990s, said Dr. Hagan, the focus has always been on seeing the child as part of the family, who, in turn, are part of the community, forming a framework that addresses the social components of child health. “If you’re not looking at the whole picture, you’re not promoting health,” he said. “It’s no big surprise that we now have a specific, called-out focus on promoting lifelong health.”
In the Fourth Edition, the theme of promoting lifelong health for families and communities is woven throughout, with social determinants of health being a specific visit priority. For example, questions about food insecurity have been drawn from the published literature and are included. Also, said Dr. Hagan, there’s specific anticipatory guidance content that’s clearly marked as addressing social determinants of health.
The fundamental importance of socioeconomic status as a social determinant of health was brought home by the Robert Wood Johnson Foundation’s Commission to Build a Healthier America, which demonstrated that, “Your ZIP code is more important to your health than your genetic code,” said Dr. Hagan. “So your work in health supervision is important, and you have been leaders in this effort.”
Research guides Bright Futures updates
The fourth edition of Bright Futures builds on health promotion themes to support the mental and physical health of children and adolescents, and has a robust framework of evidence underpinning the guidelines, said Dr. Hagan.
The goal is for clinicians to “use evidence to decide upon content of their own health supervision visits,” he explained.
The chapter of the Bright Futures guidelines that addresses the evidence and rationale for the guidelines has been expanded to better answer two questions, said Dr. Hagan: “What evidence grounds our recommendations?” and “What rationale did we use when evidence was insufficient or lacking?”
When possible, the editors of the guidelines used evidence-based sources such as recommendations from the USPSTF, the Centers for Disease Control Community Guide, and the Cochrane Collaboration.
There were many more evidence-based recommendations available to those working on the 4th edition than there had been when writing the previous edition, when, said Dr. Hagan, the USPSTF had exactly two recommendations for those under the age of 21 years. The current expanded number of USPSTF pediatric recommendations was due in part to the attention the AAP was able to bring regarding the need for evidence-based recommendations in pediatrics, he said.
When guidelines were not available, the editors also turned to high quality studies from peer reviewed publications. When such high quality evidence was lacking in a particular area, the guidelines make clear what rationale was used to formulate a given recommendation, and that some recommendations should be interpreted with a degree of caution.
And, said Dr. Hagan, even science-based guidelines will change as more data accumulates. “Don’t forget about peanuts!” he said. “It was really logical 15 years ago when we said don’t give peanut products until 1 year of age. And about 2 years ago, we found out that it really didn’t work.”
Although there are specific updates to clinical content, there also were changes made in broader strokes throughout the 4th edition. One of these shifts embeds social determinants of health in many visits. This adjustment acknowledges the growing body of knowledge that “strengths and protective factors make a difference, and risk factors make a difference” in pediatric outcomes.
A greater focus on lifelong physical and mental health is included under the general rubric of promoting lifelong health for families and communities. More emphasis is placed on promoting health for children and youth who have special health care needs as well.
Nuts-and-bolts changes in the updated 4th edition include updates for milestones of development and accompanying developmental surveillance questions, new clinical content and guidance for implementation that have been added based on strong evidence, and a variety of updates for adolescent screenings in particular.
The full 4th edition Bright Futures toolkit will be available for use in 2018.
Dr. Hagan was a coeditor of the Fourth Edition of Bright Futures.
*This article was updated on December 21, 2017
EXPERT ANALYSIS FROM AAP 2017
ADA guidelines embrace heart health
Recent studies that confirm the cardiovascular benefit of some antihyperglycemic agents are shaping the newest therapeutic recommendations for patients with type 2 diabetes and comorbid atherosclerotic cardiovascular disease (ASCVD).
Treatment for these patients – as all with diabetes – should start with lifestyle modifications and metformin. But in its new position statement, the American Diabetes Association now recommends that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin or the glucagon-like peptide 1 (GLP-1) agonist liraglutide – to the regimens of patients with diabetes and ASCVD (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
The medications are indicated if, after being treated with lifestyle and metformin therapy, the patient isn’t meeting hemoglobin A1c goals, said Rita R. Kalyani, MD, who led the ADA’s 12-member writing committee. But clinicians may also consider adding these agents for cardiovascular benefit alone, even when glucose control is adequate on a regimen of lifestyle modification and metformin, with dose adjustments as appropriate, she said in an interview.
“A1c remains the main target of sequencing antihyperglycemic therapies, if it’s not reached after 3 months,” said Dr. Kalyani of Johns Hopkins University, Baltimore. “But, it could also be that the provider, after consulting with the patient, feels it’s appropriate to add one of these agents solely for cardioprotective benefit in patients with ASCVD.”
The recommendation to incorporate agents with cardiovascular benefit is related directly to data from two trials, LEADER and EMPA-REG, which support this recommendation. All of these cardiovascular outcome trials included a majority of patients who were already on metformin. “We developed these evidence-based recommendations based on these trials and to appropriately reflect the populations studied,” said Dr. Kalyani.
The 2018 update contains a number of new recommendations; more will be added as new data emerge, since the ADA intends it to be a continuously refreshed “living document.” This makes it especially clinically useful, Paul S. Jellinger, MD, said in an interview. A member of the writing committee of the American Association of Clinical Endocrinologists’ diabetes management guidelines, Dr. Jellinger feels ADA’s previous versions have not been as targeted as this new one and, he hopes, its subsequent iterations.
“This is a nice enhancement of previously published guidelines for diabetes therapy,” said Dr. Jellinger, professor of clinical medicine at the University of Miami. “For the first time, ADA is providing some guidance in terms of which agents to use. It’s definitely more prescriptive than it was in the past, when, unlike the AACE Diabetes Guidelines, it was a palette of choice for clinicians, but with very little guidance about which agent to pick. The guidance for patients with cardiovascular disease in particular is big news because these antihyperglycemic agents showed such a significant cardiovascular benefit in the trials.”
While the document gives a detailed algorithm of advancing therapy in patients with ASCVD, it doesn’t specify a preference for a specific drug class after metformin therapy in patients without ASCVD. Instead, it provides a detailed table listing the drug-specific effects and patient factors to consider when selecting from different classes of antihyperglycemic agents ( SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, thiazolidinones, sulfonylureas, and insulins). The table notes the drugs’ general efficacy in diabetes, and their impact on hypoglycemia, weight gain, and cardiovascular and renal health. The table also includes the Food and Drug Administration black box warnings that are on some of these medications.
Another helpful feature is a cost comparison of antidiabetic agents, Dr. Kalyani noted. “Last year we added comprehensive cost tables for all the different insulins and noninsulins, and this year we added a second data set of cost information, to assist the provider when prescribing these agents.”
The pricing information is a very important addition to this guideline, and one that clinicians will appreciate, said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City.
“In this document, ADA is urging providers of care to ask about whether the cost of their diabetes care is more than they can deal with. They present tables which compare the costs of the current blood glucose lowering agents used in the U.S., and it is plain to see that many patients, without insurance coverage, will find some of the medications unaffordable,” said Dr. Hellman, a past president of AACE. “They also provide data that show half of all patients with diabetes have financial problems,” and he suspects that medication costs are an important component of their financial insecurity. 
The document also notes data from the 2017 National Health and Nutrition Examination Survey, which found that 10% of people with diabetes have severe food insecurity and 20% have mild food insecurity (Diabetes Educ. 2017;43:260-71. doi: 10.1177/0145721717699890).
“Another thing the document points out is that two-thirds of the patients who don’t take all their medications due to cost don’t tell their doctor,” Dr. Hellman said. “The ADA is making the point that providers have a responsibility to ask if a patient is not taking certain medications because of the cost. We have so many better tools to manage this disease, but so many of these tools are unaffordable.”
While the treatment algorithm for patients with ASCVD will likely be embraced, another new recommendation may stir the pot a bit, Dr. Hellman noted. The section on cardiovascular disease and risk management sticks to a definition of hypertension as 140/90 mm Hg or higher – a striking diversion from the new 130/80 mm Hg limit set this fall by both the American Heart Association and the American College of Cardiology.
“This difference in recommendations is very important and will be controversial,” Dr. Hellman said, adding that he agrees with this clinical point.
Again, this recommendation is grounded in clinical trials, which suggest that people with diabetes don’t benefit from overly strict blood pressure control. The new AHA/ACC recommendations largely drew on data from the SPRINT trial, which was conducted in an entirely nondiabetic population. “These gave a clear signal that a lower BP target is beneficial to that group,” Dr. Hellman said.
But large well-designed randomized controlled trials of intensive blood pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood-pressure lowering targeting a systolic less than120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint. And while the ADVANCE BP trial found that the composite endpoint was improved with intensive blood pressure lowering, the blood pressure level achieved in the intervention group was 136/73 mm Hg.
“This recommendation is based on current evidence for people with diabetes,” Dr. Kalyani said. “We maintain our definition of hypertension as 140/90 mm Hg or higher based on the results of large clinical trials specifically in people with diabetes but emphasize that intensification of antihypertensive therapy to target lower blood pressures (less than 130/80 mm Hg) may be beneficial for high-risk patients with diabetes such as those with cardiovascular disease. We are constantly assessing the evidence and will continue to review the results of new studies for potential incorporation into recommendations in the future.”
Dr. Kalyani and Dr. Hellman had no financial disclosures. Dr. Jellinger has been a speaker for several pharmaceutical companies.
SOURCE: Kalyani R et al. Diabetes Care 2018;41(Suppl. 1):S86-S104 doi: 10.2337/dc18-S009
This article was updated 12/21/17.
Recent studies that confirm the cardiovascular benefit of some antihyperglycemic agents are shaping the newest therapeutic recommendations for patients with type 2 diabetes and comorbid atherosclerotic cardiovascular disease (ASCVD).
Treatment for these patients – as all with diabetes – should start with lifestyle modifications and metformin. But in its new position statement, the American Diabetes Association now recommends that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin or the glucagon-like peptide 1 (GLP-1) agonist liraglutide – to the regimens of patients with diabetes and ASCVD (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
The medications are indicated if, after being treated with lifestyle and metformin therapy, the patient isn’t meeting hemoglobin A1c goals, said Rita R. Kalyani, MD, who led the ADA’s 12-member writing committee. But clinicians may also consider adding these agents for cardiovascular benefit alone, even when glucose control is adequate on a regimen of lifestyle modification and metformin, with dose adjustments as appropriate, she said in an interview.
“A1c remains the main target of sequencing antihyperglycemic therapies, if it’s not reached after 3 months,” said Dr. Kalyani of Johns Hopkins University, Baltimore. “But, it could also be that the provider, after consulting with the patient, feels it’s appropriate to add one of these agents solely for cardioprotective benefit in patients with ASCVD.”
The recommendation to incorporate agents with cardiovascular benefit is related directly to data from two trials, LEADER and EMPA-REG, which support this recommendation. All of these cardiovascular outcome trials included a majority of patients who were already on metformin. “We developed these evidence-based recommendations based on these trials and to appropriately reflect the populations studied,” said Dr. Kalyani.
The 2018 update contains a number of new recommendations; more will be added as new data emerge, since the ADA intends it to be a continuously refreshed “living document.” This makes it especially clinically useful, Paul S. Jellinger, MD, said in an interview. A member of the writing committee of the American Association of Clinical Endocrinologists’ diabetes management guidelines, Dr. Jellinger feels ADA’s previous versions have not been as targeted as this new one and, he hopes, its subsequent iterations.
“This is a nice enhancement of previously published guidelines for diabetes therapy,” said Dr. Jellinger, professor of clinical medicine at the University of Miami. “For the first time, ADA is providing some guidance in terms of which agents to use. It’s definitely more prescriptive than it was in the past, when, unlike the AACE Diabetes Guidelines, it was a palette of choice for clinicians, but with very little guidance about which agent to pick. The guidance for patients with cardiovascular disease in particular is big news because these antihyperglycemic agents showed such a significant cardiovascular benefit in the trials.”
While the document gives a detailed algorithm of advancing therapy in patients with ASCVD, it doesn’t specify a preference for a specific drug class after metformin therapy in patients without ASCVD. Instead, it provides a detailed table listing the drug-specific effects and patient factors to consider when selecting from different classes of antihyperglycemic agents ( SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, thiazolidinones, sulfonylureas, and insulins). The table notes the drugs’ general efficacy in diabetes, and their impact on hypoglycemia, weight gain, and cardiovascular and renal health. The table also includes the Food and Drug Administration black box warnings that are on some of these medications.
Another helpful feature is a cost comparison of antidiabetic agents, Dr. Kalyani noted. “Last year we added comprehensive cost tables for all the different insulins and noninsulins, and this year we added a second data set of cost information, to assist the provider when prescribing these agents.”
The pricing information is a very important addition to this guideline, and one that clinicians will appreciate, said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City.
“In this document, ADA is urging providers of care to ask about whether the cost of their diabetes care is more than they can deal with. They present tables which compare the costs of the current blood glucose lowering agents used in the U.S., and it is plain to see that many patients, without insurance coverage, will find some of the medications unaffordable,” said Dr. Hellman, a past president of AACE. “They also provide data that show half of all patients with diabetes have financial problems,” and he suspects that medication costs are an important component of their financial insecurity.
The document also notes data from the 2017 National Health and Nutrition Examination Survey, which found that 10% of people with diabetes have severe food insecurity and 20% have mild food insecurity (Diabetes Educ. 2017;43:260-71. doi: 10.1177/0145721717699890).
“Another thing the document points out is that two-thirds of the patients who don’t take all their medications due to cost don’t tell their doctor,” Dr. Hellman said. “The ADA is making the point that providers have a responsibility to ask if a patient is not taking certain medications because of the cost. We have so many better tools to manage this disease, but so many of these tools are unaffordable.”
While the treatment algorithm for patients with ASCVD will likely be embraced, another new recommendation may stir the pot a bit, Dr. Hellman noted. The section on cardiovascular disease and risk management sticks to a definition of hypertension as 140/90 mm Hg or higher – a striking diversion from the new 130/80 mm Hg limit set this fall by both the American Heart Association and the American College of Cardiology.
“This difference in recommendations is very important and will be controversial,” Dr. Hellman said, adding that he agrees with this clinical point.
Again, this recommendation is grounded in clinical trials, which suggest that people with diabetes don’t benefit from overly strict blood pressure control. The new AHA/ACC recommendations largely drew on data from the SPRINT trial, which was conducted in an entirely nondiabetic population. “These gave a clear signal that a lower BP target is beneficial to that group,” Dr. Hellman said.
But large well-designed randomized controlled trials of intensive blood pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood-pressure lowering targeting a systolic less than120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint. And while the ADVANCE BP trial found that the composite endpoint was improved with intensive blood pressure lowering, the blood pressure level achieved in the intervention group was 136/73 mm Hg.
“This recommendation is based on current evidence for people with diabetes,” Dr. Kalyani said. “We maintain our definition of hypertension as 140/90 mm Hg or higher based on the results of large clinical trials specifically in people with diabetes but emphasize that intensification of antihypertensive therapy to target lower blood pressures (less than 130/80 mm Hg) may be beneficial for high-risk patients with diabetes such as those with cardiovascular disease. We are constantly assessing the evidence and will continue to review the results of new studies for potential incorporation into recommendations in the future.”
Dr. Kalyani and Dr. Hellman had no financial disclosures. Dr. Jellinger has been a speaker for several pharmaceutical companies.
SOURCE: Kalyani R et al. Diabetes Care 2018;41(Suppl. 1):S86-S104 doi: 10.2337/dc18-S009
This article was updated 12/21/17.
Recent studies that confirm the cardiovascular benefit of some antihyperglycemic agents are shaping the newest therapeutic recommendations for patients with type 2 diabetes and comorbid atherosclerotic cardiovascular disease (ASCVD).
Treatment for these patients – as all with diabetes – should start with lifestyle modifications and metformin. But in its new position statement, the American Diabetes Association now recommends that clinicians consider adding agents proved to reduce major cardiovascular events and cardiovascular death – such as the sodium glucose cotransporter-2 (SGLT2) inhibitor empagliflozin or the glucagon-like peptide 1 (GLP-1) agonist liraglutide – to the regimens of patients with diabetes and ASCVD (Diabetes Care 2018;41(Suppl. 1):S86-S104. doi: 10.2337/dc18-S009).
The medications are indicated if, after being treated with lifestyle and metformin therapy, the patient isn’t meeting hemoglobin A1c goals, said Rita R. Kalyani, MD, who led the ADA’s 12-member writing committee. But clinicians may also consider adding these agents for cardiovascular benefit alone, even when glucose control is adequate on a regimen of lifestyle modification and metformin, with dose adjustments as appropriate, she said in an interview.
“A1c remains the main target of sequencing antihyperglycemic therapies, if it’s not reached after 3 months,” said Dr. Kalyani of Johns Hopkins University, Baltimore. “But, it could also be that the provider, after consulting with the patient, feels it’s appropriate to add one of these agents solely for cardioprotective benefit in patients with ASCVD.”
The recommendation to incorporate agents with cardiovascular benefit is related directly to data from two trials, LEADER and EMPA-REG, which support this recommendation. All of these cardiovascular outcome trials included a majority of patients who were already on metformin. “We developed these evidence-based recommendations based on these trials and to appropriately reflect the populations studied,” said Dr. Kalyani.
The 2018 update contains a number of new recommendations; more will be added as new data emerge, since the ADA intends it to be a continuously refreshed “living document.” This makes it especially clinically useful, Paul S. Jellinger, MD, said in an interview. A member of the writing committee of the American Association of Clinical Endocrinologists’ diabetes management guidelines, Dr. Jellinger feels ADA’s previous versions have not been as targeted as this new one and, he hopes, its subsequent iterations.
“This is a nice enhancement of previously published guidelines for diabetes therapy,” said Dr. Jellinger, professor of clinical medicine at the University of Miami. “For the first time, ADA is providing some guidance in terms of which agents to use. It’s definitely more prescriptive than it was in the past, when, unlike the AACE Diabetes Guidelines, it was a palette of choice for clinicians, but with very little guidance about which agent to pick. The guidance for patients with cardiovascular disease in particular is big news because these antihyperglycemic agents showed such a significant cardiovascular benefit in the trials.”
While the document gives a detailed algorithm of advancing therapy in patients with ASCVD, it doesn’t specify a preference for a specific drug class after metformin therapy in patients without ASCVD. Instead, it provides a detailed table listing the drug-specific effects and patient factors to consider when selecting from different classes of antihyperglycemic agents ( SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, thiazolidinones, sulfonylureas, and insulins). The table notes the drugs’ general efficacy in diabetes, and their impact on hypoglycemia, weight gain, and cardiovascular and renal health. The table also includes the Food and Drug Administration black box warnings that are on some of these medications.
Another helpful feature is a cost comparison of antidiabetic agents, Dr. Kalyani noted. “Last year we added comprehensive cost tables for all the different insulins and noninsulins, and this year we added a second data set of cost information, to assist the provider when prescribing these agents.”
The pricing information is a very important addition to this guideline, and one that clinicians will appreciate, said Richard Hellman, MD, clinical professor of medicine at the University of Missouri–Kansas City.
“In this document, ADA is urging providers of care to ask about whether the cost of their diabetes care is more than they can deal with. They present tables which compare the costs of the current blood glucose lowering agents used in the U.S., and it is plain to see that many patients, without insurance coverage, will find some of the medications unaffordable,” said Dr. Hellman, a past president of AACE. “They also provide data that show half of all patients with diabetes have financial problems,” and he suspects that medication costs are an important component of their financial insecurity.
The document also notes data from the 2017 National Health and Nutrition Examination Survey, which found that 10% of people with diabetes have severe food insecurity and 20% have mild food insecurity (Diabetes Educ. 2017;43:260-71. doi: 10.1177/0145721717699890).
“Another thing the document points out is that two-thirds of the patients who don’t take all their medications due to cost don’t tell their doctor,” Dr. Hellman said. “The ADA is making the point that providers have a responsibility to ask if a patient is not taking certain medications because of the cost. We have so many better tools to manage this disease, but so many of these tools are unaffordable.”
While the treatment algorithm for patients with ASCVD will likely be embraced, another new recommendation may stir the pot a bit, Dr. Hellman noted. The section on cardiovascular disease and risk management sticks to a definition of hypertension as 140/90 mm Hg or higher – a striking diversion from the new 130/80 mm Hg limit set this fall by both the American Heart Association and the American College of Cardiology.
“This difference in recommendations is very important and will be controversial,” Dr. Hellman said, adding that he agrees with this clinical point.
Again, this recommendation is grounded in clinical trials, which suggest that people with diabetes don’t benefit from overly strict blood pressure control. The new AHA/ACC recommendations largely drew on data from the SPRINT trial, which was conducted in an entirely nondiabetic population. “These gave a clear signal that a lower BP target is beneficial to that group,” Dr. Hellman said.
But large well-designed randomized controlled trials of intensive blood pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood-pressure lowering targeting a systolic less than120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint. And while the ADVANCE BP trial found that the composite endpoint was improved with intensive blood pressure lowering, the blood pressure level achieved in the intervention group was 136/73 mm Hg.
“This recommendation is based on current evidence for people with diabetes,” Dr. Kalyani said. “We maintain our definition of hypertension as 140/90 mm Hg or higher based on the results of large clinical trials specifically in people with diabetes but emphasize that intensification of antihypertensive therapy to target lower blood pressures (less than 130/80 mm Hg) may be beneficial for high-risk patients with diabetes such as those with cardiovascular disease. We are constantly assessing the evidence and will continue to review the results of new studies for potential incorporation into recommendations in the future.”
Dr. Kalyani and Dr. Hellman had no financial disclosures. Dr. Jellinger has been a speaker for several pharmaceutical companies.
SOURCE: Kalyani R et al. Diabetes Care 2018;41(Suppl. 1):S86-S104 doi: 10.2337/dc18-S009
This article was updated 12/21/17.
EXPERT ANALYSIS FROM DIABETES CARE
Testing for latent tuberculosis infection
While cases of active tuberculosis are relatively rare in the United States, TB is a major cause of morbidity and mortality worldwide. In the United States, there are an estimated 11 million individuals who have latent TB infection (LTBI). Without prophylactic treatment, somewhere between 4%-6% of individuals with LTBI will develop active disease during their lifetimes; roughly half of these cases will occur within a few years of the initial infection. Treatment of LTBI reduces – but does not eliminate – the risk for active disease, decreasing the consequences of active disease for the patient and the risk of transmitting infection to others.
Diagnostic tests for LTBI
The tuberculin skin test (TST) has been the standard method of diagnosing LTBI. It involves measuring induration caused by a delayed-type hypersensitivity reaction to Mycobacterium tuberculosis (Mtb) 2 or 3 days after injecting the reagent into the skin. The TST can result in false positives when detecting antibodies to BCG and nontuberculous mycobacteria, and false negatives when the patient does not demonstrate a robust immune response. A newer testing method is the Interferon Gamma Release Assay (IGRA), which involves phlebotomy, followed by a series of laboratory procedures that measure IFN-gamma release by T cells that have been sensitized to Mtb. The sensitivity of IGRA is similar to the TST, but it has better specificity; it is much less likely to react to antigens from BCG or nontuberculous mycobacteria. As detailed below, this guideline suggests a significantly more prominent role for IGRA, compared with previous recommendations.
Recommendation 1. Perform an IGRA, rather than a TST, in individuals 5 years or older who meet the following criteria: 1) are likely to be infected with Mtb; 2) have a low or intermediate risk of disease progression; 3) in whom it has been decided that testing for LTBI is warranted. A TST is an acceptable alternative, particularly if an IGRA is not available, is too costly, or is too burdensome. If an individual either has a history of BCG vaccination or is unlikely to return to have their TST read, then it is strongly recommended to use the IGRA as the test of choice.
Recommendation 2. There are insufficient data to recommend a preference for either a TST or an IGRA as the first-line diagnostic test in individuals 5 years or older who are likely to be infected with Mtb, who have a high risk of progression to active disease, and in whom it has been determined that diagnostic testing for LTBI infection is warranted; either test would be acceptable. In very high-risk patients, consider dual testing, with a positive result from either test (TST or IGRA) being considered positive.
Recommendation 3. Guidelines do not recommend testing for persons at low risk for Mtb infection. However, the authors recognize that testing in such persons may nevertheless be mandated in certain situations (for example in some school or child care settings). In these cases, the authors recommend performing an IGRA instead of a TST, to minimize the chance of a false-positive result, although a TST is an acceptable alternative. Furthermore, if the initial test is positive, they suggest performing a confirmatory test (either an IGRA or TST) and considering the person infected only if both tests are positive.
Recommendation 4. The authors suggest performing a TST rather than an IGRA in healthy children less than 5 years of age for whom it has been decided that diagnostic testing for LTBI is warranted. This recommendation reflects the limited body of evidence regarding IGRA testing in young children and the apparent decreased sensitivity (i.e. more false negatives) in this population, compared with TST use.
In the area of serial testing for TB infection, often done in health care and institutional settings, the guideline points out areas of uncertainty with IGRA testing. Specifically, the IGRA test is subject to variability in readings and boosting with antigen exposure that can complicate interpretation of apparent conversion on repeat testing. One longitudinal study showed conversion rates with IGRA to be six to nine times higher than that seen for the TST, and those conversions were thought to represent false positive tests. The guideline concludes that, “There is insufficient information available to guide the establishment of definitive criteria for the conversion.” The committee thought that a positive test in a low-risk individual was likely to be a false-positive result and recommended repeat testing. Because of the possibility of boosting with antigen exposure in situations where dual testing is anticipated, it may be preferable to obtain a specimen for IGRA prior to, or concurrently with TST placement.
Bottom line
Current guidelines suggest a more prominent role for IGRA in testing for LTBI, particularly when the likelihood of exposure is low and in situations where a person may have received BCG vaccination, or would be unlikely to return for TST reading.
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. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
Reference
Lewisohn DM et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Inf Dis. 2017;64(2):111-5.
While cases of active tuberculosis are relatively rare in the United States, TB is a major cause of morbidity and mortality worldwide. In the United States, there are an estimated 11 million individuals who have latent TB infection (LTBI). Without prophylactic treatment, somewhere between 4%-6% of individuals with LTBI will develop active disease during their lifetimes; roughly half of these cases will occur within a few years of the initial infection. Treatment of LTBI reduces – but does not eliminate – the risk for active disease, decreasing the consequences of active disease for the patient and the risk of transmitting infection to others.
Diagnostic tests for LTBI
The tuberculin skin test (TST) has been the standard method of diagnosing LTBI. It involves measuring induration caused by a delayed-type hypersensitivity reaction to Mycobacterium tuberculosis (Mtb) 2 or 3 days after injecting the reagent into the skin. The TST can result in false positives when detecting antibodies to BCG and nontuberculous mycobacteria, and false negatives when the patient does not demonstrate a robust immune response. A newer testing method is the Interferon Gamma Release Assay (IGRA), which involves phlebotomy, followed by a series of laboratory procedures that measure IFN-gamma release by T cells that have been sensitized to Mtb. The sensitivity of IGRA is similar to the TST, but it has better specificity; it is much less likely to react to antigens from BCG or nontuberculous mycobacteria. As detailed below, this guideline suggests a significantly more prominent role for IGRA, compared with previous recommendations.
Recommendation 1. Perform an IGRA, rather than a TST, in individuals 5 years or older who meet the following criteria: 1) are likely to be infected with Mtb; 2) have a low or intermediate risk of disease progression; 3) in whom it has been decided that testing for LTBI is warranted. A TST is an acceptable alternative, particularly if an IGRA is not available, is too costly, or is too burdensome. If an individual either has a history of BCG vaccination or is unlikely to return to have their TST read, then it is strongly recommended to use the IGRA as the test of choice.
Recommendation 2. There are insufficient data to recommend a preference for either a TST or an IGRA as the first-line diagnostic test in individuals 5 years or older who are likely to be infected with Mtb, who have a high risk of progression to active disease, and in whom it has been determined that diagnostic testing for LTBI infection is warranted; either test would be acceptable. In very high-risk patients, consider dual testing, with a positive result from either test (TST or IGRA) being considered positive.
Recommendation 3. Guidelines do not recommend testing for persons at low risk for Mtb infection. However, the authors recognize that testing in such persons may nevertheless be mandated in certain situations (for example in some school or child care settings). In these cases, the authors recommend performing an IGRA instead of a TST, to minimize the chance of a false-positive result, although a TST is an acceptable alternative. Furthermore, if the initial test is positive, they suggest performing a confirmatory test (either an IGRA or TST) and considering the person infected only if both tests are positive.
Recommendation 4. The authors suggest performing a TST rather than an IGRA in healthy children less than 5 years of age for whom it has been decided that diagnostic testing for LTBI is warranted. This recommendation reflects the limited body of evidence regarding IGRA testing in young children and the apparent decreased sensitivity (i.e. more false negatives) in this population, compared with TST use.
In the area of serial testing for TB infection, often done in health care and institutional settings, the guideline points out areas of uncertainty with IGRA testing. Specifically, the IGRA test is subject to variability in readings and boosting with antigen exposure that can complicate interpretation of apparent conversion on repeat testing. One longitudinal study showed conversion rates with IGRA to be six to nine times higher than that seen for the TST, and those conversions were thought to represent false positive tests. The guideline concludes that, “There is insufficient information available to guide the establishment of definitive criteria for the conversion.” The committee thought that a positive test in a low-risk individual was likely to be a false-positive result and recommended repeat testing. Because of the possibility of boosting with antigen exposure in situations where dual testing is anticipated, it may be preferable to obtain a specimen for IGRA prior to, or concurrently with TST placement.
Bottom line
Current guidelines suggest a more prominent role for IGRA in testing for LTBI, particularly when the likelihood of exposure is low and in situations where a person may have received BCG vaccination, or would be unlikely to return for TST reading.
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. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
Reference
Lewisohn DM et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Inf Dis. 2017;64(2):111-5.
While cases of active tuberculosis are relatively rare in the United States, TB is a major cause of morbidity and mortality worldwide. In the United States, there are an estimated 11 million individuals who have latent TB infection (LTBI). Without prophylactic treatment, somewhere between 4%-6% of individuals with LTBI will develop active disease during their lifetimes; roughly half of these cases will occur within a few years of the initial infection. Treatment of LTBI reduces – but does not eliminate – the risk for active disease, decreasing the consequences of active disease for the patient and the risk of transmitting infection to others.
Diagnostic tests for LTBI
The tuberculin skin test (TST) has been the standard method of diagnosing LTBI. It involves measuring induration caused by a delayed-type hypersensitivity reaction to Mycobacterium tuberculosis (Mtb) 2 or 3 days after injecting the reagent into the skin. The TST can result in false positives when detecting antibodies to BCG and nontuberculous mycobacteria, and false negatives when the patient does not demonstrate a robust immune response. A newer testing method is the Interferon Gamma Release Assay (IGRA), which involves phlebotomy, followed by a series of laboratory procedures that measure IFN-gamma release by T cells that have been sensitized to Mtb. The sensitivity of IGRA is similar to the TST, but it has better specificity; it is much less likely to react to antigens from BCG or nontuberculous mycobacteria. As detailed below, this guideline suggests a significantly more prominent role for IGRA, compared with previous recommendations.
Recommendation 1. Perform an IGRA, rather than a TST, in individuals 5 years or older who meet the following criteria: 1) are likely to be infected with Mtb; 2) have a low or intermediate risk of disease progression; 3) in whom it has been decided that testing for LTBI is warranted. A TST is an acceptable alternative, particularly if an IGRA is not available, is too costly, or is too burdensome. If an individual either has a history of BCG vaccination or is unlikely to return to have their TST read, then it is strongly recommended to use the IGRA as the test of choice.
Recommendation 2. There are insufficient data to recommend a preference for either a TST or an IGRA as the first-line diagnostic test in individuals 5 years or older who are likely to be infected with Mtb, who have a high risk of progression to active disease, and in whom it has been determined that diagnostic testing for LTBI infection is warranted; either test would be acceptable. In very high-risk patients, consider dual testing, with a positive result from either test (TST or IGRA) being considered positive.
Recommendation 3. Guidelines do not recommend testing for persons at low risk for Mtb infection. However, the authors recognize that testing in such persons may nevertheless be mandated in certain situations (for example in some school or child care settings). In these cases, the authors recommend performing an IGRA instead of a TST, to minimize the chance of a false-positive result, although a TST is an acceptable alternative. Furthermore, if the initial test is positive, they suggest performing a confirmatory test (either an IGRA or TST) and considering the person infected only if both tests are positive.
Recommendation 4. The authors suggest performing a TST rather than an IGRA in healthy children less than 5 years of age for whom it has been decided that diagnostic testing for LTBI is warranted. This recommendation reflects the limited body of evidence regarding IGRA testing in young children and the apparent decreased sensitivity (i.e. more false negatives) in this population, compared with TST use.
In the area of serial testing for TB infection, often done in health care and institutional settings, the guideline points out areas of uncertainty with IGRA testing. Specifically, the IGRA test is subject to variability in readings and boosting with antigen exposure that can complicate interpretation of apparent conversion on repeat testing. One longitudinal study showed conversion rates with IGRA to be six to nine times higher than that seen for the TST, and those conversions were thought to represent false positive tests. The guideline concludes that, “There is insufficient information available to guide the establishment of definitive criteria for the conversion.” The committee thought that a positive test in a low-risk individual was likely to be a false-positive result and recommended repeat testing. Because of the possibility of boosting with antigen exposure in situations where dual testing is anticipated, it may be preferable to obtain a specimen for IGRA prior to, or concurrently with TST placement.
Bottom line
Current guidelines suggest a more prominent role for IGRA in testing for LTBI, particularly when the likelihood of exposure is low and in situations where a person may have received BCG vaccination, or would be unlikely to return for TST reading.
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. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.
Reference
Lewisohn DM et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Inf Dis. 2017;64(2):111-5.
VIDEO: U.S. hypertension guidelines reset threshold to 130/80 mm Hg
ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.
Goal is to transform care
But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.
Many of these are “seismic changes,” said Lawrence J. Appel, MD. He particularly cited as seismic the new classification of stage 1 hypertension as a pressure at or above 130/80 mm Hg, the emphasis on using some form of out-of-office blood pressure measurement to confirm a diagnosis, the use of risk assessment when deciding whether to treat certain patients with drugs, and the same blood pressure goal of less than 130/80 mm Hg for all hypertensives, regardless of age, as long as they remain ambulatory and community dwelling.
One goal for all adults
“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.
In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.
“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.
“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
Preferred intervention: Lifestyle, not drugs
Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.
Team-based care essential
The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”
“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.
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On Twitter @mitchelzoler
ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.
Goal is to transform care
But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.
Many of these are “seismic changes,” said Lawrence J. Appel, MD. He particularly cited as seismic the new classification of stage 1 hypertension as a pressure at or above 130/80 mm Hg, the emphasis on using some form of out-of-office blood pressure measurement to confirm a diagnosis, the use of risk assessment when deciding whether to treat certain patients with drugs, and the same blood pressure goal of less than 130/80 mm Hg for all hypertensives, regardless of age, as long as they remain ambulatory and community dwelling.
One goal for all adults
“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.
In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.
“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.
“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
Preferred intervention: Lifestyle, not drugs
Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.
Team-based care essential
The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”
“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.
That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.
Goal is to transform care
But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.
Many of these are “seismic changes,” said Lawrence J. Appel, MD. He particularly cited as seismic the new classification of stage 1 hypertension as a pressure at or above 130/80 mm Hg, the emphasis on using some form of out-of-office blood pressure measurement to confirm a diagnosis, the use of risk assessment when deciding whether to treat certain patients with drugs, and the same blood pressure goal of less than 130/80 mm Hg for all hypertensives, regardless of age, as long as they remain ambulatory and community dwelling.
One goal for all adults
“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.
In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.
“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.
“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
Preferred intervention: Lifestyle, not drugs
Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.
Team-based care essential
The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”
“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS
VIDEO: New PsA guideline expected in 2018
SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.
“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”
“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”
The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.
According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”
During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.
The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.
Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.
Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.
“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”
None of the speakers reported having relevant financial disclosures.
SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.
“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”
“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”
The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.
According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”
During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.
The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.
Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.
Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.
“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”
None of the speakers reported having relevant financial disclosures.
SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.
“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”
“At first, I wasn’t a big fan of the idea of the GRADE guidelines because the number of questions blows up so fast, [but] it really makes you focus on what the most common [clinical] settings are,” said another core oversight team member, Alexis Ogdie, MD, a rheumatologist at the University of Pennsylvania, Philadelphia. “These guidelines also reveal the major gap of no head-to-head studies. I think we’ve known that, but this really called that out as important. When we’re making a treatment decision between [drugs] A and B, we need those studies to be able to better understand how to treat our patients, rather than using the data from one trial to make a decision. ... For my patients, I’m excited that I can now use a TNF inhibitor as a first-line agent. When we have patients come in with very severe disease, occasionally they also have severe psoriasis, so we’ve been able to use TNF inhibitors as first-line treatment in some of our patients in Pennsylvania. This differs state by state. But the exciting thing is that they get better so fast and you don’t have to tell them to wait 12 weeks for methotrexate to work.”
The ACR/NPF guideline is currently under peer review and is expected to be published in Arthritis & Rheumatology, Arthritis Care & Research, and the Journal of Psoriasis and Psoriatic Arthritis in the spring or summer of 2018. It focuses on common PsA patients, not exceptional cases. It includes recommendations on the management of patients with active PsA that is defined by the patients’ self-report and judged by the examining clinician to be caused by PsA, based on the on the presence of at least one of the following: actively inflamed joints; dactylitis; enthesitis; axial disease; active skin and/or nail involvement; and/or extra-articular manifestations such as uveitis or inflammatory bowel disease. Authors of the guideline considered cost as one of many possible factors affecting the use of the recommendations, but explicit cost-effectiveness analyses were not conducted. Also, since the NPF and the American Academy of Dermatology are concurrently developing a psoriasis treatment guideline, the treatment of skin psoriasis was not included in the guideline.
According to the guideline’s principal investigator Jasvinder Singh, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, the guideline will include 80 recommendations, 75 (94%) that are rated as “conditional,” and 5 (6%) that are rated as “strong,” based on the quality of evidence in the existing medical literature. “Most of our treatment guidelines rely on very low-to-moderate quality evidence, which means that there needs to be an active discussion between the physician and the patient with regard to which treatment to choose,” said Dr. Singh, who is also a staff rheumatologist at the Birmingham Veterans Affairs Medical Center and who led development of the 2012 and 2015 ACR treatment guidelines for RA. “When you’re not choosing the preferred treatment, there are defined specific recommendations under which that second treatment may be preferred over the first treatment.”
During a separate session at the meeting, Dr. Singh unveiled a few of the draft recommendations. One calls for using a treat-to-target strategy over not using one. In the setting of immunizing patients who are receiving a biologic, another recommendation calls for clinicians to start the indicated biologic and administer killed vaccines (as indicated) in patients with active PsA rather than delaying the biologic to give the killed vaccines. In addition, delaying the start of the indicated biologic is recommended over not delaying in order to administer a live attenuated vaccine in patients with active PsA. When patients continue to have with active PsA despite being on a TNF inhibitor, the draft guideline recommends switching to a different TNF inhibitor rather than an IL-17 inhibitor, an IL-12/IL-23 inhibitor, abatacept (Orencia), tofacitinib (Xeljanz), or adding methotrexate. If PsA is still active, the guideline recommends switching to an IL-17 inhibitor instead of an IL-12/IL-23 inhibitor, abatacept, or tofacitinib. If PsA is still active, the guideline recommends switching to an IL-12/IL-23 inhibitor over abatacept or tofacitinib.
The guideline also includes suggestions for nonpharmacologic treatments, including recommending low-impact exercise over high-impact exercise, occupational therapy, physical therapy, and weight loss. It also includes a strong recommendation to provide smoking cessation advice to patients.
Dr. Singh acknowledged significant research gaps in the current PsA medical literature, including no head-to-head comparisons of treatments. He said that the field also could benefit from specific studies for enthesitis, axial disease, and arthritis mutilans; randomized trials of nonpharmacologic interventions; more trials of monotherapy vs. combination therapy; vaccination trials for live attenuated vaccines; trials and registry studies of patients with common comorbidities, and studies of NSAIDs and glucocorticoids, to define their role.
Possible topics for future PsA guidelines, he continued, include treatment options for patients for whom biologic medication is not an option; use of therapies in pregnancy and conception; incorporation of high-quality cost or cost-effectiveness analysis into recommendations; and the role of other comorbidities, such as fibromyalgia, hepatitis, depression/anxiety, malignancy, and cardiovascular disease.
“Evidence-based medicine needs to be practiced, even in situations where it’s difficult to get a drug,” Dr. Gladman said. “One of the things we hope will happen in the near future is that companies will start doing head-to-head studies, to help us support evidence-based recommendations in the future.”
None of the speakers reported having relevant financial disclosures.
AT ACR 2017
ACOG updates guidance on pelvic organ prolapse
Using polypropylene mesh to augment surgical repair of anterior vaginal wall prolapse improves anatomic and some subjective outcomes, compared with native tissue repair, but it also comes with increased morbidity, according to new guidance from the American College of Obstetricians and Gynecologists.
(POP) to incorporate recent systematic review evidence.
When using polypropylene mesh for anterior POP repair, 11% of patients develop mesh erosion, of which 7% require surgical correction, according to the updated practice bulletin (Obstet Gynecol. 2017;130:e234-50).
“Referral to an obstetrician-gynecologist with appropriate training and experience, such as a female pelvic medicine and reconstructive surgery specialist, is recommended for surgical treatment of prolapse mesh complications,” ACOG and AUGS wrote.
The practice bulletin updates the recommendations on mesh based on a recent systematic review and meta-analysis that concluded that biological graft repair and absorbable mesh offered minimal benefits compared with native tissue repair, and did not significantly reduce rates of prolapse awareness or repeat surgery (Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014).
Porcine dermis graft, which was used in most of the studies, did not significantly reduce rates of anterior prolapse recurrence compared with native tissue repair. Use of polypropylene mesh also tends to prolong operating times and causes more blood loss than native tissue anterior repair, and is associated with an elevated combined risk of stress urinary incontinence, mesh erosion, and repeat surgery for prolapse, the review concluded.
“Uterosacral and sacrospinous ligament suspension for apical POP with native tissue are equally effective surgical treatments of POP, with comparable anatomic, functional, and adverse outcomes,” the authors wrote in the practice bulletin.
Neither synthetic mesh nor biologic grafts improve outcomes of transvaginal repair of posterior vaginal wall prolapse, they added. As an alternative to surgery, most women can be successfully fitted with a pessary and clinicians should offer them this option, the practice bulletin stated. In up to 9% of cases, pessaries cause local devascularization or erosion, in which case they should be removed for 2-4 weeks while the patient undergoes local estrogen therapy.
Although POP is common and benign, symptomatic cases undermine quality of life by causing vaginal bulge and pressure and problems voiding, defecating, and during sexual activity. Consequently, about 300,000 women in the United States undergo surgery for POP every year. By 2050, population aging in the United States will lead to about a 50% rise in the number of women with POP, according to the practice bulletin.
Using polypropylene mesh to augment surgical repair of anterior vaginal wall prolapse improves anatomic and some subjective outcomes, compared with native tissue repair, but it also comes with increased morbidity, according to new guidance from the American College of Obstetricians and Gynecologists.
(POP) to incorporate recent systematic review evidence.
When using polypropylene mesh for anterior POP repair, 11% of patients develop mesh erosion, of which 7% require surgical correction, according to the updated practice bulletin (Obstet Gynecol. 2017;130:e234-50).
“Referral to an obstetrician-gynecologist with appropriate training and experience, such as a female pelvic medicine and reconstructive surgery specialist, is recommended for surgical treatment of prolapse mesh complications,” ACOG and AUGS wrote.
The practice bulletin updates the recommendations on mesh based on a recent systematic review and meta-analysis that concluded that biological graft repair and absorbable mesh offered minimal benefits compared with native tissue repair, and did not significantly reduce rates of prolapse awareness or repeat surgery (Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014).
Porcine dermis graft, which was used in most of the studies, did not significantly reduce rates of anterior prolapse recurrence compared with native tissue repair. Use of polypropylene mesh also tends to prolong operating times and causes more blood loss than native tissue anterior repair, and is associated with an elevated combined risk of stress urinary incontinence, mesh erosion, and repeat surgery for prolapse, the review concluded.
“Uterosacral and sacrospinous ligament suspension for apical POP with native tissue are equally effective surgical treatments of POP, with comparable anatomic, functional, and adverse outcomes,” the authors wrote in the practice bulletin.
Neither synthetic mesh nor biologic grafts improve outcomes of transvaginal repair of posterior vaginal wall prolapse, they added. As an alternative to surgery, most women can be successfully fitted with a pessary and clinicians should offer them this option, the practice bulletin stated. In up to 9% of cases, pessaries cause local devascularization or erosion, in which case they should be removed for 2-4 weeks while the patient undergoes local estrogen therapy.
Although POP is common and benign, symptomatic cases undermine quality of life by causing vaginal bulge and pressure and problems voiding, defecating, and during sexual activity. Consequently, about 300,000 women in the United States undergo surgery for POP every year. By 2050, population aging in the United States will lead to about a 50% rise in the number of women with POP, according to the practice bulletin.
Using polypropylene mesh to augment surgical repair of anterior vaginal wall prolapse improves anatomic and some subjective outcomes, compared with native tissue repair, but it also comes with increased morbidity, according to new guidance from the American College of Obstetricians and Gynecologists.
(POP) to incorporate recent systematic review evidence.
When using polypropylene mesh for anterior POP repair, 11% of patients develop mesh erosion, of which 7% require surgical correction, according to the updated practice bulletin (Obstet Gynecol. 2017;130:e234-50).
“Referral to an obstetrician-gynecologist with appropriate training and experience, such as a female pelvic medicine and reconstructive surgery specialist, is recommended for surgical treatment of prolapse mesh complications,” ACOG and AUGS wrote.
The practice bulletin updates the recommendations on mesh based on a recent systematic review and meta-analysis that concluded that biological graft repair and absorbable mesh offered minimal benefits compared with native tissue repair, and did not significantly reduce rates of prolapse awareness or repeat surgery (Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014).
Porcine dermis graft, which was used in most of the studies, did not significantly reduce rates of anterior prolapse recurrence compared with native tissue repair. Use of polypropylene mesh also tends to prolong operating times and causes more blood loss than native tissue anterior repair, and is associated with an elevated combined risk of stress urinary incontinence, mesh erosion, and repeat surgery for prolapse, the review concluded.
“Uterosacral and sacrospinous ligament suspension for apical POP with native tissue are equally effective surgical treatments of POP, with comparable anatomic, functional, and adverse outcomes,” the authors wrote in the practice bulletin.
Neither synthetic mesh nor biologic grafts improve outcomes of transvaginal repair of posterior vaginal wall prolapse, they added. As an alternative to surgery, most women can be successfully fitted with a pessary and clinicians should offer them this option, the practice bulletin stated. In up to 9% of cases, pessaries cause local devascularization or erosion, in which case they should be removed for 2-4 weeks while the patient undergoes local estrogen therapy.
Although POP is common and benign, symptomatic cases undermine quality of life by causing vaginal bulge and pressure and problems voiding, defecating, and during sexual activity. Consequently, about 300,000 women in the United States undergo surgery for POP every year. By 2050, population aging in the United States will lead to about a 50% rise in the number of women with POP, according to the practice bulletin.
FROM OBSTETRICS & GYNECOLOGY
ACOG: VBAC is safe for many women
Women and their , according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.
Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).
Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.
To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.
“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”
Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.
To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.
The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.
Women and their , according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.
Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).
Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.
To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.
“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”
Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.
To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.
The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.
Women and their , according to an updated practice bulletin from the American College of Obstetricians and Gynecologists.
Trial of labor after cesarean delivery (TOLAC) results in a successful birth in 60%-80% of cases, sparing mothers from major abdominal surgery and reducing the risk of hemorrhage, thromboses, and infection, the authors of the practice bulletin wrote. “The preponderance of evidence suggests that most women with one previous cesarean delivery with a low-transverse incision are candidates for and should be counseled about and offered TOLAC,” they said (Obstet Gynecol. 2017 Nov;130[5]:e217-33. doi: 10.1097/AOG.0000000000002398).
Rates of cesarean delivery in the United States jumped from 5% to nearly 32% between 1970 and 2016. Although rates of VBAC rose between the mid-1980s and the mid-1990s, cases of uterine rupture and other complications spurred fears of malpractice litigation and reversed this trend. VBAC rates were more than 28% in 1996 but fell to 8.5% by 2006, according to the practice bulletin.
To reduce the risk of uterine rupture, avoid misoprostol for cervical ripening and labor induction in women with a prior cesarean delivery, ACOG recommended.
“No evidence suggests that epidural analgesia is a causal risk factor for unsuccessful TOLAC,” the authors added. “Therefore, epidural analgesia for labor may be used as part of TOLAC, and adequate pain relief may encourage more women to choose TOLAC.”
Women with two prior low-transverse cesareans also are potential candidates for TOLAC, depending on other predictors of successful VBAC. Factors that reduce the chances of a successful TOLAC include advanced maternal age, high body mass index, high birth weight, gestational age of more than 40 weeks at delivery, and preeclampsia at the time of delivery, according to the practice bulletin.
To reduce the risk of adverse outcomes of complications, TOLAC should not occur at home and should only occur at level I facilities (or higher) that can perform an emergency cesarean delivery if the mother or fetus is in jeopardy.
The practice bulletin recommends continuous fetal heart rate monitoring during TOLAC and notes several additional categories of TOLAC candidates. Obstetricians and patients should discuss the potential risks and benefits of both TOLAC and elective repeat cesarean delivery, and that discussion should be documented in the medical record, ACOG recommended.
FROM OBSTETRICS & GYNECOLOGY
ACOG advises against vaginal seeding
The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.
Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.
Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).
Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.
Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.
The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.
“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.
In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.
The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.
Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.
Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).
Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.
Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.
The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.
“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.
In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.
The practice of vaginal seeding should not be performed outside of an approved research protocol until adequate data on safety and potential benefits are available, according to a new policy statement from the American College of Obstetricians and Gynecologists.
Vaginal seeding is “the practice of inoculating a cotton gauze or a cotton swab with vaginal fluids to transfer the vaginal flora to the mouth, nose, or skin of a newborn infant,” according to ACOG.
Data from several studies have suggested babies delivered by cesarean may lack the immunologic and metabolic benefits of vaginally delivered babies because of the unique properties of vaginal fluid, and a proof-of-concept study showed changes in newborns’ microbiome profiles when they received transfers of vaginal fluid soon after a cesarean delivery. However, the impact of the fluid transfer (vaginal seeding) remains unknown, according to the ACOG committee opinion (Obstet Gynecol. 2017;130:e274-8).
Additional safety concerns include the potential transfer of pathogens from mother to neonate from undiagnosed maternal conditions such as gonorrhea, human papillomavirus, group A streptococci, and others, the committee noted.
Women who wish to perform neonatal seeding themselves should be educated about the risks and tested for infectious diseases and pathogenic bacteria, the committee emphasized. Additionally, ACOG urged ob.gyns. to document the discussion in the medical record. The infant’s physician should also be made aware of the procedure because of the potential for neonatal infection.
The research on vaginal seeding currently consists of one pilot study, with an outcome measure of neonatal microbiota. No studies of other clinical outcomes have been completed.
“The paucity of data on this subject supports the need for additional research on the safety and benefit of vaginal seeding,” the ACOG Committee on Obstetric Practice wrote.
In the meantime, ACOG recommends exclusive breastfeeding in the first 6 months, noting that there are mixed data on associations between breastfeeding and the development of asthma and atopic disease in childhood.
FROM OBSTETRICS & GYNECOLOGY