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Guidelines released for perimenopausal depression
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
I think the authors of this paper did a beautiful job summarizing a decade or more of very good observational research and even some randomized, controlled trials on a complex topic. This paper is really important because it takes a large body of evidence on the topic and pulls it together in a coherent way by asking specific questions and then looking to the literature to address those questions. The team of 11 experts in the field – led by Dr. Maki, who is a past president of the North American Menopause Society and began this paper as her presidential project – deserves a lot of credit for doing a beautiful job addressing some important questions with the research that is already available.
There are many clinical implications in these guidelines for any provider who cares for women in their 40s and 50s, whether they are gynecologists, family physicians, internists, psychiatrists, or psychologists. These health care practitioners need to be aware that this is a high-risk period for both depressive symptoms and major depression. The authors reported about one-third of premenopausal women complain of depressive symptoms, and yet, in those women experiencing perimenopause, that percentage is between 45% and 68%. Health care practitioners caring for women in this age group need to be aware of, and looking for, these symptoms so they can identify them, address them, let women know that they’re common at this time, and help them get appropriate treatment.
The authors also looked at the literature on the impact of the menopausal transition on sleep and how that can affect depressive symptoms and major depression; it is important for health care providers to think about sleep disruption in women at this age. The domino hypothesis, the theory that hot flashes can lead to sleep disruption that then leads to depressive symptoms of the menopause transition, was examined in a literature review. The authors found some of the literature shows that these symptoms are separate from hot flashes.
Menopausal transition and the association with symptoms of depression is not only looking at hormonal fluctuations but also recognizing this is a time of extraordinary psychosocial and physical change for women. They may have responsibilities for their partners and children as well as for aging parents. They may have their own health problems and the health problems of their partner to handle. Career changes may be happening at this time. This is a very complex psychosocial time in women’s lives that may be complicated by other health issues occurring at the same time.
Jan Leslie Shifren, MD , is director of the Midlife Women’s Health Center in the department of obstetrics and gynecology at Massachusetts General Hospital, Boston. She also is an Ob.Gyn. News editorial board member. Dr. Shifren reported no relevant conflicts of interest.
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
and affect women with no previous symptoms of depression, according to recent guidelines on perimenopausal depression copublished in the Journal of Women’s Health and Menopause.
“Epidemiologic findings, animal data, and clinical observations have shed some light into plausible mechanistic hypotheses on why some, but not all, women may be particularly sensitive to changes in the hormonal milieu experienced premenstrually, during the postpartum period or during the menopause transition,” Pauline M. Maki, PhD, past president of the North American Menopause Society (NAMS) and professor of psychiatry and psychology at the University of Illinois at Chicago, and her colleagues wrote. “The notion of a menopause-associated depression, however, has been the focus of clinical and scientific debate for years. The lack of consensus on this issue has also led to a lack of clarity in how to evaluate and treat depression in women during the menopausal transition and postmenopausal period.”
The guidelines were developed on behalf of the NAMS Board of Trustees and the Women and Mood Disorders Task Force of the National Network of Depression Centers. Dr. Maki and her colleagues convened an 11-person expert panel on perimenopausal depression, which looked at the effects of factors such as epidemiology; clinical presentation; antidepressants; hormone therapy; and other therapies such as exercise, natural health products, and psychotherapy.
Most women who experience perimenopausal depression have previously undergone a major depressive episode (MDE), while major depressive disorder (MDD) onset at midlife is less common. However, even among women with no previous history of depression, the risk of perimenopausal depression – both depressive symptoms and MDE – is elevated for women at midlife. Studies suggest that 45%-68% of perimenopausal women have elevated depression symptoms.
Dr. Maki and her associates cited studies that showed women who underwent surgical menopause in the form of hysterectomy with and without oophorectomy and women with ovarian insufficiency also showed an elevated rate of depression.
Other risk factors for perimenopausal depression included sociodemographic (black race, financial difficulties) and psychosocial factors (adverse life events, low social support), anxiety, and menopausal symptoms such as interrupted sleep and vasomotor symptoms. Risk factors for MDD include use of antidepressants, premenstrual depressive symptoms, anxiety, menopausal sleep disturbance, sociodemographic factors such as high body mass index and black race, and psychosocial factors such as social isolation and upsetting life events.
Depressive symptoms in perimenopause present as classic depressive symptoms but may also be in combination with perimenopausal symptoms such as changes in weight, cognitive shifts, night sweats, hot flashes, and sexual and sleep disturbances. In addition, the stressors of life for women in midlife can further complicate depressive symptoms.
“Many women face a series of stressors including, but not exclusive to, caring for aging parents, death of parents, medical illness in self and family, adjusting to emotional and physical sequelae of surgical menopause and other health issues that are common to this stage of life, children leaving the home, and changes in marital status. With the onset of childbirth at an increasingly later age, women are often faced with the dual responsibility of raising young children amid caring for aging parents while navigating their careers and ensuing challenges,” Dr. Maki and her colleagues wrote. “These multiple demands are often faced without supports in place to identify or address the ensuing distress placed on a woman during this stage.”
Assessment and diagnosis should include factoring all these symptoms in and disentangling menopausal and psychiatric symptoms, evaluating women with past MDEs and MDD for a mood disorder, and use of differential diagnosis for psychiatric symptoms.
There is no menopause-specific mood disorder scale, Dr. Maki and her associates emphasized, but the Patient Health Questionnaire-9 can be used to categorize mood disorder diagnoses. There are “validated menopause symptom and health-related quality of life scales [that] include mood items” such as the Menopause Rating Scale, and the Menopause-Specific Quality of Life Scale.
Frontline treatment of MDE with traditional therapies such as antidepressants, cognitive behavioral therapy, and other psychotherapies is appropriate, while previous antidepressant trial and responses should be followed to find the best efficacy and tolerability for a women with a history of MDD. There is data on some SSRIs and serotonin norepinephrine reuptake inhibitors suggesting efficacy and tolerability at usual doses. Of note, Dr. Maki and her colleagues found estrogen therapy has some evidence for use as an antidepressant, but most studies on hormone therapy examined unopposed estrogen instead of estrogen plus progestogen, which has limited data.
The authors recommended exercise as a complement to psychotherapy and pharmacotherapies for perimenopausal women with depression, but said there is no available evidence to recommend “botanical or complementary/alternative approaches for treating depression related to the perimenopause.”
Several authors have reported honoraria, research support, consulting fees, and grants from numerous pharmaceutical companies, the National Pregnancy Registry for Atypical Antipsychotics; the Brain & Behavior Research Foundation; the Ontario Brain Institute; and the Ontario Ministry of Technology, Innovation, and Science. Six of the authors reported no relevant conflicts of interest.
SOURCE: Maki PM et al. J Womens Health. 2018 Sep 5. doi: 10.1089/jwh.2018.27099.mensocrec.
FROM THE JOURNAL OF WOMEN’S HEALTH
Baseline patient-reported physical function predicts SLE-related mortality
The baseline physical component score of the Medical Outcomes Short Form 36 (SF-36) was an independent predictor of mortality for patients with systemic lupus erythematosus (SLE), according to recent analysis of data from the University of California, San Francisco, (UCSF) Lupus Outcomes Study.
Desiree R. Azizoddin, PsyD, of Stanford Health Care in Palo Alto, Calif., and her colleagues analyzed patient-reported outcomes (PROs) of 728 patients with SLE from the UCSF study, which included measures such as self-rated health, the Center for Epidemiologic Studies Depression scale (CESD), and SF-36 mental and physical component scores between 2007 and 2015. Patients had a mean age of 50.6 years and consisted of mostly whites (68.5%) and women (92.2%), with a mean SLE disease duration of 16.7 years.
“As PROs can be measured easily, quickly, reliably in a systematic manner, without use of many resources (including cost) and experts, PROs can serve as an important tool in community settings that provide care for individuals with SLE,” Dr. Azizoddin and her colleagues wrote in Arthritis Care & Research. “Implementation and integration of PROs may potentially help decrease mortality among patients with SLE in the long run.”
The researchers reported 71 deaths (9.8%) in the study. A univariate analysis showed that self-rated health as fair or poor and all SF-36 subscale scores, except for mental health and role emotional subscales, were predictors of mortality. After the investigators performed a multivariate analysis, they found that baseline SF-36 physical component scores alone were associated with an increased mortality risk (hazard ratio, 0.97; 95% confidence interval, 0.94-0.99; P less than .01), with a 3.5% lower risk for each point-rating increase in the score.
“Insight to predictors of mortality, above and beyond those that require physician resources such as assessments of renal involvement and traditional physician-completed measures of disease activity and damage in this complex disease, affords rheumatologists and SLE providers with additional tools to assess potential patient health trajectories,” Dr. Azizoddin and her colleagues wrote in their study. “Identification of such predictors will expand opportunities for early interventions aimed at the reduction of such risk, including allocation of appropriate medical resources in areas with large numbers of patients with compromised health.”
The researchers noted that bias in self-reporting, a lack of prospective evaluations at each visit, and clinical applicability to only similar cohorts were limitations in the study.
This study was funded by the Robert Wood Johnson Foundation Investigator Awards in Health Policy Research and individually was awarded grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
SOURCE: Azizoddin DR et al. Arthritis Care Res. 2018 Aug 24. doi: 10.1002/acr.23734.
The baseline physical component score of the Medical Outcomes Short Form 36 (SF-36) was an independent predictor of mortality for patients with systemic lupus erythematosus (SLE), according to recent analysis of data from the University of California, San Francisco, (UCSF) Lupus Outcomes Study.
Desiree R. Azizoddin, PsyD, of Stanford Health Care in Palo Alto, Calif., and her colleagues analyzed patient-reported outcomes (PROs) of 728 patients with SLE from the UCSF study, which included measures such as self-rated health, the Center for Epidemiologic Studies Depression scale (CESD), and SF-36 mental and physical component scores between 2007 and 2015. Patients had a mean age of 50.6 years and consisted of mostly whites (68.5%) and women (92.2%), with a mean SLE disease duration of 16.7 years.
“As PROs can be measured easily, quickly, reliably in a systematic manner, without use of many resources (including cost) and experts, PROs can serve as an important tool in community settings that provide care for individuals with SLE,” Dr. Azizoddin and her colleagues wrote in Arthritis Care & Research. “Implementation and integration of PROs may potentially help decrease mortality among patients with SLE in the long run.”
The researchers reported 71 deaths (9.8%) in the study. A univariate analysis showed that self-rated health as fair or poor and all SF-36 subscale scores, except for mental health and role emotional subscales, were predictors of mortality. After the investigators performed a multivariate analysis, they found that baseline SF-36 physical component scores alone were associated with an increased mortality risk (hazard ratio, 0.97; 95% confidence interval, 0.94-0.99; P less than .01), with a 3.5% lower risk for each point-rating increase in the score.
“Insight to predictors of mortality, above and beyond those that require physician resources such as assessments of renal involvement and traditional physician-completed measures of disease activity and damage in this complex disease, affords rheumatologists and SLE providers with additional tools to assess potential patient health trajectories,” Dr. Azizoddin and her colleagues wrote in their study. “Identification of such predictors will expand opportunities for early interventions aimed at the reduction of such risk, including allocation of appropriate medical resources in areas with large numbers of patients with compromised health.”
The researchers noted that bias in self-reporting, a lack of prospective evaluations at each visit, and clinical applicability to only similar cohorts were limitations in the study.
This study was funded by the Robert Wood Johnson Foundation Investigator Awards in Health Policy Research and individually was awarded grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
SOURCE: Azizoddin DR et al. Arthritis Care Res. 2018 Aug 24. doi: 10.1002/acr.23734.
The baseline physical component score of the Medical Outcomes Short Form 36 (SF-36) was an independent predictor of mortality for patients with systemic lupus erythematosus (SLE), according to recent analysis of data from the University of California, San Francisco, (UCSF) Lupus Outcomes Study.
Desiree R. Azizoddin, PsyD, of Stanford Health Care in Palo Alto, Calif., and her colleagues analyzed patient-reported outcomes (PROs) of 728 patients with SLE from the UCSF study, which included measures such as self-rated health, the Center for Epidemiologic Studies Depression scale (CESD), and SF-36 mental and physical component scores between 2007 and 2015. Patients had a mean age of 50.6 years and consisted of mostly whites (68.5%) and women (92.2%), with a mean SLE disease duration of 16.7 years.
“As PROs can be measured easily, quickly, reliably in a systematic manner, without use of many resources (including cost) and experts, PROs can serve as an important tool in community settings that provide care for individuals with SLE,” Dr. Azizoddin and her colleagues wrote in Arthritis Care & Research. “Implementation and integration of PROs may potentially help decrease mortality among patients with SLE in the long run.”
The researchers reported 71 deaths (9.8%) in the study. A univariate analysis showed that self-rated health as fair or poor and all SF-36 subscale scores, except for mental health and role emotional subscales, were predictors of mortality. After the investigators performed a multivariate analysis, they found that baseline SF-36 physical component scores alone were associated with an increased mortality risk (hazard ratio, 0.97; 95% confidence interval, 0.94-0.99; P less than .01), with a 3.5% lower risk for each point-rating increase in the score.
“Insight to predictors of mortality, above and beyond those that require physician resources such as assessments of renal involvement and traditional physician-completed measures of disease activity and damage in this complex disease, affords rheumatologists and SLE providers with additional tools to assess potential patient health trajectories,” Dr. Azizoddin and her colleagues wrote in their study. “Identification of such predictors will expand opportunities for early interventions aimed at the reduction of such risk, including allocation of appropriate medical resources in areas with large numbers of patients with compromised health.”
The researchers noted that bias in self-reporting, a lack of prospective evaluations at each visit, and clinical applicability to only similar cohorts were limitations in the study.
This study was funded by the Robert Wood Johnson Foundation Investigator Awards in Health Policy Research and individually was awarded grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
SOURCE: Azizoddin DR et al. Arthritis Care Res. 2018 Aug 24. doi: 10.1002/acr.23734.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: There was a 3.5% lower risk of mortality per each increased point rating on the SF-36 physical component score.
Study details: An analysis of 728 patients with SLE from the University of California, San Francisco, Lupus Outcomes Study.
Disclosures: This study was funded by the Robert Wood Johnson Foundation Investigator Awards in Health Policy Research and individually was awarded grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Source: Azizoddin DR et al. Arthritis Care Res. 2018 Aug 24. doi: 10.1002/acr.23734.
Children born from ART at increased risk of developing arterial hypertension
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Clinicians should be vigilant in detecting early cardiovascular problems in children born from ART, Larry A. Weinrauch, MD, of Harvard Medical School, Boston, and his colleagues wrote in a joint editorial comment. While the sixfold higher risk of arterial hypertension was obtained from an ambulatory blood pressure monitoring that was not repeated, the relative risk of cardiovascular problems for singleton births could be a sign that a greater risk for vascular aging exists with multiple births.
“This observation, derived from a relatively small cohort, may actually understate the importance of this problem for ART populations because higher risk populations for development of hypertension (e.g., multiple birth pregnancies) and those resulting from maternal factors of excess risk (e.g., eclampsia, chronic hypertension, diabetes, obesity) were excluded from the study,” Dr. Weinrauch and his colleagues said.
The authors cited the pediatric hypertension clinical practice guidelines of annual in-office hypertension screening after 3 years of age and noted that certain high-risk groups, such as patients with repaired aortic coarctation and chronic kidney disease, should be screened “at every health encounter.
“If adolescent hypertension risk is really sixfold higher in ART patients (and potentially subsequent generations), consequences for longevity will be vast given the millions of patients whose births were achieved by using ART methods,” wrote Dr. Weinrauch and his colleagues. “Early study, detection, and treatment of ART-conceived individuals may be the appropriate ounce of prevention.”
Dr. Weinrauch is with Harvard Medical School, Marie D. Gerhard-Herman, MD, is with Brigham and Women’s Hospital, and Michael M. Mendelson, MD, is with Boston Children’s Hospital, all in Boston. These comments summarize their editorial in response to Meister et al. (J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.07.013). Dr. Gerhard-Herman is supported by the Progeria Research Foundation and Dr. Mendelson is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. They reported no other relevant conflicts of interest.
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
Children born from assisted reproductive technologies such as in vitro fertilization and intracytoplasmic sperm injection may be at risk of developing arterial hypertension due to premature vascular aging, according to a study published in the Journal of the American College of Cardiology.
In a previous study, Emrush Rexhaj, MD, director of arterial hypertension and altitude medicine at Inselspital, University Hospital, Bern, Switzerland, and his colleagues assessed vascular function in participants who were born with assisted reproductive technology (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI); the investigators found vascular dysfunction in this patient population not “related to parental factors but to the ART procedure itself,” they said.
Dr. Rexhaj and his colleagues then reassessed vascular function in 54 participants (mean age 16.5 years old) who returned from the previous study 5 years after the initial assessment and compared the results with 43 matched patients in a control group (mean age, 17.4 years). There were no significant differences regarding body mass index, lipid, creatinine, electrolyte plasma concentrations, high-sensitive C-reactive protein, birth weight, and gestational age between children in either group, as well as no significant differences in maternal BMI, cardiovascular risk profile, and smoking status.
The investigators – with Théo A. Meister, MD, also of the university, as a joint lead author with Dr. Rexhaj – performed blinded endothelium-dependent and endothelium-independent vasodilation of the brachial artery in a supine position at room temperature and after 15 minutes of rest. They also measured carotid intima-media thickness (IMT), large artery stiffness, 24-hour ambulatory blood pressure monitoring, and short-term blood pressure variability.
“It only took five years for differences in arterial blood pressure to show,” Dr. Rexhaj stated in a press release. “This is a rapidly growing population and apparently healthy children are showing serious signs of concern for early cardiovascular risk, especially when it comes to arterial hypertension.”
Specifically, there was an approximately 25% reduction in flow-mediated dilation in the ART group (7%) compared with the control group (9%), which the investigators attributed to endothelial dysfunction (P less than .001). In ART patients, carotid IMT (463 mm) and carotid pulse-wave velocity (7.7 m/s) was significantly increased, compared with carotid IMT (435 mm; P less than .01) and pulse-wave velocity (7.2 m/s; P equals .033) in the control group.
With regard to arterial hypertension, 24-hour systolic blood pressure in the ART group (120 mm Hg) was “markedly” higher than in the control group (116 mm Hg; P equals .02); 24-hour diastolic blood pressure was also significantly higher in the ART group (71 mm Hg) compared with the control group (69 mm Hg; P equals .03). Investigators noted 8 of the 52 patients (15%) in the ART group met clinical criteria for arterial hypertension according to ambulatory blood pressure monitoring, compared with 1 of the 40 patients (2%) in the control group.
“The increased prevalence of arterial hypertension in ART participants is what is most concerning,” Dr. Rexhaj stated in the release. “There is growing evidence that ART alters the blood vessels in children, but the long-term consequences were not known. We now know that this places ART children at a six times higher rate of hypertension than children conceived naturally.”
The investigators cited as a limitation the fact that they studied only children born from singleton births recruited from a single center, which may have a lower cardiovascular risk profile than other patient populations.
This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
SOURCE: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
FROM JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: In the ART group, 24-hour systolic blood pressure was significantly higher than in the control group (120 mm Hg vs. 116 mm Hg), and 24-hour diastolic blood pressure was also significantly higher in the ART group compared with the control group (71 mm Hg vs. 69 mm Hg).
Study details: A reassessment of 54 children born from ART.
Disclosures: This study was supported by the Swiss National Science Foundation, the Placide Nicod Foundation, the Swiss Society of Hypertension, the Swiss Society of Cardiology and Mach-Gaensslen Stiftung (Schweiz). The authors reported no conflicts of interest.
Source: Meister TA et al. J Am Coll Cardiol. 2018 Sep 3. doi: 10.1016/j.jacc.2018.06.060.
Insufficient sleep is costing countries billions annually because of low productivity
in other countries worldwide, according to a cross-country comparative analysis.
“Our study shows that the effects from a lack of sleep are massive. Sleep deprivation not only influences an individual’s health and well-being but has a significant impact on a nation’s economy, with lower productivity levels and a higher mortality risk among workers,” Marco Hafner, a research leader at RAND Europe and the report’s main author, stated in a press release.
Mr. Hafner and his colleagues analyzed data from 62,366 employees from the Britain’s Healthiest Workplace competition during 2015 and 2016 to determine factors affecting lack of sleep. Specifically, they found people who were overweight or obese slept an average of 2.5 minutes to 7 minutes less each day, compared with people at a healthy body mass index. Smoking was identified as a factor associated with insufficient sleep, and people who smoke slept 5 fewer minutes per day, compared with nonsmokers. People who had more than two sugary drinks per day slept an average of 3.4 minutes less per day, compared with those who consumed less or no sugary drinks. The authors noted people who performed 120 minutes of physical activity or less per day and people with a medium to high risk of mental health problems slept an average of 2.6 minutes and 17.2 minutes less each day, respectively.
Regarding workplace-associated factors for insufficient sleep, the authors found lack of choice in their work routine was associated with 2.3 minutes less sleep per day, and those who worked irregular hours slept 2.7 minutes less per day on average; people with workplace stress and unrealistic time pressures slept 8 minutes less per day on average. Commuters slept 9.3 minutes less per day if they had a 30- to 60-minute commute to work, while those who had a commute longer than 60 minutes slept 16.5 minutes less per day than people with shorter commutes.
The authors also found the following personal and sociodemographic factors were associated with insufficient sleep:
- People who had financial concerns slept 10 minutes less per day, compared with people who did not have financial concerns.
- Unpaid care was associated with an average of 5 minutes less sleep per day.
- People with dependent children under 18 years old in the same household slept an average of 4.2 minutes less daily.
- Men slept 9 minutes less per day, compared, with women.
- Never being married was associated with sleeping an average of 4.8 minutes less per day, while people who were separated from their partner slept an average of 6.5 minutes less per day.
“At first glance, the estimates of minutes of sleep lost due to the various factors outlined above may seem small,” the authors wrote in their report. “However, it is important to stress that the estimates represent the effect on sleep duration of each single factor, holding all other factors constant.”
That lost sleep can significantly affect a person’s health, the authors noted. Sleeping less than 6 hours per night was associated with a 13% increased risk in all-cause mortality and a person sleeping between 6 hours and 7 hours per night had a 7% increased risk of all-cause mortality, compared with people who slept between 7 hours and 9 hours per night.
Insufficient sleep can also affect workplace productivity, with factors such as absenteeism and presenteeism (working while tired) affecting performance at work because of loss of sleep. There was a 1.5% higher productivity loss among people sleeping between 6 hours and 7 hours of sleep per night, compared with people who slept between 7 hours and 9 hours a night, which the authors estimated would cost an employer 6 working days per year for a person sleeping less than 6 hours per night.
In the United States, the authors reported 1.23 million working days (9.9 million working hours) are lost per year because of lack of sleep. They studied four other member countries in the Organisation for Economic Co-operation and Development and found similar results: Japan loses 0.6 million working days (4.8 million working hours) per year, the United Kingdom loses 207,224 working days (1.6 million working hours), Germany loses 209,024 working days (1.6 million working hours), and Canada loses 78,861 working days (630,886 working hours) annually because of insufficient sleep among workers. In total, the report estimates lack of sleep costs approximately $680 billion for these countries.
The authors encouraged individuals, employers, and countries to adopt policies that would lessen the economic impact of insufficient sleep and improve sleep outcomes. For individuals, recommendations included setting a consistent wake-up time, limiting electronic devices before sleep, limiting intake of substances such as caffeine, alcohol, and nicotine prior to sleep, and increasing physical activity. Employers were encouraged to recognize the benefits that getting a full night’s sleep has for their employees, adopt routines that improve their employees’ sleep outcomes, and limit use of electronic devices outside office hours. Public health authorities were encouraged to create awareness campaigns and activities supporting sleep-related help and implementing more efficient public schedules such as delayed school starting times.
“Improving individual sleep habits and duration has huge implications, with our research showing that simple changes can make a big difference,” Mr. Hafner stated in a press release. “For example, if those who sleep under 6 hours a night increase their sleep to between 6 and 7 hours a night, this could add $226.4 billion to the U.S. economy.”
The authors report no relevant conflicts of interest.
SOURCE: Hafner M et al. RAND Corporation .
in other countries worldwide, according to a cross-country comparative analysis.
“Our study shows that the effects from a lack of sleep are massive. Sleep deprivation not only influences an individual’s health and well-being but has a significant impact on a nation’s economy, with lower productivity levels and a higher mortality risk among workers,” Marco Hafner, a research leader at RAND Europe and the report’s main author, stated in a press release.
Mr. Hafner and his colleagues analyzed data from 62,366 employees from the Britain’s Healthiest Workplace competition during 2015 and 2016 to determine factors affecting lack of sleep. Specifically, they found people who were overweight or obese slept an average of 2.5 minutes to 7 minutes less each day, compared with people at a healthy body mass index. Smoking was identified as a factor associated with insufficient sleep, and people who smoke slept 5 fewer minutes per day, compared with nonsmokers. People who had more than two sugary drinks per day slept an average of 3.4 minutes less per day, compared with those who consumed less or no sugary drinks. The authors noted people who performed 120 minutes of physical activity or less per day and people with a medium to high risk of mental health problems slept an average of 2.6 minutes and 17.2 minutes less each day, respectively.
Regarding workplace-associated factors for insufficient sleep, the authors found lack of choice in their work routine was associated with 2.3 minutes less sleep per day, and those who worked irregular hours slept 2.7 minutes less per day on average; people with workplace stress and unrealistic time pressures slept 8 minutes less per day on average. Commuters slept 9.3 minutes less per day if they had a 30- to 60-minute commute to work, while those who had a commute longer than 60 minutes slept 16.5 minutes less per day than people with shorter commutes.
The authors also found the following personal and sociodemographic factors were associated with insufficient sleep:
- People who had financial concerns slept 10 minutes less per day, compared with people who did not have financial concerns.
- Unpaid care was associated with an average of 5 minutes less sleep per day.
- People with dependent children under 18 years old in the same household slept an average of 4.2 minutes less daily.
- Men slept 9 minutes less per day, compared, with women.
- Never being married was associated with sleeping an average of 4.8 minutes less per day, while people who were separated from their partner slept an average of 6.5 minutes less per day.
“At first glance, the estimates of minutes of sleep lost due to the various factors outlined above may seem small,” the authors wrote in their report. “However, it is important to stress that the estimates represent the effect on sleep duration of each single factor, holding all other factors constant.”
That lost sleep can significantly affect a person’s health, the authors noted. Sleeping less than 6 hours per night was associated with a 13% increased risk in all-cause mortality and a person sleeping between 6 hours and 7 hours per night had a 7% increased risk of all-cause mortality, compared with people who slept between 7 hours and 9 hours per night.
Insufficient sleep can also affect workplace productivity, with factors such as absenteeism and presenteeism (working while tired) affecting performance at work because of loss of sleep. There was a 1.5% higher productivity loss among people sleeping between 6 hours and 7 hours of sleep per night, compared with people who slept between 7 hours and 9 hours a night, which the authors estimated would cost an employer 6 working days per year for a person sleeping less than 6 hours per night.
In the United States, the authors reported 1.23 million working days (9.9 million working hours) are lost per year because of lack of sleep. They studied four other member countries in the Organisation for Economic Co-operation and Development and found similar results: Japan loses 0.6 million working days (4.8 million working hours) per year, the United Kingdom loses 207,224 working days (1.6 million working hours), Germany loses 209,024 working days (1.6 million working hours), and Canada loses 78,861 working days (630,886 working hours) annually because of insufficient sleep among workers. In total, the report estimates lack of sleep costs approximately $680 billion for these countries.
The authors encouraged individuals, employers, and countries to adopt policies that would lessen the economic impact of insufficient sleep and improve sleep outcomes. For individuals, recommendations included setting a consistent wake-up time, limiting electronic devices before sleep, limiting intake of substances such as caffeine, alcohol, and nicotine prior to sleep, and increasing physical activity. Employers were encouraged to recognize the benefits that getting a full night’s sleep has for their employees, adopt routines that improve their employees’ sleep outcomes, and limit use of electronic devices outside office hours. Public health authorities were encouraged to create awareness campaigns and activities supporting sleep-related help and implementing more efficient public schedules such as delayed school starting times.
“Improving individual sleep habits and duration has huge implications, with our research showing that simple changes can make a big difference,” Mr. Hafner stated in a press release. “For example, if those who sleep under 6 hours a night increase their sleep to between 6 and 7 hours a night, this could add $226.4 billion to the U.S. economy.”
The authors report no relevant conflicts of interest.
SOURCE: Hafner M et al. RAND Corporation .
in other countries worldwide, according to a cross-country comparative analysis.
“Our study shows that the effects from a lack of sleep are massive. Sleep deprivation not only influences an individual’s health and well-being but has a significant impact on a nation’s economy, with lower productivity levels and a higher mortality risk among workers,” Marco Hafner, a research leader at RAND Europe and the report’s main author, stated in a press release.
Mr. Hafner and his colleagues analyzed data from 62,366 employees from the Britain’s Healthiest Workplace competition during 2015 and 2016 to determine factors affecting lack of sleep. Specifically, they found people who were overweight or obese slept an average of 2.5 minutes to 7 minutes less each day, compared with people at a healthy body mass index. Smoking was identified as a factor associated with insufficient sleep, and people who smoke slept 5 fewer minutes per day, compared with nonsmokers. People who had more than two sugary drinks per day slept an average of 3.4 minutes less per day, compared with those who consumed less or no sugary drinks. The authors noted people who performed 120 minutes of physical activity or less per day and people with a medium to high risk of mental health problems slept an average of 2.6 minutes and 17.2 minutes less each day, respectively.
Regarding workplace-associated factors for insufficient sleep, the authors found lack of choice in their work routine was associated with 2.3 minutes less sleep per day, and those who worked irregular hours slept 2.7 minutes less per day on average; people with workplace stress and unrealistic time pressures slept 8 minutes less per day on average. Commuters slept 9.3 minutes less per day if they had a 30- to 60-minute commute to work, while those who had a commute longer than 60 minutes slept 16.5 minutes less per day than people with shorter commutes.
The authors also found the following personal and sociodemographic factors were associated with insufficient sleep:
- People who had financial concerns slept 10 minutes less per day, compared with people who did not have financial concerns.
- Unpaid care was associated with an average of 5 minutes less sleep per day.
- People with dependent children under 18 years old in the same household slept an average of 4.2 minutes less daily.
- Men slept 9 minutes less per day, compared, with women.
- Never being married was associated with sleeping an average of 4.8 minutes less per day, while people who were separated from their partner slept an average of 6.5 minutes less per day.
“At first glance, the estimates of minutes of sleep lost due to the various factors outlined above may seem small,” the authors wrote in their report. “However, it is important to stress that the estimates represent the effect on sleep duration of each single factor, holding all other factors constant.”
That lost sleep can significantly affect a person’s health, the authors noted. Sleeping less than 6 hours per night was associated with a 13% increased risk in all-cause mortality and a person sleeping between 6 hours and 7 hours per night had a 7% increased risk of all-cause mortality, compared with people who slept between 7 hours and 9 hours per night.
Insufficient sleep can also affect workplace productivity, with factors such as absenteeism and presenteeism (working while tired) affecting performance at work because of loss of sleep. There was a 1.5% higher productivity loss among people sleeping between 6 hours and 7 hours of sleep per night, compared with people who slept between 7 hours and 9 hours a night, which the authors estimated would cost an employer 6 working days per year for a person sleeping less than 6 hours per night.
In the United States, the authors reported 1.23 million working days (9.9 million working hours) are lost per year because of lack of sleep. They studied four other member countries in the Organisation for Economic Co-operation and Development and found similar results: Japan loses 0.6 million working days (4.8 million working hours) per year, the United Kingdom loses 207,224 working days (1.6 million working hours), Germany loses 209,024 working days (1.6 million working hours), and Canada loses 78,861 working days (630,886 working hours) annually because of insufficient sleep among workers. In total, the report estimates lack of sleep costs approximately $680 billion for these countries.
The authors encouraged individuals, employers, and countries to adopt policies that would lessen the economic impact of insufficient sleep and improve sleep outcomes. For individuals, recommendations included setting a consistent wake-up time, limiting electronic devices before sleep, limiting intake of substances such as caffeine, alcohol, and nicotine prior to sleep, and increasing physical activity. Employers were encouraged to recognize the benefits that getting a full night’s sleep has for their employees, adopt routines that improve their employees’ sleep outcomes, and limit use of electronic devices outside office hours. Public health authorities were encouraged to create awareness campaigns and activities supporting sleep-related help and implementing more efficient public schedules such as delayed school starting times.
“Improving individual sleep habits and duration has huge implications, with our research showing that simple changes can make a big difference,” Mr. Hafner stated in a press release. “For example, if those who sleep under 6 hours a night increase their sleep to between 6 and 7 hours a night, this could add $226.4 billion to the U.S. economy.”
The authors report no relevant conflicts of interest.
SOURCE: Hafner M et al. RAND Corporation .
FROM RAND CORPORATION REPORT
Key clinical point: Lack of sleep is economically costly and increases mortality risk for a country’s workforce.
Major finding: The United States loses approximately $411 billion per year and 1.23 million working days from insufficient sleeps among workers.
Study details: A research report of the effects of insufficient sleep in the United States, Canada, United Kingdom, Germany, and Japan.
Disclosures: The authors report no relevant conflicts of interest.
Source: Hafner M et al. RAND Corporation.
AAP cautions against marijuana use during pregnancy, breastfeeding
, according to a recent clinical report published in the journal Pediatrics.
“The fact that marijuana is legal in many states may give the impression the drug is harmless during pregnancy, especially with stories swirling on social media about using it for nausea with morning sickness,” Sheryl A. Ryan, MD, FAAP, Chair of the American Academy of Pediatrics (AAP) Committee on Substance Use and Prevention, stated in a press release. “But in fact, this is still a big question. We do not have good safety data on prenatal exposure to marijuana. Based on the limited data that do exist, as pediatricians, we believe there is cause to be concerned about how the drug will impact the long-term development of children.”
The rate of marijuana use is increasing among pregnant women 18 years to 44 years old is increasing, the committee said, with 3.84% of women in 2014 within that age range using marijuana within the past month compared with 2.37% in 2002. Among women who were between 18 years and 25 years old, the rate of marijuana use within the past month was 7.47% in 2014.
The committee also noted research has shown cannabidiol exposure in the short term may impact placental permeability to “pharmacologic agents and recreational substances, potentially placing the fetus at risk from these agents or drugs.” A more well-known substance in marijuana, delta-9-tetrahydrocannabinol (THC) crosses the placental barrier and can appear in fetal blood. Studies have reported any level of marijuana use among pregnant women put the mothers at risk of anemia, while their newborns had an increased risk of low-birth weight and neonatal intensive care unit (NICU) use. Further research has shown impaired mental development, executive function deficits, increased impulsivity and hyperactivity, behavioral problems, depressive symptoms, and greater rates of substance abuse among children exposed to marijuana.
“Many of these effects may not show up right away, but they can impact how well a child can maneuver in the world,” Dr. Ryan stated in the release. “Children’s and teens’ cognitive ability to manage their time and school work might be harmed down the line from marijuana use during their mother’s pregnancy.”
In a related study, Kerri A. Bertrand, MPH, from the department of pediatrics at the University of California in San Diego, Calif., and her colleagues studied cannabinoid concentrations in breastmilk donated to a human milk biorepository. The investigators analyzed 54 samples donated by 50 women who used marijuana while breastfeeding between 2014 and 2017 and determined whether substances such as delta-9-THC, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC), cannabidiol, and cannabinol were present in breastmilk by performing liquid chromatography mass spectrometry electrospray ionization on the samples.
They found 34 of 54 samples (64%) had detectable delta-9-THC approximately 6 days after marijuana use (median concentration, 9.47 ng/mL; range, 1.01-323 ng/mL), while 5 of 54 samples (9%) had measurable concentrations of 11-OH-THC (range, 1.33-12.80 ng/mL) and 5 of 54 samples (9%) contained measurable cannabidiol (range, 1.32-8.56 ng/mL). Predictors of log delta-9-THC concentrations included number of hours since last use (-0.03; 95% confidence interval, -0.04 to -0.01; P equals .005), the number of times per day marijuana was used (0.51; 95% CI, 0.03-0.99; P equals .039), and the amount of time between sample donation and analysis (0.08; 95% CI, 0.00-0.15; P equals .038), researchers said.
“Because marijuana is the most commonly used recreational drug among breastfeeding women, information regarding risks to breastfeeding infants is urgently needed,” Dr. Bertrand and colleagues wrote in their study.
The authors of the AAP clinical report acknowledge no relevant conflicts of interest. The study by Bertrand and colleagues was supported by the University of California San Diego Center for Better Beginnings, a grant from the National Institutes of Health, and the Gerber Foundation.
SOURCE: Bertrand KA et al. Pediatrics. 2018 Aug 27;doi:10.1542/peds.2018-1076.
The study by Bertrand and colleagues should be commended for being among the first to analyze cannabinoids in breast milk, but there are still very important questions to be answered about marijuana use among women who breast-feed, Sheryl A. Ryan, MD, FAAP, wrote in a related editorial.
Questions remain about why one-third of participants in the study had no detectable cannabinoids in their breast milk, and a frame of reference is needed for the levels that did appear in the study, Dr. Ryan said. Data are also needed on how the cannabinoids “accumulate in the infant, how the infant metabolizes these substances, how quickly they are excreted, whether they accumulate, and thus how long these metabolites remain in the infant,” she said.
Dr. Ryan also questioned what to tell mothers who use marijuana but want to breastfeed their newborns, and noted guidelines from the AAP and the American College of Obstetricians currently recommend avoiding marijuana use entirely while breastfeeding.
“With their study, Bertrand et al. have provided additional and valuable support for those current recommendations. But the picture is incomplete without our understanding of what is happening at the level of those infants exposed to cannabinoid–containing breast milk,” Dr. Ryan said. “Hopefully, the calls for research to answer these important questions will not go unheeded.”
Dr. Ryan is from the Division of Adolescent Medicine and Department of Pediatrics at Penn State Health Children’s Hospital in Hershey, Penn. These comments summarize her editorial in response to Bertrand and colleagues. She reports no relevant conflicts of interest (Ryan SA. Pediatrics. 2018;142[3]:e20181921).
The study by Bertrand and colleagues should be commended for being among the first to analyze cannabinoids in breast milk, but there are still very important questions to be answered about marijuana use among women who breast-feed, Sheryl A. Ryan, MD, FAAP, wrote in a related editorial.
Questions remain about why one-third of participants in the study had no detectable cannabinoids in their breast milk, and a frame of reference is needed for the levels that did appear in the study, Dr. Ryan said. Data are also needed on how the cannabinoids “accumulate in the infant, how the infant metabolizes these substances, how quickly they are excreted, whether they accumulate, and thus how long these metabolites remain in the infant,” she said.
Dr. Ryan also questioned what to tell mothers who use marijuana but want to breastfeed their newborns, and noted guidelines from the AAP and the American College of Obstetricians currently recommend avoiding marijuana use entirely while breastfeeding.
“With their study, Bertrand et al. have provided additional and valuable support for those current recommendations. But the picture is incomplete without our understanding of what is happening at the level of those infants exposed to cannabinoid–containing breast milk,” Dr. Ryan said. “Hopefully, the calls for research to answer these important questions will not go unheeded.”
Dr. Ryan is from the Division of Adolescent Medicine and Department of Pediatrics at Penn State Health Children’s Hospital in Hershey, Penn. These comments summarize her editorial in response to Bertrand and colleagues. She reports no relevant conflicts of interest (Ryan SA. Pediatrics. 2018;142[3]:e20181921).
The study by Bertrand and colleagues should be commended for being among the first to analyze cannabinoids in breast milk, but there are still very important questions to be answered about marijuana use among women who breast-feed, Sheryl A. Ryan, MD, FAAP, wrote in a related editorial.
Questions remain about why one-third of participants in the study had no detectable cannabinoids in their breast milk, and a frame of reference is needed for the levels that did appear in the study, Dr. Ryan said. Data are also needed on how the cannabinoids “accumulate in the infant, how the infant metabolizes these substances, how quickly they are excreted, whether they accumulate, and thus how long these metabolites remain in the infant,” she said.
Dr. Ryan also questioned what to tell mothers who use marijuana but want to breastfeed their newborns, and noted guidelines from the AAP and the American College of Obstetricians currently recommend avoiding marijuana use entirely while breastfeeding.
“With their study, Bertrand et al. have provided additional and valuable support for those current recommendations. But the picture is incomplete without our understanding of what is happening at the level of those infants exposed to cannabinoid–containing breast milk,” Dr. Ryan said. “Hopefully, the calls for research to answer these important questions will not go unheeded.”
Dr. Ryan is from the Division of Adolescent Medicine and Department of Pediatrics at Penn State Health Children’s Hospital in Hershey, Penn. These comments summarize her editorial in response to Bertrand and colleagues. She reports no relevant conflicts of interest (Ryan SA. Pediatrics. 2018;142[3]:e20181921).
, according to a recent clinical report published in the journal Pediatrics.
“The fact that marijuana is legal in many states may give the impression the drug is harmless during pregnancy, especially with stories swirling on social media about using it for nausea with morning sickness,” Sheryl A. Ryan, MD, FAAP, Chair of the American Academy of Pediatrics (AAP) Committee on Substance Use and Prevention, stated in a press release. “But in fact, this is still a big question. We do not have good safety data on prenatal exposure to marijuana. Based on the limited data that do exist, as pediatricians, we believe there is cause to be concerned about how the drug will impact the long-term development of children.”
The rate of marijuana use is increasing among pregnant women 18 years to 44 years old is increasing, the committee said, with 3.84% of women in 2014 within that age range using marijuana within the past month compared with 2.37% in 2002. Among women who were between 18 years and 25 years old, the rate of marijuana use within the past month was 7.47% in 2014.
The committee also noted research has shown cannabidiol exposure in the short term may impact placental permeability to “pharmacologic agents and recreational substances, potentially placing the fetus at risk from these agents or drugs.” A more well-known substance in marijuana, delta-9-tetrahydrocannabinol (THC) crosses the placental barrier and can appear in fetal blood. Studies have reported any level of marijuana use among pregnant women put the mothers at risk of anemia, while their newborns had an increased risk of low-birth weight and neonatal intensive care unit (NICU) use. Further research has shown impaired mental development, executive function deficits, increased impulsivity and hyperactivity, behavioral problems, depressive symptoms, and greater rates of substance abuse among children exposed to marijuana.
“Many of these effects may not show up right away, but they can impact how well a child can maneuver in the world,” Dr. Ryan stated in the release. “Children’s and teens’ cognitive ability to manage their time and school work might be harmed down the line from marijuana use during their mother’s pregnancy.”
In a related study, Kerri A. Bertrand, MPH, from the department of pediatrics at the University of California in San Diego, Calif., and her colleagues studied cannabinoid concentrations in breastmilk donated to a human milk biorepository. The investigators analyzed 54 samples donated by 50 women who used marijuana while breastfeeding between 2014 and 2017 and determined whether substances such as delta-9-THC, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC), cannabidiol, and cannabinol were present in breastmilk by performing liquid chromatography mass spectrometry electrospray ionization on the samples.
They found 34 of 54 samples (64%) had detectable delta-9-THC approximately 6 days after marijuana use (median concentration, 9.47 ng/mL; range, 1.01-323 ng/mL), while 5 of 54 samples (9%) had measurable concentrations of 11-OH-THC (range, 1.33-12.80 ng/mL) and 5 of 54 samples (9%) contained measurable cannabidiol (range, 1.32-8.56 ng/mL). Predictors of log delta-9-THC concentrations included number of hours since last use (-0.03; 95% confidence interval, -0.04 to -0.01; P equals .005), the number of times per day marijuana was used (0.51; 95% CI, 0.03-0.99; P equals .039), and the amount of time between sample donation and analysis (0.08; 95% CI, 0.00-0.15; P equals .038), researchers said.
“Because marijuana is the most commonly used recreational drug among breastfeeding women, information regarding risks to breastfeeding infants is urgently needed,” Dr. Bertrand and colleagues wrote in their study.
The authors of the AAP clinical report acknowledge no relevant conflicts of interest. The study by Bertrand and colleagues was supported by the University of California San Diego Center for Better Beginnings, a grant from the National Institutes of Health, and the Gerber Foundation.
SOURCE: Bertrand KA et al. Pediatrics. 2018 Aug 27;doi:10.1542/peds.2018-1076.
, according to a recent clinical report published in the journal Pediatrics.
“The fact that marijuana is legal in many states may give the impression the drug is harmless during pregnancy, especially with stories swirling on social media about using it for nausea with morning sickness,” Sheryl A. Ryan, MD, FAAP, Chair of the American Academy of Pediatrics (AAP) Committee on Substance Use and Prevention, stated in a press release. “But in fact, this is still a big question. We do not have good safety data on prenatal exposure to marijuana. Based on the limited data that do exist, as pediatricians, we believe there is cause to be concerned about how the drug will impact the long-term development of children.”
The rate of marijuana use is increasing among pregnant women 18 years to 44 years old is increasing, the committee said, with 3.84% of women in 2014 within that age range using marijuana within the past month compared with 2.37% in 2002. Among women who were between 18 years and 25 years old, the rate of marijuana use within the past month was 7.47% in 2014.
The committee also noted research has shown cannabidiol exposure in the short term may impact placental permeability to “pharmacologic agents and recreational substances, potentially placing the fetus at risk from these agents or drugs.” A more well-known substance in marijuana, delta-9-tetrahydrocannabinol (THC) crosses the placental barrier and can appear in fetal blood. Studies have reported any level of marijuana use among pregnant women put the mothers at risk of anemia, while their newborns had an increased risk of low-birth weight and neonatal intensive care unit (NICU) use. Further research has shown impaired mental development, executive function deficits, increased impulsivity and hyperactivity, behavioral problems, depressive symptoms, and greater rates of substance abuse among children exposed to marijuana.
“Many of these effects may not show up right away, but they can impact how well a child can maneuver in the world,” Dr. Ryan stated in the release. “Children’s and teens’ cognitive ability to manage their time and school work might be harmed down the line from marijuana use during their mother’s pregnancy.”
In a related study, Kerri A. Bertrand, MPH, from the department of pediatrics at the University of California in San Diego, Calif., and her colleagues studied cannabinoid concentrations in breastmilk donated to a human milk biorepository. The investigators analyzed 54 samples donated by 50 women who used marijuana while breastfeeding between 2014 and 2017 and determined whether substances such as delta-9-THC, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC), cannabidiol, and cannabinol were present in breastmilk by performing liquid chromatography mass spectrometry electrospray ionization on the samples.
They found 34 of 54 samples (64%) had detectable delta-9-THC approximately 6 days after marijuana use (median concentration, 9.47 ng/mL; range, 1.01-323 ng/mL), while 5 of 54 samples (9%) had measurable concentrations of 11-OH-THC (range, 1.33-12.80 ng/mL) and 5 of 54 samples (9%) contained measurable cannabidiol (range, 1.32-8.56 ng/mL). Predictors of log delta-9-THC concentrations included number of hours since last use (-0.03; 95% confidence interval, -0.04 to -0.01; P equals .005), the number of times per day marijuana was used (0.51; 95% CI, 0.03-0.99; P equals .039), and the amount of time between sample donation and analysis (0.08; 95% CI, 0.00-0.15; P equals .038), researchers said.
“Because marijuana is the most commonly used recreational drug among breastfeeding women, information regarding risks to breastfeeding infants is urgently needed,” Dr. Bertrand and colleagues wrote in their study.
The authors of the AAP clinical report acknowledge no relevant conflicts of interest. The study by Bertrand and colleagues was supported by the University of California San Diego Center for Better Beginnings, a grant from the National Institutes of Health, and the Gerber Foundation.
SOURCE: Bertrand KA et al. Pediatrics. 2018 Aug 27;doi:10.1542/peds.2018-1076.
PEDIATRICS
Key clinical point: More studies are needed to analyze the long-term effects marijuana has on mother and child during pregnancy and while breastfeeding.
Major finding: Of women between 18 years and 44 years old, 3.84% used marijuana during pregnancy in 2014 compared with 2.37% in 2002; 64% of samples in Bertrand and colleagues’ study had THC traceable in breastmilk approximately 6 days after marijuana use.
Study details:A clinical report on marijuana use during pregnancy and while breastfeeding, and a study of 50 women who used marijuana while breastfeeding and donated samples to a human milk biorepository.
Disclosures:The authors of the AAP clinical report no relevant conflicts of interest. The study by Bertrand and colleagues was supported by the University of California San Diego Center for Better Beginnings, a grant from the National Institutes of Health, and the Gerber Foundation.
Source: Ryan SA et al. Pediatrics. 2018 Aug 27;doi:10.1542/peds.2018-1889. Bertrand KA et al. Pediatrics. 2018 Aug 27;doi:10.1542/peds.2018-1076.
Breastfeeding lowered later stroke risk in WHI
Postmenopausal women who breastfed their children had a lower risk of stroke compared with women who had children but never breastfed, with non-Hispanic black women showing a significantly stronger association between breastfeeding and lower stroke risk, according to results from the prospective Women’s Health Initiative Observational Study.
“Some studies have reported that breastfeeding may reduce the rates of breast cancer, ovarian cancer and risk of developing type 2 diabetes in mothers. Recent findings point to the benefits of breastfeeding on heart disease and other specific cardiovascular risk factors,” Lisette T. Jacobson, PhD, of the department of preventive medicine and public health at the University of Kansas, Wichita, said in a statement.
Dr. Jacobson and her colleagues evaluated 80,191 women from the Women’s Health Initiative (WHI) Observational Study who were aged 50-79 at baseline. The average age was 64 years, and 83% were white, 8% were non-Hispanic black, 4% were Hispanic, and 5% were another race or ethnicity. Of the women observed, 58% had breastfed and 3.4% had a stroke within an average of 13 years of follow-up. The investigators used three adjusted regression models to analyze stroke risk: Model 1 was minimally adjusted, model 2 was adjusted for nonmodifiable potential confounders, and model 3 was adjusted for modifiable lifestyle factors.
There was a 23% lower risk of stroke among all postmenopausal women who breastfed compared with those who never breastfed, with women who breastfed between 1 month and 6 months carrying a 19% lower risk of stroke. In the minimally adjusted model, non-Hispanic white women who breastfed carried a 21% lower risk, Hispanic women had an adjusted 32% lower risk, and women of other races and ethnicity had a 24% lower risk of stroke. However, women who were non-Hispanic black had a stronger association with breastfeeding and stroke reduction, with a 48% lower risk, and non-Hispanic white and non-Hispanic black women showed a stronger association between longer duration of breastfeeding and lower stroke risk when results were minimally adjusted, the investigators said. All differences were statistically significant.
The investigators noted the study’s observational nature and said they were not able to determine what caused breastfeeding’s association with lower stroke risk, with other factors potentially affecting results.
“Breastfeeding is only one of many factors that could potentially protect against stroke,” Dr. Jacobson said in the report, published online in the Journal of the American Heart Association. “Others include getting adequate exercise, choosing healthy foods, not smoking, and seeking treatment if needed to keep your blood pressure, cholesterol, and blood sugar in the normal range.”
They also noted potential limitations in the study: the WHI cohort’s low number of strokes in follow-up, lack of classification of stroke, recall bias due to the women self-reporting strokes, average age at baseline, and lack of data on pregnancy.
“Our study did not address whether racial/ethnic differences in breastfeeding contribute to disparities in stroke risk,” Dr. Jacobson said. “Additional research should consider the degree to which breastfeeding might alter racial/ethnic differences in stroke risk.”
“This is an observational, prospective cohort study that was performed very carefully, but it is important to not conclude causality in that breastfeeding results in a reduction in late life stroke,” Larry B. Goldstein, MD, said in an email interview.
Dr. Goldstein, a neurologist who has published several guidelines on primary prevention and early management of stroke with the American Heart Association, noted that although the authors addressed many confounders, studies of this type are still open to residual confounding. He said one of the factors the authors could not measure was eclampsia and preeclampsia, which inhibits breastfeeding.
“The possibility of unmeasured confounding despite how well the study was done is still there. But having said that, the recommendations for breastfeeding are strong from the American Academy of Pediatrics and from the World Health Organization,” and other studies have found an association with a reduction in later life cardiovascular disease, said Dr. Goldstein, the Ruth L. Works professor and chairman in the department of neurology at the University of Kentucky, Lexington. “But just in terms of the benefits to the mother and to the child from breastfeeding, this is another potential plus [in that] even if it doesn’t pan out, it doesn’t really change the recommendation for breastfeeding.”
Dr. Goldstein noted that finding these results in a different prospective cohort would strengthen the recommendations, as would examining whether factors such as lifestyle affected stroke risk for women.
“Showing causality is always going to be difficult,” he stressed. “There is no particular causal mechanism that’s been espoused for how this might decrease stroke risk in later life.”
This study is funded by Frontiers: The Heartland Institute for Clinical and Translational Research and the Wichita Center for Graduate Medical Education–Kansas Bioscience Authority. The WHI program is funded by the National Heart, Lung, and Blood Institute, the National Institutes of Health, and the U.S. Department of Health and Human Services. The authors reported having no conflicts of interest.
SOURCE: Jacobson LT et al. J Am Heart Assoc. 2018 Aug 22. doi:10.1161/JAHA.118.008739.
This is an important study for pediatricians who counsel breastfeeding mothers and families on the benefits of breastfeeding for mothers and their families.
The current study is important because of its large scale and the fact that it shows an association between any breastfeeding longer than 1 month and protection against stroke, especially for the non-Hispanic black population. These women face higher risks of cardiovascular disease, including hypertension and heart disease, and also higher risks from obesity and hypertension. Longer duration of breastfeeding showed an association with decreased risk of stroke for both non-Hispanic white women and non-Hispanic black women in this study.
On the basis of this study, pediatricians can include potential protection against strokes, as part of the list of protective effects when counseling mothers, either prenatally or in the postpartum setting. Women of childbearing age are not at high risk for stroke, but breastfeeding is a healthy life choice that has significant benefits not just during the period of direct breastfeeding but for years afterward. This study also emphasizes that the benefits of breastfeeding are often dose related. In other words, the longer the mother breastfeeds, the greater the health benefits are for her and for her child.
It would be helpful to have further long-term prospective studies that collect information about breastfeeding at the time that the mother is breastfeeding and then throughout her lifespan. That way, the risk of stroke as well as other cardiovascular risks and cancer risks could be more precisely delineated without the potential for recall bias.
Joan Younger Meek, MD, is chair of the American Academy of Pediatrics Section on Breastfeeding and associate dean for graduate medical education at Florida State University, Orlando. These comments were excerpted from an email interview. She has no relevant conflicts of interest.
This is an important study for pediatricians who counsel breastfeeding mothers and families on the benefits of breastfeeding for mothers and their families.
The current study is important because of its large scale and the fact that it shows an association between any breastfeeding longer than 1 month and protection against stroke, especially for the non-Hispanic black population. These women face higher risks of cardiovascular disease, including hypertension and heart disease, and also higher risks from obesity and hypertension. Longer duration of breastfeeding showed an association with decreased risk of stroke for both non-Hispanic white women and non-Hispanic black women in this study.
On the basis of this study, pediatricians can include potential protection against strokes, as part of the list of protective effects when counseling mothers, either prenatally or in the postpartum setting. Women of childbearing age are not at high risk for stroke, but breastfeeding is a healthy life choice that has significant benefits not just during the period of direct breastfeeding but for years afterward. This study also emphasizes that the benefits of breastfeeding are often dose related. In other words, the longer the mother breastfeeds, the greater the health benefits are for her and for her child.
It would be helpful to have further long-term prospective studies that collect information about breastfeeding at the time that the mother is breastfeeding and then throughout her lifespan. That way, the risk of stroke as well as other cardiovascular risks and cancer risks could be more precisely delineated without the potential for recall bias.
Joan Younger Meek, MD, is chair of the American Academy of Pediatrics Section on Breastfeeding and associate dean for graduate medical education at Florida State University, Orlando. These comments were excerpted from an email interview. She has no relevant conflicts of interest.
This is an important study for pediatricians who counsel breastfeeding mothers and families on the benefits of breastfeeding for mothers and their families.
The current study is important because of its large scale and the fact that it shows an association between any breastfeeding longer than 1 month and protection against stroke, especially for the non-Hispanic black population. These women face higher risks of cardiovascular disease, including hypertension and heart disease, and also higher risks from obesity and hypertension. Longer duration of breastfeeding showed an association with decreased risk of stroke for both non-Hispanic white women and non-Hispanic black women in this study.
On the basis of this study, pediatricians can include potential protection against strokes, as part of the list of protective effects when counseling mothers, either prenatally or in the postpartum setting. Women of childbearing age are not at high risk for stroke, but breastfeeding is a healthy life choice that has significant benefits not just during the period of direct breastfeeding but for years afterward. This study also emphasizes that the benefits of breastfeeding are often dose related. In other words, the longer the mother breastfeeds, the greater the health benefits are for her and for her child.
It would be helpful to have further long-term prospective studies that collect information about breastfeeding at the time that the mother is breastfeeding and then throughout her lifespan. That way, the risk of stroke as well as other cardiovascular risks and cancer risks could be more precisely delineated without the potential for recall bias.
Joan Younger Meek, MD, is chair of the American Academy of Pediatrics Section on Breastfeeding and associate dean for graduate medical education at Florida State University, Orlando. These comments were excerpted from an email interview. She has no relevant conflicts of interest.
Postmenopausal women who breastfed their children had a lower risk of stroke compared with women who had children but never breastfed, with non-Hispanic black women showing a significantly stronger association between breastfeeding and lower stroke risk, according to results from the prospective Women’s Health Initiative Observational Study.
“Some studies have reported that breastfeeding may reduce the rates of breast cancer, ovarian cancer and risk of developing type 2 diabetes in mothers. Recent findings point to the benefits of breastfeeding on heart disease and other specific cardiovascular risk factors,” Lisette T. Jacobson, PhD, of the department of preventive medicine and public health at the University of Kansas, Wichita, said in a statement.
Dr. Jacobson and her colleagues evaluated 80,191 women from the Women’s Health Initiative (WHI) Observational Study who were aged 50-79 at baseline. The average age was 64 years, and 83% were white, 8% were non-Hispanic black, 4% were Hispanic, and 5% were another race or ethnicity. Of the women observed, 58% had breastfed and 3.4% had a stroke within an average of 13 years of follow-up. The investigators used three adjusted regression models to analyze stroke risk: Model 1 was minimally adjusted, model 2 was adjusted for nonmodifiable potential confounders, and model 3 was adjusted for modifiable lifestyle factors.
There was a 23% lower risk of stroke among all postmenopausal women who breastfed compared with those who never breastfed, with women who breastfed between 1 month and 6 months carrying a 19% lower risk of stroke. In the minimally adjusted model, non-Hispanic white women who breastfed carried a 21% lower risk, Hispanic women had an adjusted 32% lower risk, and women of other races and ethnicity had a 24% lower risk of stroke. However, women who were non-Hispanic black had a stronger association with breastfeeding and stroke reduction, with a 48% lower risk, and non-Hispanic white and non-Hispanic black women showed a stronger association between longer duration of breastfeeding and lower stroke risk when results were minimally adjusted, the investigators said. All differences were statistically significant.
The investigators noted the study’s observational nature and said they were not able to determine what caused breastfeeding’s association with lower stroke risk, with other factors potentially affecting results.
“Breastfeeding is only one of many factors that could potentially protect against stroke,” Dr. Jacobson said in the report, published online in the Journal of the American Heart Association. “Others include getting adequate exercise, choosing healthy foods, not smoking, and seeking treatment if needed to keep your blood pressure, cholesterol, and blood sugar in the normal range.”
They also noted potential limitations in the study: the WHI cohort’s low number of strokes in follow-up, lack of classification of stroke, recall bias due to the women self-reporting strokes, average age at baseline, and lack of data on pregnancy.
“Our study did not address whether racial/ethnic differences in breastfeeding contribute to disparities in stroke risk,” Dr. Jacobson said. “Additional research should consider the degree to which breastfeeding might alter racial/ethnic differences in stroke risk.”
“This is an observational, prospective cohort study that was performed very carefully, but it is important to not conclude causality in that breastfeeding results in a reduction in late life stroke,” Larry B. Goldstein, MD, said in an email interview.
Dr. Goldstein, a neurologist who has published several guidelines on primary prevention and early management of stroke with the American Heart Association, noted that although the authors addressed many confounders, studies of this type are still open to residual confounding. He said one of the factors the authors could not measure was eclampsia and preeclampsia, which inhibits breastfeeding.
“The possibility of unmeasured confounding despite how well the study was done is still there. But having said that, the recommendations for breastfeeding are strong from the American Academy of Pediatrics and from the World Health Organization,” and other studies have found an association with a reduction in later life cardiovascular disease, said Dr. Goldstein, the Ruth L. Works professor and chairman in the department of neurology at the University of Kentucky, Lexington. “But just in terms of the benefits to the mother and to the child from breastfeeding, this is another potential plus [in that] even if it doesn’t pan out, it doesn’t really change the recommendation for breastfeeding.”
Dr. Goldstein noted that finding these results in a different prospective cohort would strengthen the recommendations, as would examining whether factors such as lifestyle affected stroke risk for women.
“Showing causality is always going to be difficult,” he stressed. “There is no particular causal mechanism that’s been espoused for how this might decrease stroke risk in later life.”
This study is funded by Frontiers: The Heartland Institute for Clinical and Translational Research and the Wichita Center for Graduate Medical Education–Kansas Bioscience Authority. The WHI program is funded by the National Heart, Lung, and Blood Institute, the National Institutes of Health, and the U.S. Department of Health and Human Services. The authors reported having no conflicts of interest.
SOURCE: Jacobson LT et al. J Am Heart Assoc. 2018 Aug 22. doi:10.1161/JAHA.118.008739.
Postmenopausal women who breastfed their children had a lower risk of stroke compared with women who had children but never breastfed, with non-Hispanic black women showing a significantly stronger association between breastfeeding and lower stroke risk, according to results from the prospective Women’s Health Initiative Observational Study.
“Some studies have reported that breastfeeding may reduce the rates of breast cancer, ovarian cancer and risk of developing type 2 diabetes in mothers. Recent findings point to the benefits of breastfeeding on heart disease and other specific cardiovascular risk factors,” Lisette T. Jacobson, PhD, of the department of preventive medicine and public health at the University of Kansas, Wichita, said in a statement.
Dr. Jacobson and her colleagues evaluated 80,191 women from the Women’s Health Initiative (WHI) Observational Study who were aged 50-79 at baseline. The average age was 64 years, and 83% were white, 8% were non-Hispanic black, 4% were Hispanic, and 5% were another race or ethnicity. Of the women observed, 58% had breastfed and 3.4% had a stroke within an average of 13 years of follow-up. The investigators used three adjusted regression models to analyze stroke risk: Model 1 was minimally adjusted, model 2 was adjusted for nonmodifiable potential confounders, and model 3 was adjusted for modifiable lifestyle factors.
There was a 23% lower risk of stroke among all postmenopausal women who breastfed compared with those who never breastfed, with women who breastfed between 1 month and 6 months carrying a 19% lower risk of stroke. In the minimally adjusted model, non-Hispanic white women who breastfed carried a 21% lower risk, Hispanic women had an adjusted 32% lower risk, and women of other races and ethnicity had a 24% lower risk of stroke. However, women who were non-Hispanic black had a stronger association with breastfeeding and stroke reduction, with a 48% lower risk, and non-Hispanic white and non-Hispanic black women showed a stronger association between longer duration of breastfeeding and lower stroke risk when results were minimally adjusted, the investigators said. All differences were statistically significant.
The investigators noted the study’s observational nature and said they were not able to determine what caused breastfeeding’s association with lower stroke risk, with other factors potentially affecting results.
“Breastfeeding is only one of many factors that could potentially protect against stroke,” Dr. Jacobson said in the report, published online in the Journal of the American Heart Association. “Others include getting adequate exercise, choosing healthy foods, not smoking, and seeking treatment if needed to keep your blood pressure, cholesterol, and blood sugar in the normal range.”
They also noted potential limitations in the study: the WHI cohort’s low number of strokes in follow-up, lack of classification of stroke, recall bias due to the women self-reporting strokes, average age at baseline, and lack of data on pregnancy.
“Our study did not address whether racial/ethnic differences in breastfeeding contribute to disparities in stroke risk,” Dr. Jacobson said. “Additional research should consider the degree to which breastfeeding might alter racial/ethnic differences in stroke risk.”
“This is an observational, prospective cohort study that was performed very carefully, but it is important to not conclude causality in that breastfeeding results in a reduction in late life stroke,” Larry B. Goldstein, MD, said in an email interview.
Dr. Goldstein, a neurologist who has published several guidelines on primary prevention and early management of stroke with the American Heart Association, noted that although the authors addressed many confounders, studies of this type are still open to residual confounding. He said one of the factors the authors could not measure was eclampsia and preeclampsia, which inhibits breastfeeding.
“The possibility of unmeasured confounding despite how well the study was done is still there. But having said that, the recommendations for breastfeeding are strong from the American Academy of Pediatrics and from the World Health Organization,” and other studies have found an association with a reduction in later life cardiovascular disease, said Dr. Goldstein, the Ruth L. Works professor and chairman in the department of neurology at the University of Kentucky, Lexington. “But just in terms of the benefits to the mother and to the child from breastfeeding, this is another potential plus [in that] even if it doesn’t pan out, it doesn’t really change the recommendation for breastfeeding.”
Dr. Goldstein noted that finding these results in a different prospective cohort would strengthen the recommendations, as would examining whether factors such as lifestyle affected stroke risk for women.
“Showing causality is always going to be difficult,” he stressed. “There is no particular causal mechanism that’s been espoused for how this might decrease stroke risk in later life.”
This study is funded by Frontiers: The Heartland Institute for Clinical and Translational Research and the Wichita Center for Graduate Medical Education–Kansas Bioscience Authority. The WHI program is funded by the National Heart, Lung, and Blood Institute, the National Institutes of Health, and the U.S. Department of Health and Human Services. The authors reported having no conflicts of interest.
SOURCE: Jacobson LT et al. J Am Heart Assoc. 2018 Aug 22. doi:10.1161/JAHA.118.008739.
FROM JOURNAL OF THE AMERICAN HEART ASSOCIATION
Key clinical point:
Major finding: Women who had ever breastfed had a 23% decreased risk of stroke, while breastfeeding between 1 month and 6 months carried a 19% lower risk of stroke.
Study details: A longitudinal national health study of 80,191 postmenopausal women in the Women’s Health Initiative.
Disclosures: This study is funded by the Heartland Institute for Clinical and Translational Research and the Wichita Center for Graduate Medical Education–Kansas Bioscience Authority. The authors reported having no conflicts of interest.
Source: Jacobson LT et al. J Am Heart Assoc. 2018 Aug 22. doi: 10.1161/JAHA.118.008739.
Oral prednisone is not effective for OME in older children
because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
The inclusion criteria for this study were age between 2 and 8 years, which is “generally older” than pediatric patients who develop otitis media with effusion, so the study can apply only to this patient population, Michael E. Pichichero, MD, wrote in a related editorial.
“The pathophysiology of otitis media with effusion and mechanistic work in animal models support the use of systematic steroids for clearing otitis media with effusion,” Dr. Pichichero said. “Given the evidence from trials suggesting that oral steroids alone and in combination with antibiotics help clear otitis media with effusion, the issue remains an open question for children who do not meet the enrollment criteria applied in the current trial.”
Further, he noted that because two-thirds of patients had the condition for a minimum of 12 months were likely to have high viscosity fluid, so-called glue ear, a “temporary opening of the Eustachian tube with 1 week of oral steroids might not have been a fair test.” In addition, pediatric patients with otitis media have a high rate of spontaneous resolution, he said, and noted that Francis et al. addressed the evidence gap with their research.
“Apart from a clear answer about the effect of oral steroids in children aged 2-8 years with prolonged otitis media with effusion, the unique natural history data of otitis media with effusion provided in Francis and colleagues’ study will help inform discussions about whether to opt for grommet surgery or to continue with watchful waiting,” Dr. Pichichero said.
Dr. Pichichero is with the Rochester (N.Y.) General Hospital Research Institute. He reports no relevant conflicts of interest. These comments summarize his editorial on the article by Francis et al. (Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736[18]31862-2 .)
because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.
“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.
Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.
At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.
While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.
“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.
The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.
SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
FROM THE LANCET
Key clinical point: Oral prednisone was well tolerated by children with otitis media with effusion, but there was a high rate of spontaneous resolution in the trial.
Major finding: Acceptable hearing was achieved in 73 of 183 children in the oral steroid group and 59 of 180 children in the placebo group, with a number needed to treat of 14.
Study details: A randomized, parallel, double-blinded, placebo-controlled trial of 389 children aged 2-8 years with symptoms of otitis media with effusion.
Disclosures: The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors report no conflicts of interest.
Source: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.
AAP report: Prioritize play for young children
Pediatricians, parents, and teachers should prioritize play for children under their care because of its significant benefits, such as encouraging learning, building social bonds, and regulating stress, according to a clinical report from the American Academy of Pediatrics.
“We’re recommending that doctors write a prescription for play because it’s so important,” Michael Yogman, MD, of the department of pediatrics at Harvard Medical School, Boston, and Mount Auburn Hospital in Cambridge, Mass., said in a press release.
“Play with parents and peers is fundamentally important for developing a suite of 21st century skills, including social, emotional, language, and cognitive skills, all needed by the next generation in an economically competitive world that requires collaboration and innovation,” he continued. “The benefits of play cannot really be overstated in terms of mitigating stress, improving academic skills, and helping to build the safe, stable, and nurturing relationships that buffer against toxic stress and build social-emotional resilience.”
The report, published in the journal Pediatrics, is an update to a 2007 report that adds new research about the importance of play for children even as society has shifted its focus to “academic readiness” rather than “playful learning.” In the report, the authors cited the numerous benefits of active play for both children and adults. They noted a study of children who were aged 3-4 years that showed a twofold decrease in their anxiety after playing with toys or with their peers for 15 minutes, compared with listening to a teacher read a story. In another study, preschool children who played with blocks at home with minimal adult supervision and guidance had better language acquisition skills after 6 months. Results from studies also have shown that children who had 1 hour each day of active playtime had better creative and multitasking skills. For adults, the authors said playtime is an opportunity for them to “reawaken the joy of childhood and rejuvenate themselves,” as well as a chance to bond and become more effective communicators with their children.
However, Dr. Yogman and his associates noted there are many modern barriers to play. They cited how overscheduling of enrichment programs leaves little time for free play, an increased focus on academic achievement and test scores, the ways that economically challenged families may have less time to play with their children, and safety concerns about playing outdoors as some of the reasons for a decrease in active play among children. Between 1981 and 1997, there was a 25% decrease in the number of children who went outdoors to play once per day, and there is now a 30% decrease in kindergarten children who have access to recess because of an increased focus on academics, they wrote. In addition, the average child of preschool age spends 4.5 hours each day watching television.
“Media use, such as television, video games, smartphone, and tablet apps, [is] increasingly distracting children from play. It’s concerning when immersion in electronic media takes away time for real play, either outdoors or indoors,” Jeffrey Hutchinson, MD, a study coauthor, said in a press release.
“Although active engagement with age-appropriate media can be beneficial for older children, especially if supported by co-watching or co-play with peers or parents, real time social interactions and play are superior to digital media for learning,” said Dr. Hutchinson of the Uniformed Services University, Bethesda, Md.
The AAP made the following recommendations, among many others, to parents, pediatricians, and teachers for encouraging play in children aged 6 years and younger:
- During the first year, parents should place children in different positions so they can crawl, explore, and see their environment from different perspectives.
- Parents should talk to their children so they learn their parents’ voices and answer their children when they babble or coo.
- When children are aged 1-3 years, parents should read to them often and encourage pretend play based on the stories.
- When children are aged 1-3 years, their parents should be encouraged to provide blocks, plastic containers, wooden spoons, and puzzles for play.
- Pediatricians should check in with new parents during the first 2 years and write a “prescription for play” at well visits.
- Educators should promote and encourage unstructured playtime and playful learning, rather than didactic learning, at preschool and school.
- All adult caregivers of children should schedule some form of active play or recess each day.
“The next time your child wants to play with you, say yes. It’s one of the best parts of being a parent and one of the best things you can do for your child,” Dr. Yogman said. “Play helps children learn language, math, and social skills and lowers stress. Play is important both for children and their parents since sharing joyful moments together during play can only enhance their relationship.”
The authors reported no relevant conflicts of interest.
SOURCE: Yogman M et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-2058.
I wholeheartedly agree with the new American Academy of Pediatrics clinical report, “The power of play: A pediatric role in enhancing development in young children.” We should not be surprised that play – and not play structured by predetermined rules such as those in sports or those that are part of lessons such as piano – has such a meaningful role in development. For thousands of years, humans grew up without schools, electricity, and sports leagues and with only apprentice-level training in survival skills. As a result, thousands of hours of children’s activities were self-generated, and these activities, by their nature, encouraged the development of physical, social, and cognitive abilities.
And we still see elements of natural play, especially as we observe babies and toddlers playing – before our culture begins to channel this play activity into more structured, less spontaneous, and less social forms. As Jean Piaget, PhD, observed, play stems from a child’s “need to function” – to move, explore, learn, understand, and integrate the world around them. Watch a 9-month-old drop a toy and learn that it still exists and that dropping it is an interpersonal, fun game. Or watch how a toddler figures out how to stack and knock over some metal pots and pans on the kitchen floor or how 5-year-olds climb all over rocks or jungle gyms in a local park.
Of course, in a complex society like ours, these evolving activities have to be channeled into school, specific skills, and even homework. What the AAP clinical report suggests is that we may be pushing the structure, expectations, and isolation of learning too far, too rigidly, and too prematurely. We may be decreasing natural play below some threshold essential to necessary for skill development, especially that of self-esteem and social skills.
Children have a wide range of developmental paths and adaptability, but too much structure, too much isolation, too much screen time, overly high expectations, and now too little play all can have unanticipated and unhappy consequences.
Michael S. Jellinek, MD, is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. He was asked to comment on the AAP clinical report (http://pediatrics.aappublications.org/content/early/2018/08/16/peds.2018-2058).
I wholeheartedly agree with the new American Academy of Pediatrics clinical report, “The power of play: A pediatric role in enhancing development in young children.” We should not be surprised that play – and not play structured by predetermined rules such as those in sports or those that are part of lessons such as piano – has such a meaningful role in development. For thousands of years, humans grew up without schools, electricity, and sports leagues and with only apprentice-level training in survival skills. As a result, thousands of hours of children’s activities were self-generated, and these activities, by their nature, encouraged the development of physical, social, and cognitive abilities.
And we still see elements of natural play, especially as we observe babies and toddlers playing – before our culture begins to channel this play activity into more structured, less spontaneous, and less social forms. As Jean Piaget, PhD, observed, play stems from a child’s “need to function” – to move, explore, learn, understand, and integrate the world around them. Watch a 9-month-old drop a toy and learn that it still exists and that dropping it is an interpersonal, fun game. Or watch how a toddler figures out how to stack and knock over some metal pots and pans on the kitchen floor or how 5-year-olds climb all over rocks or jungle gyms in a local park.
Of course, in a complex society like ours, these evolving activities have to be channeled into school, specific skills, and even homework. What the AAP clinical report suggests is that we may be pushing the structure, expectations, and isolation of learning too far, too rigidly, and too prematurely. We may be decreasing natural play below some threshold essential to necessary for skill development, especially that of self-esteem and social skills.
Children have a wide range of developmental paths and adaptability, but too much structure, too much isolation, too much screen time, overly high expectations, and now too little play all can have unanticipated and unhappy consequences.
Michael S. Jellinek, MD, is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. He was asked to comment on the AAP clinical report (http://pediatrics.aappublications.org/content/early/2018/08/16/peds.2018-2058).
I wholeheartedly agree with the new American Academy of Pediatrics clinical report, “The power of play: A pediatric role in enhancing development in young children.” We should not be surprised that play – and not play structured by predetermined rules such as those in sports or those that are part of lessons such as piano – has such a meaningful role in development. For thousands of years, humans grew up without schools, electricity, and sports leagues and with only apprentice-level training in survival skills. As a result, thousands of hours of children’s activities were self-generated, and these activities, by their nature, encouraged the development of physical, social, and cognitive abilities.
And we still see elements of natural play, especially as we observe babies and toddlers playing – before our culture begins to channel this play activity into more structured, less spontaneous, and less social forms. As Jean Piaget, PhD, observed, play stems from a child’s “need to function” – to move, explore, learn, understand, and integrate the world around them. Watch a 9-month-old drop a toy and learn that it still exists and that dropping it is an interpersonal, fun game. Or watch how a toddler figures out how to stack and knock over some metal pots and pans on the kitchen floor or how 5-year-olds climb all over rocks or jungle gyms in a local park.
Of course, in a complex society like ours, these evolving activities have to be channeled into school, specific skills, and even homework. What the AAP clinical report suggests is that we may be pushing the structure, expectations, and isolation of learning too far, too rigidly, and too prematurely. We may be decreasing natural play below some threshold essential to necessary for skill development, especially that of self-esteem and social skills.
Children have a wide range of developmental paths and adaptability, but too much structure, too much isolation, too much screen time, overly high expectations, and now too little play all can have unanticipated and unhappy consequences.
Michael S. Jellinek, MD, is professor emeritus of psychiatry and pediatrics at Harvard Medical School, Boston. He was asked to comment on the AAP clinical report (http://pediatrics.aappublications.org/content/early/2018/08/16/peds.2018-2058).
Pediatricians, parents, and teachers should prioritize play for children under their care because of its significant benefits, such as encouraging learning, building social bonds, and regulating stress, according to a clinical report from the American Academy of Pediatrics.
“We’re recommending that doctors write a prescription for play because it’s so important,” Michael Yogman, MD, of the department of pediatrics at Harvard Medical School, Boston, and Mount Auburn Hospital in Cambridge, Mass., said in a press release.
“Play with parents and peers is fundamentally important for developing a suite of 21st century skills, including social, emotional, language, and cognitive skills, all needed by the next generation in an economically competitive world that requires collaboration and innovation,” he continued. “The benefits of play cannot really be overstated in terms of mitigating stress, improving academic skills, and helping to build the safe, stable, and nurturing relationships that buffer against toxic stress and build social-emotional resilience.”
The report, published in the journal Pediatrics, is an update to a 2007 report that adds new research about the importance of play for children even as society has shifted its focus to “academic readiness” rather than “playful learning.” In the report, the authors cited the numerous benefits of active play for both children and adults. They noted a study of children who were aged 3-4 years that showed a twofold decrease in their anxiety after playing with toys or with their peers for 15 minutes, compared with listening to a teacher read a story. In another study, preschool children who played with blocks at home with minimal adult supervision and guidance had better language acquisition skills after 6 months. Results from studies also have shown that children who had 1 hour each day of active playtime had better creative and multitasking skills. For adults, the authors said playtime is an opportunity for them to “reawaken the joy of childhood and rejuvenate themselves,” as well as a chance to bond and become more effective communicators with their children.
However, Dr. Yogman and his associates noted there are many modern barriers to play. They cited how overscheduling of enrichment programs leaves little time for free play, an increased focus on academic achievement and test scores, the ways that economically challenged families may have less time to play with their children, and safety concerns about playing outdoors as some of the reasons for a decrease in active play among children. Between 1981 and 1997, there was a 25% decrease in the number of children who went outdoors to play once per day, and there is now a 30% decrease in kindergarten children who have access to recess because of an increased focus on academics, they wrote. In addition, the average child of preschool age spends 4.5 hours each day watching television.
“Media use, such as television, video games, smartphone, and tablet apps, [is] increasingly distracting children from play. It’s concerning when immersion in electronic media takes away time for real play, either outdoors or indoors,” Jeffrey Hutchinson, MD, a study coauthor, said in a press release.
“Although active engagement with age-appropriate media can be beneficial for older children, especially if supported by co-watching or co-play with peers or parents, real time social interactions and play are superior to digital media for learning,” said Dr. Hutchinson of the Uniformed Services University, Bethesda, Md.
The AAP made the following recommendations, among many others, to parents, pediatricians, and teachers for encouraging play in children aged 6 years and younger:
- During the first year, parents should place children in different positions so they can crawl, explore, and see their environment from different perspectives.
- Parents should talk to their children so they learn their parents’ voices and answer their children when they babble or coo.
- When children are aged 1-3 years, parents should read to them often and encourage pretend play based on the stories.
- When children are aged 1-3 years, their parents should be encouraged to provide blocks, plastic containers, wooden spoons, and puzzles for play.
- Pediatricians should check in with new parents during the first 2 years and write a “prescription for play” at well visits.
- Educators should promote and encourage unstructured playtime and playful learning, rather than didactic learning, at preschool and school.
- All adult caregivers of children should schedule some form of active play or recess each day.
“The next time your child wants to play with you, say yes. It’s one of the best parts of being a parent and one of the best things you can do for your child,” Dr. Yogman said. “Play helps children learn language, math, and social skills and lowers stress. Play is important both for children and their parents since sharing joyful moments together during play can only enhance their relationship.”
The authors reported no relevant conflicts of interest.
SOURCE: Yogman M et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-2058.
Pediatricians, parents, and teachers should prioritize play for children under their care because of its significant benefits, such as encouraging learning, building social bonds, and regulating stress, according to a clinical report from the American Academy of Pediatrics.
“We’re recommending that doctors write a prescription for play because it’s so important,” Michael Yogman, MD, of the department of pediatrics at Harvard Medical School, Boston, and Mount Auburn Hospital in Cambridge, Mass., said in a press release.
“Play with parents and peers is fundamentally important for developing a suite of 21st century skills, including social, emotional, language, and cognitive skills, all needed by the next generation in an economically competitive world that requires collaboration and innovation,” he continued. “The benefits of play cannot really be overstated in terms of mitigating stress, improving academic skills, and helping to build the safe, stable, and nurturing relationships that buffer against toxic stress and build social-emotional resilience.”
The report, published in the journal Pediatrics, is an update to a 2007 report that adds new research about the importance of play for children even as society has shifted its focus to “academic readiness” rather than “playful learning.” In the report, the authors cited the numerous benefits of active play for both children and adults. They noted a study of children who were aged 3-4 years that showed a twofold decrease in their anxiety after playing with toys or with their peers for 15 minutes, compared with listening to a teacher read a story. In another study, preschool children who played with blocks at home with minimal adult supervision and guidance had better language acquisition skills after 6 months. Results from studies also have shown that children who had 1 hour each day of active playtime had better creative and multitasking skills. For adults, the authors said playtime is an opportunity for them to “reawaken the joy of childhood and rejuvenate themselves,” as well as a chance to bond and become more effective communicators with their children.
However, Dr. Yogman and his associates noted there are many modern barriers to play. They cited how overscheduling of enrichment programs leaves little time for free play, an increased focus on academic achievement and test scores, the ways that economically challenged families may have less time to play with their children, and safety concerns about playing outdoors as some of the reasons for a decrease in active play among children. Between 1981 and 1997, there was a 25% decrease in the number of children who went outdoors to play once per day, and there is now a 30% decrease in kindergarten children who have access to recess because of an increased focus on academics, they wrote. In addition, the average child of preschool age spends 4.5 hours each day watching television.
“Media use, such as television, video games, smartphone, and tablet apps, [is] increasingly distracting children from play. It’s concerning when immersion in electronic media takes away time for real play, either outdoors or indoors,” Jeffrey Hutchinson, MD, a study coauthor, said in a press release.
“Although active engagement with age-appropriate media can be beneficial for older children, especially if supported by co-watching or co-play with peers or parents, real time social interactions and play are superior to digital media for learning,” said Dr. Hutchinson of the Uniformed Services University, Bethesda, Md.
The AAP made the following recommendations, among many others, to parents, pediatricians, and teachers for encouraging play in children aged 6 years and younger:
- During the first year, parents should place children in different positions so they can crawl, explore, and see their environment from different perspectives.
- Parents should talk to their children so they learn their parents’ voices and answer their children when they babble or coo.
- When children are aged 1-3 years, parents should read to them often and encourage pretend play based on the stories.
- When children are aged 1-3 years, their parents should be encouraged to provide blocks, plastic containers, wooden spoons, and puzzles for play.
- Pediatricians should check in with new parents during the first 2 years and write a “prescription for play” at well visits.
- Educators should promote and encourage unstructured playtime and playful learning, rather than didactic learning, at preschool and school.
- All adult caregivers of children should schedule some form of active play or recess each day.
“The next time your child wants to play with you, say yes. It’s one of the best parts of being a parent and one of the best things you can do for your child,” Dr. Yogman said. “Play helps children learn language, math, and social skills and lowers stress. Play is important both for children and their parents since sharing joyful moments together during play can only enhance their relationship.”
The authors reported no relevant conflicts of interest.
SOURCE: Yogman M et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-2058.
FROM PEDIATRICS
AAN and others update practice guidelines for prolonged disorders of consciousness
An updated set of practice guidelines developed by the American Academy of Neurology recommends that patients with prolonged disorders of consciousness, such as a vegetative state or minimally conscious state, first undergo treatment for other outside symptoms and conditions to increase the likelihood of initial accurate diagnosis. The AAN also recommends that patients be evaluated by multidisciplinary specialists using standardized neurobehavioral assessments.
“People are sometimes misdiagnosed due to underlying impairments that can mask awareness,” guidelines first author Joseph T. Giacino, PhD, of Harvard Medical School, Boston, and Spaulding Rehabilitation Hospital, Charlestown, Mass., stated in a press release about the guidelines. “An inaccurate diagnosis can lead to inappropriate care decisions and poor health outcomes. Misdiagnosis may result in premature or inappropriate treatment withdrawal, failure to recommend beneficial rehabilitative treatments, and worse outcome. That is why an early and accurate diagnosis is so important.”
The practice guidelines, published Aug. 8 in Neurology, update the 1995 recommendations from the AAN on persistent vegetative state (VS) as well as a 2002 case definition of minimally conscious state (MCS) developed by the AAN, American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research. In the new document, these same organizations made 18 recommendations about prolonged disorders of consciousness (DoC) based on three levels of evidence: Level A evidence was defined as the strongest recommendation, Level B evidence consisted of recommendations with a confident rationale and a “favorable benefit-risk profile,” and Level C evidence was the lowest level of recommendation that was still useful to clinical practice. Evidence was grouped into four different classifications based on the modified Grading of Recommendations Assessment, Development, and Evaluation process in a systematic review and based on “strong related evidence, established principles of care, and inferences.”
In the guidelines, the committee made the following recommendations:
- Medically stable patients with DoC should be moved to multidisciplinary care settings where specialists can “optimize diagnostic evaluation, prognostication, and subsequent management, including effective medical monitoring and rehabilitative care” (Level B).
- Patients should receive care for confounding conditions, receive serial standardized assessments, and undergo care that “optimizes arousal” to maximize initial accurate diagnoses (Level B).
- Clinicians should communicate to families of patients with prolonged DoC that adult patients in an MCS caused by traumatic injury tend to have “more favorable outcomes,” compared with patients who are in a VS and patients with unresponsive wakefulness syndrome (UWS) caused by a nontraumatic injury (Level B).
- Clinicians must discuss long-term care with families of patients with prolonged DoC and a poor prognosis (Level A), indicate that not all patients of this type have a poor prognosis, administer Coma Recovery Scale–Revised, and perform imaging, such as structural MRI and single-photon emission CT, to determine prognosis in these patients (Level B).
- Regarding discussion of long-term care with families of children with prolonged DoC, clinicians should acknowledge that prognostic assessment, treatment, and natural history of recovery is not well-defined for children with prolonged DoC (Level B).
- In patients with traumatic VS, UWS, or MCS, amantadine should be prescribed (100-200 mg) between 4 weeks and 16 weeks after injury to lower the risk of disability and increase the likelihood of functional recovery (Level B).
- Clinicians should always assess and treat pain as well as discuss “evidence supporting treatment approaches” (Level B).
In addition, the subcommittee recommended changing the term permanent VS to chronic VS/UWS, citing Level B evidence. “Continued use of the term permanent VS is not justified. Use of this term implies irreversibility, which is not supported by the current research and has implications for family counseling, decision making, and the ethics of the field,” Dr. Giacino and his colleagues wrote.
In a separate summary of the guidelines, Dr. Giacino and his colleagues expressed concern about the lack of moderate or strong evidence for diagnostic assessment procedures in the literature, which they partially attributed to the inclusion of patients out 28 days or less from their injury in the systematic review for the guidelines. They further noted the lack of a gold-standard diagnostic approach for these patients, a lack of masking in diagnostic studies and tracking of recovery milestones and long-term functional outcomes for patients, and the limitations of the mainly retrospective analyses of outcomes in studies that they included. In addition, Dr. Giacino and his colleagues noted a lack of therapeutic studies with patients in inpatient rehabilitation centers and a “tendency by insurers to preferentially authorize rehabilitative care in lower-cost settings.” They excluded studies that had less than 20 patients, no control group, and were not “methodologically sound.”
Shorter lengths of stay in inpatient rehabilitation at academic medical centers have also led to problems in recruiting for placebo-controlled clinical trials, they noted.
“Under these circumstances, family members are often reticent to enroll patients with prolonged DoC in a placebo-controlled trial in view of the 50% likelihood of assignment to the placebo arm, preventing any possibility of active treatment during rehabilitation apart from routine physical, occupational, and speech therapies,” the authors wrote.
Several of the guidelines’ 16 authors disclosed ties to publishing houses and commercial or government entities, and participate in other activities related to the content of the published guidelines. Please see the full study for a complete list of disclosures.
The American Academy of Neurology Guideline on Disorders of Consciousness should be lauded for its focus on rehabilitation of this population, but it misses an opportunity to address “the broader ethical implications for patient care and institutional reform,” Joseph J. Fins, MD, and James L. Bernat, MD, wrote in a related editorial.
The authors commended the guidelines for recommending a change in reclassifying permanent vegetative state (VS) as “chronic vegetative state” but noted that the designation may be too broad, considering it encompasses patients who were misdiagnosed, patients who improved after treatment, patients with cognitive-motor disassociation, and patients who have undergone late improvements to achieve some level of consciousness. Defining these patients to clarify their prognoses will be important in determining which patients with VS are able to make late improvements, they said.
“While this redesignation seems warranted on clinical and epidemiologic grounds, it will create repercussions beyond the house of medicine given that the right to refuse life-sustaining treatment initially was predicated upon the irreversibility of the VS,” the authors wrote.
Dr. Fins and Dr. Bernat also acknowledged the seemingly contradictory recommendation of systematizing the care of patients with prolonged disorders of consciousness given that the infrastructure to provide this care is unavailable and unaffordable for many patients.
“Now that the Guideline has stipulated benchmarks for practice, practitioners and institutions need to meet this standard of care, and payers must ensure that these services are covered. It is acceptable neither to plead ignorance of these conditions nor to assert that nothing can be done to help ameliorate the burden of severe brain injury,” the authors wrote. “Given the utility of greater specialized care in diagnosis, treatment, and rehabilitation, and the equal importance of avoiding medical complications that can impede recovery, our society must provide the infrastructure and resources needed to offer quality care.”
Dr. Fins is with the division of medical ethics and the Consortium for the Advanced Study of Brain Injury at Cornell University, New York. Dr. Bernat is with the departments of neurology and medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. They receive royalties from several published books that are relevant to the content of the guidelines.
The American Academy of Neurology Guideline on Disorders of Consciousness should be lauded for its focus on rehabilitation of this population, but it misses an opportunity to address “the broader ethical implications for patient care and institutional reform,” Joseph J. Fins, MD, and James L. Bernat, MD, wrote in a related editorial.
The authors commended the guidelines for recommending a change in reclassifying permanent vegetative state (VS) as “chronic vegetative state” but noted that the designation may be too broad, considering it encompasses patients who were misdiagnosed, patients who improved after treatment, patients with cognitive-motor disassociation, and patients who have undergone late improvements to achieve some level of consciousness. Defining these patients to clarify their prognoses will be important in determining which patients with VS are able to make late improvements, they said.
“While this redesignation seems warranted on clinical and epidemiologic grounds, it will create repercussions beyond the house of medicine given that the right to refuse life-sustaining treatment initially was predicated upon the irreversibility of the VS,” the authors wrote.
Dr. Fins and Dr. Bernat also acknowledged the seemingly contradictory recommendation of systematizing the care of patients with prolonged disorders of consciousness given that the infrastructure to provide this care is unavailable and unaffordable for many patients.
“Now that the Guideline has stipulated benchmarks for practice, practitioners and institutions need to meet this standard of care, and payers must ensure that these services are covered. It is acceptable neither to plead ignorance of these conditions nor to assert that nothing can be done to help ameliorate the burden of severe brain injury,” the authors wrote. “Given the utility of greater specialized care in diagnosis, treatment, and rehabilitation, and the equal importance of avoiding medical complications that can impede recovery, our society must provide the infrastructure and resources needed to offer quality care.”
Dr. Fins is with the division of medical ethics and the Consortium for the Advanced Study of Brain Injury at Cornell University, New York. Dr. Bernat is with the departments of neurology and medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. They receive royalties from several published books that are relevant to the content of the guidelines.
The American Academy of Neurology Guideline on Disorders of Consciousness should be lauded for its focus on rehabilitation of this population, but it misses an opportunity to address “the broader ethical implications for patient care and institutional reform,” Joseph J. Fins, MD, and James L. Bernat, MD, wrote in a related editorial.
The authors commended the guidelines for recommending a change in reclassifying permanent vegetative state (VS) as “chronic vegetative state” but noted that the designation may be too broad, considering it encompasses patients who were misdiagnosed, patients who improved after treatment, patients with cognitive-motor disassociation, and patients who have undergone late improvements to achieve some level of consciousness. Defining these patients to clarify their prognoses will be important in determining which patients with VS are able to make late improvements, they said.
“While this redesignation seems warranted on clinical and epidemiologic grounds, it will create repercussions beyond the house of medicine given that the right to refuse life-sustaining treatment initially was predicated upon the irreversibility of the VS,” the authors wrote.
Dr. Fins and Dr. Bernat also acknowledged the seemingly contradictory recommendation of systematizing the care of patients with prolonged disorders of consciousness given that the infrastructure to provide this care is unavailable and unaffordable for many patients.
“Now that the Guideline has stipulated benchmarks for practice, practitioners and institutions need to meet this standard of care, and payers must ensure that these services are covered. It is acceptable neither to plead ignorance of these conditions nor to assert that nothing can be done to help ameliorate the burden of severe brain injury,” the authors wrote. “Given the utility of greater specialized care in diagnosis, treatment, and rehabilitation, and the equal importance of avoiding medical complications that can impede recovery, our society must provide the infrastructure and resources needed to offer quality care.”
Dr. Fins is with the division of medical ethics and the Consortium for the Advanced Study of Brain Injury at Cornell University, New York. Dr. Bernat is with the departments of neurology and medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. They receive royalties from several published books that are relevant to the content of the guidelines.
An updated set of practice guidelines developed by the American Academy of Neurology recommends that patients with prolonged disorders of consciousness, such as a vegetative state or minimally conscious state, first undergo treatment for other outside symptoms and conditions to increase the likelihood of initial accurate diagnosis. The AAN also recommends that patients be evaluated by multidisciplinary specialists using standardized neurobehavioral assessments.
“People are sometimes misdiagnosed due to underlying impairments that can mask awareness,” guidelines first author Joseph T. Giacino, PhD, of Harvard Medical School, Boston, and Spaulding Rehabilitation Hospital, Charlestown, Mass., stated in a press release about the guidelines. “An inaccurate diagnosis can lead to inappropriate care decisions and poor health outcomes. Misdiagnosis may result in premature or inappropriate treatment withdrawal, failure to recommend beneficial rehabilitative treatments, and worse outcome. That is why an early and accurate diagnosis is so important.”
The practice guidelines, published Aug. 8 in Neurology, update the 1995 recommendations from the AAN on persistent vegetative state (VS) as well as a 2002 case definition of minimally conscious state (MCS) developed by the AAN, American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research. In the new document, these same organizations made 18 recommendations about prolonged disorders of consciousness (DoC) based on three levels of evidence: Level A evidence was defined as the strongest recommendation, Level B evidence consisted of recommendations with a confident rationale and a “favorable benefit-risk profile,” and Level C evidence was the lowest level of recommendation that was still useful to clinical practice. Evidence was grouped into four different classifications based on the modified Grading of Recommendations Assessment, Development, and Evaluation process in a systematic review and based on “strong related evidence, established principles of care, and inferences.”
In the guidelines, the committee made the following recommendations:
- Medically stable patients with DoC should be moved to multidisciplinary care settings where specialists can “optimize diagnostic evaluation, prognostication, and subsequent management, including effective medical monitoring and rehabilitative care” (Level B).
- Patients should receive care for confounding conditions, receive serial standardized assessments, and undergo care that “optimizes arousal” to maximize initial accurate diagnoses (Level B).
- Clinicians should communicate to families of patients with prolonged DoC that adult patients in an MCS caused by traumatic injury tend to have “more favorable outcomes,” compared with patients who are in a VS and patients with unresponsive wakefulness syndrome (UWS) caused by a nontraumatic injury (Level B).
- Clinicians must discuss long-term care with families of patients with prolonged DoC and a poor prognosis (Level A), indicate that not all patients of this type have a poor prognosis, administer Coma Recovery Scale–Revised, and perform imaging, such as structural MRI and single-photon emission CT, to determine prognosis in these patients (Level B).
- Regarding discussion of long-term care with families of children with prolonged DoC, clinicians should acknowledge that prognostic assessment, treatment, and natural history of recovery is not well-defined for children with prolonged DoC (Level B).
- In patients with traumatic VS, UWS, or MCS, amantadine should be prescribed (100-200 mg) between 4 weeks and 16 weeks after injury to lower the risk of disability and increase the likelihood of functional recovery (Level B).
- Clinicians should always assess and treat pain as well as discuss “evidence supporting treatment approaches” (Level B).
In addition, the subcommittee recommended changing the term permanent VS to chronic VS/UWS, citing Level B evidence. “Continued use of the term permanent VS is not justified. Use of this term implies irreversibility, which is not supported by the current research and has implications for family counseling, decision making, and the ethics of the field,” Dr. Giacino and his colleagues wrote.
In a separate summary of the guidelines, Dr. Giacino and his colleagues expressed concern about the lack of moderate or strong evidence for diagnostic assessment procedures in the literature, which they partially attributed to the inclusion of patients out 28 days or less from their injury in the systematic review for the guidelines. They further noted the lack of a gold-standard diagnostic approach for these patients, a lack of masking in diagnostic studies and tracking of recovery milestones and long-term functional outcomes for patients, and the limitations of the mainly retrospective analyses of outcomes in studies that they included. In addition, Dr. Giacino and his colleagues noted a lack of therapeutic studies with patients in inpatient rehabilitation centers and a “tendency by insurers to preferentially authorize rehabilitative care in lower-cost settings.” They excluded studies that had less than 20 patients, no control group, and were not “methodologically sound.”
Shorter lengths of stay in inpatient rehabilitation at academic medical centers have also led to problems in recruiting for placebo-controlled clinical trials, they noted.
“Under these circumstances, family members are often reticent to enroll patients with prolonged DoC in a placebo-controlled trial in view of the 50% likelihood of assignment to the placebo arm, preventing any possibility of active treatment during rehabilitation apart from routine physical, occupational, and speech therapies,” the authors wrote.
Several of the guidelines’ 16 authors disclosed ties to publishing houses and commercial or government entities, and participate in other activities related to the content of the published guidelines. Please see the full study for a complete list of disclosures.
An updated set of practice guidelines developed by the American Academy of Neurology recommends that patients with prolonged disorders of consciousness, such as a vegetative state or minimally conscious state, first undergo treatment for other outside symptoms and conditions to increase the likelihood of initial accurate diagnosis. The AAN also recommends that patients be evaluated by multidisciplinary specialists using standardized neurobehavioral assessments.
“People are sometimes misdiagnosed due to underlying impairments that can mask awareness,” guidelines first author Joseph T. Giacino, PhD, of Harvard Medical School, Boston, and Spaulding Rehabilitation Hospital, Charlestown, Mass., stated in a press release about the guidelines. “An inaccurate diagnosis can lead to inappropriate care decisions and poor health outcomes. Misdiagnosis may result in premature or inappropriate treatment withdrawal, failure to recommend beneficial rehabilitative treatments, and worse outcome. That is why an early and accurate diagnosis is so important.”
The practice guidelines, published Aug. 8 in Neurology, update the 1995 recommendations from the AAN on persistent vegetative state (VS) as well as a 2002 case definition of minimally conscious state (MCS) developed by the AAN, American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research. In the new document, these same organizations made 18 recommendations about prolonged disorders of consciousness (DoC) based on three levels of evidence: Level A evidence was defined as the strongest recommendation, Level B evidence consisted of recommendations with a confident rationale and a “favorable benefit-risk profile,” and Level C evidence was the lowest level of recommendation that was still useful to clinical practice. Evidence was grouped into four different classifications based on the modified Grading of Recommendations Assessment, Development, and Evaluation process in a systematic review and based on “strong related evidence, established principles of care, and inferences.”
In the guidelines, the committee made the following recommendations:
- Medically stable patients with DoC should be moved to multidisciplinary care settings where specialists can “optimize diagnostic evaluation, prognostication, and subsequent management, including effective medical monitoring and rehabilitative care” (Level B).
- Patients should receive care for confounding conditions, receive serial standardized assessments, and undergo care that “optimizes arousal” to maximize initial accurate diagnoses (Level B).
- Clinicians should communicate to families of patients with prolonged DoC that adult patients in an MCS caused by traumatic injury tend to have “more favorable outcomes,” compared with patients who are in a VS and patients with unresponsive wakefulness syndrome (UWS) caused by a nontraumatic injury (Level B).
- Clinicians must discuss long-term care with families of patients with prolonged DoC and a poor prognosis (Level A), indicate that not all patients of this type have a poor prognosis, administer Coma Recovery Scale–Revised, and perform imaging, such as structural MRI and single-photon emission CT, to determine prognosis in these patients (Level B).
- Regarding discussion of long-term care with families of children with prolonged DoC, clinicians should acknowledge that prognostic assessment, treatment, and natural history of recovery is not well-defined for children with prolonged DoC (Level B).
- In patients with traumatic VS, UWS, or MCS, amantadine should be prescribed (100-200 mg) between 4 weeks and 16 weeks after injury to lower the risk of disability and increase the likelihood of functional recovery (Level B).
- Clinicians should always assess and treat pain as well as discuss “evidence supporting treatment approaches” (Level B).
In addition, the subcommittee recommended changing the term permanent VS to chronic VS/UWS, citing Level B evidence. “Continued use of the term permanent VS is not justified. Use of this term implies irreversibility, which is not supported by the current research and has implications for family counseling, decision making, and the ethics of the field,” Dr. Giacino and his colleagues wrote.
In a separate summary of the guidelines, Dr. Giacino and his colleagues expressed concern about the lack of moderate or strong evidence for diagnostic assessment procedures in the literature, which they partially attributed to the inclusion of patients out 28 days or less from their injury in the systematic review for the guidelines. They further noted the lack of a gold-standard diagnostic approach for these patients, a lack of masking in diagnostic studies and tracking of recovery milestones and long-term functional outcomes for patients, and the limitations of the mainly retrospective analyses of outcomes in studies that they included. In addition, Dr. Giacino and his colleagues noted a lack of therapeutic studies with patients in inpatient rehabilitation centers and a “tendency by insurers to preferentially authorize rehabilitative care in lower-cost settings.” They excluded studies that had less than 20 patients, no control group, and were not “methodologically sound.”
Shorter lengths of stay in inpatient rehabilitation at academic medical centers have also led to problems in recruiting for placebo-controlled clinical trials, they noted.
“Under these circumstances, family members are often reticent to enroll patients with prolonged DoC in a placebo-controlled trial in view of the 50% likelihood of assignment to the placebo arm, preventing any possibility of active treatment during rehabilitation apart from routine physical, occupational, and speech therapies,” the authors wrote.
Several of the guidelines’ 16 authors disclosed ties to publishing houses and commercial or government entities, and participate in other activities related to the content of the published guidelines. Please see the full study for a complete list of disclosures.
FROM NEUROLOGY
Two approaches lowered opioid use after cesarean deliveries
An individual prescribing plan based on inpatient use for women who delivered by cesarean section was associated with a lower number of unused oxycodone tablets, according to research published in Obstetrics & Gynecology.
In a second study, there was a significantly lower number of opioid tablets prescribed for women who delivered by cesarean section after a shared decision-making quality improvement plan was implemented on an inpatient basis.
Sarah S. Osmundson, MD, MS, of Vanderbilt University Medical Center in Nashville, Tenn., and her colleagues conducted a randomized, controlled trial of women who underwent cesarean delivery between June and August 2017. Of these women, 85 were randomized to receive standard care of 30 oxycodone tablets (5 mg) and 87 received an individualized care plan based on inpatient use of oxycodone. Patients were a minimum of 18 years old with similar baseline characteristics and inpatient pain scores.
The investigators found that women who were randomized to the individual care group received 14 oxycodone tablets (interquartile range, 12-16) and had 5 tablets (IQR, 1-8) left 2 weeks after discharge, compared with women who were prescribed 30 tablets in the standard care group (IQR, 30-30; P less than .001) and left 10 tablets unused (IQR, 0-22; P less than .001). There were no significant differences regarding patient-reported pain outcomes in either group, and women used about half as many prescribed tablets in the individualized group (8; IQR, 4-14), compared with women in the standard care group (15; IQR, 6-30; P less than .001).
Most women reported that they used opioids to treat pain and 30% said they believed they were supposed to finish all the tablets that were prescribed, the researchers noted. There were 11 patients (13%) in the standard care group and 12 (14%) in the individualized group who did not use any opioids; similarly, 23 patients (27%) in the standard care group and 21 (24%) in the individual care group used all tablets prescribed.
“If pain were the only determinant of opioid use, randomization should yield similar opioid use in both study groups,” Dr. Osmundson and her colleagues wrote. “These findings suggest that factors other than pain influence opioid use patterns.”
In a second study, Malavika Prabhu, MD, of Massachusetts General Hospital in Boston, and her colleagues employed a prospective quality improvement (QI) initiative for women prescribed opioids after cesarean delivery. They evaluated the opioid use of 624 women and counseled them at discharge on the need for prescription opioids, using shared decision-making to determine the number of opioid tablets, with a maximum number of 30 oxycodone tablets (5 mg). The investigators also changed their protocol for multimodal analgesia to scheduled acetaminophen and NSAIDs. Patients were a mean of 30 years old and more than 50% were white. Median gestational age was 39 weeks at delivery. In a second phase of the study, the investigators lowered the maximum number of opioid tablets prescribed to 25 tablets.
At discharge, the mean number of prescribed opioid tablets decreased to 27 tablets from 33 tablets in phase 1 (P less than .01). In phase 2, the number of tablets further decreased to 22 tablets from 25 tablets (P less than .01). The investigators noted no significant difference in the refill rate during phase 1 (8% vs. 9%; P less than .79) and phase 2 (6% vs. 6%; P = .72). There was a significant increase in prescribing of acetaminophen from 33% at baseline to 77% at the end of phase 1 and an increase at the beginning of phase 2 at 91% to 92% at the end of phase 2. There were no statistically significant differences among prescriptions of ibuprofen at any phase time point.
“As a result of our success in decreasing opioid prescribing after cesarean delivery, our current protocol has again been amended to recommend a maximum of 20 tablets of 5-mg oxycodone (or equivalent opioid) prescribed at the time of discharge,” Dr. Prabhu and her colleagues wrote. “This decrease, which represents a 50% decrease in the departmental standard before this study, has been successfully implemented in 18 months. In addition, efforts to optimize multimodal analgesic use continue both inpatient and on discharge.”
Dr. Osmundson was supported by a grant from the National Institutes of Health, and the research also was supported by an award from the National Center for Advancing Translational Sciences; the authors of the study reported no relevant conflicts of interest. The authors led by Dr. Prabhu had no relevant financial disclosures.
SOURCE: Prabhu M et al. Obstet Gyncol. 2018 Aug 4; doi: 10.1097/AOG.0000000000002789, and Osmundson SS et al. Obstet Gynecol. 2018 Aug 6; doi: 10.1097/AOG.0000000000002782.
While overprescribing opioids for women after cesarean delivery will probably have little effect on the opioid crisis, reducing prescription rates for these women post partum still has benefits for mother and child, Bankole Johnson, MD, DSc, said in an interview.
“The larger problem is with mothers who are dependent on opiates who get pregnant,” Dr. Johnson said. “These mothers give birth to children who need significant support and weaning off opiates, sometime in the NICU, and the mother also has to be treated by the addiction services. Sometimes, the mother simply abandons the baby who is difficult to nurse and comfort because he or she is weaning off opiates.”
Dr. Johnson said overprescribing has three main implications or risks: a risk of developing dependence in newborn babies that are breastfed, an increased risk of dependence for the mother, and a decrease in nurturing skills and bonding from the mother due to high opioid use.
He said these studies had “notable caveats” and noted there may not be much clinical significance because of the small numeric difference in opioid use.
“The best take-home message from these papers is that individualized care with supportive services decreases opioid use and optimizes the care of mothers and their babies after a cesarean section,” he said.
Dr. Johnson is the Dr. Irving J. Taylor Professor and Chair in the department of psychiatry; professor of both neurology and pharmacology, among others; and director of the Brain Science Research Consortium Unit at the University of Maryland, Baltimore. He had no relevant financial disclosures.
While overprescribing opioids for women after cesarean delivery will probably have little effect on the opioid crisis, reducing prescription rates for these women post partum still has benefits for mother and child, Bankole Johnson, MD, DSc, said in an interview.
“The larger problem is with mothers who are dependent on opiates who get pregnant,” Dr. Johnson said. “These mothers give birth to children who need significant support and weaning off opiates, sometime in the NICU, and the mother also has to be treated by the addiction services. Sometimes, the mother simply abandons the baby who is difficult to nurse and comfort because he or she is weaning off opiates.”
Dr. Johnson said overprescribing has three main implications or risks: a risk of developing dependence in newborn babies that are breastfed, an increased risk of dependence for the mother, and a decrease in nurturing skills and bonding from the mother due to high opioid use.
He said these studies had “notable caveats” and noted there may not be much clinical significance because of the small numeric difference in opioid use.
“The best take-home message from these papers is that individualized care with supportive services decreases opioid use and optimizes the care of mothers and their babies after a cesarean section,” he said.
Dr. Johnson is the Dr. Irving J. Taylor Professor and Chair in the department of psychiatry; professor of both neurology and pharmacology, among others; and director of the Brain Science Research Consortium Unit at the University of Maryland, Baltimore. He had no relevant financial disclosures.
While overprescribing opioids for women after cesarean delivery will probably have little effect on the opioid crisis, reducing prescription rates for these women post partum still has benefits for mother and child, Bankole Johnson, MD, DSc, said in an interview.
“The larger problem is with mothers who are dependent on opiates who get pregnant,” Dr. Johnson said. “These mothers give birth to children who need significant support and weaning off opiates, sometime in the NICU, and the mother also has to be treated by the addiction services. Sometimes, the mother simply abandons the baby who is difficult to nurse and comfort because he or she is weaning off opiates.”
Dr. Johnson said overprescribing has three main implications or risks: a risk of developing dependence in newborn babies that are breastfed, an increased risk of dependence for the mother, and a decrease in nurturing skills and bonding from the mother due to high opioid use.
He said these studies had “notable caveats” and noted there may not be much clinical significance because of the small numeric difference in opioid use.
“The best take-home message from these papers is that individualized care with supportive services decreases opioid use and optimizes the care of mothers and their babies after a cesarean section,” he said.
Dr. Johnson is the Dr. Irving J. Taylor Professor and Chair in the department of psychiatry; professor of both neurology and pharmacology, among others; and director of the Brain Science Research Consortium Unit at the University of Maryland, Baltimore. He had no relevant financial disclosures.
An individual prescribing plan based on inpatient use for women who delivered by cesarean section was associated with a lower number of unused oxycodone tablets, according to research published in Obstetrics & Gynecology.
In a second study, there was a significantly lower number of opioid tablets prescribed for women who delivered by cesarean section after a shared decision-making quality improvement plan was implemented on an inpatient basis.
Sarah S. Osmundson, MD, MS, of Vanderbilt University Medical Center in Nashville, Tenn., and her colleagues conducted a randomized, controlled trial of women who underwent cesarean delivery between June and August 2017. Of these women, 85 were randomized to receive standard care of 30 oxycodone tablets (5 mg) and 87 received an individualized care plan based on inpatient use of oxycodone. Patients were a minimum of 18 years old with similar baseline characteristics and inpatient pain scores.
The investigators found that women who were randomized to the individual care group received 14 oxycodone tablets (interquartile range, 12-16) and had 5 tablets (IQR, 1-8) left 2 weeks after discharge, compared with women who were prescribed 30 tablets in the standard care group (IQR, 30-30; P less than .001) and left 10 tablets unused (IQR, 0-22; P less than .001). There were no significant differences regarding patient-reported pain outcomes in either group, and women used about half as many prescribed tablets in the individualized group (8; IQR, 4-14), compared with women in the standard care group (15; IQR, 6-30; P less than .001).
Most women reported that they used opioids to treat pain and 30% said they believed they were supposed to finish all the tablets that were prescribed, the researchers noted. There were 11 patients (13%) in the standard care group and 12 (14%) in the individualized group who did not use any opioids; similarly, 23 patients (27%) in the standard care group and 21 (24%) in the individual care group used all tablets prescribed.
“If pain were the only determinant of opioid use, randomization should yield similar opioid use in both study groups,” Dr. Osmundson and her colleagues wrote. “These findings suggest that factors other than pain influence opioid use patterns.”
In a second study, Malavika Prabhu, MD, of Massachusetts General Hospital in Boston, and her colleagues employed a prospective quality improvement (QI) initiative for women prescribed opioids after cesarean delivery. They evaluated the opioid use of 624 women and counseled them at discharge on the need for prescription opioids, using shared decision-making to determine the number of opioid tablets, with a maximum number of 30 oxycodone tablets (5 mg). The investigators also changed their protocol for multimodal analgesia to scheduled acetaminophen and NSAIDs. Patients were a mean of 30 years old and more than 50% were white. Median gestational age was 39 weeks at delivery. In a second phase of the study, the investigators lowered the maximum number of opioid tablets prescribed to 25 tablets.
At discharge, the mean number of prescribed opioid tablets decreased to 27 tablets from 33 tablets in phase 1 (P less than .01). In phase 2, the number of tablets further decreased to 22 tablets from 25 tablets (P less than .01). The investigators noted no significant difference in the refill rate during phase 1 (8% vs. 9%; P less than .79) and phase 2 (6% vs. 6%; P = .72). There was a significant increase in prescribing of acetaminophen from 33% at baseline to 77% at the end of phase 1 and an increase at the beginning of phase 2 at 91% to 92% at the end of phase 2. There were no statistically significant differences among prescriptions of ibuprofen at any phase time point.
“As a result of our success in decreasing opioid prescribing after cesarean delivery, our current protocol has again been amended to recommend a maximum of 20 tablets of 5-mg oxycodone (or equivalent opioid) prescribed at the time of discharge,” Dr. Prabhu and her colleagues wrote. “This decrease, which represents a 50% decrease in the departmental standard before this study, has been successfully implemented in 18 months. In addition, efforts to optimize multimodal analgesic use continue both inpatient and on discharge.”
Dr. Osmundson was supported by a grant from the National Institutes of Health, and the research also was supported by an award from the National Center for Advancing Translational Sciences; the authors of the study reported no relevant conflicts of interest. The authors led by Dr. Prabhu had no relevant financial disclosures.
SOURCE: Prabhu M et al. Obstet Gyncol. 2018 Aug 4; doi: 10.1097/AOG.0000000000002789, and Osmundson SS et al. Obstet Gynecol. 2018 Aug 6; doi: 10.1097/AOG.0000000000002782.
An individual prescribing plan based on inpatient use for women who delivered by cesarean section was associated with a lower number of unused oxycodone tablets, according to research published in Obstetrics & Gynecology.
In a second study, there was a significantly lower number of opioid tablets prescribed for women who delivered by cesarean section after a shared decision-making quality improvement plan was implemented on an inpatient basis.
Sarah S. Osmundson, MD, MS, of Vanderbilt University Medical Center in Nashville, Tenn., and her colleagues conducted a randomized, controlled trial of women who underwent cesarean delivery between June and August 2017. Of these women, 85 were randomized to receive standard care of 30 oxycodone tablets (5 mg) and 87 received an individualized care plan based on inpatient use of oxycodone. Patients were a minimum of 18 years old with similar baseline characteristics and inpatient pain scores.
The investigators found that women who were randomized to the individual care group received 14 oxycodone tablets (interquartile range, 12-16) and had 5 tablets (IQR, 1-8) left 2 weeks after discharge, compared with women who were prescribed 30 tablets in the standard care group (IQR, 30-30; P less than .001) and left 10 tablets unused (IQR, 0-22; P less than .001). There were no significant differences regarding patient-reported pain outcomes in either group, and women used about half as many prescribed tablets in the individualized group (8; IQR, 4-14), compared with women in the standard care group (15; IQR, 6-30; P less than .001).
Most women reported that they used opioids to treat pain and 30% said they believed they were supposed to finish all the tablets that were prescribed, the researchers noted. There were 11 patients (13%) in the standard care group and 12 (14%) in the individualized group who did not use any opioids; similarly, 23 patients (27%) in the standard care group and 21 (24%) in the individual care group used all tablets prescribed.
“If pain were the only determinant of opioid use, randomization should yield similar opioid use in both study groups,” Dr. Osmundson and her colleagues wrote. “These findings suggest that factors other than pain influence opioid use patterns.”
In a second study, Malavika Prabhu, MD, of Massachusetts General Hospital in Boston, and her colleagues employed a prospective quality improvement (QI) initiative for women prescribed opioids after cesarean delivery. They evaluated the opioid use of 624 women and counseled them at discharge on the need for prescription opioids, using shared decision-making to determine the number of opioid tablets, with a maximum number of 30 oxycodone tablets (5 mg). The investigators also changed their protocol for multimodal analgesia to scheduled acetaminophen and NSAIDs. Patients were a mean of 30 years old and more than 50% were white. Median gestational age was 39 weeks at delivery. In a second phase of the study, the investigators lowered the maximum number of opioid tablets prescribed to 25 tablets.
At discharge, the mean number of prescribed opioid tablets decreased to 27 tablets from 33 tablets in phase 1 (P less than .01). In phase 2, the number of tablets further decreased to 22 tablets from 25 tablets (P less than .01). The investigators noted no significant difference in the refill rate during phase 1 (8% vs. 9%; P less than .79) and phase 2 (6% vs. 6%; P = .72). There was a significant increase in prescribing of acetaminophen from 33% at baseline to 77% at the end of phase 1 and an increase at the beginning of phase 2 at 91% to 92% at the end of phase 2. There were no statistically significant differences among prescriptions of ibuprofen at any phase time point.
“As a result of our success in decreasing opioid prescribing after cesarean delivery, our current protocol has again been amended to recommend a maximum of 20 tablets of 5-mg oxycodone (or equivalent opioid) prescribed at the time of discharge,” Dr. Prabhu and her colleagues wrote. “This decrease, which represents a 50% decrease in the departmental standard before this study, has been successfully implemented in 18 months. In addition, efforts to optimize multimodal analgesic use continue both inpatient and on discharge.”
Dr. Osmundson was supported by a grant from the National Institutes of Health, and the research also was supported by an award from the National Center for Advancing Translational Sciences; the authors of the study reported no relevant conflicts of interest. The authors led by Dr. Prabhu had no relevant financial disclosures.
SOURCE: Prabhu M et al. Obstet Gyncol. 2018 Aug 4; doi: 10.1097/AOG.0000000000002789, and Osmundson SS et al. Obstet Gynecol. 2018 Aug 6; doi: 10.1097/AOG.0000000000002782.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Individualized opioid prescription and a quality improvement plan for opioid prescribing among women who underwent cesarean delivery lowered the number of overall tablets used among these patients.
Major finding: Patients who were prescribed at discharge the number of inpatient opioid tablets used had fewer leftover tablets than did patients prescribed the standard of care; there was a mean lower number of opioid tablets prescribed after delivery in the study with a quality improvement plan, from 33 tablets to 27 tablets.
Data source: A randomized controlled trial of 323 women who underwent cesarean delivery and were prescribed opioid tablets, and a quality improvement trial of 624 women.
Disclosures: Dr. Osmundson was supported by a grant from the National Institutes of Health, and the research also was supported by an award from the National Center for Advancing Translational Sciences; the authors of the study reported no relevant conflicts of interest. The authors led by Dr. Prabhu had no relevant financial disclosures.
Source: Prabhu M et al. Obstet Gyncol. 2018 Aug 4. doi: 10.1097/AOG.0000000000002789 and Osmundson SS et al. Obstet Gynecol. 2018 Aug 6. doi: 10.1097/AOG.0000000000002782.