2019 Update on menopause

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Among peri- and postmenopausal women, abnormal bleeding, breast cancer, and mood disorders represent prevalent conditions. In this Update, we discuss data from a review that provides quantitative information on the likelihood of finding endometrial cancer among women with postmenopausal bleeding (PMB). We also summarize 2 recent consensus recommendations: One addresses the clinically important but controversial issue of the treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors, and the other provides guidance on the management of depression in perimenopausal women.

Endometrial cancer is associated with a high prevalence of PMB 

Clarke MA, Long BJ, Del Mar Morillo A, et al. Association of endometrial cancer risk with postmenopausal bleeding in women: a systematic review and meta-analysis. JAMA Intern Med. 2018;178:1210-1222. 

Endometrial cancer is the most common gynecologic malignancy and the fourth most common cancer among US women. In recent years, the incidence of and mortality from endometrial cancer have increased.1 Despite the high prevalence of endometrial cancer, population-based screening currently is not recommended. 

PMB affects up to 10% of women and can be caused by endometrial atrophy, endometrial polyps, uterine leiomyoma, and malignancy. While it is well known that PMB is a common presenting symptom of endometrial cancer, we do not have good data to guide counseling patients with PMB on the likelihood that endometrial cancer is present. Similarly, estimates are lacking regarding what proportion of women with endometrial cancer will present with PMB. 

To address these 2 issues, Clarke and colleagues conducted a comprehensive systematic review and meta-analysis of the prevalence of PMB among women with endometrial cancer (sensitivity) and the risk of endometrial cancer among women with PMB (positive predictive value). The authors included 129 studies--with 34,432 women with PMB and 6,358 with endometrial cancer--in their report.

Cancer prevalence varied with HT use, geographic location 

The study findings demonstrated that the prevalence of PMB in women with endometrial cancer was 90% (95% confidence interval [CI], 84%-94%), and there was no significant difference in the occurrence of PMB by cancer stage. The risk of endometrial cancer in women with PMB ranged from 0% to 48%, yielding an overall pooled estimate of 9% (95% CI, 8%-11%). As an editorialist pointed out, the risk of endometrial cancer in women with PMB is similar to that of colorectal cancer in individuals with rectal bleeding (8%) and breast cancer in women with a palpable mass (10%), supporting current guidance that recommends evaluation of women with PMB.2 Evaluating 100 women with PMB to diagnose 9 endometrial cancers does not seem excessive. 

Interestingly, among women with PMB, the prevalence of endometrial cancer was significantly higher among women not using hormone therapy (HT) than among users of HT (12% and 7%, respectively). In 7 studies restricted to women with PMB and polyps (n = 2,801), the pooled risk of endometrial cancer was 3% (95% CI, 3%-4%). In an analysis stratified by geographic region, a striking difference was noted in the risk of endometrial cancer among women with PMB in North America (5%), Northern Europe (7%), and in Western Europe (13%). This finding may be explained by regional differences in the approach to evaluating PMB, cultural perceptions of PMB that can affect thresholds to present for care, and differences in risk factors between these populations. 

The study had several limitations, including an inability to evaluate the number of years since menopause and the effects of body mass index. Additionally, the study did not address endometrial hyperplasia or endometrial intraepithelial neoplasia. 

 
WHAT THIS EVIDENCE MEANS FOR PRACTICE

PMB accounts for two-thirds of all gynecologic visits among perimenopausal and postmenopausal women.3 This study revealed a 9% risk of endometrial cancer in patients experiencing PMB, which supports current practice guidelines to further evaluate and rule out endometrial cancer among all women presenting with PMB4; it also provides reassurance that targeting this high-risk group of women for early detection and prevention strategies will capture most cases of endometrial cancers. However, the relatively low positive predictive value of PMB emphasizes the need for additional triage tests with high specificity to improve management of PMB and minimize unnecessary biopsies in low-risk women.

 

Treating GSM in breast cancer survivors: New guidance targets QoL and sexuality 

Faubion SS, Larkin LC, Stuenkel CA, et al. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health. Menopause. 2018;25:596-608. 

More than 3 million breast cancer survivors reside in the United States. Accordingly, ObGyns see survivors on a frequent basis. For several reasons, genitourinary syndrome of menopause (also known as vulvovaginal atrophy) is particularly prevalent in women who have been treated for breast cancer. Chemotherapy, for example, often induces ovarian failure. For some premenopausal women, bilateral salpingo-oophorectomy may be performed or gonadotropin-releasing hormone agonists may be prescribed as part of breast cancer treatment. In postmenopausal survivors with hormone receptor-positive tumors, adjuvant aromatase inhibitor (AI) therapy may be used for up to 10 years. Treatment with AIs is associated with GSM symptoms.5 Although vaginal estrogen is an effective treatment for GSM, package labeling for all estrogens, including vaginal estrogens, lists a personal history of breast cancer as a contraindication. 

Given that there is little evidence addressing the safety of vaginal estrogen, other hormonal therapies, and nonprescription treatments for GSM in breast cancer survivors, many survivors with bothersome GSM symptoms are not appropriately treated.

 

Continue to: Expert panel creates evidence-based guidance...

 

 

Expert panel creates evidence-based guidance 

Against this backdrop, The North American Menopause Society and the International Society for the Study of Women's Sexual Health convened a group comprised of menopause specialists (ObGyns, internists, and nurse practitioners), specialists in sexuality, medical oncologists specializing in breast cancer, and a psychologist to create evidence-based interdisciplinary consensus guidelines for enhancing quality of life and sexuality for breast cancer survivors with GSM. 

Measures to help enhance quality of life and sexuality 

The group's key recommendations for clinicians include: 

  • Sexual function and quality of life (QoL) should be assessed in all women with or at high risk for breast cancer. 
  • Management of GSM should be individualized based on shared decision-making involving the patient and her oncologist. 
  • Initial treatment options include: 

—over-the-counter vaginal moisturizers used several times weekly on a regular basis 
—lubricants used with intercourse  
—vaginal dilator therapy  
—pelvic floor physical therapy. 
 

  • Low-dose vaginal estrogen therapy may be appropriate for select women who have been treated for breast cancer: 

—With use of vaginal estrogen, serum estradiol levels remain in the postmenopausal range. 
—Based on limited data, use of vaginal estrogen is associated with a minimal risk for recurrence of breast cancer. 
—Because their use is associated with the lowest serum estradiol levels, vaginal tablets, rings, or inserts may be preferable to creams.  
—Decisions regarding use of vaginal estrogen in breast cancer survivors should involve the woman's oncologist. Appropriate candidates for off-label use of vaginal estrogen may be survivors:

–who are at relatively low risk for recurrence 
–with hormone receptor-negative disease
–using tamoxifen rather than an AI 
–who are particularly concerned about quality of life.

—Given that AIs prevent recurrence by lowering estrogen levels, oncologists may be reluctant to consider use of vaginal estrogen in survivors using adjuvant agents. 
—With respect to use of vaginal estrogen, oncologists may be more comfortable with use in patients taking tamoxifen. 

  • Neither intravaginal dehydroepiandrosterone (DHEA; prasterone) nor the oral selective estrogen receptor modulator ospemifene has been studied in breast cancer survivors. 

In women with metastatic disease, QoL, comfort, and sexual intimacy are key considerations when weighing potential therapies; optimal choices will vary with probability of long-term survival. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although more data addressing the safety of vaginal estrogen as well as prasterone and ospemifene in breast cancer survivors clearly are needed, these guidelines should help clinicians who care for breast cancer survivors with GSM.

Framework provided for managing depressive disorders in perimenopausal women 

Maki PM, Kornstein SG, Joffe H, et al; Board of Trustees for The North American Menopause Society (NAMS) and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. Menopause. 2018;25:1069-1085. 

Although perimenopausal women are more susceptible to the development of depressive symptoms and major depressive episodes (MDE), there is a lack of consensus regarding how to evaluate and treat depression in women during the menopausal transition and postmenopausal period. 

Recently, an expert panel comprised of representatives from The North American Menopause Society and the National Network of Depression Centers Women and Mood Disorders Task Group developed clinical guidelines addressing epidemiology, clinical presentation, therapeutic effects of antidepressants, effects of HT, and efficacy of other therapies. Here we provide a summary of the expert panel's findings and guidelines. 

 

Continue to: Certain factors are associated with higher risk for depression...

 

 

Certain factors are associated with higher risk for depression 

The perimenopause represents a time of increased risk for depressive symptoms and major depressive disorder (MDD), even in women with no prior history of depression. Several characteristics and health factors are associated with the increased risk during the menopause transition. These include a prior history of MDD, current antidepressant use, anxiety, premenstrual depressive symptoms, African American race, high body mass index, younger age, social isolation, upsetting life events, and menopausal sleep disturbances.  

Although data are inconclusive on whether surgical menopause increases or decreases the risk for developing depression compared with women who transition through menopause naturally, recent studies show an elevated risk of depression in women following hysterectomy with and without oophorectomy.6,7 

Menopausal and depressive symptoms can overlap 

Midlife depression presents with classic depressive symptoms that commonly occur in combination with menopausal symptoms, including vasomotor symptoms, sleep and sexual disturbances, and weight and energy changes. These menopausal symptoms can complicate, co-occur, and overlap with the clinical presentation of depression. 

Conversely, depression may affect an individual's judgment of the degree of bother from menopausal somatic symptoms, thereby further magnifying the effect of symptoms on quality of life. The interrelationship between depressive symptoms and menopausal symptoms may pose a challenge when attempting to parse out contributing etiologies, relative contributions of each etiology, and the potential additive effects. 

Diagnosis and treatment options 

Diagnosis involves identifying the menopausal stage, assessing for co-existing psychiatric and menopause symptoms, appreciating the psychosocial factors common in midlife, and considering the differential diagnosis. Validated screening instruments can be helpful. Although a menopause-specific mood disorder scale does not yet exist, several general validated screening measures, such as the Patient Health Questionnaire-9, or PHQ-9, can be used for categorical determination of mood disorder diagnoses during the menopause transition. 

Antidepressants, cognitive-behavioral therapy, and other psychotherapies are considered first-line treatments for perimenopausal major depressive episodes. Only desvenlafaxine has been studied in large randomized placebo-controlled trials and has proven efficacious for the treatment of MDD in perimenopausal and postmenopausal women. 

A number of small open-label studies of other selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and mirtazapine to treat MDD in perimenopausal and postmenopausal women have demonstrated a positive effect on mood, and several SSRIs and SNRIs also have the added benefit of improving menopause-related symptoms. 

In women with a history of MDD, a prior adequate response to a particular antidepressant should guide treatment selection when MDD recurs during the midlife years. 

Although estrogen is not approved by the US Food and Drug Administration specifically for the treatment of mood disturbances, some evidence suggests that unopposed estrogen therapy has efficacy similar to that of antidepressant medications in treating depressive disorders in perimenopausal women,8-11 but it is ineffective in treating depressive disorders in postmenopausal women. Estrogen therapy also may augment the clinical response to antidepressants in midlife and older women.12,13 The data on combined HT (estrogen plus progestogen) or for different progestogens in treating depressive disorders in perimenopausal women are lacking and inconclusive.  

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The findings from this expert review panel demonstrate that women in the perimenopausal transition are at increased risk for depressive symptoms, major depressive episodes, and major depressive disorder. The interrelationship between symptoms of depression and menopause can complicate, co-occur, overlap, and magnify one another. Clinicians treating perimenopausal women with depression that is unresponsive to conventional antidepressant therapy should consider concurrent use of estrogen-based hormone therapy or referring the patient to a clinician comfortable doing so.

References
  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30. 
  2. Matteson KA, Robison K, Jacoby VL. Opportunities for early detection of endometrial cancer in women with postmenopausal bleeding. JAMA Intern Med. 2018;178:1222-1223.  
  3. van Hanegem N, Breijer MC, Khan KS, et al. Diagnostic evaluation of the endometrium in postmenopausal bleeding: an evidence-based approach. Maturitas. 2011;68:155-164.  
  4. American College of Obstetricians and Gynecologists. ACOG Committee Opinion no. 734 summary. The role of transvaginal ultrasonography in evaluating the endometrium of women with postmenopausal bleeding. Obstet Gynecol. 2018; 131:945-946. 
  5. Baumgart J, Nilsson K, Evers AS, et al. Sexual dysfunction in women on adjuvant endocrine therapy after breast cancer. Menopause. 2013;20:162-168. 
  6. Chou PH, Lin CH, Cheng C, et al. Risk of depressive disorders in women undergoing hysterectomy: a population-based follow-up study. J Psychiatr Res. 2015;68:186-191. 
  7. Wilson L, Pandeya N, Byles J, et al. Hysterectomy and incidence of depressive symptoms in midlife women: the Australian Longitudinal Study on Women's Health. Epidemiol Psychiatr Sci. 2018;27:381-392. 
  8. Schmidt PJ, Nieman L, Danaceau MA, et al. Estrogen replacement in perimenopause-related depression: a preliminary report. Am J Obstet Gynecol. 2000;183:414-420. 
  9. Rasgon NL, Altshuler LL, Fairbanks L. Estrogen-replacement therapy for depression. Am J Psychiatry. 2001;158:1738. 
  10. Soares CN, Almeida OP, Joffe H, et al. Efficacy of estradiol for the treatment of major depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial. Arch Gen Psychiatry. 2001;58:529-534. 
  11. Cohen LS, Soares CN, Poitras JR, et al. Short-term use of estradiol for depression in perimenopausal and postmenopausal women: a preliminary report. Am J Psychiatry. 2003;160:1519-1522. 
  12. Schneider LS, Small GW, Hamilton SH, et al. Estrogen replacement and response to fluoxetine in a multicenter geriatric depression trial. Fluoxetine Collaborative Study Group. Am J Geriatr Psychiatry. 1997;5:97-106. 
  13. Schneider LS, Small GW, Clary CM. Estrogen replacement therapy and antidepressant response to sertraline in older depressed women. Am J Geriatr Psychiatry. 2001;9:393-399. 
     
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Author and Disclosure Information

Andrew M. Kaunitz, MD, NCMP 

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women's Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors. 

Deanna C. McCullough, MD  

Dr. McCullough is Assistant Professor, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. 

Dr. Kaunitz reports receiving grant or research support from Allergan and Mithra and that he is a consultant to AMAG, Merck, and Pfizer. Dr. McCullough reports no financial relationships relevant to this article. 
 

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Andrew M. Kaunitz, MD, NCMP 

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women's Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors. 

Deanna C. McCullough, MD  

Dr. McCullough is Assistant Professor, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. 

Dr. Kaunitz reports receiving grant or research support from Allergan and Mithra and that he is a consultant to AMAG, Merck, and Pfizer. Dr. McCullough reports no financial relationships relevant to this article. 
 

Author and Disclosure Information

Andrew M. Kaunitz, MD, NCMP 

Dr. Kaunitz is University of Florida Term Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville; Medical Director and Director of Menopause and Gynecologic Ultrasound Services, UF Women's Health Specialists at Emerson, Jacksonville. He serves on the OBG Management Board of Editors. 

Deanna C. McCullough, MD  

Dr. McCullough is Assistant Professor, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. 

Dr. Kaunitz reports receiving grant or research support from Allergan and Mithra and that he is a consultant to AMAG, Merck, and Pfizer. Dr. McCullough reports no financial relationships relevant to this article. 
 

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Among peri- and postmenopausal women, abnormal bleeding, breast cancer, and mood disorders represent prevalent conditions. In this Update, we discuss data from a review that provides quantitative information on the likelihood of finding endometrial cancer among women with postmenopausal bleeding (PMB). We also summarize 2 recent consensus recommendations: One addresses the clinically important but controversial issue of the treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors, and the other provides guidance on the management of depression in perimenopausal women.

Endometrial cancer is associated with a high prevalence of PMB 

Clarke MA, Long BJ, Del Mar Morillo A, et al. Association of endometrial cancer risk with postmenopausal bleeding in women: a systematic review and meta-analysis. JAMA Intern Med. 2018;178:1210-1222. 

Endometrial cancer is the most common gynecologic malignancy and the fourth most common cancer among US women. In recent years, the incidence of and mortality from endometrial cancer have increased.1 Despite the high prevalence of endometrial cancer, population-based screening currently is not recommended. 

PMB affects up to 10% of women and can be caused by endometrial atrophy, endometrial polyps, uterine leiomyoma, and malignancy. While it is well known that PMB is a common presenting symptom of endometrial cancer, we do not have good data to guide counseling patients with PMB on the likelihood that endometrial cancer is present. Similarly, estimates are lacking regarding what proportion of women with endometrial cancer will present with PMB. 

To address these 2 issues, Clarke and colleagues conducted a comprehensive systematic review and meta-analysis of the prevalence of PMB among women with endometrial cancer (sensitivity) and the risk of endometrial cancer among women with PMB (positive predictive value). The authors included 129 studies--with 34,432 women with PMB and 6,358 with endometrial cancer--in their report.

Cancer prevalence varied with HT use, geographic location 

The study findings demonstrated that the prevalence of PMB in women with endometrial cancer was 90% (95% confidence interval [CI], 84%-94%), and there was no significant difference in the occurrence of PMB by cancer stage. The risk of endometrial cancer in women with PMB ranged from 0% to 48%, yielding an overall pooled estimate of 9% (95% CI, 8%-11%). As an editorialist pointed out, the risk of endometrial cancer in women with PMB is similar to that of colorectal cancer in individuals with rectal bleeding (8%) and breast cancer in women with a palpable mass (10%), supporting current guidance that recommends evaluation of women with PMB.2 Evaluating 100 women with PMB to diagnose 9 endometrial cancers does not seem excessive. 

Interestingly, among women with PMB, the prevalence of endometrial cancer was significantly higher among women not using hormone therapy (HT) than among users of HT (12% and 7%, respectively). In 7 studies restricted to women with PMB and polyps (n = 2,801), the pooled risk of endometrial cancer was 3% (95% CI, 3%-4%). In an analysis stratified by geographic region, a striking difference was noted in the risk of endometrial cancer among women with PMB in North America (5%), Northern Europe (7%), and in Western Europe (13%). This finding may be explained by regional differences in the approach to evaluating PMB, cultural perceptions of PMB that can affect thresholds to present for care, and differences in risk factors between these populations. 

The study had several limitations, including an inability to evaluate the number of years since menopause and the effects of body mass index. Additionally, the study did not address endometrial hyperplasia or endometrial intraepithelial neoplasia. 

 
WHAT THIS EVIDENCE MEANS FOR PRACTICE

PMB accounts for two-thirds of all gynecologic visits among perimenopausal and postmenopausal women.3 This study revealed a 9% risk of endometrial cancer in patients experiencing PMB, which supports current practice guidelines to further evaluate and rule out endometrial cancer among all women presenting with PMB4; it also provides reassurance that targeting this high-risk group of women for early detection and prevention strategies will capture most cases of endometrial cancers. However, the relatively low positive predictive value of PMB emphasizes the need for additional triage tests with high specificity to improve management of PMB and minimize unnecessary biopsies in low-risk women.

 

Treating GSM in breast cancer survivors: New guidance targets QoL and sexuality 

Faubion SS, Larkin LC, Stuenkel CA, et al. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health. Menopause. 2018;25:596-608. 

More than 3 million breast cancer survivors reside in the United States. Accordingly, ObGyns see survivors on a frequent basis. For several reasons, genitourinary syndrome of menopause (also known as vulvovaginal atrophy) is particularly prevalent in women who have been treated for breast cancer. Chemotherapy, for example, often induces ovarian failure. For some premenopausal women, bilateral salpingo-oophorectomy may be performed or gonadotropin-releasing hormone agonists may be prescribed as part of breast cancer treatment. In postmenopausal survivors with hormone receptor-positive tumors, adjuvant aromatase inhibitor (AI) therapy may be used for up to 10 years. Treatment with AIs is associated with GSM symptoms.5 Although vaginal estrogen is an effective treatment for GSM, package labeling for all estrogens, including vaginal estrogens, lists a personal history of breast cancer as a contraindication. 

Given that there is little evidence addressing the safety of vaginal estrogen, other hormonal therapies, and nonprescription treatments for GSM in breast cancer survivors, many survivors with bothersome GSM symptoms are not appropriately treated.

 

Continue to: Expert panel creates evidence-based guidance...

 

 

Expert panel creates evidence-based guidance 

Against this backdrop, The North American Menopause Society and the International Society for the Study of Women's Sexual Health convened a group comprised of menopause specialists (ObGyns, internists, and nurse practitioners), specialists in sexuality, medical oncologists specializing in breast cancer, and a psychologist to create evidence-based interdisciplinary consensus guidelines for enhancing quality of life and sexuality for breast cancer survivors with GSM. 

Measures to help enhance quality of life and sexuality 

The group's key recommendations for clinicians include: 

  • Sexual function and quality of life (QoL) should be assessed in all women with or at high risk for breast cancer. 
  • Management of GSM should be individualized based on shared decision-making involving the patient and her oncologist. 
  • Initial treatment options include: 

—over-the-counter vaginal moisturizers used several times weekly on a regular basis 
—lubricants used with intercourse  
—vaginal dilator therapy  
—pelvic floor physical therapy. 
 

  • Low-dose vaginal estrogen therapy may be appropriate for select women who have been treated for breast cancer: 

—With use of vaginal estrogen, serum estradiol levels remain in the postmenopausal range. 
—Based on limited data, use of vaginal estrogen is associated with a minimal risk for recurrence of breast cancer. 
—Because their use is associated with the lowest serum estradiol levels, vaginal tablets, rings, or inserts may be preferable to creams.  
—Decisions regarding use of vaginal estrogen in breast cancer survivors should involve the woman's oncologist. Appropriate candidates for off-label use of vaginal estrogen may be survivors:

–who are at relatively low risk for recurrence 
–with hormone receptor-negative disease
–using tamoxifen rather than an AI 
–who are particularly concerned about quality of life.

—Given that AIs prevent recurrence by lowering estrogen levels, oncologists may be reluctant to consider use of vaginal estrogen in survivors using adjuvant agents. 
—With respect to use of vaginal estrogen, oncologists may be more comfortable with use in patients taking tamoxifen. 

  • Neither intravaginal dehydroepiandrosterone (DHEA; prasterone) nor the oral selective estrogen receptor modulator ospemifene has been studied in breast cancer survivors. 

In women with metastatic disease, QoL, comfort, and sexual intimacy are key considerations when weighing potential therapies; optimal choices will vary with probability of long-term survival. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although more data addressing the safety of vaginal estrogen as well as prasterone and ospemifene in breast cancer survivors clearly are needed, these guidelines should help clinicians who care for breast cancer survivors with GSM.

Framework provided for managing depressive disorders in perimenopausal women 

Maki PM, Kornstein SG, Joffe H, et al; Board of Trustees for The North American Menopause Society (NAMS) and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. Menopause. 2018;25:1069-1085. 

Although perimenopausal women are more susceptible to the development of depressive symptoms and major depressive episodes (MDE), there is a lack of consensus regarding how to evaluate and treat depression in women during the menopausal transition and postmenopausal period. 

Recently, an expert panel comprised of representatives from The North American Menopause Society and the National Network of Depression Centers Women and Mood Disorders Task Group developed clinical guidelines addressing epidemiology, clinical presentation, therapeutic effects of antidepressants, effects of HT, and efficacy of other therapies. Here we provide a summary of the expert panel's findings and guidelines. 

 

Continue to: Certain factors are associated with higher risk for depression...

 

 

Certain factors are associated with higher risk for depression 

The perimenopause represents a time of increased risk for depressive symptoms and major depressive disorder (MDD), even in women with no prior history of depression. Several characteristics and health factors are associated with the increased risk during the menopause transition. These include a prior history of MDD, current antidepressant use, anxiety, premenstrual depressive symptoms, African American race, high body mass index, younger age, social isolation, upsetting life events, and menopausal sleep disturbances.  

Although data are inconclusive on whether surgical menopause increases or decreases the risk for developing depression compared with women who transition through menopause naturally, recent studies show an elevated risk of depression in women following hysterectomy with and without oophorectomy.6,7 

Menopausal and depressive symptoms can overlap 

Midlife depression presents with classic depressive symptoms that commonly occur in combination with menopausal symptoms, including vasomotor symptoms, sleep and sexual disturbances, and weight and energy changes. These menopausal symptoms can complicate, co-occur, and overlap with the clinical presentation of depression. 

Conversely, depression may affect an individual's judgment of the degree of bother from menopausal somatic symptoms, thereby further magnifying the effect of symptoms on quality of life. The interrelationship between depressive symptoms and menopausal symptoms may pose a challenge when attempting to parse out contributing etiologies, relative contributions of each etiology, and the potential additive effects. 

Diagnosis and treatment options 

Diagnosis involves identifying the menopausal stage, assessing for co-existing psychiatric and menopause symptoms, appreciating the psychosocial factors common in midlife, and considering the differential diagnosis. Validated screening instruments can be helpful. Although a menopause-specific mood disorder scale does not yet exist, several general validated screening measures, such as the Patient Health Questionnaire-9, or PHQ-9, can be used for categorical determination of mood disorder diagnoses during the menopause transition. 

Antidepressants, cognitive-behavioral therapy, and other psychotherapies are considered first-line treatments for perimenopausal major depressive episodes. Only desvenlafaxine has been studied in large randomized placebo-controlled trials and has proven efficacious for the treatment of MDD in perimenopausal and postmenopausal women. 

A number of small open-label studies of other selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and mirtazapine to treat MDD in perimenopausal and postmenopausal women have demonstrated a positive effect on mood, and several SSRIs and SNRIs also have the added benefit of improving menopause-related symptoms. 

In women with a history of MDD, a prior adequate response to a particular antidepressant should guide treatment selection when MDD recurs during the midlife years. 

Although estrogen is not approved by the US Food and Drug Administration specifically for the treatment of mood disturbances, some evidence suggests that unopposed estrogen therapy has efficacy similar to that of antidepressant medications in treating depressive disorders in perimenopausal women,8-11 but it is ineffective in treating depressive disorders in postmenopausal women. Estrogen therapy also may augment the clinical response to antidepressants in midlife and older women.12,13 The data on combined HT (estrogen plus progestogen) or for different progestogens in treating depressive disorders in perimenopausal women are lacking and inconclusive.  

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The findings from this expert review panel demonstrate that women in the perimenopausal transition are at increased risk for depressive symptoms, major depressive episodes, and major depressive disorder. The interrelationship between symptoms of depression and menopause can complicate, co-occur, overlap, and magnify one another. Clinicians treating perimenopausal women with depression that is unresponsive to conventional antidepressant therapy should consider concurrent use of estrogen-based hormone therapy or referring the patient to a clinician comfortable doing so.

Among peri- and postmenopausal women, abnormal bleeding, breast cancer, and mood disorders represent prevalent conditions. In this Update, we discuss data from a review that provides quantitative information on the likelihood of finding endometrial cancer among women with postmenopausal bleeding (PMB). We also summarize 2 recent consensus recommendations: One addresses the clinically important but controversial issue of the treatment of genitourinary syndrome of menopause (GSM) in breast cancer survivors, and the other provides guidance on the management of depression in perimenopausal women.

Endometrial cancer is associated with a high prevalence of PMB 

Clarke MA, Long BJ, Del Mar Morillo A, et al. Association of endometrial cancer risk with postmenopausal bleeding in women: a systematic review and meta-analysis. JAMA Intern Med. 2018;178:1210-1222. 

Endometrial cancer is the most common gynecologic malignancy and the fourth most common cancer among US women. In recent years, the incidence of and mortality from endometrial cancer have increased.1 Despite the high prevalence of endometrial cancer, population-based screening currently is not recommended. 

PMB affects up to 10% of women and can be caused by endometrial atrophy, endometrial polyps, uterine leiomyoma, and malignancy. While it is well known that PMB is a common presenting symptom of endometrial cancer, we do not have good data to guide counseling patients with PMB on the likelihood that endometrial cancer is present. Similarly, estimates are lacking regarding what proportion of women with endometrial cancer will present with PMB. 

To address these 2 issues, Clarke and colleagues conducted a comprehensive systematic review and meta-analysis of the prevalence of PMB among women with endometrial cancer (sensitivity) and the risk of endometrial cancer among women with PMB (positive predictive value). The authors included 129 studies--with 34,432 women with PMB and 6,358 with endometrial cancer--in their report.

Cancer prevalence varied with HT use, geographic location 

The study findings demonstrated that the prevalence of PMB in women with endometrial cancer was 90% (95% confidence interval [CI], 84%-94%), and there was no significant difference in the occurrence of PMB by cancer stage. The risk of endometrial cancer in women with PMB ranged from 0% to 48%, yielding an overall pooled estimate of 9% (95% CI, 8%-11%). As an editorialist pointed out, the risk of endometrial cancer in women with PMB is similar to that of colorectal cancer in individuals with rectal bleeding (8%) and breast cancer in women with a palpable mass (10%), supporting current guidance that recommends evaluation of women with PMB.2 Evaluating 100 women with PMB to diagnose 9 endometrial cancers does not seem excessive. 

Interestingly, among women with PMB, the prevalence of endometrial cancer was significantly higher among women not using hormone therapy (HT) than among users of HT (12% and 7%, respectively). In 7 studies restricted to women with PMB and polyps (n = 2,801), the pooled risk of endometrial cancer was 3% (95% CI, 3%-4%). In an analysis stratified by geographic region, a striking difference was noted in the risk of endometrial cancer among women with PMB in North America (5%), Northern Europe (7%), and in Western Europe (13%). This finding may be explained by regional differences in the approach to evaluating PMB, cultural perceptions of PMB that can affect thresholds to present for care, and differences in risk factors between these populations. 

The study had several limitations, including an inability to evaluate the number of years since menopause and the effects of body mass index. Additionally, the study did not address endometrial hyperplasia or endometrial intraepithelial neoplasia. 

 
WHAT THIS EVIDENCE MEANS FOR PRACTICE

PMB accounts for two-thirds of all gynecologic visits among perimenopausal and postmenopausal women.3 This study revealed a 9% risk of endometrial cancer in patients experiencing PMB, which supports current practice guidelines to further evaluate and rule out endometrial cancer among all women presenting with PMB4; it also provides reassurance that targeting this high-risk group of women for early detection and prevention strategies will capture most cases of endometrial cancers. However, the relatively low positive predictive value of PMB emphasizes the need for additional triage tests with high specificity to improve management of PMB and minimize unnecessary biopsies in low-risk women.

 

Treating GSM in breast cancer survivors: New guidance targets QoL and sexuality 

Faubion SS, Larkin LC, Stuenkel CA, et al. Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from The North American Menopause Society and The International Society for the Study of Women's Sexual Health. Menopause. 2018;25:596-608. 

More than 3 million breast cancer survivors reside in the United States. Accordingly, ObGyns see survivors on a frequent basis. For several reasons, genitourinary syndrome of menopause (also known as vulvovaginal atrophy) is particularly prevalent in women who have been treated for breast cancer. Chemotherapy, for example, often induces ovarian failure. For some premenopausal women, bilateral salpingo-oophorectomy may be performed or gonadotropin-releasing hormone agonists may be prescribed as part of breast cancer treatment. In postmenopausal survivors with hormone receptor-positive tumors, adjuvant aromatase inhibitor (AI) therapy may be used for up to 10 years. Treatment with AIs is associated with GSM symptoms.5 Although vaginal estrogen is an effective treatment for GSM, package labeling for all estrogens, including vaginal estrogens, lists a personal history of breast cancer as a contraindication. 

Given that there is little evidence addressing the safety of vaginal estrogen, other hormonal therapies, and nonprescription treatments for GSM in breast cancer survivors, many survivors with bothersome GSM symptoms are not appropriately treated.

 

Continue to: Expert panel creates evidence-based guidance...

 

 

Expert panel creates evidence-based guidance 

Against this backdrop, The North American Menopause Society and the International Society for the Study of Women's Sexual Health convened a group comprised of menopause specialists (ObGyns, internists, and nurse practitioners), specialists in sexuality, medical oncologists specializing in breast cancer, and a psychologist to create evidence-based interdisciplinary consensus guidelines for enhancing quality of life and sexuality for breast cancer survivors with GSM. 

Measures to help enhance quality of life and sexuality 

The group's key recommendations for clinicians include: 

  • Sexual function and quality of life (QoL) should be assessed in all women with or at high risk for breast cancer. 
  • Management of GSM should be individualized based on shared decision-making involving the patient and her oncologist. 
  • Initial treatment options include: 

—over-the-counter vaginal moisturizers used several times weekly on a regular basis 
—lubricants used with intercourse  
—vaginal dilator therapy  
—pelvic floor physical therapy. 
 

  • Low-dose vaginal estrogen therapy may be appropriate for select women who have been treated for breast cancer: 

—With use of vaginal estrogen, serum estradiol levels remain in the postmenopausal range. 
—Based on limited data, use of vaginal estrogen is associated with a minimal risk for recurrence of breast cancer. 
—Because their use is associated with the lowest serum estradiol levels, vaginal tablets, rings, or inserts may be preferable to creams.  
—Decisions regarding use of vaginal estrogen in breast cancer survivors should involve the woman's oncologist. Appropriate candidates for off-label use of vaginal estrogen may be survivors:

–who are at relatively low risk for recurrence 
–with hormone receptor-negative disease
–using tamoxifen rather than an AI 
–who are particularly concerned about quality of life.

—Given that AIs prevent recurrence by lowering estrogen levels, oncologists may be reluctant to consider use of vaginal estrogen in survivors using adjuvant agents. 
—With respect to use of vaginal estrogen, oncologists may be more comfortable with use in patients taking tamoxifen. 

  • Neither intravaginal dehydroepiandrosterone (DHEA; prasterone) nor the oral selective estrogen receptor modulator ospemifene has been studied in breast cancer survivors. 

In women with metastatic disease, QoL, comfort, and sexual intimacy are key considerations when weighing potential therapies; optimal choices will vary with probability of long-term survival. 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although more data addressing the safety of vaginal estrogen as well as prasterone and ospemifene in breast cancer survivors clearly are needed, these guidelines should help clinicians who care for breast cancer survivors with GSM.

Framework provided for managing depressive disorders in perimenopausal women 

Maki PM, Kornstein SG, Joffe H, et al; Board of Trustees for The North American Menopause Society (NAMS) and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations. Menopause. 2018;25:1069-1085. 

Although perimenopausal women are more susceptible to the development of depressive symptoms and major depressive episodes (MDE), there is a lack of consensus regarding how to evaluate and treat depression in women during the menopausal transition and postmenopausal period. 

Recently, an expert panel comprised of representatives from The North American Menopause Society and the National Network of Depression Centers Women and Mood Disorders Task Group developed clinical guidelines addressing epidemiology, clinical presentation, therapeutic effects of antidepressants, effects of HT, and efficacy of other therapies. Here we provide a summary of the expert panel's findings and guidelines. 

 

Continue to: Certain factors are associated with higher risk for depression...

 

 

Certain factors are associated with higher risk for depression 

The perimenopause represents a time of increased risk for depressive symptoms and major depressive disorder (MDD), even in women with no prior history of depression. Several characteristics and health factors are associated with the increased risk during the menopause transition. These include a prior history of MDD, current antidepressant use, anxiety, premenstrual depressive symptoms, African American race, high body mass index, younger age, social isolation, upsetting life events, and menopausal sleep disturbances.  

Although data are inconclusive on whether surgical menopause increases or decreases the risk for developing depression compared with women who transition through menopause naturally, recent studies show an elevated risk of depression in women following hysterectomy with and without oophorectomy.6,7 

Menopausal and depressive symptoms can overlap 

Midlife depression presents with classic depressive symptoms that commonly occur in combination with menopausal symptoms, including vasomotor symptoms, sleep and sexual disturbances, and weight and energy changes. These menopausal symptoms can complicate, co-occur, and overlap with the clinical presentation of depression. 

Conversely, depression may affect an individual's judgment of the degree of bother from menopausal somatic symptoms, thereby further magnifying the effect of symptoms on quality of life. The interrelationship between depressive symptoms and menopausal symptoms may pose a challenge when attempting to parse out contributing etiologies, relative contributions of each etiology, and the potential additive effects. 

Diagnosis and treatment options 

Diagnosis involves identifying the menopausal stage, assessing for co-existing psychiatric and menopause symptoms, appreciating the psychosocial factors common in midlife, and considering the differential diagnosis. Validated screening instruments can be helpful. Although a menopause-specific mood disorder scale does not yet exist, several general validated screening measures, such as the Patient Health Questionnaire-9, or PHQ-9, can be used for categorical determination of mood disorder diagnoses during the menopause transition. 

Antidepressants, cognitive-behavioral therapy, and other psychotherapies are considered first-line treatments for perimenopausal major depressive episodes. Only desvenlafaxine has been studied in large randomized placebo-controlled trials and has proven efficacious for the treatment of MDD in perimenopausal and postmenopausal women. 

A number of small open-label studies of other selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and mirtazapine to treat MDD in perimenopausal and postmenopausal women have demonstrated a positive effect on mood, and several SSRIs and SNRIs also have the added benefit of improving menopause-related symptoms. 

In women with a history of MDD, a prior adequate response to a particular antidepressant should guide treatment selection when MDD recurs during the midlife years. 

Although estrogen is not approved by the US Food and Drug Administration specifically for the treatment of mood disturbances, some evidence suggests that unopposed estrogen therapy has efficacy similar to that of antidepressant medications in treating depressive disorders in perimenopausal women,8-11 but it is ineffective in treating depressive disorders in postmenopausal women. Estrogen therapy also may augment the clinical response to antidepressants in midlife and older women.12,13 The data on combined HT (estrogen plus progestogen) or for different progestogens in treating depressive disorders in perimenopausal women are lacking and inconclusive.  

 

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The findings from this expert review panel demonstrate that women in the perimenopausal transition are at increased risk for depressive symptoms, major depressive episodes, and major depressive disorder. The interrelationship between symptoms of depression and menopause can complicate, co-occur, overlap, and magnify one another. Clinicians treating perimenopausal women with depression that is unresponsive to conventional antidepressant therapy should consider concurrent use of estrogen-based hormone therapy or referring the patient to a clinician comfortable doing so.

References
  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30. 
  2. Matteson KA, Robison K, Jacoby VL. Opportunities for early detection of endometrial cancer in women with postmenopausal bleeding. JAMA Intern Med. 2018;178:1222-1223.  
  3. van Hanegem N, Breijer MC, Khan KS, et al. Diagnostic evaluation of the endometrium in postmenopausal bleeding: an evidence-based approach. Maturitas. 2011;68:155-164.  
  4. American College of Obstetricians and Gynecologists. ACOG Committee Opinion no. 734 summary. The role of transvaginal ultrasonography in evaluating the endometrium of women with postmenopausal bleeding. Obstet Gynecol. 2018; 131:945-946. 
  5. Baumgart J, Nilsson K, Evers AS, et al. Sexual dysfunction in women on adjuvant endocrine therapy after breast cancer. Menopause. 2013;20:162-168. 
  6. Chou PH, Lin CH, Cheng C, et al. Risk of depressive disorders in women undergoing hysterectomy: a population-based follow-up study. J Psychiatr Res. 2015;68:186-191. 
  7. Wilson L, Pandeya N, Byles J, et al. Hysterectomy and incidence of depressive symptoms in midlife women: the Australian Longitudinal Study on Women's Health. Epidemiol Psychiatr Sci. 2018;27:381-392. 
  8. Schmidt PJ, Nieman L, Danaceau MA, et al. Estrogen replacement in perimenopause-related depression: a preliminary report. Am J Obstet Gynecol. 2000;183:414-420. 
  9. Rasgon NL, Altshuler LL, Fairbanks L. Estrogen-replacement therapy for depression. Am J Psychiatry. 2001;158:1738. 
  10. Soares CN, Almeida OP, Joffe H, et al. Efficacy of estradiol for the treatment of major depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial. Arch Gen Psychiatry. 2001;58:529-534. 
  11. Cohen LS, Soares CN, Poitras JR, et al. Short-term use of estradiol for depression in perimenopausal and postmenopausal women: a preliminary report. Am J Psychiatry. 2003;160:1519-1522. 
  12. Schneider LS, Small GW, Hamilton SH, et al. Estrogen replacement and response to fluoxetine in a multicenter geriatric depression trial. Fluoxetine Collaborative Study Group. Am J Geriatr Psychiatry. 1997;5:97-106. 
  13. Schneider LS, Small GW, Clary CM. Estrogen replacement therapy and antidepressant response to sertraline in older depressed women. Am J Geriatr Psychiatry. 2001;9:393-399. 
     
References
  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67:7-30. 
  2. Matteson KA, Robison K, Jacoby VL. Opportunities for early detection of endometrial cancer in women with postmenopausal bleeding. JAMA Intern Med. 2018;178:1222-1223.  
  3. van Hanegem N, Breijer MC, Khan KS, et al. Diagnostic evaluation of the endometrium in postmenopausal bleeding: an evidence-based approach. Maturitas. 2011;68:155-164.  
  4. American College of Obstetricians and Gynecologists. ACOG Committee Opinion no. 734 summary. The role of transvaginal ultrasonography in evaluating the endometrium of women with postmenopausal bleeding. Obstet Gynecol. 2018; 131:945-946. 
  5. Baumgart J, Nilsson K, Evers AS, et al. Sexual dysfunction in women on adjuvant endocrine therapy after breast cancer. Menopause. 2013;20:162-168. 
  6. Chou PH, Lin CH, Cheng C, et al. Risk of depressive disorders in women undergoing hysterectomy: a population-based follow-up study. J Psychiatr Res. 2015;68:186-191. 
  7. Wilson L, Pandeya N, Byles J, et al. Hysterectomy and incidence of depressive symptoms in midlife women: the Australian Longitudinal Study on Women's Health. Epidemiol Psychiatr Sci. 2018;27:381-392. 
  8. Schmidt PJ, Nieman L, Danaceau MA, et al. Estrogen replacement in perimenopause-related depression: a preliminary report. Am J Obstet Gynecol. 2000;183:414-420. 
  9. Rasgon NL, Altshuler LL, Fairbanks L. Estrogen-replacement therapy for depression. Am J Psychiatry. 2001;158:1738. 
  10. Soares CN, Almeida OP, Joffe H, et al. Efficacy of estradiol for the treatment of major depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial. Arch Gen Psychiatry. 2001;58:529-534. 
  11. Cohen LS, Soares CN, Poitras JR, et al. Short-term use of estradiol for depression in perimenopausal and postmenopausal women: a preliminary report. Am J Psychiatry. 2003;160:1519-1522. 
  12. Schneider LS, Small GW, Hamilton SH, et al. Estrogen replacement and response to fluoxetine in a multicenter geriatric depression trial. Fluoxetine Collaborative Study Group. Am J Geriatr Psychiatry. 1997;5:97-106. 
  13. Schneider LS, Small GW, Clary CM. Estrogen replacement therapy and antidepressant response to sertraline in older depressed women. Am J Geriatr Psychiatry. 2001;9:393-399. 
     
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What’s in store for ObGyn reimbursement in the EHR age and beyond

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In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for
potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

 

 

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

  • current framework (1995 or 1997 guidelines)
  • medical decision making (MDM)
  • time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

 

 

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

  1. to decrease the administrative burden of documentation and coding
  2. to decrease the need for audits
  3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
  4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Summary of CPT Editorial Panel actions for office or other outpatient services, February 2019 (Effective Date January 1, 2021)
  • CPT code 99201 to be deleted
  • Revision of codes 99202-99215 as follows:
  • removing history and examination as key components

(A) for selecting the level of service but requiring a medically appropriate history and or examination be performed in order to report codes 99202-99215

(B) making the basis for code selection on either the level of medical decision making (MDM) performed or the total time spent performing the service on the day of the encounter

(C) changing the definition of the time element associated with codes 99202-99215 from typical face-to-face time to total time spent on the day of the encounter and changing the amount of time associated with each code.

  • Revision of the MDM elements associated with codes 99202-99215 as follows:

(i) revising "Number of Diagnoses or Management Options" to "Number and Complexity of Problems Addressed";

(ii) revising "Amount and/or Complexity of Data to be Reviewed" to "Amount and/or Complexity of Data to be Reviewed and Analyzed"; and

(iii) revising "Risk of Complications and/or Morbidity or Mortality" to "Risk of Complications and/or Morbidity or Mortality of Patient Management."

  • Revision of the E/M guidelines by:

(A) restructuring the guidelines into three sections: "Guidelines Common to All E/M Services," "Guidelines for Hospital Observation, Hospital Inpatient, Consultations, Emergency Department, Nursing Facility, Domiciliary, Rest Home or Custodial Care and Home E/M Services," and "Guidelines for Office or Other Outpatient E/M Services" to distinguish the new reporting guidelines for the Office or Other Outpatient Services codes 99202-99215

(B) adding new guidelines that are applicable only to Office or Other Outpatient codes (99202-99215); adding a Summary of Guideline Differences table of the differences between the sets of guidelines

(C) revised existing E/M guidelines to ensure there is no conflicting information between the different sets of guidelines

(D) adding definitions of terms associated with the elements of MDM applicable to codes 99202-99215

(E) adding an MDM table that is applicable to codes 99202-99215

(F) defining total time associated with codes 99202-99215

(G) adding guidelines for reporting time when more than one individual performs distinct parts of an E/M service; revision of the MDM table in the Amount and/or Complexity of Data to be Reviewed and Analyzed column:

(1) inserted a dash (-) after the asterisk in the asterisk definition, "* - Each unique test, order, or document may be summed if multiple," to clarify this is the meaning of the asterisk and not an asterisked item itself

(2) for limited amount of data to be reviewed and analyzed (codes 99203/99213), the parenthetical regarding the number of categories for which requirements must be met was revised to state, "¬categories of tests and documents, or independent historian(s)" rather than "categories within tests, documents, or independent historian(s)"

(3) removing the word "or" after each of the bulleted items for limited, moderate (codes 99202/99214), and high (99205/99215) amount and/or complexity of data to be reviewed and analyzed.

Continue to: ACOG is at the helm, with a watchful eye...

 

 

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

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Ms. Tyler is Director of Coding, American College of Obstetricians and Gynecologists (ACOG), Washington, DC.

Dr. Levy is Vice President for Health Policy at ACOG.

The authors report no financial relationships relevant to this article.

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In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for
potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

 

 

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

  • current framework (1995 or 1997 guidelines)
  • medical decision making (MDM)
  • time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

 

 

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

  1. to decrease the administrative burden of documentation and coding
  2. to decrease the need for audits
  3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
  4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Summary of CPT Editorial Panel actions for office or other outpatient services, February 2019 (Effective Date January 1, 2021)
  • CPT code 99201 to be deleted
  • Revision of codes 99202-99215 as follows:
  • removing history and examination as key components

(A) for selecting the level of service but requiring a medically appropriate history and or examination be performed in order to report codes 99202-99215

(B) making the basis for code selection on either the level of medical decision making (MDM) performed or the total time spent performing the service on the day of the encounter

(C) changing the definition of the time element associated with codes 99202-99215 from typical face-to-face time to total time spent on the day of the encounter and changing the amount of time associated with each code.

  • Revision of the MDM elements associated with codes 99202-99215 as follows:

(i) revising "Number of Diagnoses or Management Options" to "Number and Complexity of Problems Addressed";

(ii) revising "Amount and/or Complexity of Data to be Reviewed" to "Amount and/or Complexity of Data to be Reviewed and Analyzed"; and

(iii) revising "Risk of Complications and/or Morbidity or Mortality" to "Risk of Complications and/or Morbidity or Mortality of Patient Management."

  • Revision of the E/M guidelines by:

(A) restructuring the guidelines into three sections: "Guidelines Common to All E/M Services," "Guidelines for Hospital Observation, Hospital Inpatient, Consultations, Emergency Department, Nursing Facility, Domiciliary, Rest Home or Custodial Care and Home E/M Services," and "Guidelines for Office or Other Outpatient E/M Services" to distinguish the new reporting guidelines for the Office or Other Outpatient Services codes 99202-99215

(B) adding new guidelines that are applicable only to Office or Other Outpatient codes (99202-99215); adding a Summary of Guideline Differences table of the differences between the sets of guidelines

(C) revised existing E/M guidelines to ensure there is no conflicting information between the different sets of guidelines

(D) adding definitions of terms associated with the elements of MDM applicable to codes 99202-99215

(E) adding an MDM table that is applicable to codes 99202-99215

(F) defining total time associated with codes 99202-99215

(G) adding guidelines for reporting time when more than one individual performs distinct parts of an E/M service; revision of the MDM table in the Amount and/or Complexity of Data to be Reviewed and Analyzed column:

(1) inserted a dash (-) after the asterisk in the asterisk definition, "* - Each unique test, order, or document may be summed if multiple," to clarify this is the meaning of the asterisk and not an asterisked item itself

(2) for limited amount of data to be reviewed and analyzed (codes 99203/99213), the parenthetical regarding the number of categories for which requirements must be met was revised to state, "¬categories of tests and documents, or independent historian(s)" rather than "categories within tests, documents, or independent historian(s)"

(3) removing the word "or" after each of the bulleted items for limited, moderate (codes 99202/99214), and high (99205/99215) amount and/or complexity of data to be reviewed and analyzed.

Continue to: ACOG is at the helm, with a watchful eye...

 

 

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

In an effort to reduce burden on physicians and qualified health care professionals, the Centers for Medicare and Medicaid Services ( CMS) has made changes to Evaluation and Management (E/M) documentation requirements and payment policies. Get ready for fairly extensive changes planned for CY 2021. Here we outline already-implemented and future changes and describe the commitment of the American College of Obstetricians and Gynecologists (ACOG) to ObGyn payment in its collaborations with CMS and the American Medical Association (AMA).

E/M services: CMS reduced documentation

Effective January 2019, the CMS made changes to the documentation requirements for E/M services to provide some common-sense relief for physicians facing excessive documentation requirements in their practices. Most physicians agree that modern medical practice, with the use of electronic health records (EHRs), is different now than in the mid-1990s, when the current E/M structures were developed and implemented. Streamlining documentation requirements reduces paperwork burden and some of the time-consuming duplicative work involved in medical practice today.

For instance, when relevant information is already contained in the medical record, it is not necessary to re-document a full medical history. Physicians will now be able to focus their documentation on the interval since the previous visit. Physicians should still review prior data, update as necessary, and indicate in the medical record that they have done so.

Also, for E/M office and outpatient visits for both new and established patients, physicians are no longer required to re-document information that has already been entered in the patient’s record by practice staff or by the patient. If the patient’s chief complaint and history already has been entered by ancillary staff or the beneficiary, the physician should simply indicate in the medical record that the information has been reviewed and verified.

For E/M visits furnished by teaching physicians, CMS has removed the requirement for
potentially duplicative notations that may have been made previously in the medical records by residents or other members of the medical team.

Finally, CMS eliminated the requirement to document the medical necessity of a home visit in lieu of an office visit.

Continue to: Outpatient coding changes for 2021...

 

 

Outpatient coding changes for 2021

Outpatient coding for E/M will continue in its current form for the remainder of 2019 and 2020. However, in 2021, expect substantial changes to take effect. If the CMS rule is instituted, payment for E/M office and outpatient visits will be drastically “simplified.” The current CMS plan for 2021 is to collapse payment for existing E/M Levels 2 through 4 to one payment level for new patients and one payment level for established patients, with optional add-on codes. Level 5 visits will continue at a separate payment level and with continuation of current documentation requirements.

In addition to collapsing the payment in E/M Levels 2, 3, and 4, CMS also will allow flexibility in how those E/M office and outpatient visits are documented. Specifically, documentation may be based on any of the following:

  • current framework (1995 or 1997 guidelines)
  • medical decision making (MDM)
  • time.

When using MDM or the current 1995/1997 framework to document an office visit, Medicare will only require documentation to support a Level 2 E/M outpatient visit code for history, exam, and/or MDM. When time is used as the basis for coding the visit, physicians will document the medical necessity of the visit and that the billing practitioner personally spent the required amount of time face-to-face with the beneficiary.

CMS also has finalized the creation of new add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of nonprocedural specialized medical care (and will not be restricted by physician specialty). These codes would only be reportable with E/M office and outpatient level 2 through 4 visits, and their use generally would not impose new documentation requirements. It is not clear which types of visits would support the use of these add-on codes at this time.

Finally, a new “extended visit” add-on code will be available for use only with E/M Level 2 through 4 visits to account for the additional resources required when spending extended time with a patient.

CMS believes these policies will allow physicians, and all who bill E/M codes, greater flexibility to exercise clinical judgment in their documentation, so that they can focus on what is clinically relevant and medically necessary for the beneficiary.

ACOG’s voice in the process

ACOG strongly opposed several proposals that CMS made during the rule-making process that the agency decided not to finalize. These aspects of the proposal would have:

1. reduced payment by 50% for the least expensive procedure or visit when an E/M office or outpatient visit is furnished on the same day as a procedure by the same physician. These are separately identifiable E/M visits that normally would be reported with a modifier 25.
2. established separate coding and payment for podiatric E/M visits, or
3. standardized the allocation of practice expense relative value units (RVUs) for the codes that describe these services.

CMS has stated that they intend to engage in further discussions with the public and stakeholders to potentially further refine the policies for CY 2021.

Continue to: AMA-CPT and RUC initiative...

 

 

AMA-CPT and RUC initiative

Although the AMA, ACOG, and physicians in general applauded the CMS initiative to reduce the administrative and documentation burden on providers, there was concern about the unintended consequences of the payment changes that are currently scheduled to take effect in 2021. To address these concerns, the AMA convened a work group of physician experts who are knowledgeable in the Current Procedural Terminology (CPT) code development and valuation processes. The charge to the E/M work group is to collaborate across the provider, payer, and coding communities to establish or revise the coding structure and guidelines for outpatient E/M services. The members formed a multispecialty work group representing primary care and surgical specialties and have experience in developing, defining, and valuing codes.

Dr. Barbara Levy, ACOG’s Vice President of Health Policy, co-chaired this expert panel with geriatrician Dr. Peter Hollmann to develop comprehensive consensus-led changes to revise and modernize E/M codes. The work group followed 4 guiding principles to inform their E/M work:

  1. to decrease the administrative burden of documentation and coding
  2. to decrease the need for audits
  3. to decrease unnecessary and redundant documentation in the medical record that is not needed for patient care
  4. to ensure that payment for E/M services is resource based. There is no direct goal for payment redistribution among specialties.

A primary concern expressed by physicians about the CMS proposal was that the collapse of payment for E/M visit across levels 2–4 might lead to a lack of appropriate care for more complex patients since the CMS rule does not provide payment based on the resources required to perform the work of the visit. No one believes that the work needed to care for someone with a sore throat or pink eye is equivalent to the work involved in diagnosing and managing depression, for example.

Beginning in August 2018, the work group met regularly to build consensus. The work group worked at an accelerated pace to develop and value codes that better fit the current medical workflows and meet patient needs.

The work group submitted a code change proposal for E/M codes to the CPT Editorial Panel for consideration during the February 2019 meeting. The next step was the code valuation process through the AMA/Specialty Society RVS Update Committee (RUC) process.

CMS has stated that the 2-year delay to 2021 in implementation of their original proposed changes is to allow time for the E/M code change proposals to move through the development and valuation process and subsequent review by the agency. To date, commercial payers and coders have been supportive of the AMA E/M work group proposals. Dr. Levy, Dr. Hollmann, and AMA staff are meeting with CMS and Department of Health and Human Services staff to provide clarity as they review the CPT proposals. ACOG supports the changes, which would simplify documentation for outpatient E/M codes while retaining differential payments. CMS is closely following the progress of the code changes through the CPT process and RUC code valuation process. We await further rulemaking by CMS in defining and valuing this important code set.

Summary of CPT Editorial Panel actions for office or other outpatient services, February 2019 (Effective Date January 1, 2021)
  • CPT code 99201 to be deleted
  • Revision of codes 99202-99215 as follows:
  • removing history and examination as key components

(A) for selecting the level of service but requiring a medically appropriate history and or examination be performed in order to report codes 99202-99215

(B) making the basis for code selection on either the level of medical decision making (MDM) performed or the total time spent performing the service on the day of the encounter

(C) changing the definition of the time element associated with codes 99202-99215 from typical face-to-face time to total time spent on the day of the encounter and changing the amount of time associated with each code.

  • Revision of the MDM elements associated with codes 99202-99215 as follows:

(i) revising "Number of Diagnoses or Management Options" to "Number and Complexity of Problems Addressed";

(ii) revising "Amount and/or Complexity of Data to be Reviewed" to "Amount and/or Complexity of Data to be Reviewed and Analyzed"; and

(iii) revising "Risk of Complications and/or Morbidity or Mortality" to "Risk of Complications and/or Morbidity or Mortality of Patient Management."

  • Revision of the E/M guidelines by:

(A) restructuring the guidelines into three sections: "Guidelines Common to All E/M Services," "Guidelines for Hospital Observation, Hospital Inpatient, Consultations, Emergency Department, Nursing Facility, Domiciliary, Rest Home or Custodial Care and Home E/M Services," and "Guidelines for Office or Other Outpatient E/M Services" to distinguish the new reporting guidelines for the Office or Other Outpatient Services codes 99202-99215

(B) adding new guidelines that are applicable only to Office or Other Outpatient codes (99202-99215); adding a Summary of Guideline Differences table of the differences between the sets of guidelines

(C) revised existing E/M guidelines to ensure there is no conflicting information between the different sets of guidelines

(D) adding definitions of terms associated with the elements of MDM applicable to codes 99202-99215

(E) adding an MDM table that is applicable to codes 99202-99215

(F) defining total time associated with codes 99202-99215

(G) adding guidelines for reporting time when more than one individual performs distinct parts of an E/M service; revision of the MDM table in the Amount and/or Complexity of Data to be Reviewed and Analyzed column:

(1) inserted a dash (-) after the asterisk in the asterisk definition, "* - Each unique test, order, or document may be summed if multiple," to clarify this is the meaning of the asterisk and not an asterisked item itself

(2) for limited amount of data to be reviewed and analyzed (codes 99203/99213), the parenthetical regarding the number of categories for which requirements must be met was revised to state, "¬categories of tests and documents, or independent historian(s)" rather than "categories within tests, documents, or independent historian(s)"

(3) removing the word "or" after each of the bulleted items for limited, moderate (codes 99202/99214), and high (99205/99215) amount and/or complexity of data to be reviewed and analyzed.

Continue to: ACOG is at the helm, with a watchful eye...

 

 

ACOG is at the helm, with a watchful eye

This is a challenging undertaking because E/M codes are used across specialties for office visits and outpatient care. The potential for unintended consequences for all services that include E/M, such as the global obstetrical services or 90-day global surgical services, is substantial. ACOG is intimately involved in this undertaking, watching the developments carefully to ensure that the interests of ObGyns and their patients are protected.

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VIDEO: Did You Know? Psoriasis and mental health

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The American Academy of Dermatology and the National Psoriasis Foundation recently issued a joint guideline on the management and treatment of psoriasis, with a focus on comorbidities. The guideline offers information and recommendations on mental health in patients with psoriasis.

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A warning song to keep our children safe

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Pay heed to “The House of the Rising Sun”

 

“There is a house in New Orleans. They call the Rising Sun. And it’s been the ruin of many a poor boy. And, God, I know I’m one.”

Dr. Jordan Messler

The 1960s rock band the Animals will tell you a tale to convince you to get vaccinated. Don’t believe me? Follow along.

The first hints of the song “House of the Rising Sun” rolled out of the hills of Appalachia.

Somewhere in the Golden Triangle, far away from New Orleans, where Virginia, Kentucky, and Tennessee rise in quiet desolation, a warning song about a tailor and a drunk emerged. Sometime around the Civil War, a hint of a tune began. Over the next century, it evolved, until it became cemented in rock culture 50 years ago by The Animals, existing as the version played most commonly today.

In the mid-19th century, medicine shows rambled through the South, stopping in places like Noetown or Daisy. The small towns would empty out for the day to see the entertainers, singers, and jugglers perform. Hundreds gathered in the hot summer day, the entertainment solely a pretext for the traveling doctors to sell their wares, the snake oil, and cure-alls, as well as various patent medicines.

These were isolated towns, with no deliveries, few visitors, and the railroad yet to arrive. Frequently, the only news from outside came from these caravans of entertainers and con men who swept into town. They were like Professor Marvel from The Wizard of Oz, or a current-day Dr. Oz, luring the crowd with false advertising, selling colored water, and then disappearing before you realized you were duped. Today, traveling doctors of the same ilk convince parents to not vaccinate their children, tell them to visit stem cell centers that claim false cures, and offer them a shiny object with one hand while taking their cash with the other.

Yet, there was a positive development in the wake of these patent medicine shows: the entertainment lingered. New songs traveled the same journeys as these medicine shows – new earworms that would then be warbled in the local bars, while doing chores around the barn, or simply during walks on the Appalachian trails.

In 1937, Alan Lomax arrived in Noetown, Ky., with a microphone and an acetate record and recorded the voice of 16-year-old Georgia Turner singing “House of the Rising Sun.” She didn’t know where she heard that song, but most likely picked it up at the medicine show.

One of those singers was Clarence Ashley, who would croon about the Rising Sun Blues. He sang with Doc Cloud and Doc Hauer, who offered tonics for whatever ailed you. Perhaps Georgia Turner heard the song in the early 1900s as well. Her 1937 version contains the lyrics most closely related to the Animals’ tune.

Lomax spent the 1940s gathering songs around the Appalachian South. He put these songs into a songbook and spread them throughout the country. He would also return to New York City and gather in a room with legendary folk singers. They would hear these new lyrics, new sounds, and make them their own.

In that room would be Lead Belly, Pete Seeger, Woody Guthrie, and Josh White, the fathers of folk music. The music Lomax pulled out of the mountains in small towns would become new again in the guitars and harmonicas of the Greenwich Village singers and musicians. Pete Seeger performed with the Weavers, named because they would weave songs from the past into new versions.

“House of the Rising Sun” was woven into the folk music landscape, evolving and growing. Josh White is credited with changing the song from a major key into the minor key we know today. Bob Dylan sang a version. And then in 1964, Eric Burdon and The Animals released their version, which became the standard. An arpeggio guitar opening, the rhythm sped up, a louder sound, and that minor key provides an emotional wallop for this warning song.

Numerous covers followed, including a beautiful version of “Amazing Grace”, sung to the tune of “House of the Rising Sun” by the Blind Boys of Alabama.

The song endures for its melody as well as for its lyrics. This was a warning song, a universal song, “not to do what I have done.” The small towns in Kentucky may have heard of the sinful ways of New Orleans and would spread the message with these songs to avoid the brothels, the drink, and the broken marriages that would reverberate with visits to the Crescent City.

“House of the Rising Sun” is one of the most covered songs, traveling wide and far, no longer with the need for a medicine show. It was a pivotal moment in rock ‘n roll, turning folk music into rock music. The Animals became huge because of this song, and their version became the standard on which all subsequent covers based their version. It made Bob Dylan’s older version seem quaint.

The song has been in my head for a while now. My wife is hoping writing about it will keep it from being played in our household any more. There are various reasons it has been resonating with me, including the following:

 

 

  • It traces the origins of folk music and the importance of people like Lomax and Guthrie to collect and save Americana.
  • The magic of musical evolution – a reminder of how art is built on the work of those who came before, each version with its unique personality.
  • The release of “House of the Rising Sun” was a seminal, transformative moment when folk became rock music.
  • The lasting power of warning songs.
  • The hucksters that enabled this song to be kept alive.

That last one has really stuck with me. The medicine shows are an important part of American history. For instance, Coca-Cola started as one of those patent medicines; it was one of the many concoctions of the Atlanta pharmacist John Stith Pemberton, sold to treat all that ails us. Dr. Pepper, too, was a medicine in a sugary bottle – another that often contained alcohol or cocaine. Society wants a cure-all, and the marketing and selling done during these medicine shows offered placebos.

The hucksters exist in various forms today, selling detoxifications, magic diet cures, psychic powers of healing, or convincing parents that their kids don’t need vaccines. We need a warning song that goes viral to keep our children safe. We are blessed to be in a world without smallpox, almost rid of polio, and we have the knowledge and opportunity to rid the world of other preventable illnesses. Measles was declared eliminated in the United States in 2000; now, outbreaks emerge in every news cycle.

The CDC admits they have not been targeting misinformation well. How can we spread the science, the truth, the message faster than the lies? Better marketing? The answer may be through stories and narratives and song, with the backing of good science. “House of the Rising Sun” is a warning song. Maybe we need more. We need that deep history, that long trail to remind us of the world before vaccines, when everyone knew someone, either in their own household or next door, who succumbed to one of the childhood illnesses.

Let the “House of the Rising Sun” play on. Create a new version, and let that message reverberate, too.

Tell your children; they need to be vaccinated.
 

Dr. Messler is a hospitalist at Morton Plant Hospitalist group in Clearwater, Fla. He previously chaired SHM’s Quality and Patient Safety Committee and has been active in several SHM mentoring programs, most recently with Project BOOST and Glycemic Control. This article appeared originally in SHM's official blog The Hospital Leader. Read more recent posts here.

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Pay heed to “The House of the Rising Sun”

Pay heed to “The House of the Rising Sun”

 

“There is a house in New Orleans. They call the Rising Sun. And it’s been the ruin of many a poor boy. And, God, I know I’m one.”

Dr. Jordan Messler

The 1960s rock band the Animals will tell you a tale to convince you to get vaccinated. Don’t believe me? Follow along.

The first hints of the song “House of the Rising Sun” rolled out of the hills of Appalachia.

Somewhere in the Golden Triangle, far away from New Orleans, where Virginia, Kentucky, and Tennessee rise in quiet desolation, a warning song about a tailor and a drunk emerged. Sometime around the Civil War, a hint of a tune began. Over the next century, it evolved, until it became cemented in rock culture 50 years ago by The Animals, existing as the version played most commonly today.

In the mid-19th century, medicine shows rambled through the South, stopping in places like Noetown or Daisy. The small towns would empty out for the day to see the entertainers, singers, and jugglers perform. Hundreds gathered in the hot summer day, the entertainment solely a pretext for the traveling doctors to sell their wares, the snake oil, and cure-alls, as well as various patent medicines.

These were isolated towns, with no deliveries, few visitors, and the railroad yet to arrive. Frequently, the only news from outside came from these caravans of entertainers and con men who swept into town. They were like Professor Marvel from The Wizard of Oz, or a current-day Dr. Oz, luring the crowd with false advertising, selling colored water, and then disappearing before you realized you were duped. Today, traveling doctors of the same ilk convince parents to not vaccinate their children, tell them to visit stem cell centers that claim false cures, and offer them a shiny object with one hand while taking their cash with the other.

Yet, there was a positive development in the wake of these patent medicine shows: the entertainment lingered. New songs traveled the same journeys as these medicine shows – new earworms that would then be warbled in the local bars, while doing chores around the barn, or simply during walks on the Appalachian trails.

In 1937, Alan Lomax arrived in Noetown, Ky., with a microphone and an acetate record and recorded the voice of 16-year-old Georgia Turner singing “House of the Rising Sun.” She didn’t know where she heard that song, but most likely picked it up at the medicine show.

One of those singers was Clarence Ashley, who would croon about the Rising Sun Blues. He sang with Doc Cloud and Doc Hauer, who offered tonics for whatever ailed you. Perhaps Georgia Turner heard the song in the early 1900s as well. Her 1937 version contains the lyrics most closely related to the Animals’ tune.

Lomax spent the 1940s gathering songs around the Appalachian South. He put these songs into a songbook and spread them throughout the country. He would also return to New York City and gather in a room with legendary folk singers. They would hear these new lyrics, new sounds, and make them their own.

In that room would be Lead Belly, Pete Seeger, Woody Guthrie, and Josh White, the fathers of folk music. The music Lomax pulled out of the mountains in small towns would become new again in the guitars and harmonicas of the Greenwich Village singers and musicians. Pete Seeger performed with the Weavers, named because they would weave songs from the past into new versions.

“House of the Rising Sun” was woven into the folk music landscape, evolving and growing. Josh White is credited with changing the song from a major key into the minor key we know today. Bob Dylan sang a version. And then in 1964, Eric Burdon and The Animals released their version, which became the standard. An arpeggio guitar opening, the rhythm sped up, a louder sound, and that minor key provides an emotional wallop for this warning song.

Numerous covers followed, including a beautiful version of “Amazing Grace”, sung to the tune of “House of the Rising Sun” by the Blind Boys of Alabama.

The song endures for its melody as well as for its lyrics. This was a warning song, a universal song, “not to do what I have done.” The small towns in Kentucky may have heard of the sinful ways of New Orleans and would spread the message with these songs to avoid the brothels, the drink, and the broken marriages that would reverberate with visits to the Crescent City.

“House of the Rising Sun” is one of the most covered songs, traveling wide and far, no longer with the need for a medicine show. It was a pivotal moment in rock ‘n roll, turning folk music into rock music. The Animals became huge because of this song, and their version became the standard on which all subsequent covers based their version. It made Bob Dylan’s older version seem quaint.

The song has been in my head for a while now. My wife is hoping writing about it will keep it from being played in our household any more. There are various reasons it has been resonating with me, including the following:

 

 

  • It traces the origins of folk music and the importance of people like Lomax and Guthrie to collect and save Americana.
  • The magic of musical evolution – a reminder of how art is built on the work of those who came before, each version with its unique personality.
  • The release of “House of the Rising Sun” was a seminal, transformative moment when folk became rock music.
  • The lasting power of warning songs.
  • The hucksters that enabled this song to be kept alive.

That last one has really stuck with me. The medicine shows are an important part of American history. For instance, Coca-Cola started as one of those patent medicines; it was one of the many concoctions of the Atlanta pharmacist John Stith Pemberton, sold to treat all that ails us. Dr. Pepper, too, was a medicine in a sugary bottle – another that often contained alcohol or cocaine. Society wants a cure-all, and the marketing and selling done during these medicine shows offered placebos.

The hucksters exist in various forms today, selling detoxifications, magic diet cures, psychic powers of healing, or convincing parents that their kids don’t need vaccines. We need a warning song that goes viral to keep our children safe. We are blessed to be in a world without smallpox, almost rid of polio, and we have the knowledge and opportunity to rid the world of other preventable illnesses. Measles was declared eliminated in the United States in 2000; now, outbreaks emerge in every news cycle.

The CDC admits they have not been targeting misinformation well. How can we spread the science, the truth, the message faster than the lies? Better marketing? The answer may be through stories and narratives and song, with the backing of good science. “House of the Rising Sun” is a warning song. Maybe we need more. We need that deep history, that long trail to remind us of the world before vaccines, when everyone knew someone, either in their own household or next door, who succumbed to one of the childhood illnesses.

Let the “House of the Rising Sun” play on. Create a new version, and let that message reverberate, too.

Tell your children; they need to be vaccinated.
 

Dr. Messler is a hospitalist at Morton Plant Hospitalist group in Clearwater, Fla. He previously chaired SHM’s Quality and Patient Safety Committee and has been active in several SHM mentoring programs, most recently with Project BOOST and Glycemic Control. This article appeared originally in SHM's official blog The Hospital Leader. Read more recent posts here.

 

“There is a house in New Orleans. They call the Rising Sun. And it’s been the ruin of many a poor boy. And, God, I know I’m one.”

Dr. Jordan Messler

The 1960s rock band the Animals will tell you a tale to convince you to get vaccinated. Don’t believe me? Follow along.

The first hints of the song “House of the Rising Sun” rolled out of the hills of Appalachia.

Somewhere in the Golden Triangle, far away from New Orleans, where Virginia, Kentucky, and Tennessee rise in quiet desolation, a warning song about a tailor and a drunk emerged. Sometime around the Civil War, a hint of a tune began. Over the next century, it evolved, until it became cemented in rock culture 50 years ago by The Animals, existing as the version played most commonly today.

In the mid-19th century, medicine shows rambled through the South, stopping in places like Noetown or Daisy. The small towns would empty out for the day to see the entertainers, singers, and jugglers perform. Hundreds gathered in the hot summer day, the entertainment solely a pretext for the traveling doctors to sell their wares, the snake oil, and cure-alls, as well as various patent medicines.

These were isolated towns, with no deliveries, few visitors, and the railroad yet to arrive. Frequently, the only news from outside came from these caravans of entertainers and con men who swept into town. They were like Professor Marvel from The Wizard of Oz, or a current-day Dr. Oz, luring the crowd with false advertising, selling colored water, and then disappearing before you realized you were duped. Today, traveling doctors of the same ilk convince parents to not vaccinate their children, tell them to visit stem cell centers that claim false cures, and offer them a shiny object with one hand while taking their cash with the other.

Yet, there was a positive development in the wake of these patent medicine shows: the entertainment lingered. New songs traveled the same journeys as these medicine shows – new earworms that would then be warbled in the local bars, while doing chores around the barn, or simply during walks on the Appalachian trails.

In 1937, Alan Lomax arrived in Noetown, Ky., with a microphone and an acetate record and recorded the voice of 16-year-old Georgia Turner singing “House of the Rising Sun.” She didn’t know where she heard that song, but most likely picked it up at the medicine show.

One of those singers was Clarence Ashley, who would croon about the Rising Sun Blues. He sang with Doc Cloud and Doc Hauer, who offered tonics for whatever ailed you. Perhaps Georgia Turner heard the song in the early 1900s as well. Her 1937 version contains the lyrics most closely related to the Animals’ tune.

Lomax spent the 1940s gathering songs around the Appalachian South. He put these songs into a songbook and spread them throughout the country. He would also return to New York City and gather in a room with legendary folk singers. They would hear these new lyrics, new sounds, and make them their own.

In that room would be Lead Belly, Pete Seeger, Woody Guthrie, and Josh White, the fathers of folk music. The music Lomax pulled out of the mountains in small towns would become new again in the guitars and harmonicas of the Greenwich Village singers and musicians. Pete Seeger performed with the Weavers, named because they would weave songs from the past into new versions.

“House of the Rising Sun” was woven into the folk music landscape, evolving and growing. Josh White is credited with changing the song from a major key into the minor key we know today. Bob Dylan sang a version. And then in 1964, Eric Burdon and The Animals released their version, which became the standard. An arpeggio guitar opening, the rhythm sped up, a louder sound, and that minor key provides an emotional wallop for this warning song.

Numerous covers followed, including a beautiful version of “Amazing Grace”, sung to the tune of “House of the Rising Sun” by the Blind Boys of Alabama.

The song endures for its melody as well as for its lyrics. This was a warning song, a universal song, “not to do what I have done.” The small towns in Kentucky may have heard of the sinful ways of New Orleans and would spread the message with these songs to avoid the brothels, the drink, and the broken marriages that would reverberate with visits to the Crescent City.

“House of the Rising Sun” is one of the most covered songs, traveling wide and far, no longer with the need for a medicine show. It was a pivotal moment in rock ‘n roll, turning folk music into rock music. The Animals became huge because of this song, and their version became the standard on which all subsequent covers based their version. It made Bob Dylan’s older version seem quaint.

The song has been in my head for a while now. My wife is hoping writing about it will keep it from being played in our household any more. There are various reasons it has been resonating with me, including the following:

 

 

  • It traces the origins of folk music and the importance of people like Lomax and Guthrie to collect and save Americana.
  • The magic of musical evolution – a reminder of how art is built on the work of those who came before, each version with its unique personality.
  • The release of “House of the Rising Sun” was a seminal, transformative moment when folk became rock music.
  • The lasting power of warning songs.
  • The hucksters that enabled this song to be kept alive.

That last one has really stuck with me. The medicine shows are an important part of American history. For instance, Coca-Cola started as one of those patent medicines; it was one of the many concoctions of the Atlanta pharmacist John Stith Pemberton, sold to treat all that ails us. Dr. Pepper, too, was a medicine in a sugary bottle – another that often contained alcohol or cocaine. Society wants a cure-all, and the marketing and selling done during these medicine shows offered placebos.

The hucksters exist in various forms today, selling detoxifications, magic diet cures, psychic powers of healing, or convincing parents that their kids don’t need vaccines. We need a warning song that goes viral to keep our children safe. We are blessed to be in a world without smallpox, almost rid of polio, and we have the knowledge and opportunity to rid the world of other preventable illnesses. Measles was declared eliminated in the United States in 2000; now, outbreaks emerge in every news cycle.

The CDC admits they have not been targeting misinformation well. How can we spread the science, the truth, the message faster than the lies? Better marketing? The answer may be through stories and narratives and song, with the backing of good science. “House of the Rising Sun” is a warning song. Maybe we need more. We need that deep history, that long trail to remind us of the world before vaccines, when everyone knew someone, either in their own household or next door, who succumbed to one of the childhood illnesses.

Let the “House of the Rising Sun” play on. Create a new version, and let that message reverberate, too.

Tell your children; they need to be vaccinated.
 

Dr. Messler is a hospitalist at Morton Plant Hospitalist group in Clearwater, Fla. He previously chaired SHM’s Quality and Patient Safety Committee and has been active in several SHM mentoring programs, most recently with Project BOOST and Glycemic Control. This article appeared originally in SHM's official blog The Hospital Leader. Read more recent posts here.

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Restless legs syndrome in MS linked to cognitive impairment

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A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

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A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

 

A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

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Developing new measurements for better MS outcomes

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Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

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Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

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Mindfulness meditation may boost cognition in MS

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Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

Heena Manglani

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

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Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

Heena Manglani

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

 

Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

Heena Manglani

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

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The urge to move

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When you have a few spare minutes on your lunch break, walk by the grade school playground in your neighborhood. Even at a quick glance you will notice that almost all the children are in motion – running, chasing, or being chased. Don’t linger too long or make repeat visits because unfortunately your presence may raise suspicions about your motives. But, even on your brief visit, you will also notice that there are a few children who are sitting down either chatting with a classmate or playing by themselves. If despite my caution you returned several days in a row, you would have noticed that the sedentary outliers tend to be the same children.

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Some of the children playing alone simply may be shy loners or socially inept. But I’ve always suspected that there are some people who come in the world genetically predisposed to being sedentary. You can try to make the environment more enticing and stimulating, but the children predestined to be inactive will choose to sit and watch. Not surprisingly, most of those less active children are predestined to be overweight and obese.

At least as young children we seem to be driven to be active, and it is the few outliers who are sedentary. A recent investigation from the department of health and kinesiology at Texas A&M University at College Station is beginning to shed some light on when in our evolutionary history the urge to be active was incorporated into our genome (PLOS ONE. 2019 Apr 29. doi: 10.1371/journal.pone.0216155). The researchers found that snippets of DNA already known to be associated with levels of activity emerged in our ancestors before we were Homo sapiens about 500,000 years ago. This finding surprised the investigators who had suspected that this incorporation of a gene sequence driving activity was more likely to have occurred ten thousand years ago when subsistence farming and its physical demands first appeared.

The authors now postulate that the drive to be active coincided as pre–Homo sapiens grew larger and moved from a treed landscape into the open savanna (“To Move Is to Thrive. It’s in Our Genes” by Gretchen Reynolds. The New York Times, May 15, 2019). As J. Timothy Lightfoot, the senior investigator, observed, “If you were lazy then, you did not survive.”

So if the drive to be active is so deeply buried in our genome why have we slipped so easily into a species in which being sedentary is the norm? Our observation of a playground in contact motion is probably evidence that those snippets of DNA still are buried in our genome. However, it is abundantly clear that in North America one doesn’t need to be active to survive, at least in the sense of being reproductively fit. It only takes a few us who must be physically active to grow and build things that we in the sedentary majority can buy or trade for.

There are some of us who have inherited some DNA snippets that drive us to be active post early childhood. My father walked two or three times a day until a few months before his death at 92, and not because someone told him it do it for his health. Like him, I just feel better if I have spent a couple of hours being active every day.

Dr. William G. Wilkoff

The challenge for us as pediatricians is to help families create environments that foster continued activity by discouraging sedentary entertainments and modeling active lifestyles. For example, simple things like choosing a spot at the periphery of the parking lot instead of close to the store. Choosing stairs instead of the elevator. Of course, anything you will be doing is artificial because the truth is we don’t need to be active to survive even though the urge to move is deeply rooted in our genes.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

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When you have a few spare minutes on your lunch break, walk by the grade school playground in your neighborhood. Even at a quick glance you will notice that almost all the children are in motion – running, chasing, or being chased. Don’t linger too long or make repeat visits because unfortunately your presence may raise suspicions about your motives. But, even on your brief visit, you will also notice that there are a few children who are sitting down either chatting with a classmate or playing by themselves. If despite my caution you returned several days in a row, you would have noticed that the sedentary outliers tend to be the same children.

©Jupiterimages/Thinkstock.com

Some of the children playing alone simply may be shy loners or socially inept. But I’ve always suspected that there are some people who come in the world genetically predisposed to being sedentary. You can try to make the environment more enticing and stimulating, but the children predestined to be inactive will choose to sit and watch. Not surprisingly, most of those less active children are predestined to be overweight and obese.

At least as young children we seem to be driven to be active, and it is the few outliers who are sedentary. A recent investigation from the department of health and kinesiology at Texas A&M University at College Station is beginning to shed some light on when in our evolutionary history the urge to be active was incorporated into our genome (PLOS ONE. 2019 Apr 29. doi: 10.1371/journal.pone.0216155). The researchers found that snippets of DNA already known to be associated with levels of activity emerged in our ancestors before we were Homo sapiens about 500,000 years ago. This finding surprised the investigators who had suspected that this incorporation of a gene sequence driving activity was more likely to have occurred ten thousand years ago when subsistence farming and its physical demands first appeared.

The authors now postulate that the drive to be active coincided as pre–Homo sapiens grew larger and moved from a treed landscape into the open savanna (“To Move Is to Thrive. It’s in Our Genes” by Gretchen Reynolds. The New York Times, May 15, 2019). As J. Timothy Lightfoot, the senior investigator, observed, “If you were lazy then, you did not survive.”

So if the drive to be active is so deeply buried in our genome why have we slipped so easily into a species in which being sedentary is the norm? Our observation of a playground in contact motion is probably evidence that those snippets of DNA still are buried in our genome. However, it is abundantly clear that in North America one doesn’t need to be active to survive, at least in the sense of being reproductively fit. It only takes a few us who must be physically active to grow and build things that we in the sedentary majority can buy or trade for.

There are some of us who have inherited some DNA snippets that drive us to be active post early childhood. My father walked two or three times a day until a few months before his death at 92, and not because someone told him it do it for his health. Like him, I just feel better if I have spent a couple of hours being active every day.

Dr. William G. Wilkoff

The challenge for us as pediatricians is to help families create environments that foster continued activity by discouraging sedentary entertainments and modeling active lifestyles. For example, simple things like choosing a spot at the periphery of the parking lot instead of close to the store. Choosing stairs instead of the elevator. Of course, anything you will be doing is artificial because the truth is we don’t need to be active to survive even though the urge to move is deeply rooted in our genes.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

When you have a few spare minutes on your lunch break, walk by the grade school playground in your neighborhood. Even at a quick glance you will notice that almost all the children are in motion – running, chasing, or being chased. Don’t linger too long or make repeat visits because unfortunately your presence may raise suspicions about your motives. But, even on your brief visit, you will also notice that there are a few children who are sitting down either chatting with a classmate or playing by themselves. If despite my caution you returned several days in a row, you would have noticed that the sedentary outliers tend to be the same children.

©Jupiterimages/Thinkstock.com

Some of the children playing alone simply may be shy loners or socially inept. But I’ve always suspected that there are some people who come in the world genetically predisposed to being sedentary. You can try to make the environment more enticing and stimulating, but the children predestined to be inactive will choose to sit and watch. Not surprisingly, most of those less active children are predestined to be overweight and obese.

At least as young children we seem to be driven to be active, and it is the few outliers who are sedentary. A recent investigation from the department of health and kinesiology at Texas A&M University at College Station is beginning to shed some light on when in our evolutionary history the urge to be active was incorporated into our genome (PLOS ONE. 2019 Apr 29. doi: 10.1371/journal.pone.0216155). The researchers found that snippets of DNA already known to be associated with levels of activity emerged in our ancestors before we were Homo sapiens about 500,000 years ago. This finding surprised the investigators who had suspected that this incorporation of a gene sequence driving activity was more likely to have occurred ten thousand years ago when subsistence farming and its physical demands first appeared.

The authors now postulate that the drive to be active coincided as pre–Homo sapiens grew larger and moved from a treed landscape into the open savanna (“To Move Is to Thrive. It’s in Our Genes” by Gretchen Reynolds. The New York Times, May 15, 2019). As J. Timothy Lightfoot, the senior investigator, observed, “If you were lazy then, you did not survive.”

So if the drive to be active is so deeply buried in our genome why have we slipped so easily into a species in which being sedentary is the norm? Our observation of a playground in contact motion is probably evidence that those snippets of DNA still are buried in our genome. However, it is abundantly clear that in North America one doesn’t need to be active to survive, at least in the sense of being reproductively fit. It only takes a few us who must be physically active to grow and build things that we in the sedentary majority can buy or trade for.

There are some of us who have inherited some DNA snippets that drive us to be active post early childhood. My father walked two or three times a day until a few months before his death at 92, and not because someone told him it do it for his health. Like him, I just feel better if I have spent a couple of hours being active every day.

Dr. William G. Wilkoff

The challenge for us as pediatricians is to help families create environments that foster continued activity by discouraging sedentary entertainments and modeling active lifestyles. For example, simple things like choosing a spot at the periphery of the parking lot instead of close to the store. Choosing stairs instead of the elevator. Of course, anything you will be doing is artificial because the truth is we don’t need to be active to survive even though the urge to move is deeply rooted in our genes.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

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Pediatricians report low knowledge, comfort discussing e-cigarettes

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Pediatricians appear less comfortable discussing e-cigarettes and their harms with adolescents and parents than they do discussing dangers of tobacco products, according to a recent study.

LiudmylaSupynska/Thinkstock

“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.

A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.

Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.

Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.

The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.

Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.

Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.

Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).

Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).

Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).

Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).

The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).

Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).

More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).

The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.

The researchers noted no external funding or disclosures.

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Pediatricians appear less comfortable discussing e-cigarettes and their harms with adolescents and parents than they do discussing dangers of tobacco products, according to a recent study.

LiudmylaSupynska/Thinkstock

“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.

A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.

Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.

Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.

The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.

Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.

Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.

Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).

Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).

Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).

Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).

The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).

Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).

More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).

The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.

The researchers noted no external funding or disclosures.

Pediatricians appear less comfortable discussing e-cigarettes and their harms with adolescents and parents than they do discussing dangers of tobacco products, according to a recent study.

LiudmylaSupynska/Thinkstock

“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.

A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.

Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.

Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.

The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.

Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.

Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.

Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).

Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).

Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).

Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).

The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).

Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).

More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).

The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.

The researchers noted no external funding or disclosures.

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Key clinical point: Physicians report less training and less comfort when discussing e-cigarettes with teens and parents than when discussing tobacco products.

Major finding: 7% of physicians reported helping adolescent patients quit using e-cigarettes, compared with 37% helping with quitting tobacco use (P less than .001).

Study details: The findings are based on a cross-sectional survey of 62 pediatric residents and attendings at a large urban academic primary care clinic in the Northeast.

Disclosures: The researchers noted no external funding or disclosures.

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FDA approves new treatment for hospital-acquired, ventilator-associated bacterial pneumonia

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The Food and Drug Administration has approved a new indication for Zerbaxa (ceftolozane and tazobactam), authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.

The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.

Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.

Find the full press release on the FDA website.

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The Food and Drug Administration has approved a new indication for Zerbaxa (ceftolozane and tazobactam), authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.

The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.

Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.

Find the full press release on the FDA website.

 

The Food and Drug Administration has approved a new indication for Zerbaxa (ceftolozane and tazobactam), authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.

The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.

“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.

Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.

Find the full press release on the FDA website.

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